Phytopharm Announces Results of Interim Data Review for Phase II Proof of Principle Study in Alzheimer's Disease.GODMANCHESTER, U.K. -- Preliminary Results of Completed Study Expected Fourth Quarter 2005 Phytopharm plc (LSE LSE - Language Sensitive Editor :PYM) (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). :PHYOF) (OTC:PHYOY) ("Phytopharm") announces today the outcome of a scheduled interim data review for the ongoing phase II proof of principle clinical study of PYM50028 (Cogane(TM)). The compound is an orally active, synthetic, neuroprotective and neuroregenerative product that is under development as a treatment for Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. . The study is being conducted in the UK under the terms of a clinical trial authorization (CTA An abbreviation for cum testamento annexo, Latin for "with the will annexed." ), which has been granted by the Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. (MHRA MHRA Medicines and Healthcare Products Regulatory Agency MHRA Modern Humanities Research Association (United Kingdom) MHRA Minnesota Human Rights Act MHRA Malta Hotels and Restaurants Association ). This randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetic profile of PYM50028 after once daily oral administration for 12 weeks to patients with Alzheimer's disease. In accordance with the protocol, an interim review was conducted after the first 60 subjects completed the study. The objectives of this review were to evaluate the emergent safety profile of the study and to re-estimate the total number of subjects required to measure the efficacy of PYM50028 on cognitive performance. The safety review was conducted by an independent consultant physician, who was provided with blinded data for each of the two treatment groups. He concluded that "the data obtained to date indicate that the study medication is not associated with any safety concerns." Therefore, the study will continue with no changes to the safety monitoring Safety Monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution. . The sample size re-assessment was conducted by an independent statistician, who reported that the sample size for the study should be increased from 200 to 238 subjects. Phytopharm is seeking regulatory and ethics approval for this amendment. Subject recruitment for the study is expected to be completed during the second quarter of 2005, with preliminary results still anticipated to be available in the fourth quarter of 2005. On 1 May 2003, Phytopharm entered a licensing agreement with Yamanouchi Pharmaceutical Co., Ltd., a leading Japanese pharmaceutical company, for the development and commercialization of PYM50028 in Japan and other Asian territories. Dr. Richard Dixey, Chief Executive of Phytopharm, said: "We are encouraged by the emerging safety profile of Cogane(TM) and look forward to completing the study by the end of the year. With more than 4.5 million people thought to be suffering from Alzheimer's disease in the U.S., and similar prevalence in other major markets, Cogane(TM) addresses a major opportunity where there is a clear need for improved medication." NOTES TO EDITORS Alzheimer's disease Alzheimer's disease is a neurodegenerative disorder neurodegenerative disorder Neurology A chronic progressive neuropathy characterized by selective and generally symmetrical loss of neurons in motor, sensory, or cognitive systems Types by area Cerebral cortex–Alzheimer's disease, Pick's disease, Lewy body that mainly affects the elderly and is characterized by a progressive loss of learning ability and memory. Alzheimer's disease is thought to affect 4.5 million Americans, and it is believed that this number will continue to grow to approximately 16 million by 2050 (Source: Alzheimer's Association The Alzheimer's Association, incorportated on April 10, 1980 as the Alzheimer’s Disease and Related Disorders Association, Inc., is a non-profit American voluntary health organization which focuses on care, support and research for Alzheimer's disease. ). Several factors have been proposed to play a role in the underlying neurodegeneration, including the excessive formation of beta-amyloid, glutamate glutamate /glu·ta·mate/ (gloo´tah-mat) a salt of glutamic acid; in biochemistry, the term is often used interchangeably with glutamic acid. glu·ta·mate n. 1. A salt of glutamic acid. and a decrease in neurotrophic factors Neurotrophic factors are a family of proteins that are responsible for the growth and survival of developing neurons and the maintenance of mature neurons. Recent research has proven that neurotrophic factors promote the initial growth and development of neurons in the CNS and PNS in the brain. In pre-clinical studies, the synthetic chemical PYM50028 has been shown to be neuroprotective against beta-amyloid and glutamate damage, to reverse the decrease of neuronal growth factors and to reverse neuronal degeneration observed in the aging brain. Importantly, this product restores levels of proteins that are altered in the aging brain, returning them to levels observed in the young and causing beneficial neurite outgrowth and branching. In addition, PYM50028 restores the learning and memory ability in Alzheimer's disease models and thereby offers the potential to reverse the symptoms of Alzheimer's disease. The global annual market for Alzheimer's disease is estimated to be worth in excess of $2.5 billion (source: Datamonitor); it is also estimated that in the U.S., the total annual cost burden for Alzheimer's disease exceeds $100 billion (source: U.S. Alzheimer's Association). Phytopharm plc Phytopharm is focused on the research and development of novel pharmaceutical and functional food products based on clinical and pre-clinical data generated from medicinal plant extracts. The Company has seven development programs in four disease areas: neurodegeneration, obesity and metabolic disease metabolic disease, n a disorder that causes dysfunction of the metabolic action of the body, resulting in loss of control of homeostasis. paraneoplastic syndrome , dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin. and inflammation and has a portfolio of two marketed veterinary products. More information concerning Phytopharm's activities can be found on its web site at http://www.phytopharm.com This press release may contain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S. Securities Exchange Act of 1934 with respect to the financial condition, results and business achievements/performance of Phytopharm and certain of the plans and objectives of its management. These statements are statements that are not historical facts. Words such as "should," "expects," "anticipates," "estimates," "believes" or similar expressions, as they relate to Phytopharm, are intended to identify forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect Phytopharm's current expectations and assumptions as to future events and circumstances that may not prove accurate. There is no guarantee that the expected events, trends or results will actually occur. Any changes in such assumptions or expectations could cause actual results to differ materially from current expectations. |
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