Replies to post #145724 on Biotech Values

[ghmm]

The encouraging thing to me was there seems to be a dose response correlation. I wonder if they need (and safely can) dose higher. The mechanism is not one I've heard tried before. For patients hope it works.

[mcbio]

EnVivo Pharmaceuticals Announces Statistically Significant Improvement in Cognition and Clinical Function in Phase 2b Clinical Trial in Alzheimer’s Disease

I see that EnVivo is private but, among publicly-traded small-cap biotechs, I know that TRGT is also working on an alpha-7 agonist (http://www.targacept.com/wt/page/tc_5619 ). TRGT is running Phase 2 trials in ADHD and schizophrenia, with the former set to report 2H this year and they say they are evaluating a Phase 2 trial in Alzheimer's. Perhaps these results will compel them to run such a trial. I haven't been much of a fan of TRGT but shares have been battered and you have to wonder if there could be some salvage value given the news for EnVivo and the fact that TRGT is involved in this space as well.

Here are links to the prior Phase 2a results for TC-5619 in schizophrenia and ADHD: http://www.targacept.com/wt/page/pr_1302179429 and http://www.targacept.com/wt/page/pr_1300969304 respectively. The schizophrenia results seem promising though AZN decided against licensing the drug after these results and it remains wholly-owned by TRGT right now.

[jq1234]

Pfizer Announces Topline Results Of First Of Four Studies In Bapineuzumab Phase 3 Program


Co-Primary Clinical Endpoints Not Met in Study of Patients with Alzheimer’s Disease Who Carry The ApoE4 Genotype


NEW YORK--(BUSINESS WIRE)--

Pfizer Inc. (PFE) announced today that the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in the Janssen Alzheimer Immunotherapy R&D LLC (Janssen AI)-led Phase 3 trial of intravenous (IV) bapineuzumab in patients with mild-to-moderate Alzheimer’s disease who carry the ApoE4 (apolipoprotein E epsilon 4) genotype (Study 302). Pfizer and Janssen AI are partners in the Alzheimer’s Immunotherapy Program (AIP).

These clinical findings have been shared with regulatory authorities and study investigators so that participants in the ongoing clinical program can be informed. Because in this study clinical efficacy was not demonstrated in ApoE4 carriers, the Janssen AI and Pfizer Joint Steering Committee for the AIP has decided that participants from this study who enrolled in a follow-on extension study will no longer receive doses of bapineuzumab. However, these patients will have a follow-up evaluation.

Based on a comprehensive review of the data by the independent safety monitoring committee, all other ongoing Janssen AI and Pfizer bapineuzumab studies are continuing as planned and without modifications.

Study 302 is the first of four placebo-controlled Phase 3 studies to complete in the comprehensive development program of bapineuzumab IV. Janssen AI is leading two Phase 3 studies of patients who are ApoE4 carriers (Study 302) and non-carriers (Study 301) at sites primarily in North America. Pfizer is conducting two Phase 3 studies of patients who are ApoE4 carriers (Study 3001) and non-carriers (Study 3000) at sites primarily outside of North America.

The Alliance will expedite the completion of an interim analysis for the on-going, Pfizer-conducted Phase 3 study of ApoE4 carriers (Study 3001) based on the results of Study 302.

The topline results from Study 301 in patients with mild-to-moderate Alzheimer’s disease who do not carry the ApoE4 genotype are expected to be announced later this summer.

“While we are disappointed in the topline results of Study 302, a more complete understanding of bapineuzumab and its potential utility in mild-to-moderate Alzheimer’s disease will be gained following the availability of additional data, including data from the soon-to-be available non-carrier Study 301,” said Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. “We recognize that Alzheimer’s disease is very complex, but Pfizer, along with our partner Janssen AI, remains committed to advancing the science of Alzheimer’s disease, with the ultimate goal of delivering innovative and meaningful new treatment options to patients.”

Data from both the ApoE4 carrier (Study 302) and non-carrier (Study 301) studies have been accepted as a late-breaker and will be presented in September at the European Federation of Neurological Societies meeting in Stockholm.

The presence of the ApoE epsilon 4 genotype is a genetic risk factor for Alzheimer’s disease and is associated with increased beta-amyloid plaques in the brains of patients with the disease. Topline results of Study 302 indicate that among patients treated with bapineuzumab IV the most commonly observed serious adverse events which occurred more commonly than placebo and with an incidence of at least 1 percent were ARIA-E and dehydration. ARIA-E (amyloid-related imaging abnormalities-edema or effusion) refers to changes in the brain that may be due to fluid (water and protein) leaking from blood vessels, which can be detected using magnetic resonance imaging (MRI) of the brain.

http://finance.yahoo.com/news/pfizer-announces-topline-results-first-210100914.html

[jq1234]

EnVivo Pharmaceuticals Announces Appointment of Deborah Dunsire, M.D., as President and Chief Executive Officer

Industry Leader to Direct Company Growth, Commercialization of Phase 3 Programs in Alzheimer’s Disease and Schizophrenia, and Expansion of Diverse CNS Pipeline

WATERTOWN, Mass. – July 11, 2013 – EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel therapies for central nervous system (CNS) diseases, today announced the appointment of Deborah Dunsire, M.D., as president and chief executive officer. She also joins the company’s board of directors. Dr. Dunsire, formerly president and chief executive officer of Millennium: The Takeda Oncology Company, brings more than 25 years of scientific, clinical, operational and commercial experience, and proven leadership in the biological and pharmaceutical industry.

Dr. Dunsire served as president and chief executive officer of Millennium Pharmaceuticals, Inc., now Millennium: The Takeda Oncology Company, from 2005 to 2013. During that period, she transformed the company into a biotechnology industry leader by focusing R&D, driving the development pipeline, fostering a culture of employee engagement and increasing the commercial mindset across the organization to enhance the commercial success of marketed products. The company was acquired by Takeda Pharmaceutical Company Limited in 2008 for $8.8 billion – one of the largest biotech acquisitions at that time – and became Millennium: The Takeda Oncology Company. Dr. Dunsire was the first woman appointed to Takeda’s board of directors.

http://www.envivopharma.com/news-item.php?id=47