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250-403 - Administration of Symantec(TM)(R) Management Platform 7.1 - Dump Information

Vendor : Symantec
Exam Code : 250-403
Exam Name : Administration of Symantec(TM)(R) Management Platform 7.1
Questions and Answers : 174 Q & A
Updated On : April 17, 2019
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250-403 Questions and Answers

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250-403 Administration of Symantec(TM)(R) Management Platform 7.1

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250-403 exam Dumps Source : Administration of Symantec(TM)(R) Management Platform 7.1

Test Code : 250-403
Test Name : Administration of Symantec(TM)(R) Management Platform 7.1
Vendor Name : Symantec
Q&A : 174 Real Questions

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Symantec Administration of Symantec(TM)(R) Management

EFI adds skilled government to Board of administrators | killexams.com Real Questions and Pass4sure dumps

November 08, 2018 sixteen:05 ET | source: EFI

Addition of Janice Chaffin Expands Board to Eight contributors

FREMONT, Calif., Nov. 08, 2018 (GLOBE NEWSWIRE) -- Electronics For Imaging, Inc. (Nasdaq: EFII), a global chief in consumer-focused digital printing innovation, nowadays announced the appointment of Janice Chaffin to its Board of administrators.

Ms. Chaffin is an experienced expertise trade govt, that specialize in strategic advertising and global operations. She has held several senior govt positions with Symantec agency, together with serving as community president of its customer business unit from 2007 to 2013. Ms. Chaffin additionally serves on the boards of directors of Nasdaq-traded businesses Synopsys, Inc. and PTC Inc. She is an Advisory Council member for Illuminate Ventures and a member of the Board of company for the UCLA Anderson faculty of management. prior to now she served on the boards of Informatica organization and international video game expertise, along with the working Committee of privately held Ancestry.com.  

Gill Cogan, Chairman of EFI’s Board of directors, commented, “with her established competencies in world marketing, approach, enterprise construction, R&D management and product construction, Janice is an excellent addition to the EFI board.”

“i am excited concerning the opportunities forward for EFI, and i look ahead to contributing to the enterprise’s growth and strategic direction,” mentioned Ms. Chaffin.

Commenting on the appointment, EFI CEO bill Muir pointed out, “Janice is a confirmed leader and innovator within the utility and hardware industries. We look ahead to profiting from her potential as we continue to develop our business.”

earlier than main Symantec's client business unit, Ms. Chaffin served as the business's govt vice president and chief advertising officer from 2006 to 2007, and as senior vice president and chief advertising officer from 2003 to 2006. earlier than becoming a member of Symantec, Ms. Chaffin worked for more than twenty years at Hewlett-Packard company in lots of management and advertising and marketing management positions. Ms. Chaffin graduated summa cum laude from the school of California, San Diego, with a Bachelor of Arts degree in Political Science, and earned a master of business Administration from the university of California, l. a., where she became an Edward W. Carter Fellow.

About EFIEFI™ is a world expertise company, primarily based in Silicon Valley, and is main the global transformation from analog to digital imaging. we are captivated with fueling customer success with products that enhance competitiveness and enhance productivity. To try this, we increase breakthrough technologies for the manufacturing of signage, packaging, textiles, ceramic tiles, and personalized files, with a wide range of printers, inks, digital entrance ends, and a complete enterprise and creation workflow suite that transforms and streamlines the complete production process. (www.efi.com)

Contact tips:

Investor RelationsJoAnn HorneMarket road Partnersir@efi.com415-445-3233

Fremont, California, united states

Electronics For Imaging, Inc.

formats obtainable:

CYA SmartRecovery Reduces EMC Documentum Storage costs through Integration With main enterprise Backup options | killexams.com Real Questions and Pass4sure dumps

TEMPE, AZ, Jan 14, 2014 (Marketwired by the use of COMTEX) -- enChoice(R), Inc. announced these days that its CYA Extender tool for CYA SmartRecovery(TM) now helps EMC(R) Documentum(R) consumers the usage of IBM(R) Tivoli(R) Storage manager (TSM). CYA Extender reduces storage expenses with the aid of enabling content backups carried out by CYA SmartRecovery to skip high priced disk storage and be streamed directly to TSM or Symantec NetBackup(TM).

CYA SmartRecovery performs sizzling, consistent backups of repository content material and metadata. it is the simplest answer enabling businesses to quickly recuperate from operational incidents equivalent to consumer error, programmatic mistakes, and metadata corruption via at once getting better simply the affected guidance to its normal state in the repository with out taking Documentum offline. CYA SmartRecovery also improves restoration point aims by working seamlessly with enterprise backup solutions to reduce the Documentum facts loss window to simply 15 minutes within the event of a full equipment failure.

"commercial enterprise content management systems are being used to deal with extraordinary volumes of information, and as a result, storage fees are unexpectedly rising," spoke of Mike Fernandes, vice president, items, enChoice. "through the use of CYA Extender together with CYA SmartRecovery, Documentum customers can greatly reduce the storage costs associated with CYA content material backups by means of leveraging low cost storage on their latest business backup methods."

CYA SmartRecovery and CYA Extender can be found for EMC Documentum and IBM FileNet(R) P8 commercial enterprise content material management (ECM) methods. For greater tips, consult with www.cya.com.

About enChoice

enChoice(R), Inc. deploys, supports, administers, keeps and protects business content material management (ECM) solutions. We carry options for Underwriting, bills Payable, Claims and Human resources that can also be deployed on premises, hosted, or by way of the cloud. enChoice also offers ECM-conscious scorching backup and operational recuperation solutions that work seamlessly with gadget-level backup programs to optimize efficiency, facilitate compliance and give protection to towards information loss. The enterprise offers far flung gadget administration, as well as single-factor-of-contact aid for present and legacy systems.

Contact: Lauren LaFronz +1.480.477.3838 llafronz@enchoice.com

source: enChoice, Inc.

(C) 2014 Marketwire L.P. All rights reserved.

MTN moves to give protection to SA company in opposition t cybercrime spike | killexams.com Real Questions and Pass4sure dumps

With the charge of global cyber crime anticipated to pass the $2 trillion mark via 2019, MTN company has moved to give protection to its business shoppers from the becoming risk of cyber-primarily based fraud and theft.

"MTN business has extended its portfolio of business ICT features to turn into an conclusion-to-conclusion ICT accomplice for enterprise. and since cybercrime and fraud pose a quick-turning out to be chance to the fiscal health and even survival of South African groups, we've stepped up our protection focus to enable us to present an entire suite of cyber safety options to the local enterprise market," says Mandisa Ntloko, Head of advertising and marketing at MTN enterprise.

MTN company has integrated essentially the most important IT protection technologies into its conclusion-to-end security features offering for small and mid-sized enterprise via to business valued clientele. At a competitive price factor and hosted on MTN company's advanced backbone, the security portfolio is designed to deliver a compelling cost proposition.

MTN business's safety portfolio comprises:

MTN electronic mail security suite helps give protection to in opposition t malicious e-mails spam, phishing attempts and provides a way of getting better e-mails within the experience of mail bills or a computer being compromised by malware. not obligatory content filtering, as much as 10 years' archiving and branding are additionally purchasable. cheaper than competing items and powered with the aid of the Symantec hazard analysis engine, MTN e-mail protection offers purchasers full manage over rule sets, quarantine and entire visibility into mail circulation.

Symantec Endpoint protection gives intrusion coverage, proactive danger insurance plan and anti-virus protection towards viruses, worms, Trojans, adware, bots and spy ware. This managed offering hosted with the aid of MTN in a highly comfortable information centre combines choicest-of-breed endpoint insurance policy technologies with MTN-developed protection options, round-the-clock monitoring and wide competencies.

MTN's superior next technology Firewall includes URL filtering, managed/unmanaged intrusion prevention and logging. using the main globally recognized solutions from Fortinet, the committed firewall can be hosted either in the consumer's premises or MTN information centre, and MTN company is totally chargeable for implementation, configuration, administration, maintenance and infrastructure help.

The virtual Firewall. This not pricey choice for low bandwidth network links or hosting environments presents the entire functionality of a committed firewall including firewall configuration, administration, monitoring and support to protect corporate information and systems in a 24/7/365 managed answer hosted in South Africa by way of MTN enterprise.

MTN company Vulnerability assessment is an advanced web-based vulnerability and safety scanning provider the usage of the Symantec handle Compliance Suite Vulnerability management answer (Symantec CCS VM), that scans net purposes, databases, networks, operating methods and other elements to accurately find threats, check their possibility to the ambiance, and devise remediation plans.

Mimecast is an software, computing and storage infrastructure solution designed and developed to deliver a comprehensive electronic mail safety service. Mimecast protection facets eliminate unsolicited mail and viruses from e-mails earlier than they attain the mail alternate. Mimecast additionally contains email continuity and archiving.

MTN's MobileIron enterprise Mobility management (EMM) solution provides end-to-end security on cell gadgets and offers IT Managers a peace of intellect that IT corporate policies are pushed beyond computing device, enabling constructive cell fleet and application administration and safety.

MTN's IBM MAAS360 is MTN's cloud EMM (commercial enterprise Mobility administration) provider, relevant for the excessive, mid-latitude and small client base. IBM(R) MaaS360(R) cell gadget management gives visibility, protection and handle of smartphones and tablets within the business. IBM(R) MaaS360(R) cell utility administration provides an business app catalogue with developed-in safety and operational lifecycle management capabilities, and IBM(R) MaaS360(R) cell expense administration helps businesses set company-extensive rate policies and proactively video display and music mobile statistics and application utilization.

valuable IT safety must include potent IT governance and the right partner or know-how choices. "this could aid to either mitigate an assault or enable for swift action when a breach happens. The features of entry into a company network have multiplied due to carry Your personal device (BYOD) enterprise choices, migration to cloud based techniques and relocating to wireless access as primary capacity of connectivity. whereas there is no silver bullet to conclusion these threats, there are risk mitigating steps enterprise should still be taking," concludes Ntloko.

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Prometic reports fourth quarter and 2018 year-end financial results | killexams.com real questions and Pass4sure dumps

  • Total revenues for 2018 of $47.4 million compared to $39.1 million in 2017
  • Significant increase in bioseparation 2018 revenues to $22.7 million, a 35% increase over 2017
  • Net loss of $ 237.9 million for the year ended December 31, 2018 includes a non-cash writedown of intangible assets related to IVIG of $ 150.0 million
  • Near-term financing shortfall requires urgent action to restructure the Corporation's indebtedness and raise capital
  • LAVAL, QC, April 1, 2019 /CNW Telbec/ - Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic or the Corporation) reported today its financial results for the fourth quarter and year-ended December 31, 2018.

    2018 Fourth Quarter and Year-End Financial Results

    RevenuesTotal revenues for the year ended December 31, 2018 were $47.4 million compared to $39.1 million during the comparative period of 2017, which represents an increase of $8.3 million. Total revenues for the quarter ended December 31, 2018 were $10.6 million compared to $6.6 million during the comparative period of 2017, representing an increase of $4.0 million.

    Revenues from the sale of goods were $45.6 million during the year ended December 31, 2018 compared to $16.5 million during the corresponding period of 2017, representing an increase of $29.1 million. The increased sales revenues for 2018 were mainly due to $22.8 million in sales of normal source plasma. The Corporation decided to sell this inventory as a result of the change in the production forecast due to the delay of the Biologics License Application ("BLA") approval for Ryplazim™ (plasminogen), ("RyplazimTM"). The remainder of the increase is mainly due to an increase in third party sales in the Bioseparations segment of $5.9 million.

    Revenues from the sale of goods were $10.3 million during the fourth quarter of 2018 compared to $5.5 million during the corresponding period of 2017, representing an increase of $4.8 million which was due to sales of $3.1 million of normal source plasma and an increase in third party bioseparations sales of $1.7 million.

    Cost of sales and other production expensesCost of sales and production were $38.0 million during the year ended December 31, 2018 compared to $10.1 million for the corresponding period in 2017, representing an increase of $27.9 million. Cost of sales and production for the quarter ended December 31, 2018 were $7.6 million compared to $2.4 million for the corresponding period in 2017, representing an increase of $5.2 million. The majority of the increase is due to the sales of normal source plasma in 2018 which overall was sold slightly below its carrying amount on a cumulative basis for the year but at a slight profit during the fourth quarter of 2018. The remainder of the increase in both periods is explained by the increase in products sold by the Bioseparations segment.

    Research and Development ("R&D")R&D expenses were $91.7 million during the year ended December 31, 2018 compared to $100.4 million for the corresponding period in 2017, representing a decrease of $8.7 million. R&D expenses were $21.1 million during the quarter ended December 31, 2018 compared to $28.2 million for the corresponding period in 2017, representing a decrease of $7.1 million.

    R&D expenses include the manufacturing cost of plasma-derived and small molecule therapeutics to be used in clinical trials and for the development of our production processes, with the majority of R&D expenses incurred in the plasma-derived therapeutics segment. The manufacturing cost of plasma-derived and small molecule therapeutics was $38.6 million during the year ended December 31, 2018 compared to $34.7 million during the year ended December 31, 2017, representing an increase of $3.9 million. The manufacturing cost of plasma-derived and small molecule therapeutics to be used in clinical trials and for the development of our production processes was $10.5 million during the three months ended December 31, 2018 compared to $10.9 million during the corresponding period of 2017, representing a decrease of $0.5 million.

    In 2018, there was a reduction in production activities at the Laval manufacturing plant while the facility focused on addressing the comments received by the U.S. Food and Drug Administration ("FDA") following their audit of this facility as part of the review of the BLA for RyplazimTM. This resulted in a reduction in overall manufacturing expenses for Plasma-derived therapeutics. However since there was no commercial production in 2018, none of these expenses were capitalized to inventories as compared to 2017.

    Other R&D expenses were $53.0 million during the year ended December 31, 2018 compared to $65.7 million for the corresponding period in 2017, representing a decrease of $12.6 million, and $10.7 million during the quarter ended December 31, 2018 compared to $17.3 million for the corresponding period in 2017, representing a decrease of $6.6 million. The decrease in the clinical trial and pre-clinical research expenses in both the small molecules and plasma-derived therapeutics segments were partially offset by additional spending in relation to the implementation and validation of additional analytical assays and "in-process" controls in the manufacturing of Ryplazim™.

    Administration, Sales & MarketingAdministration, selling and marketing expenses were $31.5 million during the year ended December 31, 2018 compared to $31.4 million for the corresponding period in 2017, representing an increase of $0.1 million. The increase is mainly due to the increase in severance compensation which was partially offset by a decline in marketing expense.

    Administration, selling and marketing expenses were $10.7 million during the quarter ended December 31, 2018 compared to $8.8 million for the corresponding period in 2017, representing an increase of $1.9 million. The increase is mainly due to the increase in severance compensation.

    Finance CostsFinance costs were $22.1 million for the year ended December 31, 2018 compared to $8.0 million during the corresponding period of 2017, representing an increase of $14.1 million. Finance costs were $6.6 million for the quarter ended December 31, 2018 compared to $2.6 million during the corresponding period of 2017, representing an increase of $3.9 million. This increase reflects the higher level of debt during the year ended December 31, 2018 compared to the same period of 2017. 

    Gain on extinguisment of LiabilitesOn November 14, 2018, the Corporation and Structured Alpha LP ("SALP"), an affiliate of Thomvest, modified the terms of the four loan agreements to extend, subject to compliance with covenants and debt servicing obligations, the maturity date of the non-revolving credit facility ("Credit Facility") from November 30, 2019 to September 30, 2024 and all three original issue discount notes from July 31, 2022 to September 30, 2024. The debt modification was accounted for as an extinguishment of the previous loans and the recording of new loans at their fair value determined as of the date of the modification, resulting in the recording of a gain on extinguishment of liabilities of $34.9 million

    Impairment losses on Intravenous Immunoglobulin ("IVIG") AssetsAs a result of various events affecting the Corporation during 2018, including; 1) the delay of the commercial launch of Ryplazim™ following the identification by the FDA of a number of changes required in the Chemistry, Manufacturing and Controls ("CMC") section of the BLA submission for congenital plasminogen deficiency, 2) the Corporation's limited financial resources since Q4 2018, which significantly delayed manufacturing expansion plans and resulted in the Corporation focusing its resources on refiling the RyplazimTM BLA as soon as possible; 3) the recognition of the larger than anticipated commercial opportunities for RyplazimTM, and 4) the change in executive leadership in Q4, the Corporation modified its strategic plans in Q4 to focus all available plasma-derived therapeutic segment resources on the manufacturing and development of RyplazimTM, for the treatment of congenital plasminogen deficiency and other indications. This, combined with the significant work determined to be required on the CMC section of an IVIG BLA, has caused the Corporation to suspend any new  activities on IVIG.

    These changes and their various impacts prompted management to perform an impairment test of the intangible assets related to IVIG. Cash inflows beginning beyond 2023 were not considered in the calculation of the value in use impairment test due to the inherent uncertainty in forecasting cash flows beyond a five year period. As a result, Impairment losses totalling $150.0 million were recorded on these assets for the year and fourth quarter ended December 31, 2018.

    Net LossThe Corporation incurred a net loss of $237.9 million during the year ended December 31, 2018 compared to a net loss of $120.0 million for the corresponding period of 2017, representing an increase in the net loss of $117.9 million. The net loss in 2018 is higher mainly due to the non-cash impairment losses of $150.0 million related to IVIG, and the increase in finance cost of $14.1 million in the year ended December 31, 2018 compared to the corresponding period of 2017. This was partially offset by the recognition of a gain on extinguishments of liabilities of $33.6 million during the year ended December 31, 2018 compared to a loss on extinguishment of liabilities of $4.2 million for the corresponding period in 2017. Offsetting the increase in loss was the fact that no bad debt expense was recorded in 2018 while a $20.5 million expense was recorded in the previous year.

    The Corporation incurred a net loss of $141.3 million during the quarter ended December 31, 2018 compared to a net loss of $41.6 million for the corresponding period of 2017, representing an increase in net loss of $99.7 million. The increase was mainly affected by the impairment losses of $150.0 million related to IVIG recorded during the quarter ended December 31, 2018. This was partially offset by the recognition of a gain on extinguishment of liabilities of $33.6 million during the year ended December 31, 2018 compared to a loss on extinguishment of liabilities of $4.2 million for the corresponding period in 2017. Offsetting the increase in loss was the fact that no bad debt expense was recorded in 2018 while a $20.5 million expense was recorded during the fourth quarter of 2017.

    Commenting on the fourth quarter and 2018 year-end financial results, Bruce Pritchard, Prometic's Chief Operating Officer and Chief Financial Officer, said, "We have delivered on the financial guidance provided for 2018 with significantly reduced expenses and cash flows used in operating activities and increasing product sales. This allowed us to extend our cash runway into early 2019. We extended the repayment terms of our debt to 2024, subject to compliance with our covenants and debt service obligations, and implemented an at-the-market ("ATM") equity distribution program to help provide short term operating funds. We also retained the services of a global financial advisory and asset management firm to help us raise non-dilutive capital from partnerships and monetization of non-core assets. However, cash remains limited  and we continue to rely on the support of SALP while working on these other initiatives."

    "Addressing our material liquidity and balance sheet challenges remains our highest priority. We anticipate that it will most likely require a combination of material corporate, financial and business development transactions to successfully stabilize the financial and liquidity position. This could include a restructuring of the SALP debt and / or recapitalization transaction, and a significant additional equity financing to finance the Corporation to value-creation catalysts such as partnerships and monetization of non-core assets " added Mr. Pritchard.

    Small Molecule Therapeutics Segment

    Key Events for 2018:

  • PBI-4050 – Published papers on the novel anti-fibrotic mechanism of action of its small molecule lead drug candidate, PBI-4050, in the American Journal of Pathology, in the Journal of Clinical Investigation and in the Journal of Pharmacology and Experimental Therapeutics 
  • PBI-4050 – Disclosed new clinical data from the ongoing Alström Syndrome ("AS") phase 2 open label clinical trial being conducted in the U.K. demonstrating that the clinical activity and tolerability of PBI-4050 were sustained with prolonged treatment with further clinical activity in the heart and liver observed with longer treatment exposure
  • PBI-4050 – Received a Rare Pediatric Disease designation from the FDA for the treatment of AS
  • 2019 Updates:

    Following the completion of the review and prioritization of all programs and assets, the main priorities for the small molecule therapeutics segment are:

  • PBI-4050 – The filing and approval of an Investigational New Drug application to enable the commencement of the pivotal phase 3 clinical study of PBI-4050 in AS during H2 2019.
  • PBI-4050 - Prometic is planning a randomized, placebo-controlled phase 2 clinical study of PBI-4050 in patients with Nonalcoholic steatohepatitis ("NASH") to be initiated before the end of 2019 following successful financing
  • PBI-4050 – Prometic is planning a randomized, placebo-controlled, phase 2b clinical study of PBI-4050 in patients with idiopathic pulmonary fibrosis ("IPF") before the end of 2019 following successful financing.
  • PBI-4547 – Prometic is planning a phase 1 clinical study for its next small molecule compound, PBI-4547. This study is also expected to commence before the end of 2019 following successful financing.
  • Plasma-Derived Therapeutics Segment

    Key Events for 2018:

  • RyplazimTM – Received a Complete Response Letter ("CRL") from the FDA arising from its review of the RyplazimTM BLA. The FDA identified the need for Prometic to make a number of changes in the Chemistry, Manufacturing and Controls ("CMC") portion of its BLA filing requiring the implementation and validation of additional analytical assays and "in-process controls" in the manufacturing process of Ryplazim™.
  • RyplazimTM – Completed a Type C meeting with the FDA to discuss the Company's proposed action plan for the implementation of additional analytical assays and in-process controls related to the RyplazimTM manufacturing process.
  • IVIG – Presented new clinical data from the Corporation's pivotal phase 3 clinical study at the Clinical Immunology Society annual meeting in Toronto. The clinical data presented demonstrated comparable safety and efficacy data to existing commercial IVIG products without any significant drug related safety issues. Both clinical primary and secondary endpoints in adult patients suffering from primary immunodeficiencies were met and achieved.
  • 2019 Updates:

    Following the completion of the review and prioritization of all programs and assets, the main priorities for the plasma-derived therapeutics segment are

  • RyplazimTM – The corporation expects to refile the BLA for Ryplazim during H2- 2019. After acceptance of the BLA, FDA would establish a new PDUFA date which the Corporation still believes would be eligible for a priority review.
  • RyplazimTM – The Corporation has determined that the best course of action would be to seek third party partners to assist in the commercialization of Ryplazim for all global markets, and discussions are currently ongoing to establish such arrangements.
  • IVIG – Prometic has now completed the required clinical package for IVIG required for a future BLA submission to the FDA. The completion of a robust CMC package for IVIG prior to filing a BLA still requires substantial work, time and investment. The Corporation needs to prioritize manufacturing capacity planning to meet the volume demands for RyplazimTM. IVIG and selected further proteins remain in our pipeline. However, the advanced stage of development and economics of RyplazimTM support a compelling case to focus all the available resources of the plasma-derived therapeutics segment on this therapeutic family to optimize its launch and growth. This, combined with the significant work determined to be required on the CMC section of an IVIG BLA, caused the Corporation to suspend any new activities on IVIG. This will result in a material delay to the commercialization of IVIG as compared to previous timelines and as such, $150.0 million of impairments on the assets pertaining to IVIG activiteswas recorded.
  • Bioseparations Segment

    Key Events for 2018:

  • External sales for 2018 exceeded $22.7 million, which represents a 35% increase over 2017. The Corporation anticipates moderate revenue growth for 2019 due to a number of factors including, the expansion of manufacturing activities by existing clients who utilize Prometic's products in their production processes, the adoption of products by new clients, and the introduction of new products in the bioseparation market.
  • 2019 Update:

  • The ongoing manufacturing expansion of the Isle of Man facility will enable the company to manufacture over 35,000 litres of chromatography adsorbents annually, with a potential sales value exceeding $133 million per annum. This additional manufacturing capacity will be used to meet the growing demand for the segment's products, and to provide the resins required for Prometic's own PPPSTM plasma protein manufacturing operations.
  • Corporate and Operational Update

    Key Events for 2018:

  • Subject to compliance with applicable covenants and servicing obligations, extended the maturity dates of its US$80 million (approx. $100 million) Credit Facility and original issue discount notes to September 2024 with SALP.
  • Provided a corporate update related to a series of initiatives aiming at lengthening the cash runway to better position the Corporation to achieve its objectives. These included a significant reduction in the Corporation's cash used in operations for 2019, driven in part by growth in its bioseparation revenues and by a reduction of anticipated R&D expenditures by up to $30 million.
  • Announced the closing of an ATM equity distribution agreement with Canaccord Genuity Corp. The ATM allows the Corporation, at its sole discretion and subject to conditions set forth in the equity distribution agreement, to issue small tranches of common shares from treasury, at prevailing prices and in appropriate market conditions.
  • Named Prof. Simon Best as Interim Chief Executive Officer. Prof. Best has served as the Chairman of the Prometic Board of Directors since May 2014 and has over 30 years of global life sciences expertise with a focus on business development, strategic planning and product commercialization. Prof. Best succeeded Mr. Pierre Laurin who stepped down from his management and board responsibilities in December 2018.
  • Subsequent Events to Fourth Quarter and 2018 Year-End

  • Management and the Board of Directors are engaged in a comprehensive strategy to improve the financial and business conditions of the Corporation and, in January 2019, commenced a process to explore and evaluate potential strategic alternatives focused on maximizing shareholder value, including potential acquisitions, joint ventures, strategic alliances, or other merger and acquisition or capital markets transactions as well as any other transaction or alternative available to the Corporation. Concurrently, management and the Board of Directors have been actively exploring opportunities to bring forward cash flows to repay debt and fund working capital requirements.
  • In conjunction with the strategic review and liquidity issues faced by the Corporation, in February 2019, the Board of Directors formed a special committee of independent directors to oversee the strategic review process (the "Special Committee"). The Special Committee meets regulary and oversees the work of management and the Corporation's financial and legal advisors in respect of such mandate.
  • In February 2019, the Corporation engaged Lazard, a global financial advisory and asset management firm, to review and execute key strategic transactions focused on maximizing shareholder value. These transactions could include, among other things, the out-licensing of drug candidates and monetization of non-core assets.The Corporation has not set a timetable for this process, and there can be no assurance that a transaction will be entered into or consummated, or, if a transaction is undertaken, as to its terms, structure or timing. The Corporation does not expect to make further public comment regarding these matters unless and until the Board has approved a specific transaction or has concluded its review of strategic alternatives.
  • In February and March 2019, the Corporation secured two additional tranches for a total of US$15.0 million from SALP under the existing Credit Facility. Concurrently, 19,401,832 warrants exercisable for Series A Preferred Shares of the Corporation with a term of eight years and an exercise price of $0.156 per warrant were issued on February 22, 2019. The Corporation drew US$10.0 million ($13.2 million) and US$5.0 million ($6.7 million) on February 22 and March 22 2019, respectively.
  • During the first quarter of 2019, the Corporation issued 12,870,600 common shares under the ATM for total cash proceeds of $4.1 million.
  • On March 31, 2019, Ms. Kory Sorenson resigned from Prometic's Board of Directors.
  • Conference Call Information

    Prometic will host a conference call at 11:00 am (ET) on Tuesday April 2, 2019. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (toll-free). A replay of the call will be available as of Tuesday April 2, 2019 at 2:00 pm. The numbers to access the replay are 1-416-849-0833 and 1-855-859-2056 (passcode: 3198209). A live audio webcast of the conference call, with slides, will be available through the following : https://event.on24.com/wcc/r/1969851/0D5A0C85F48EBF7260AFC1BE9877F748

    Additional Information in Respect to the Fourth Quarter and Year Ended December 31, 2018

    Prometic's MD&A and 2018 consolidated financial statements for the quarter and year ended December 31, 2018 will be filed on SEDAR (https://www.sedar.com) and will be available on the Company's website at www.prometic.com.

    Prometic has decided to use the "notice-and-access" mechanism for delivery of its materials to its shareholders. Under the Notice-and-Access model, instead of receiving printed copies of Prometic's Audited Consolidated Financial Statements for the year ended December 31, 2018 and Management's Discussion and Analysis for the year-ended December 31, 2018 (collectively, the "Annual Report"), shareholders are invited to consult the Annual Report on Prometic's website at www.prometic.com under investors & media/investor briefcase, or on SEDAR's website. A copy of the Annual Report will also be available upon request, by telephone at 1-888-959-4007 or online at www.prometic.com/contactus.

    About Prometic Life Sciences Inc.

    Prometic (www.prometic.com) is a biopharmaceutical corporation with two drug discovery platforms focusing on unmet medical needs. The first platform (small molecule therapeutics) stems from the discovery of two receptors which we believe are at the core of how the body heals: namely, promoting tissue regeneration and scar resolution as opposed to fibrosis. One of the lead drug candidates emerging from this platform, PBI-4050, is expected to enter pivotal phase 3 clinical trials for the treatment of Alström syndrome. The second drug discovery and development platform (plasma-derived therapeutics) leverages Prometic's experience in bioseparation technologies used to isolate and purify biopharmaceuticals from human plasma. The Corporation's primary goal with respect to this second platform is to address unmet medical needs with therapeutic proteins not currently commercially available, such as Ryplazim™.The Corporation also provides access to its proprietary bioseparation technologies to enable pharmaceutical companies in their production of non-competing biopharmaceuticals. Recognized as a bioseparations expert, the Corporation derives revenue from this activity through sales of affinity chromatography media which contributes to offset the costs of its own R&D investments.

    We are headquartered in Laval, Quebec (Canada) with R&D facilities in Canada, the United Kingdom  and the United States, manufacturing facilities in Canada and the Isle of Man and corporate and business development activities in Canada, the United States, Europe and Asia.

    Forward Looking Statements

    This press release contains forward-looking statements about Prometic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, Prometic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Prometic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in Prometic's Annual Information Form for the year ended December 31, 2018, under the heading "Risk and Uncertainties related to Prometic's business". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.


    Cision View original content:https://www.prnewswire.com/news-releases/prometic-reports-fourth-quarter-and-2018-year-end-financial-results-300822305.html

    SOURCE ProMetic Life Sciences Inc.

    10-Q: ANAVEX LIFE SCIENCES CORP. | killexams.com real questions and Pass4sure dumps

    (EDGAR Online via COMTEX) -- Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.

    Forward-Looking Statements

    This Quarterly Report on Form 10-Q includes forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our anticipated future clinical and regulatory milestone events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "expect" "should," "forecast," "could," "suggest," "plan" and similar expressions, as they relate to us, are intended to identify forward-looking statements. Such forward-looking statements include, without limitation, statements regarding:

    ? our ability to generate any revenue or to continue as a going concern;

    ? our ability to successfully conduct clinical and preclinical trials for our product candidates;

    ? our ability to raise additional capital on favorable terms;

    ? our ability to execute our development plan on time and on budget;

    ? our products ability to demonstrate efficacy or an acceptable safety profile;

    ? our ability to obtain the support of qualified scientific collaborators;

    ? our ability, whether alone or with commercial partners, to successfully commercialize any of our product candidates that may be approved for sale;

    ? our ability to identify and obtain additional product candidates;

    ? intellectual property rights and protections;

    ? competition;

    ? the anticipated start dates, durations and completion dates of our ongoing and future clinical studies;

    ? the anticipated designs of our future clinical studies;

    ? our anticipated future regulatory submissions and our ability to receive regulatory approvals to develop and market our product candidates; and

    ? our anticipated future cash position.

    We have based these forward-looking statements largely on our current expectations and projections about future events, including the responses we expect from the U.S. Food and Drug Administration, ("FDA"), and other regulatory authorities and financial trends that we believe may affect our financial condition, results of operations, business strategy, preclinical and clinical trials, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions including without limitation the risks described in "Risk Factors" in Part II, Item 1A of this Quarterly Report on Form 10-Q. These risks are not exhaustive. Other sections of this Quarterly Report on Form 10-Q include additional factors which could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable laws including the securities laws of the United States, we assume no obligation to update or supplement forward-looking statements.

    As used in this Quarterly Report on Form 10-Q, the terms "we," "us," "our," and "Anavex" mean Anavex Life Sciences Corp., unless the context clearly requires otherwise.

    Our Current Business

    Anavex Life Sciences Corp. is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including drug candidates to treat Alzheimer's disease, other central nervous system ("CNS") diseases, pain and various types of cancer. Our lead compound, ANAVEX(R)2-73, is being developed to treat Alzheimer's disease, Parkinson's disease and potentially other central nervous system diseases, including rare diseases, such as Rett syndrome, a severe neurological disorder caused by mutations in the X-linked gene, methyl-CpG-binding protein 2 ("MECP2").

    In November 2016, we completed a Phase 2a clinical trial, consisting of PART A and PART B, which lasted a total of 57 weeks, for ANAVEX(R)2-73 in mild-to-moderate Alzheimer's patients. This open-label randomized trial met both primary and secondary endpoints and was designed to assess the safety and exploratory efficacy of ANAVEX(R)2-73 in 32 patients. ANAVEX(R)2-73 targets sigma-1 and muscarinic receptors, which have been shown in preclinical studies to reduce stress levels in the brain believed to restore cellular homeostasis and to reverse the pathological hallmarks observed in Alzheimer's disease. In October 2017, we presented positive pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 2a study, which established a concentration-effect relationship between ANAVEX(R)2-73 and study measurements. These measures obtained from all patients who participated in the entire 57 weeks include exploratory cognitive and functional scores as well as biomarker signals of brain activity. Additionally, the study appears to show that ANAVEX(R)2-73 activity is enhanced by its active metabolite (ANAVEX19-144), which also targets the sigma-1 receptor and has a half-life approximately twice as long as the parent molecule.

    In March 2016, we received approval from the Ethics Committee in Australia to extend the Phase 2a clinical trial, which had been requested by patients and their caregivers. The trial extension allows participants who completed the 52-week PART B of the study to roll-over into a new trial and continue taking ANAVEX(R)2-73 for an additional 104 weeks, providing an opportunity to gather extended safety data. The trial is independent of our planned larger Phase 2/3 double-blind, placebo-controlled study of ANAVEX(R)2-73 in Alzheimer's disease.

    In February 2016, we presented positive preclinical data for ANAVEX(R)2-73 in Rett syndrome, a rare neurodevelopmental disease. The study was funded by the International Rett Syndrome Foundation (the "Rettsyndrome.org foundation"). In January 2017, we were awarded a financial grant from the Rettsyndrome.org foundation of a minimum of $0.6 million to cover some of the costs of a planned U.S. multicenter Phase 2 clinical trial of ANAVEX(R)2-73 for the treatment of Rett syndrome. The Phase 2 trial is scheduled to begin following the FDA's approval of our investigational new drug (IND) application and will be a randomized, double blind, placebo-controlled study of ANAVEX(R)2-73 in patients with Rett syndrome lasting up to 12 weeks. Primary and secondary endpoints include safety as well as Rett syndrome conditions such as cognitive impairment, motor impairment, behavioral symptoms and seizure activity.

    In September 2016, we presented positive preclinical data for ANAVEX(R)2-73 in Parkinson's disease, which demonstrated significant improvements on all measures: behavioral, histopathological, and neuroinflammatory endpoints. The study was funded by the Michael J Fox Foundation. Additional data was announced in October 2017 from the model for experimental parkinsonism. The data presented indicates that ANAVEX(R)2-73 induces robust neurorestoration in experimental parkinsonism. The encouraging results we have gathered in this model, coupled with the favorable profile of this compound in the Alzheimer's disease trial, support the notion that ANAVEX(R)2-73 is a promising clinical candidate drug for Parkinson's disease. The Company is moving forward with a Phase 2 trial with ANAVEX(R)2-73 in Parkinson's Disease Dementia ("PDD"), which will study the effect of the compound on both the cognitive and motor impairment of Parkinson's disease. The double-blind, randomized, placebo-controlled Phase 2 PDD study has been submitted to regulatory authorities in Europe, and pending approval, the Company plans to initiate this clinical trial in the second half of calendar 2018.

    We continue to identify and initiate discussions with potential strategic and commercial partners to most effectively advance our programs and realize maximum shareholder value. Further, we may acquire or develop new intellectual property and assign, license, or otherwise transfer our intellectual property to further our goals.

    Our Pipeline

    Our research and development pipeline includes one clinical drug candidate and several compounds in different stages of pre-clinical study.

    Our proprietary SIGMACEPTOR(TM) Discovery Platform produced small molecule drug candidates with unique modes of action, based on our understanding of sigma receptors. Sigma receptors may be targets for therapeutics to combat many human diseases, both of neurodegenerative nature, including Alzheimer's disease, as well as of neurodevelopmental nature, like Rett syndrome. When bound by the appropriate ligands, sigma receptors influence the functioning of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease.

    Compounds that have been subjects of our research include the following:


    ANAVEX(R)2-73 may offer a disease-modifying approach in Alzheimer's disease (AD) by using ligands that activate sigma-1 receptors.

    In AD animal models, ANAVEX(R)2-73 has shown pharmacological, histological and behavioral evidence as a potential neuroprotective, anti-amnesic, anti-convulsive and anti-depressive therapeutic agent, due to its potent affinity to sigma-1 receptors and moderate affinities to M1-4 type muscarinic receptors. In addition, ANAVEX(R)2-73 has shown a potential dual mechanism which may impact both amyloid and tau pathology. In a transgenic AD animal model Tg2576 ANAVEX(R)2-73 induced a statistically significant neuroprotective effect against the development of oxidative stress in the mouse brain, as well as significantly increased the expression of functional and synaptic plasticity markers that is apparently amyloid-beta independent. It also statistically alleviated the learning and memory deficits developed over time in the animals, regardless of sex, both in terms of spatial working memory and long-term spatial reference memory.

    Based on the results of pre-clinical testing, we initiated and completed a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX(R)2-73 in 2011. In this Phase 1 SAD trial, the maximum tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown to have positive effects in mouse models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters. ANAVEX(R)2-73 was well tolerated below the 55-60 mg dose with only mild adverse events in some subjects. Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target CNS conditions, including AD.

    The ANAVEX(R)2-73 Phase 1 SAD trial was conducted as a randomized, placebo-controlled study. Healthy male volunteers between the ages of 18 and 55 received single, ascending oral doses over the course of the trial. Study endpoints included safety and tolerability together with pharmacokinetic parameters. Pharmacokinetics includes the absorption and distribution of a drug, the rate at which a drug enters the blood and the duration of its effect, as well as chemical changes of the substance in the body. This study was conducted in Germany in collaboration with ABX-CRO, a clinical research organization that has conducted several Alzheimer's disease studies, and the Technical University of Dresden.

    In December 2014, a Phase 2a clinical trial was initiated for ANAVEX(R)2-73, which is being evaluated for the treatment of Alzheimer's disease. The open-label randomized trial was designed to assess the safety and exploratory efficacy of ANAVEX(R)2-73 in 32 patients with mild-to-moderate Alzheimer's disease. ANAVEX(R) 2-73 targets sigma-1 and muscarinic receptors, which have been shown in preclinical studies to reduce stress levels in the brain believed to restore cellular homeostasis and to reverse the pathological hallmarks observed in Alzheimer's disease.

    The Phase 2a study met both primary and secondary objectives of the study. The 31-week preliminary exploratory safety and efficacy data from the Phase 2a study of ANAVEX(R)2-73 in Alzheimer's patients, with most receiving also donepezil, the current standard of care, demonstrated favorable safety, maximum tolerated dose, positive dose response, sustained efficacy response through 31 weeks for both cognitive and functional measures, as well as positive unexpected therapeutic response events. ANAVEX(R)2-73 continued to demonstrate a favorable adverse event (AE) profile through 31 weeks in a patient population of elderly Alzheimer's patients with varying degrees of physical fragility. The most common side effects across all AE categories tended to be of mild severity grade 1 and were resolved with dose reductions that were anticipated within the adaptive design of the study protocol.

    Through 57 weeks, Alzheimer's patients taking a daily oral dose between 10mg and 50mg of ANAVEX(R)2-73 was well tolerated. There were no clinically significant treatment-related adverse events and no serious adverse events. Despite non-optimized dosing of ANAVEX(R)2-73 throughout the 57-week study, continued significant improvements from baseline of cognitive, functional and behavioral scores in a group of patients were observed, respectively. This data was analyzed using refined mathematical modeling methods in conjunction with the detailed pharmacokinetic (PK) information.

    In October 2017, we presented positive PK and pharmacodynamic (PD) data from the Phase 2a study, which established a concentration-effect relationship between ANAVEX(R)2-73 and study measurements. These measures, obtained from all patients who participated in the entire 57 weeks, include exploratory cognitive and functional scores as well as biomarker signals of brain activity. Additionally, the study appears to show that ANAVEX(R)2-73 activity is enhanced by its active metabolite (ANAVEX19-144), which also targets the sigma-1 receptor and has a half-life approximately twice as long as the parent molecule.

    Pre-specified exploratory analyses included the cognitive (MMSE) and the functional (ADCS-ADL) changes from baseline. A continued stabilization of both cognitive (MMSE) and functional (ADCS-ADL) measures in patients treated with ANAVEX(R)2-73 was observed. This correlation was positive with all measured scores (MMSE, ADCS-ADL, Cogstate, HAM-D and EEG/ERP).

    ANAVEX(R)2-73 data presented meets prerequisite information in order to progress into a Phase 2/3 placebo-controlled study, which is currently in the preparation phase.

    Preclinical data also validates ANAVEX(R)2-73 as a prospective platform drug for other neurodegenerative diseases beyond Alzheimer's as well as neurodevelopmental diseases, more specifically, Parkinson's disease, epilepsy, Rett syndrome, Angelman syndrome and Fragile X syndrome and, more recently, tuberous sclerosis complex. ANAVEX(R)2-73 demonstrated significant improvements in all of these indications in the respective preclinical animal models.

    For Parkinson's disease, data demonstrates significant improvements and restoration of function in a classic animal model of Parkinson's disease. Significant improvements were seen on all measures tested: behavioral, histopathological, and neuroinflammatory endpoints. We are currently in preparation for a Phase 2 clinical trial for the treatment of Parkinson's disease.

    For epilepsy, data demonstrates both significant and dose related improvement in the reduction of seizures, as well as significant synergy with each of three generations of epilepsy drugs currently on the market.

    In Rett syndrome, administration of ANAVEX(R)2-73 resulted in both significant and dose related improvements in an array of behavioral paradigms in the MECP2 HET Rett syndrome disease model. In addition, in a further experiment sponsored by the Rettsyndrome.org foundation, ANAVEX(R)2-73 was evaluated in automatic visual response and respiration tests in 7-month old mice, an age at which advanced pathology is evident. Vehicle-treated MECP2 mice demonstrated fewer automatic visual responses than wild-type mice. Treatment with ANAVEX(R)2-73 for four weeks significantly increased the automatic visual response in the MECP2 Rett syndrome disease mouse.

    We have filed an investigational new drug application, or IND, for ANAVEX(R)2-73 for the treatment of Rett syndrome and are currently in preparation for a Phase 2 clinical trial. The IND might not be approved by the FDA, or it may be delayed or put on clinical hold or partial hold, or additional preclinical studies may be required.

    In May 2017, we announced new preclinical data for ANAVEX(R)2-73 in the neurodevelopmental disorders Angelman syndrome and Fragile X syndrome. In a study sponsored by the Foundation for Angelman Syndrome, ANAVEX(R)2-73 was assessed in a mouse model for the development of audiogenic seizures. The results indicated that ANAVEX(R)2-73 administration significantly reduced audiogenic-induced seizures. In a recent study sponsored by FRAXA Research Foundation regarding Fragile X syndrome, data demonstrated that ANAVEX(R)2-73 restored hippocampal brain-derived neurotrophic factor (BDNF) expression to normal levels. BDNF under-expression has been observed in many neurodevelopmental and neurodegenerative pathologies. BDNF signaling promotes maturation of both excitatory and inhibitory synapses. ANAVEX(R)2-73 normalization of BDNF expression could be a contributing factor for the positive data observed in both neurodevelopmental and neurodegenerative disorders like Angelman and Fragile X syndromes.

    Preclinical data presented also indicates that ANAVEX(R)2-73 demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases. In May 2016 and June 2016, the FDA granted Orphan Drug Designation to ANAVEX(R)2-73 for the treatment of Rett syndrome and infantile spasms, respectively.

    Additionally, in October 2017 we presented additional data from a preclinical study on ANAVEX(R)2-73 related to multiple sclerosis. Data presented indicates that ANAVEX(R)2-73 may promote remyelination in multiple sclerosis disease. Further, data also demonstrates that ANAVEX(R)2-73 provides protection for oligodendrocytes ("OL's") and oligodendrocyte precursor cells ("OPC's"), as well as central nervous system neurons in addition to helping repair by increasing OPC proliferation and maturation in tissue culture.

    In March 2018, we presented preclinical data of ANAVEX(R)2-73 in a genetic mouse model of tuberous sclerosis complex ("TSC"). TSC is a rare genetic disorder characterized by the growth of numerous benign tumors in many parts of the body with a high incidence of seizures. The new preclinical data demonstrates that treatment with ANAVEX(R)2-73 significantly increases survival and reduces seizures.


    ANAVEX(R)3-71 is a preclinical drug candidate with a novel mechanism of action via sigma-1 receptor activation and M1 muscarinic allosteric modulation, which has been shown to enhance neuroprotection and cognition in Alzheimer's disease. ANAVEX(R)3-71 is a CNS-penetrable mono-therapy that bridges treatment of both cognitive impairments with disease modifications. It is highly effective in very small doses against the major Alzheimer's hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on inflammation and mitochondrial dysfunctions. ANAVEX(R)3-71 indicates extensive therapeutic advantages in Alzheimer's and other protein-aggregation-related diseases given its ability to enhance neuroprotection and cognition via sigma-1 receptor activation and M1 muscarinic allosteric modulation.

    A recent preclinical study examined the response of ANAVEX(R)3-71 in aged transgenic animal models and showed a significant reduction in the rate of cognitive deficit, amyloid beta pathology and inflammation with the administration of ANAVEX 3-71. In April 2016, the FDA granted Orphan Drug Designation to ANAVEX(R)3-71 for the treatment of Frontotemporal dementia.

    In April 2017, new preclinical data was presented for ANAVEX(R)3-71 indicating that during pathological conditions, ANAVEX(R)3-71 demonstrated the formation of new synapses between neurons (synaptogenesis) without causing an abnormal increase in the number of astrocytes. In neurodegenerative diseases such as Alzheimer's and Parkinson's disease, synaptogenesis is believed to be impaired. Additional preclinical data presented also indicates that in addition to reducing oxidative stress, ANAVEX(R)3-71 demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.


    ANAVEX 1-41 is a sigma-1 agonist. Pre-clinical tests revealed significant neuroprotective benefits (i.e., protects nerve cells from degeneration or death) through the modulation of endoplasmic reticulum, mitochondrial and oxidative stress, which damages and impairs cell viability. In addition, in animal models, ANAVEX(R)1-41 prevented the expression of caspase-3, an enzyme that plays a key role in apoptosis (programmed cell death) and loss of cells in the hippocampus, the part of the brain that regulates learning, emotion and memory. These activities involve both muscarinic and sigma-1 receptor systems through a novel mechanism of action.

    Recent preclinical data presented also indicates that ANAVEX(R)1-41 demonstrates protective effects of mitochondrial enzyme complexes during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.


    ANAVEX(R)1037 is designed for the treatment of prostate cancer. It is a low molecular weight, synthetic compound exhibiting high affinity for sigma-1 receptors at nanomolar levels and moderate affinity for sigma-2 receptors and sodium channels at micromolar levels. In advanced pre-clinical studies, this compound revealed antitumor potential. It has also been shown to selectively kill human cancer cells without affecting normal/healthy cells and also to significantly suppress tumor growth in immune-deficient mice models. Scientific publications highlight the possibility that these ligands may stop tumor growth and induce selective cell death in various tumor cell lines. Sigma receptors are highly expressed in different tumor cell types. Binding by appropriate sigma-1 and/or sigma-2 ligands can induce selective apoptosis. In addition, through tumor cell membrane reorganization and interactions with ion channels, our drug candidates may play an important role in inhibiting the processes of metastasis (spreading of cancer cells from the original site to other parts of the body), angiogenesis (the formation of new blood vessels) and tumor cell proliferation.


    ANAVEX(R)1066, a mixed sigma-1/sigma-2 ligand is designed for the potential treatment of neuropathic and visceral pain. ANAVEX(R)1066 was tested in two preclinical models of neuropathic and visceral pain that have been extensively validated in rats. In the chronic constriction injury model of neuropathic pain, a single oral administration of ANAVEX(R)1066 dose-dependently restored the nociceptive threshold in the affected paw to normal levels while leaving the contralateral healthy paw unchanged. Efficacy was rapid and remained significant for two hours. In a model of visceral pain, chronic colonic hypersensitivity was induced by injection of an inflammatory agent directly into the colon and a single oral administration of ANAVEX(R)1066 returned the nociceptive threshold to control levels in a dose-dependent manner. Companion studies in rats demonstrated the lack of any effects on normal gastrointestinal transit with ANAVEX(R)1066 and a favorable safety profile in a battery of behavioral measures.

    Our compounds are in the pre-clinical and clinical testing stages of development, and there is no guarantee that the activity demonstrated in pre-clinical models will be shown in human testing.

    Our Target Indications

    We have developed compounds with potential application to two broad categories and several specific indications. including:

    Central Nervous System Diseases

    ? Alzheimer's disease - In 2016, an estimated 5.4 million Americans were suffering from Alzheimer's disease. The Alzheimer's Association(R) reports that by 2025, 7.1 million Americans will be afflicted by the disease, a 30 percent increase from currently affected patients. Medications on the market today treat only the symptoms of Alzheimer's disease and do not have the ability to stop its onset or its progression. There is an urgent and unmet need for both a disease modifying cure for Alzheimer's disease as well as for better symptomatic treatments.

    ? Parkinson's disease - Parkinson's disease is a progressive disease of the nervous system marked by tremors, muscular rigidity, and slow, imprecise movement. It is associated with degeneration of the basal ganglia of the brain and a deficiency of the neurotransmitter dopamine. Parkinson's disease afflicts more than 10 million people worldwide, typically middle-aged and elderly people. The Parkinson's disease market is set to expand from $2.1 billion in 2014 to $3.2 billion by 2021, according to business intelligence provider GBI Research.

    ? Rett syndrome - Rett syndrome is a rare X-linked genetic neurological and developmental disorder that affects the way the brain develops, including protein transcription, which is altered and as a result leads to severe disruptions in neuronal homeostasis. It is considered a rare, progressive neurodevelopmental disorder and is caused by a single mutation in the MECP2 gene. Because males have a different chromosome combination from females, boys who have the genetic MECP2 mutation are affected in devastating ways. Most of them die before birth or in early infancy. For females who survive infancy, Rett syndrome leads to severe impairments, affecting nearly every aspect of the child's life; severe mental retardation, their ability to speak, walk and eat, sleeping problems, seizures and even the ability to breathe easily. Rett syndrome affects approximately 1 in every 10,000-15,000 females.

    ? Depression - Depression is a major cause of morbidity worldwide according to the World Health Organization. Pharmaceutical treatment for depression is dominated by blockbuster brands, with the leading nine brands accounting for approximately 75% of total sales. However, the dominance of the leading brands is waning, largely due to the effects of patent expiration and generic competition.

    ? Epilepsy - Epilepsy is a common chronic neurological disorder characterized by recurrent unprovoked seizures. These seizures are transient signs and/or symptoms of abnormal, excessive or synchronous neuronal activity in the brain. According to the Centers for Disease Control and Prevention, epilepsy affects 2.2 million Americans. Today, epilepsy is often controlled, but not cured, with medication that is categorized as older traditional anti-epileptic drugs and second generation anti-epileptic drugs. Because epilepsy afflicts sufferers in different ways, there is a need for drugs used in combination with both traditional anti-epileptic drugs and second generation anti-epileptic drugs. GBI Research estimates that the epilepsy market will increase to $4.5 billion by 2019.

    ? Neuropathic Pain - We define neuralgia, or neuropathic pain, as pain that is not related to activation of pain receptor cells in any part of the body. Neuralgia is more difficult to treat than some other types of pain because it does not respond well to normal pain medications. Special medications have become more specific to neuralgia and typically fall under the category of membrane stabilizing drugs or antidepressants.


    . . .

    May 10, 2018

    (c) 1995-2018 Cybernet Data Systems, Inc. All Rights Reserved

    Emerging Categories of Disease in Advanced Prostate Cancer and Their Therapeutic Implications | killexams.com real questions and Pass4sure dumps

    No result found, try new keyword![3] Now that multiple therapies have been approved by the US Food and Drug Administration ... TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N ...

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