Any ideas anyone?

RNS Number : 2232L

Phytopharm PLC

27 July 2011

28 July 2011


Company Contact: U.K. Investor Relations
Phytopharm plc Contact:
Tim Sharpington CEO FD
Roger Hickling R & John Dineen
D Director Ben Atwell
+44 1480 437 697 +44 207 831 3113
www.phytopharm.com

Cogane(TM) - US FDA Grant Orphan Drug status for treatment of ALS

Phytopharm plc (PYM: London Stock Exchange) ("Phytopharm" or the "Company") today announces that the United States Food & Drug Administration (US FDA) has granted Orphan Drug status to Cogane(TM) (PYM50028) for the treatment of 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 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. There are estimated to be 20-30,000 people with ALS in the United States with approximately 5,600 new cases diagnosed each year. For a product to gain orphan drug status in the United States, the condition must affect less than 200,000 people in the United States.

As reported in the Company's Interim Results, Cogane(TM) has previously shown promising activity in preclinical in vitro and in vivo models of ALS. A study of Cogane(TM) in the genetic "gold standard" in vivo model of ALS is ongoing. This study has 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 and, if positive, offers the potential to support a rapid progression into clinical trials of ALS.

Research Update.

Phytopharm plc (PYM: London Stock Exchange) ("Phytopharm" or the "Company") today announces that the European Commission has granted Orphan Drug status to Cogane (PYM50028) for the treatment of amyotrophic lateral sclerosis (ALS).

The United States Food & Drug Administration (US FDA) granted Orphan Drug status to Cogane (PYM50028) for the treatment of amyotrophic lateral sclerosis (ALS) in July 2011

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 characterised by progressive loss of motor neurones, which eventually leads to death. There is an urgent need for the development of new approaches to this devastating condition. It is estimated that the prevalence of ALS in Europe is 0.5‑1.1 per 10,000. For a product to gain orphan drug status in Europe, the condition must affect less than 5 in 10,000 people in the member states.

As reported in the Company's Interim Results, Cogane has previously shown promising activity in preclinical in vitro and in vivo models of ALS. A study of Cogane in the genetic "gold standard" in vivo model of ALS is ongoing. This study has 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 and, if positive, offer the potential to support a rapid progression into clinical trials of ALS.

Research Update.

Phytopharm is Awarded a Technology Strategy Board Grant to Support the Development of Myogane in Glaucoma
Phytopharm plc (PYM: London Stock Exchange) ("Phytopharm" or the "Company") today announces that it has been awarded a grant by the Technology Strategy Board to provide funding to support the evaluation of Myogane in an in vivo preclinical model of glaucoma.
Myogane has the potential to be a neuro-protectant treatment of glaucoma. Glaucoma is a neurodegenerative disease of the eye affecting 60 million people and is the second leading cause of blindness worldwide. Current treatments of glaucoma are predominantly targeted at reducing intra ocular pressure within the eye, however the remains a major unmet medical need for treatments which can slow the underlying neurodegenerative disease process.

Myogane has demonstrated neuro-protective and neuro-restorative effects in a range of neuronal cell types including retinal ganglion cells, which are the cells affected in glaucoma. Myogane exhibits it's effect via the modulation of neurotrophic factors, naturally occurring proteins which protect and promote the growth of neurones and which have been shown to be effective in protecting against neurodegeneration in a number of models of glaucoma.

The study, if positive, will support the further clinical development of Myogane in glaucoma. Myogane is a small molecule drug which has been shown to have good oral bioavailability when dosed once daily in Phase I studies.

Despite the woeful sp, I'm thinking that maybe (only Maybe!) this is showing signs of potential.
EDIT. Ooops, sorry a lorry-load of chimps has taken over my keyboards...
EDIT 26March2012, AGM tomorrow, shan#t go as it's just too tedious welcoming new faces to the Board, who replace other faces that were welcomed a while back. Still this is buzzing about, waiting to land on the fly-paper one suspects . . . a long slow and painful future awaits..... all IMHO. Grr.

Annual Financial Report.

Directorate Change.

Interim Management Statement.

Highlights for the period
· Cogane™ demonstrated efficacy in a genetic preclinical model of amyotrophic lateral sclerosis (ALS).
· Dr Ian Tulloch, former Global Product Marketing Director at Novartis Pharma AG appointed as a Non-Executive Board Director. Dr Tulloch will succeed Mr Sandy Morrison who will step down as a Non-Executive Board Director following the Company's 2012 Annual General Meeting.
· Recruitment of patients with Parkinson's disease (PD) into the multi-national Cogane™ Phase II dose ranging study (CONFIDENT-PD) is ongoing.

Confirmatory data supports effectiveness of Cogane™ in
Amyotrophic Lateral Sclerosis

This time?

Interim Management Statement

Maybe this time?

preliminary Results

Business highlights

Operational

· Recruitment into CONFIDENT-PD Phase II clinical trial of Cogane™ in untreated patients with early stage Parkinson's disease was completed in April 2012 and the last patient is expected to complete the trial in late November 2012. Headline results from the trial remain on track to be available in February 2013.

· Cogane™ demonstrated efficacy in the "gold standard" preclinical model of amyotrophic lateral sclerosis ("ALS"), the most common form of motor neurone disease. Positive data have now been obtained in four models of ALS, providing a strong rationale for Cogane™ as a potential treatment for this devastating condition.

· A Phase I clinical trial to evaluate Cogane™ solid dose oral formulations for up to 28 days has been initiated.

· A study of Myogane™ in a preclinical model of glaucoma was inconclusive due to an unexpectedly low neuronal cell loss in the control group which prevented evaluation of a neuroprotective effect of Myogane™.

Corporate

· Dr Ian Tulloch was appointed as a non-executive Board director in February 2012. As planned, Mr Sandy Morrison stepped down from the Board following the Company's Annual General Meeting in March 2012.


Financial
· Loss after tax of £7.77 million in line with expectations reflects ongoing focus on the development of our pharmaceutical programmes (2011: £7.66 million).

· Cash and money market investments of £8.89 million (2011: £17.57 million). Based on our current expectations Phytopharm is financed to at least the end of Q1 2014.

Looks like the rumour mill is active.

Still quiet skinny,not even a mill traded so just mm playing games been watching all day.

Still have up tp 8 weeks or so before i jump on board......

Will get a new thread up and running soon as one to keep an eye on.

Coincidence?

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 CoganeTM 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.

Interim Management Statement

During the period

· The last patient completed participation in the CONFIDENT-PD Phase II clinical trial of Cogane™ in untreated patients with early-stage Parkinson's disease in December 2012. Results from this trial remain on track to be available in February 2013.

· Further work is ongoing with a number of leading opinion leaders and charities with an interest in Cogane™ in Amyotrophic Lateral Sclerosis ("ALS") to design a clinical development plan. Provisional indications for financial and logistical support for future studies of Cogane™ as a treatment for ALS have been received.

· A meeting has been held with the US Food and Drug Administration ("FDA") at which a clinical development plan for Cogane™ in ALS was agreed. Cogane™ for ALS has been granted Orphan Drug status which offers the potential for accelerated development compared with conventional drug development programs.

· A Phase I study of new solid dose formulations of Cogane™ was initiated and results are expected in Q1 2013.

· Our financial performance from 1 October 2012 to date continues to be in line with our expectations. Based on our current expectations Phytopharm is financed until at least the end of Q1 2014.

Last postings were a bit too optimistic . . and confused, some say - "...Despite the woeful sp, I'm thinking that maybe (only Maybe!) this is showing signs of potential.
EDIT. Ooops, sorry a lorry-load of chimps has taken over my keyboards...
EDIT 26March2012, AGM tomorrow, shan#t go as it's just too tedious welcoming new faces to the Board, who replace other faces that were welcomed a while back. Still this is buzzing about, waiting to land on the fly-paper one suspects . . . a long slow and painful future awaits..... all IMHO. Grr.

Todays failure of the Parkinson's Drug [ RNS- DYOR], is just another failure for this Co . . . . I say:- "Get on with something that makes a profit . . . . and leave cutting-edge research to the professionsals . . . selling doggy-cream wasn't your bag either, so make it something easy, eh?"

ooops! "Analyst Paul Cuddon at Peel Hunt said the result was a conclusive failure for Phytopharm's key asset, and he attributed no value to the group's remaining pipeline of drugs."

one for the dustbin

Yes looks that way!

Strategic Review Update

Phytopharm plc (PYM: London Stock Exchange) ("Phytopharm", the "Group" or the "Company") today announces an update on the on-going strategic review which was initiated following the announcement of headline results from its Phase II clinical trial of Cogane™ in Parkinson's disease. The update will also be provided to shareholders attending the Company's AGM today.

On the 18th February Phytopharm announced that analysis of the headline results from its Phase II clinical trial of Cogane™ in Parkinson's disease indicated that the drug had not demonstrated clinically meaningful efficacy. A full analysis of the complete dataset has now been completed which confirms the initial view that no efficacy was demonstrated in the primary or secondary endpoints measured in the study.

As a result of these findings no further research and development expenditure will be committed and a staff reduction and cost saving programme has been initiated.
After discussions with major shareholders the Board has initiated a review of the strategic options available to the Company which includes the review of a number of merger and acquisition opportunities. Exploratory discussions have been held with a number of parties and further updates will be made as appropriate.

Re: Suspension of Trading


On the 18th February 2013 Phytopharm announced that analysis of the headline results from its Phase II clinical trial of Cogane™ in Parkinson's disease indicated that the drug had not demonstrated clinically meaningful efficacy. After discussions with the Company's major shareholder the Board initiated a review of the strategic options available to the Company, including a review of a number of merger and acquisition opportunities. Further to this, the Board of Phytopharm is pleased to announce that Phytopharm has recently signed heads of terms in connection with the possible acquisition of a revenue generating UK based private company in the healthcare sector ("Target").



The transaction would be structured by way of an acquisition of the Target by Phytopharm in consideration for the issue of new Phytopharm shares to the shareholders of the Target. Due to its size in relation to Phytopharm, the proposed acquisition of the Target constitutes a "reverse takeover" for the purposes of the Listing Rules. At the request of the Company, trading in Phytopharm's Premium listed shares on the Main Market of the London Stock Exchange ("Main Market") has been suspended by the UK Listing Authority pending publication of the required shareholder documents. Shareholder approval would be required to approve the acquisition of the Target which would be sought at a general meeting to be convened in due course, after which the Company also expects to delist from the Main Market and seek admission of the enlarged share capital to trading on AIM.



The Board expects to make a further announcement in due course.