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8/18/2009 12:39:12 PM
Phytopharm plc (PYM: London Stock Exchange) (“Phytopharm” or the “Company”) today issues its Interim Management Statement (“IMS”) which relates to the period from 1 April 2009 to 30 June 2009 and contains information up to the date of publication of this IMS.
During the period, the management continued to progress key pharmaceutical development programmes utilising non-dilutive funding & current cash reserves, while continuing to tightly manage the Company’s cost base.
Phytopharm continues to focus on the development of its innovative pharmaceutical programmes. These programmes will move forward with resources focused on the progression of lead programme, Cogane™, to proof of concept.
The Company continues to pursue sources of non-dilutive funding and is progressing opportunities with specific focused charities, grants and other viable sources in the UK, Europe and the US. Potential EU funding submission dates have now been confirmed with applications possible in Q4 2009.
The cost savings programme initiated in late 2008, which targeted an overall reduction in the Company’s expenditure of up to 20% in the current financial year, is on target to be achieved. The Company expects to have sufficient cash resources to at least mid 2010.
The Company is in continued discussions with potential partners for both its pharmaceutical and functional food programmes.
Highlights for the period
In April 2009, the Company commenced a safety, tolerability and pharmacokinetic (PK) study of Cogane™, involving both healthy volunteers and patients with Parkinson’s disease. The study is being conducted on a part residential, part outpatient basis, employing a randomised, double-blind, multiple dose ascending, placebo-controlled design to evaluate the safety, tolerability and PK profile of a new oral formulation of Cogane™ when taken for up to 28 days at various dose levels. In total, 18 healthy male and female volunteers and up to 19 male and female patients with PD aged between 40-80 years have been enrolled, with doses being escalated sequentially following a safety review at each dose level. The results of this study will be reported in Q4 2009.
The UK-based Cure Parkinson’s Trust has provided further support including jointly funding the Scientific Advisory Panel event held in May 2009. The event was attended by experienced Senior Research Scientists, Physicians and Neurologists from the US, Canada and Europe. The Scientific Advisory Panel successfully assisted Phytopharm in creating the most appropriate design of a protocol for the proof of concept clinical study for Cogane™, which the Company intends to commence in first half of 2010.
The Cogane™ pre-clinical in vivo efficacy studies initiated in early 2008, with significant financial support from the Michael J Fox Foundation, is progressing well. The initial results from these studies are expected to be reported in Q4 2009.
In July 2009, the Company announced that it had entered into an agreement with the CHDI Foundation Inc. in the USA to evaluate the efficacy of Cogane™ in a preclinical model of Huntington’s disease (HD). CHDI will fund the testing of Cogane™ in its network of industrial contract research organisations, employing its standardised criteria for the rigorous evaluation of novel therapeutic approaches for HD treatment. This testing is expected to be completed in Q1 2010.
This project is in preparation for further clinical studies, pending a decision on funding and the Company continues to have constructive dialogue with The Motor Neurone Disease Association.
Following the Mutual Termination Agreement concluded with Unilever, the original IP rights have been restored to Phytopharm and access to Unilever Hoodia patents has been secured. In addition, Phytopharm has secured access to the Hoodia supply chain (Hoodia extract, Hoodia dried product and plantations).
Phytopharm is committed to the potential benefits of Hoodia extract as a functional food targeting weight management and is in early stage discussions with a number of interested partners. It is Phytopharm’s intention to licence the Hoodia programme once a satisfactory business proposition emerges. During this process, Phytopharm’s expenditure on the programme remains minimal.
In January 2006, Phytopharm entered into an exclusive global agreement with Intervet/Schering-Plough (“Schering-Plough”) for Phytopica®. Schering-Plough launched the product in the UK in April 2006 and has subsequently launched the product in Italy, France and Hong Kong.
Sales with our licensee have been negatively impacted, in part due to Schering-Plough’s M & A activity. Strategic options for the future of this programme are being evaluated with Schering-Plough.
Sandy Morrison, CEO commented: “We are delighted with the success in leveraging non-dilutive resources to progress Cogane™, our lead programme, in a new indication, Huntington’s disease, with support from the CHDI Foundation Inc. This, combined with our ongoing clinical and pre-clinical studies, demonstrates that our current business strategy of focusing on Cogane™ and managing costs tightly is delivering progress efficiently. We look forward to reporting the results of our key activities and progress in Q4 2009.”
Phytopharm is a pharmaceutical development and functional food company. Our products are developed from medicinal plants, thereby reducing the development risk, cost and time to market. As a virtual company, Phytopharm’s model is centred on a lean cash burn with all laboratory, manufacturing and clinical work out-sourced to specialists, while core competencies such as strategy and management are maintained in-house. Close collaboration with charitable organisations enhances our interaction with worldwide specialists and accelerates our development programmes increasing their value.
Cogane™ is in clinical development as a treatment for Parkinson’s disease and in pre-clinical evaluation for Huntington’s disease.
In pre-clinical models, Cogane™ reverses the changes in the area of the brain involved in Parkinson’s disease by inducing the body’s own production of proteins known as neurotrophic factors. In particular, one of these factors known as “GDNF” has been shown to be particularly effective in re-growing damaged nerves. GDNF can work only when injected into or when produced inside the brain. Direct injection of GDNF into the area of the brain involved in Parkinson’s disease has shown substantial beneficial effects in small-scale clinical studies but requires highly complex and difficult surgical procedures. Cogane™, which can be taken orally, readily crosses the blood-brain barrier and in pre-clinical models has been shown to stimulate the release of GDNF in the brain and therefore has the potential to overcome many of the difficulties associated with GDNF administration.
The MJFF funding is providing substantial financial support for our pre-clinical in vivo efficacy to determine the optimal dosing requirements for Cogane™ which are being carried out by Dr Jonathan Brotchie, a Senior Scientist at the Toronto Western Hospital and part of the University Health Network (UHN) in Toronto, Canada. Dr Brotchie is a recognised expert in the field of Parkinson’s disease.
In preclinical models, Cogane™ increases the body’s production of BDNF which is know to be decreased in the brains of HD patients. Increasing the brain level of BDNF has been postulated as a potential treatment for HD. However, since BDNF is a protein it cannot be given orally (in pill or liquid form) because it is degraded in the stomach and intestine, and also does not readily cross the blood-brain barrier. Cogane™, which can be taken orally, readily distributes into the brain and stimulates the release of endogenous BDNF in the brain. It therefore has the potential to overcome the technical difficulties associated with exogenous BDNF administration.
Myogane™ is in clinical development as a treatment for ALS (also known as Lou Gehrig’s disease). ALS is the most prevalent motor neurone disease and results from progressive degeneration of motor neurones. This condition has a high unmet medical need.
Myogane™ is a novel non-peptide, orally bioavailable neurotrophic inducer that readily crosses he blood-brain barrier. Myogane™ induces the body’s own production of proteins known as neurotrophic factors. Myogane™ readily crosses the blood-brain barrier and in preclinical models has been shown to protect against neuronal damage when administered orally to preclinical models of ALS, delaying the loss of muscle strength and extending survival time.
Hoodia extract is a weight management functional food product based on an extract of the succulent plant, Hoodia, which contains a strongly patent protected novel satiety stimulator that reduces calorie intake in overweight subjects, as demonstrated in a double-blind, placebo-controlled clinical study.
Phytopica® is a natural, three plant product for canine skin health that provides a novel approach to help maintain a normal healthy immune system, support normal white cell function and provide anti-oxidant benefits. The beneficial effects and excellent safety profile of Phytopica® have been proven extensively in clinical trials in dogs.
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 results of operations and financial conditions, market estimates, the Company’s plans and objectives for future operations, including future revenues, financial plans and expected expenditures and divestments. All forward-looking statements in this report are based upon information known to the Company on the date of this IMS. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events of otherwise.
It is not reasonably possible to itemise all of the many factors and specific events that could cause the Company’s forward looking statements to be incorrect or that could otherwise have a material adverse effect on the future operations or results of the Company.
For further information about Phytopharm please see our website www.phytopharm.com