News

24-Feb-2021

Parkinson's UK creates Vivifi Biotech to research 'promising' experimental treatment

Charity organisation Parkinson's UK has announced it is creating a dedicated company to drive forward research into an experimental treatment for Parkinson's disease.

The company, Vivifi Biotech, has been created through the Parkinson's Virtual Biotech – the drug development arm of Parkinson's UK.

It will seek to further the development of Glial Cell-Line Derived Neurotrophic Factor (GDNF), and investigate if this naturally-occurring protein can regenerate dying brain cells in people with Parkinson's and reverse their condition.

Previously, a clinical trial to test Medgenesis' GDNF product was conducted, under the sponsorship of North Bristol NHS Trust, and with funding from Parkinson's UK.

Parkinson's UK has now signed an agreement with MedGenesis, which means that Vivifi will own the intellectual property and data needed to continue development of the GDNF programme.

Although the initial trial did not meet its 'critical' endpoint, the new biotech company will investigate if the challenges presented in this first study can be overcome to further the development of GDNF for the treatment of Parkinson's.

In the first study, there were some 'encouraging' signs of improvements among those receiving GDNF treatment, but there was no statistically significant difference between the active treatment group and the placebo group.

However, further analysis of the data using a novel combined metric – the Parkinson's Disease Comprehensive Response (PDCORE) – showed a significant difference between GDNF-treated patients and placebo.

"While our initial trial didn't meet its primary endpoint, it did reveal robust evidence indicating that GDNF can be safely delivered to the brain, and trigger the intended changes in dopamine-producing nerve cells" said Arthur Roach, head of research at Parkinson's UK.

"This is why Parkinson's UK is committed to continuing research into this potential treatment. We've created this company, Vivifi Biotech, through the Parkinson's Virtual Biotech, our drug development arm."

"The new company will bring the right people together to plan a new trial that meets the needs of patients, regulatory authorities and potential investors. Most importantly, we need to ensure that all the challenges identified by the previous trial are addressed and overcome," he added.

 


15-Nov-2019

Winner - Best Science Documentary
2019 British Documentary Awards (The Grierson Awards)

"The Parkinson's Drug Trial: A Miracle Cure?"

Filmed over six years, this series follows a group of volunteers with Parkinson's as they take part in a ground-breaking medical trial testing a controversial drug called GDNF. 42 patients undergo complex brain surgery and months of infusions via a port embedded into their skull. Can the trial give hope the estimated 10 million affected by Parkinson's globally?

The judges said: "The winning film stood out for its lean storytelling of a complex subject, its scale and its heart. The film was 'an examination of the nature of progress,' managing to straddle both the science involved with clarity and the emotional, human dimension with real compassion."

https://griersontrust.org/grierson-awards/the-grierson-awards/nominations/#awards6

 


 

Feb-27-2019

Additional Coverage:

 


 

27-Feb-2019

Read the latest news about the GDNF clinical trial on the Parkinson's UK website:

"The results from the trial are not clearcut, but offer promising signs that it may be possible to restore the cells damaged in Parkinson's."

 


MedGenesis Therapeutix Announces Termination of GDNF Option Agreement with Pfizer Inc.

Victoria BC, 11-Feb-2018

MedGenesis Therapeutix Inc., a privately held biotechnology company focused on the development of glial cell line-derived neurotrophic factor (GDNF), announced today termination of the agreement with Pfizer Inc. ("Pfizer") which had granted Pfizer an exclusive, worldwide option to license the GDNF protein to be used in research for potential treatments for Parkinson's disease.

MedGenesis has completed a Phase 2 program of GDNF in Parkinson's disease and previously reported on the successful outcome of national scientific advice meetings with three European regulatory agencies during which the design of a proposed Phase 3 study to support registration of GDNF as a disease-modifying therapy for Parkinson's disease was discussed. Show More

"MedGenesis is committed to improving the lives of people living with Parkinson's disease," said Dr. Erich Mohr, Chairman and CEO of MedGenesis. "While we are disappointed by the termination, we are pleased to have regained full ownership of GDNF. We remain encouraged by our recent national scientific advice meetings, and look forward to initiating Phase 3 after completing our scheduled meetings with the European Medicines Agency and US Food and Drug Administration."

About MedGenesis Therapeutix Inc.

MedGenesis is a privately held biopharmaceutical company committed to developing and commercializing innovative therapeutics to provide life-enhancing treatments to patients with serious neurologic diseases. MedGenesis' GDNF program has been supported by a grant from the Michael J Fox Foundation for Parkinson's Research, and benefitted from a direct grant from Parkinson's UK to an investigator-sponsored clinical trial conducted by the North Bristol Trust.

Learn more about MedGenesis at: www.medgenesis.com

FOR FURTHER INFORMATION PLEASE CONTACT:
MedGenesis Therapeutix Inc.:
Lara Longpre, M.Sc., MBA
Chief Operating Officer
+1 (250) 386-3000

This news release contains certain forward looking statements that reflect the current views and/or expectations of the company with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.

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MedGenesis Therapeutix Announces Successful National Scientific Advice Meetings for GDNF in Parkinson's Disease

Victoria BC, 1-Sep-2017

MedGenesis Therapeutix Inc., a privately held biotechnology company focused on the development of glial cell line-derived neurotrophic factor (GDNF), announced today the successful outcome of national scientific advice meetings with three European regulatory agencies including the British Medicines and Healthcare products Regulatory Agency (MHRA), the Dutch Medicines Evaluation Board (MEB), and the German Federal Institute for Drugs and Medical Devices (BfArM). Show More

The primary purpose of the meetings was to discuss the design of a proposed Phase 3 study to support registration of GDNF as a disease-modifying therapy for Parkinson's disease.

"The consulted agencies are regulatory leaders in neurodegenerative diseases in the European Union. All three endorsed our proposed Phase 3 study design and strongly encouraged further development of GDNF in Parkinson's disease," said Dr. Erich Mohr, Chairman and CEO of MedGenesis. "The consistent feedback gives us confidence as we next review our strategy with the Scientific Advice Working Party of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). These upcoming meetings are expected to be cornerstones on the way forward to initiating Phase 3."

Dr. Matthias Luz, Chief Medical Officer of MedGenesis added, "Importantly, we are encouraged by the provided guidance that if the proposed study achieves its key endpoints and demonstrates a favorable benefit-risk ratio, it could be the only study required for marketing authorization. We are now focused on preparing for the next stage of regulatory meetings and finalizing the Phase 3 study design."

MedGenesis' proposed target population for its Phase 3 study of GDNF is patients with bilateral idiopathic Parkinson's disease of moderate severity. Details of the study design will be announced following the completion of discussions with the EMA and FDA.

About MedGenesis Therapeutix Inc.

MedGenesis is a privately held biopharmaceutical company committed to developing and commercializing innovative therapeutics to provide life-enhancing treatments to patients with serious neurologic diseases. MedGenesis' GDNF program has been supported by a grant from the Michael J Fox Foundation for Parkinson's Research, and benefitted from a direct grant from Parkinson's UK to an investigator-sponsored clinical trial conducted by the North Bristol Trust.

Learn more about MedGenesis at: www.medgenesis.com

FOR FURTHER INFORMATION PLEASE CONTACT:
MedGenesis Therapeutix Inc.:
Lara Longpre, M.Sc., MBA
Chief Operating Officer
+1 (250) 386-3000

This news release contains certain forward looking statements that reflect the current views and/or expectations of the company with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.

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MedGenesis Therapeutix Reacquires Rights for GDNF

8-Nov-2010

MedGenesis Therapeutix Inc. ("MedGenesis"), announced today that it has regained all rights to glial cell line-derived neurotrophic factor (GDNF) protein and related Convection Enhanced Delivery (CED) technology from Biovail Laboratories International SRL ("BLS"), a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE and TSX: VRX). Show More

MedGenesis and BLS agreed to conclude their previously established collaboration to develop and commercialize GDNF, returning the product to MedGenesis together with a one-time cash payment of $5 million to accelerate the development of GDNF in Parkinsonís disease. At the same time, MedGenesis has broadened GDNF applications to hearing loss and epilepsy.

FOR FURTHER INFORMATION PLEASE CONTACT:

Michael Lincoln
Chief Financial Officer
(250) 386-3000

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MedGenesis and Biovail Announce Grant from The Michael J. Fox Foundation for the Development of GDNF

22-Jun-2010

MedGenesis Therapeutix Inc. and Biovail Corporation (NYSE, TSX: BVF) today announced that The Michael J. Fox Foundation (MJFF) for Parkinson's Research has awarded a $2.1 million USD grant to MedGenesis Therapeutix Inc. and Biovail Laboratories International SRL (BLS) to further their collaboration in the development of glial cell line derived neurotrophic factor (GDNF). Show More

The grant will be made over a 3-year period; with the total amount being subject to the attainment of specific milestones.

"We are delighted and deeply appreciative to partner with The Michael J. Fox Foundation in our common search for a disease-modifying treatment to significantly change the quality of life of patients with Parkinson's disease," said Dr. Erich Mohr, Chairman and CEO of MedGenesis.

GDNF is being developed by MedGenesis and BLS pursuant to a December 2009 collaboration agreement. In previous clinical studies, GDNF has shown promise as a potential disease-modifying therapy for the treatment of Parkinson's disease. GDNF is a naturally-occurring growth factor capable of protecting and promoting the survival of dopamine producing nerve cells.

"We are grateful for MJFF's support and look forward to a productive relationship in the future," said Bill Wells, Biovail's Chief Executive Officer.

About MedGenesis Therapeutix Inc.

MedGenesis is a privately-held biopharmaceutical company committed to developing and commercializing innovative therapeutics to provide life-enhancing treatments to patients with serious neurologic diseases. MedGenesis is a worldwide leader in Convection Enhanced Delivery (CED), a minimally invasive technique that provides for targeted, local treatment of CNS conditions such as epilepsy, brain cancer and other severely debilitating diseases of the CNS.

About Biovail Corporation

Biovail Corporation is a specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products. The Company is focused on the development and commercialization of medicines that address unmet medical needs in niche specialty central nervous system (CNS) markets. For more information about Biovail, visit the Companyís Web site at www.biovail.com.

About The Michael J. Fox Foundation

The Michael J. Fox Foundation is dedicated to ensuring the development of better treatments, and ultimately a cure, for Parkinsonís disease through an aggressively funded research agenda. MJFF has funded almost $184 million in research to date.

Caution Regarding Forward-Looking Information and "Safe Harbor" Statement

To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information under applicable Canadian provincial securities legislation (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, Biovail's and MedGenesisí objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, and can generally be identified by the use of words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may", "potential" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.

Although Biovail and MedGenesis believe that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: uncertainties with respect to the development path that will be required by regulatory authorities, uncertainties associated with the launch of a new product and the accuracy of associated research, availability of raw materials and finished products, the regulatory environment and associated filings and approvals, and other risks detailed from time to time in Biovail's filings with the Securities and Exchange Commission and the Canadian Securities Administrators, as well as the ability of Biovail and MedGenesis to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this news release, as well as under the heading "Risk Factors" in Biovail's most recent Annual Report on Form 10-K.

Biovail and MedGenesis caution that the foregoing list of important factors that may affect future results is not exhaustive. When relying on these forward-looking statements to make decisions, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Biovail and MedGenesis undertake no obligation to update or revise any forward-looking statement, except as required by law.

FOR FURTHER INFORMATION PLEASE CONTACT:

Michael Lincoln
Chief Financial Officer
(250) 386-3000

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MedGenesis Announces Agreements with Amgen and Biovail

12-Jan-2010

MedGenesis Therapeutix Inc. ("MedGenesis"), a biopharmaceutical company developing and commercializing innovative treatments for patients with serious central nervous system (CNS) diseases, announced today that it has successfully entered into an agreement with Amgen Inc. (Nasdaq:AMGN) ("Amgen"), granting MedGenesis an exclusive, worldwide license for glial cell line-derived neurotrophic factor (GDNF) protein in CNS and non-CNS indications, subject to the rights of a co-exclusive licensee for CNS indications in certain countries, as further described below. Show More

As part of the license agreement, Amgen now holds a small equity stake in MedGenesis. In parallel, Biovail Laboratories International SRL, a subsidiary of Biovail Corporation (NYSE:BVF) (TSX:BVF), Canada's largest publicly traded pharmaceutical company, and MedGenesis have concluded an agreement to collaborate on the development of GDNF in Parkinson's disease and potentially other CNS indications. Biovail, which is also a party to the Amgen license for CNS indications and which has a co-exclusive license to exploit GDNF in certain countries (including the U.S., Canada, Japan and a number of European countries), contributes significant development expertise, a broad-based commercialization track record, and a focus on CNS disorders.

MedGenesis has also granted Biovail a license to its Convection Enhanced Delivery (CED) platform for use with GDNF in CNS indications. MedGenesis and Biovail will initially focus on the development of GDNF for Parkinson's disease, a progressive and debilitating neurological disease affecting close to 5 million patients worldwide. GDNF is a naturally-occurring growth factor capable of protecting and promoting the survival of dopamine producing nerve cells.

"This license of GDNF from Amgen presents MedGenesis and Biovail with an exciting opportunity to develop a potential breakthrough therapy for the treatment of patients with Parkinson's disease. We believe that our Convection Enhanced Delivery approach will result in accurate, targeted delivery of GDNF to the regions of the brain affected by this severely debilitating disease and holds the promise of providing patients for the first time with a treatment which could potentially modify the disease, rather than just treat the symptoms," said Dr. Erich Mohr, Chairman and CEO of MedGenesis. "We are also excited to have licensed the GDNF protein exclusively from Amgen in non-CNS indications and to have the opportunity to investigate additional applications of the molecule through similar collaborations with other potential partners."

About MedGenesis Therapeutix Inc.

MedGenesis is a privately-held biopharmaceutical company committed to developing and commercializing innovative therapeutics to provide life-enhancing treatments to patients with serious neurologic diseases. MedGenesis is a worldwide leader in CED, a minimally invasive technique that provides for targeted, local treatment of CNS conditions such as epilepsy, brain cancer and other severely debilitating diseases of the CNS. For more information, please visit http://www.medgenesis.com.

FOR FURTHER INFORMATION PLEASE CONTACT:

Michael Lincoln
Chief Financial Officer
MedGenesis Therapeutix Inc.
MichaelLincoln@medgenesis.com
(250) 386-3107

This news release contains certain forward looking statements that reflect the current views and/or expectations of the company with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.

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MedGenesis Therapeutix Named One of Canada's Top 10 Life Science Companies

10-Dec-2007

MedGenesis Therapeutix Inc., a privately-held biopharmaceutical company, today announced that it has been recognized as one of Canada's Top 10 Life Sciences Companies for 2008. MedGenesis was chosen by a group of distinguished venture capital investors based on the Company's attractiveness as an exceptional investment in Canada. Show More

"We are honoured to have received this award," said Chairman and Chief Executive Officer, Dr. Erich Mohr. "It recognizes the value and potential of our platform technology and the significant achievements made by our company in the last year."

Winners of the Canadaís Top 10 Competition are chosen by an independent expert panel of Canadian and U.S. venture capitalists. Originally developed to promote the 10 most promising life science companies from across Canada to Canadian and international investors and partners, the competition has now expanded to showcase Canada's cleantech and technology sectors. Winning companies, working in partnership with OCRI, and the Canadian Consulates in Boston, New York City, San Diego and San Francisco, will participate in targeted investment forums in each city, providing them with an opportunity to meet with venture capital investors who have expressed an active interest in financing these companies.

For more information about the Canada's Top 10 Competition visit www.topcanadiancompanies.com.

About MedGenesis Therapeutix

MedGenesis Therapeutix Inc. is a privately-held biopharmaceutical company committed to developing and commercializing innovative therapeutics to provide life enhancing treatments to patients with serious Central Nervous System (CNS) Disease. MedGenesis is a worldwide leader in Convection Enhanced Delivery (CED), with a groundbreaking CED platform for local drug delivery inside the brain. For more information please visit http://www.medgenesis.com

Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.

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MedGenesis Therapeutix Closes $3.2 Million Round of Financing

8-Nov-2006

MedGenesis Therapeutix Inc. ("MedGenesis") announced today that it has successfully raised $3.2 Million in private equity financing. The proceeds of the financing will be used to advance the clinical development of its lead therapeutic program and the filing of an IND to initiate human studies. Show More

"Investors were very receptive to the uniqueness of our business model and to the potential for success of our development programs," commented Dr. Erich Mohr, Chairman and Chief Executive Officer of MedGenesis. "This financing will enable MedGenesis to enter into phase I/II clinical trials with our lead drug candidate by the end of 2007 and provide us with sufficient funding to meet our other business objectives."

MedGenesis is a biopharmaceutical company focused on the development of therapeutics with established safety and efficacy profiles for the treatment of serious Central Nervous System (CNS) disease. The company utilizes Convection Enhanced Delivery as a method of direct and targeted delivery of molecules to the relevant area in the CNS. Key therapeutic focus areas include Neuro Oncology, Parkinson's Disease and Alzheimer's Disease.

FOR FURTHER INFORMATION PLEASE CONTACT:

Erich Mohr, Ph.D., R.Psych.
Chairman & Chief Executive Officer
MedGenesis Therapeutix Inc.
ErichMohr@medgenesis.com

Michael Lincoln
Chief Financial Officer
MedGenesis Therapeutix Inc.
MichaelLincoln@medgenesis.com

This news release contains certain forward looking statements that reflect the current views and/or expectations of the company with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.

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MedGenesis Appoints Ken Newport to Board of Directors

31-Mar-2006

MedGenesis Therapeutix Inc. (MedGenesis) is pleased to announce that Mr. Ken Newport has been appointed to the Company's Board of Directors. Show More

Ken brings to the MedGenesis Board a wealth of experience in business development and corporate finance and we believe his leadership and complementary skill set will be an invaluable asset to the strategic direction and growth of our organization," said Dr. Erich Mohr, Chairman & Chief Executive Officer of MedGenesis.

Ken Newport is an entrepreneur and life sciences business executive and a chartered accountant. He was a co-founder and President of CroMedica Global Inc. Prior to its merger with PRA International, CroMedica had annual revenues of over $40 million with 600 employees in offices in 9 countries. From 2002-2005, Mr. Newport served as a Senior Vice President and Executive Committee member of PRA International. Mr. Newport was also a founding member of Global Biomedical Capital Corporation, Zelos Therapeutics Inc., Prime Trials Inc. and other life science organizations. He currently serves as the Chairman of the Ottawa Life Science Council.

"I am looking forward to contributing to the growth of MedGenesis. The business model is extremely unique and potentially allows for the Company to have products in the clinic as early as next year," said Mr. Newport.

This news release contains certain forward-looking statements that reflect the current views and/or expectations of the Company with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.

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