Ixico Regulatory News (IXI)

11 May 2012

Phytopharm plc

Update on Preclinical Study of Myogane™ in Glaucoma

Phytopharm plc (PYM: London Stock Exchange) ("Phytopharm" or the "Company") today announces that a study in an animal model of glaucoma was inconclusive. The study did not yield a valid result because of a failure to induce sufficient neuronal cell death in both treatment and control groups.

The study was designed to evaluate the neuroprotective effects of treatment with Myogane™ in an established model of glaucoma. In this model intraocular pressure is elevated in order to induce neuronal cell loss in the retina, which is characteristic in glaucoma. The endpoint was a comparative measurement of neuronal cell loss, an accepted marker of disease. However, the extent of induced neuronal cell loss was much less than anticipated (from literature precedent) in both treatment and control groups. While there were some indications of a neuroprotective effect following Myogane™ treatment, it is not possible to draw definitive conclusions because of the limited neurodegeneration in the control group.

Pharmacokinetic evaluation indicated that levels of Myogane™ in the plasma were broadly in line with that expected from previous studies and that Myogane™ was present in the retina. Previous in vitro studies have demonstrated that Myogane™ is protective of retinal ganglion cells, the neuronal cells which degenerate in glaucoma.

This study was performed with the financial support of the UK Technology Strategy Board.

Dr Pamela Ko, from the Biological Test Centre, Irvine California, who was the scientist leading the study, said "The increase in intraocular pressure in the current study was similar to other studies which also demonstrated significant neuronal damage. Therefore, it is disappointing that greater neuronal damage was not observed in the current study."

Mr Tim Sharpington, CEO, Phytopharm, said, "It is disappointing that this study did not produce a definitive result which would have given us further insight into the potential of Myogane™ in glaucoma. We will analyse the results from this study in consultation with our scientific advisors before deciding on the next steps for this programme. "

About Phytopharm

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 Myogane™ and Cogane™), has the potential to be a new class of therapy for a range of neurodegenerative diseases. The Company's lead development product, Cogane™, is being evaluated in an international clinical trial in patients with Parkinson's disease. Cogane™ has recently demonstrated efficacy in a series of pre-clinical studies in amyotrophic lateral sclerosis, the most common form of motor neurone disease.

Phytopharm operates as a virtual company ensuring the majority of our financial resources are focused on our pharmaceutical pipeline. 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.

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

About Myogane™

Myogane™, a member of the sapogenin class of compounds, is an orally bioavailable neurotrophic factor modulator that readily crosses the blood‑brain barrier. Myogane™ has demonstrated neuroprotective effects in a range of preclinical models of neurodegenerative diseases. Specifically, MyoganeTM has been shown to induce and modulate the production of neurotrophic factors.

About glaucoma

Current pharmacological treatments for glaucoma are predominantly focused on reducing the elevated intraocular 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, specifically degeneration of retinal ganglion cells, resulting in deterioration of sight. There is therefore a major unmet need and a commercial opportunity for products that 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 factor ("BDNF") and glial-cell derived neurotrophic factor ("GDNF") in models of glaucoma.

About the glaucoma model

The study was performed in rodents with raised but stable intraocular pressure (the pressure within the eye). Intraocular pressure was measured throughout the dosing period and at the end of the study the retinas were examined and the number of retinal ganglion cells counted.

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 upon information known to the Company on the date of this announcement. 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.