Interim Management Statement

RNS Number : 2416B

Phytopharm PLC

15 February 2011

 



15 February 2011

Interim Management Statement

Phytopharm plc (PYM: London Stock Exchange) ("Phytopharm" or the "Company") today issues its Interim Management Statement ("IMS") which relates to the period from 1 October 2010 to 14 February 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 Cogane™ Phase II dose ranging study (CONFIDENT-PD) commenced in November 2010

·     Encouraging early data from the recently initiated programme investigating the effect of Cogane™ and Myogane™ in glaucoma

·     Initiation of "gold standard" in-vivo model investigating the effect of Cogane™ in Amyotrophic Lateral Sclerosis (ALS) with the support of the Motor Neurone Disease Association

·     Re-activation of P61 anti-inflammatory project

·     Co-operation agreement on Hoodia gordonii signed with the Council for Scientific and Industrial Research, South Africa

·     Cessation of research and development activity on legacy functional food programmes. Reduction in headcount and cost base associated with these programmes

Cogane™ in Parkinson's disease

Phytopharm continues to focus its resources on the development of its pharmaceutical pipeline. The Company's priority remains the development of Cogane™ for the treatment of Parkinson's disease and good progress has been made in the initiation of our Phase II study investigating the effects of Cogane™ in early stage PD (CONFIDENT-PD). The study is being conducted in leading movement disorder centres in North America and Europe. All regulatory approvals required to initiate the study have been received and patient recruitment commenced in November 2010.  We anticipate that results from the study will be available at the end of 2012 as previously reported.

Myogane™ in glaucoma

A programme investigating the effect of Cogane™ and Myogane™ in glaucoma, a neurodegenerative condition of the eye, has recently been initiated. Current pharmacological treatments of glaucoma are predominantly focussed on reducing the elevated intra ocular pressure (IOP) in the eye, which is often associated with glaucoma. However a significant number of patients with glaucoma do not exhibit raised IOP and, in addition, a significant number of patients whose IOP is successfully reduced still experience ongoing neurodegeneration resulting in deterioration of sight.  We therefore believe there is a major unmet need and a commercial opportunity for products which could successfully treat the underlying neurodegenerative process in glaucoma.

There is a growing body of scientific literature describing the neuroprotective effects of neurotrophic factors, specifically Brain derived neurotrophic factors (BDNF) and Glial-cell derived neurotrophic factors (GDNF) in models of glaucoma. Both Cogane™ and Myogane™ have been shown to modulate the production of BDNF and GDNF in a number of cell types. The first stage of this project investigated the effects of Cogane™ and Myogane™ on retinal ganglion cells, the cells which degenerate in glaucoma. In vitro models, in which retinal ganglion cells are stressed, demonstrated that Cogane™ and Myogane™ exhibited encouraging neuroprotective and neurorestorative effects.

In light of these encouraging data we are moving forward with an assessment of the efficacy using in vivo models of glaucoma. Results from these pre-clinical models will be available in Q4 2011. As both compounds have already been tested in standard pre-clinical safety studies and have completed Phase I studies, proving to be suitable to be administered as a once-daily oral product with a good safety profile, we believe that, subject to funding, we will be able to progress the project rapidly into Phase II studies if in-vivo models provide positive data.

Cogane™ in Amyotrophic Lateral Sclerosis (ALS)

ALS is the most common form of Motor Neurone Disease, a neurodegenerative disease with limited treatment options and poor prognosis. Cogane™ has previously shown promising activity in preliminary in vitro and in vivo models of ALS. We have initiated a study of Cogane™ in the "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 Cogane™ is already in clinical trials for PD, rapid progression into efficacy indicating trials will be possible, subject to funding, if results from this study are positive. ALS is an orphan indication which also supports expedited clinical development.

P61 in Inflammatory Disease

During the last quarter the Company's P61 programme was re-activated. P61 is a series of novel new chemical entities (NCE's) 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. In 2011 a lead optimisation programme will be conducted in which these molecules will be characterised pharmacologically and tested in a number of models.

Legacy Functional Food Projects

All research and development activities on Phytopharm's legacy functional food projects have been concluded. A co-operation agreement was signed with the Council for Scientific and Industrial Research, South Africa, who will fund the future development and commercialisation of Hoodia gordonii as an appetite suppressant. Phytopharm retains a commercial interest in the project and will receive a proportion of any future commercial milestones and royalties from the project.

The sales and distribution agreement with Intervet/Schering Plough Animal Health for Phytopica, our canine animal health product, came to an end in December 2010. We are in discussion with a number of animal health companies with a potential interest in taking over the commercialisation of Phytopica.

Finance

In line with our stated focus on the development of our pharmaceutical pipeline, cost savings activities and a reduction in headcount have been successfully undertaken. In addition to concentrating our resources on our lead programme, Cogane™, we have initiated the next stage of development in a number of new pharmaceutical programmes, as described above. Our financial performance from 1 October 2010 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.

Notes to Editors

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

U.K. Investor Relations FD Ben Atwell John Dineen [phone]

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™), have the potential to be a new class of therapy for neurodegenerative diseases including Parkinson's disease, motor neurone disease and glaucoma.

Phytopharm's strategic direction has evolved from developing products extracted from natural botanical sources to investigating single chemical entities.

Phytopharm operates as a virtual company. We utilise a network of 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. We will consider retaining certain rights to products targeting orphan indications.

Phytopharm is listed on the Official List of the London Stock Exchange. Further information on Phytopharm is available from the Company's website www.phytopharm.com

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 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 on information known to the Company on the date of this release.  The Company 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 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.

 

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