Cogane in ALS Update

RNS Number : 7480T

Phytopharm PLC

18 December 2012

 



18th December 2012

COGANE™ IN ALS UPDATE

Phytopharm plc (PYM: London Stock Exchange) ("Phytopharm", the "Group", or the "Company") today announces an update on plans for the further clinical development of Cogane^TM as a potential treatment for Amyotrophic Lateral Sclerosis ("ALS").

Earlier this year the Company announced the successful completion of the preclinical evaluation of Cogane™ in ALS, which provided strong support for progression into clinical trials in this indication. Subsequently the Company has been working with a number of leading opinion leaders and charities with an interest in ALS to design a clinical development plan for Cogane™ in ALS.

As part of this process two leading grant-giving bodies, the ALS Association ("ALSA") and the North-East ALS Consortium ("NEALS") in conjunction with Massachusetts General Hospital, have provisionally indicated that they will provide financial and logistic support for future studies of Cogane™ in ALS. Both of these grants are contingent on the Company moving forward with a study in ALS.

The Company is also in discussion with leading regulatory agencies with regard to the design of a clinical development plan for Cogane™ in ALS.

Cogane™ has been granted orphan drug designation for the treatment of ALS in both the US and Europe. Orphan drug designation provides a number of research and development as well as financial advantages to companies developing products targeting the relatively uncommon conditions labelled as "orphan".

In parallel with this work, Phytopharm has been completing a 400-patient, Phase II trial of Cogane™ in early-stage Parkinson's disease (CONFIDENT-PD). All patients have now completed the trial and the Company is on-track to receive the results from this trial in February 2013 as previously announced.

The Company will determine the best way forward for Cogane™ in both Parkinson's disease and ALS once it has analysed the results from the CONFIDENT-PD trial.

Tim Sharpington, Phytopharm CEO, commented "We believe that the pre-clinical data received earlier this year provide a clear rationale for moving forward with clinical trials with Cogane™ in ALS. We are pleased to have received strong support for this programme from leading experts and charities in the field and are working to finalise our development plans with regulatory agencies.

"Whilst the progression of the ALS programme is not wholly dependent on the outcome of the CONFIDENT-PD trial for Cogane^TM in Parkinson's Disease, its results may inform the design and conduct of future studies in this setting. We continue to eagerly await the results from this important phase II trial which are expected in February, before making definitive decisions on how best to proceed in both indications, be that alone or in partnership with other companies."

Notes to Editors

Enquiries Phytopharm plc Tim Sharpington, CEO [phone] Roger Hickling, R&D Director [phone]

U.K. Investor Relations FTI Consulting Limited Ben Atwell John Dineen [phone]

Phytopharm plc

Phytopharm plc ("Phytopharm") is a development stage pharmaceutical company developing novel treatments targeting diseases with high levels of unmet need. Our lead series of compounds, the sapogenins (including Cogane™ and Myogane™), has the potential to be a new class of therapy for neurodegenerative diseases including Parkinson's disease (PD), amyotrophic lateral sclerosis ("ALS") and glaucoma.

Phytopharm operates as a virtual company ensuring the majority of our financial resources are focused on our pharmaceutical pipeline. We utilise a network of external scientific and clinical experts to help guide our development projects with our experienced pharmaceutical managers overseeing operations.

Our commercially focused development projects have the potential to produce significant treatment advances in our target areas of neurodegeneration and inflammatory disease. Our products are single chemical entities with novel mechanisms of action protected by strong patent families. Our pipeline has been sourced from our own research activities and from licensing activities, particularly from leading research institutions in China with whom the Company has long-standing relationships.

Our objective is to develop products aimed at major markets with high unmet medical need to key value inflection points before seeking late-stage development and commercial partners as appropriate.

Phytopharm is listed on the premium segment of the Official List of the FSA and traded on the main market of the London Stock Exchange. Further information on Phytopharm is available from the Company's website www.phytopharm.com

About Cogane™

Phytopharm's lead development candidate is Cogane™, a member of the sapogenin class of compounds. It is an orally bioavailable neurotrophic factor modulator that readily crosses the blood‑brain barrier. Cogane™ has demonstrated neuroprotective effects in a range of preclinical models of neurodegenerative diseases. Specifically, Cogane^TM has been shown to induce and modulate the production of neurotrophic factors. The neuroprotective and neurotrophic actions of Cogane™ suggest potential beneficial effects in a range of neurodegenerative diseases, including ALS and Parkinson's disease.

Cogane™ has completed long term toxicology studies, has been formulated as a once daily, orally administered therapy and has completed Phase I studies demonstrating a good bioavailability and safety profile.

In addition to the preclinical programme in ALS, Cogane™ is being studied in an ongoing 28 week Phase II clinical trial of patients with early stage Parkinson's disease (CONFIDENT‑PD). The last patient completed this trial in early December 2012.

Cogane™ has been granted Orphan Drug status by both the European Commission and by the US Food & Drug Administration for development in ALS and this will allow significant access to the regulatory authorities for advice and expedited clinical progression as well as providing financial advantages.

About amyotrophic lateral sclerosis (ALS)

ALS, also known as Lou Gehrig's disease, is the most prevalent form of motor neurone disease, which generally strikes people between 40 and 60 years of age. It is estimated that there are over 400,000 patients living with ALS globally. It is a neurodegenerative disease with limited treatment options and poor prognosis. It is characterised by progressive loss of both lower (spinal cord and brain stem) and upper (cerebral cortex) motor neurones, which leads to severe muscle weakness and wasting, followed by paralysis and death, generally caused by respiratory failure. There is an urgent need for the development of new approaches to this devastating condition.

About Orphan Drug Designation

For a product to gain orphan drug status in the United States, the clinical condition must affect less than 200,000 people in the United States. If a product has been granted orphan drug status, FDA will provide assistance in the design of the preclinical and clinical studies needed to achieve marketing approval for the designated clinical condition. Additionally, there are financial incentives available (such as waiver of the fee for the marketing application, currently over $1.5M) and 7 years' market exclusivity (compared to 5 years available for non‑orphan diseases).

Forward looking statements

Certain information included in these statements is forward looking and involves risk and uncertainties that could cause results to differ materially from those expressed or implied by the forward looking statements.

Forward looking statements include, without limitation, projections relating to the Group's plans and objectives for future operations, including future revenues, financial plans and expected expenditure and divestments. All forward looking statements in this report are based upon information known to the Group at the date of this release. The Group undertakes no obligation to publicly update or revise any forward looking statement, whether as a result of new information, future events or otherwise.

It is not reasonably possible to itemise all of the many factors and specific events that could cause the Group's forward looking statements to be incorrect or that could otherwise have a material adverse effect on the future operations of the Group.

 

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