EnteroMedics, Expansion of EMPOWER Pivotal Study for Obesity to 300 Patients

Feb 26, 2008 - EnteroMedics Inc., (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced that the Food and Drug Administration (FDA) has granted approval for the expansion of its pivotal clinical trial, known as the EMPOWER Study, from 220 patients to 300 patients. Full enrollment in the EMPOWER Study is expected in the first half of 2008, consistent with previous projections, despite expansion of the study.

The EMPOWER Study, which is currently enrolling patients at 10 of its projected 15 clinical sites, is a randomized, double-blind, placebo-controlled study being conducted to evaluate the safety and effectiveness of investigational VBLOC(TM) vagal blocking therapy using the Maestro(TM) System in obese patients. VBLOC Therapy is designed to empower weight loss by promoting earlier feelings of fullness and reduced hunger while minimizing the side effects and complications associated with existing surgical options and preserving the individual's normal anatomy... EnteroMedics' Press Release -

OREXIGEN Therapeutics, European Patent Office Allows Composition and Use Claims for its Patent on Contrave™ to Treat Obesity

Feb 28, 2008 - Orexigen Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, announced that the European Patent Office has issued a Decision to Grant a Patent covering compositions and uses of bupropion and naltrexone for affecting weight loss. These two drugs are the active constituents in Contrave™, Orexigen's lead product candidate for the treatment of obesity. This development is an important milestone toward an eventual patent validation in individual European countries. This patent, once issued, would provide exclusive rights on this combination in those countries until 2024.

This is the latest in a series of decisions strengthening Orexigen's intellectual property portfolio. A notice allowing the corresponding U.S. patent was received from the United States Patent Office (USPTO) in January, and a notice of allowance from the USPTO was received earlier this month for zonisamide to treat obesity. Zonisamide is a key ingredient in Empatic™, which is in the later stages of Phase II clinical development... Orexigen's Press Release -

Athersys, Results for Phase 1 Safety Study of Its Novel Obesity Drug, ATHX-105

Feb. 27, 2008 - Athersys, Inc. (Nasdaq:ATHX) announced top-line results from its Phase 1 clinical trial of ATHX-105, its orally administered drug candidate for the treatment of obesity. ATHX-105 was well-absorbed, providing good drug exposures, well-tolerated up to high doses, and had no negative effect on cardiovascular, hematology or other clinical parameters.

"We are pleased with the results of our Phase 1 study," said Gil Van Bokkelen, Ph.D., Athersys Chairman and CEO. "The data is in line with our expectations for ATHX-105, a highly selective 5HT2c agonist. As we have previously noted, we believe that high selectivity for 5HT2c relative to other receptors, such as 5HT2b and 5HT2a, is key to safety and tolerability. We believe that these results support the view that better selectivity results in superior tolerability for drugs in this class, which is an important factor for achieving effectiveness and patient compliance."... Athersys' Press Release -

TransTech Pharma, Three Programs for the Treatment of Metabolic Disorder from Novo Nordisk

January 25, 2008 – TransTech Pharma, Inc. and Novo Nordisk A/S announced today that TransTech has acquired all rights from Novo Nordisk to a portfolio of drug candidates being developed to treat metabolic disorders. This portfolio is comprised of three distinct therapeutic approaches to such treatment: H3 receptor antagonists, PPARd agonists, and 11βHSD1 inhibitors......TransTech's current diabetes and obesity portfolio includes orally administered and novel therapeutic development candidates targeting PTP1b inhibitors, AgRP inhibitors, GLP1R agonists, AMPK activators and glucokinase activators. Now, with the addition of the three Novo Nordisk programs, TransTech is engaged in 11 clinical and preclinical programs in this area...TransTech Pharma's Press Release- Novo Nordisk's Press Release-

Phase I studies of Compellis Pharmaceuticals’ novel and patented obesity therapy

Boston, Mass., January 7, 2008 – Compellis Pharmaceuticals, an early-stage biopharmaceutical company developing novel mechanism-based therapeutics for the treatment of obesity, announced that its collaborator Pennington Biomedical Research Institute at Louisiana State University, with Principal Investigator Dr. Frank Greenway, MD, has received FDA approval to begin human clinical Phase I studies. Enrollment for the program will begin in the first quarter of 2008 with an expected completion date in the second half of the year...
CP404 is a calcium channel blocker used in a nasal formulation to block olfactory activity and alter behavior to reduce food intake. Compellis Pharmaceuticals has tested a series of like compounds and believes the effect can be seen in the overall class of calcium channel blockers. The advantage of CP404 is that it is a small molecule that is well tolerated in man and is readily manufactured... Compellis' Press Release-