Interim Management Statement Phytopharm plc
(PYM: London Stock Exchange) ("Phytopharm", the "Group" or the "Company") today issues its Interim Management Statement ("IMS") which relates to the period from 1 April 2011 to 16 August 2011 and contains information up to the date of publication of this IMS. Highlights for the period · Recruitment of patients with Parkinson's disease (PD) into the multi-national CoganeTM Phase II dose ranging study (CONFIDENT-PD) ongoing.· Achieved positive results demonstrating that CoganeTM reduced side effects associated with L-DOPA treatment in a preclinical model of PD; data presented at the Movement Disorders Conference in June 2011.· Positive preclinical in vitro data was presented at the World Glaucoma Congress in June 2011 supporting the ongoing development of MyoganeTM in glaucoma.· United States Food & Drug Administration (FDA) granted Orphan Drug status to CoganeTM for the treatment of amyotrophic lateral sclerosis (ALS) in July 2011. CoganeTM in Parkinson's disease CoganeTM is currently being evaluated in a 400 patient multi-national Phase II, randomised, double blind, placebo controlled, dose ranging study (CONFIDENT-PD). The study has been designed to compare the safety, tolerability and efficacy of three doses of CoganeTM and placebo when administered for 28 weeks to untreated patients with early stage PD. Patient recruitment commenced in November 2010. Our target remains to have headline results from the study available at the end of 2012. A preclinical model conducted by Phytopharm has shown that administration of CoganeTM in conjunction with L-DOPA (the standard treatment for PD) resulted in improved control of symptoms compared to treatment with L-DOPA alone. We have also now demonstrated that CoganeTM reduced the side-effects of L-DOPA in preclinical models; this data was presented at the International Congress of Parkinson's disease and Movement Disorders held in June 2011 in Toronto, Canada. Together, these results demonstrate the potential of CoganeTM not only as a monotherapy for PD but also in combination with L-DOPA to widen the therapeutic window of L-DOPA. These data continue to support the development of CoganeTM as a new and potentially disease-modifying therapy for PD. In addition to its effects in preclinical models of PD CoganeTM has shown efficacy in preclinical models of cognitive impairment and therefore may have utility in treating the non-motor symptoms of PD. CoganeTM in motor neurone disease / ALS We have initiated a study of CoganeTM in the genetic "gold standard" in vivo model of ALS, with the support of the Motor Neurone Disease Association, a UK based charitable organisation which has provided a grant to cover the costs of the study. Results from the study are expected in Q4 2011. As CoganeTM is already in clinical trials for PD, rapid progression into efficacy indicating trials will be possible, subject to funding, if results from this preclinical study are positive. In July 2011, the FDA granted orphan drug status to CoganeTM for the treatment of ALS. 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 $1.5m) and 7 years' marketing exclusivity (compared to 5 years available for non-orphan diseases). An application to gain Orphan Drug status in the European Union has also been made to the European Medicines Agency. MyoganeTM in glaucoma Following a preclinical assessment of CoganeTM and MyoganeTM in glaucoma, a neurodegenerative condition of the eye, MyoganeTM has been selected for further investigation. Preclinical in vitro data was presented at the World Glaucoma Congress in June 2011. The assessment of efficacy using an in vivo preclinical model of glaucoma is ongoing and results from this model will be available in Q4 2011. P61 in Inflammatory Disease P61 is a series of novel new chemical entities which exhibit anti-inflammatory, anti-remodelling, anti-spasmodic and TRPV1 modulating activities. This range of activity within single molecules could provide attractive therapeutic options in a number of inflammatory diseases. A lead optimisation programme has been conducted and a lead candidate has been selected for further evaluation. Finance We continue to focus our resources on our lead programme, CoganeTM in PD, together with the next stage of development of our sapogenin programmes investigating the effects of CoganeTM in ALS, MyoganeTM in glaucoma. We are also completing the current phase of the P61 programme. Our financial performance from 1 April 2011 to date has been in line with our expectations. We continue to operate with a lean operational structure whilst also diversifying our development pipeline in a cost efficient manner, with the potential for further programmes to enter the clinic or become licensed in the medium term. Based on our current expectations Phytopharm is financed to the end of 2013. Mo Noonan
Senior ManagerFinancial Dynamics
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