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Indevus Reports Positive Results From Phase II Clinical Trial With IP 751 in Neuropathic Pain
Tuesday December 3, 9:13 am ET
LEXINGTON, Mass.--(BUSINESS WIRE)--Dec. 3, 2002--Indevus Pharmaceuticals, Inc. (NASDAQ:IDEV - News) today announced that treatment with IP 751 (previously known as CT-3), a novel anti-inflammatory and analgesic synthetic cannabinoid compound, significantly reduced the degree of neuropathic pain in a Phase II clinical trial.
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Investigators at the Hannover Medical School in Hannover, Germany, reported that patients experienced significantly less pain when treated with IP 751 compared with placebo during the two-week, crossover design trial among 21 patients. In addition, no significant differences were observed between IP 751 and placebo with respect to adverse events, and notably, the lack of psychoactive properties related to IP 751 was confirmed in this study.
Patients in this trial had chronic pain syndromes as a result of previous spinal or peripheral nerve injuries, despite the continuation of standard pain medications. For inclusion, they had to have experienced pain for at least six months, although the average duration of their pain syndromes was greater than ten years. Patients were randomized to two 7-day treatment periods in a crossover design. They received one of two doses of IP 751 (20 milligrams or 40 milligrams) or placebo twice a day during the first week, then were switched to the other regimen during the second week. The degree of pain, as shown by visual analog scores (VAS), decreased significantly during treatment periods (p<0.05).
"We are pleased with the results of this trial, which will lead to the continued development of IP 751 and build upon the findings from an initial Phase I trial and multiple pre-clinical models of pain and inflammation," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus.
"Despite the well-known anecdotal reports of the analgesic effects of cannabinoids such as tetrahydrocannabinol (THC), to our knowledge, this is the first controlled trial of a synthetic non-psychoactive cannabinoid in patients with an intractable pain syndrome," said Dr. Cooper. "We believe IP 751 may have broad potential applications in pain management and inflammatory conditions such as arthritis, post-operative pain, musculoskeletal injuries, headache and neuropathic pain.
"Should the efficacy of IP 751 be confirmed in future studies, such a novel non-steroidal anti-inflammatory agent lacking the pharmacological propensity to cause stomach ulceration would have important clinical ramifications," said Dr. Cooper.
IP 751, a new chemical entity, is a non-psychoactive synthetic cannabinoid. The principal mechanism of action of the compound appears to be the potent inhibition of the inflammatory cytokines, particularly interleukin-1 beta and TNF-alpha. The compound has significant activity in multiple pre-clinical models of pain and inflammation. Unlike most available non-steroidal anti-inflammatory agents (NSAIDS), in pre-clinical studies IP 751 does not appear to produce gastrointestinal ulceration.
"New agonists at cannabinoid receptors may offer therapeutic benefits without conferring psychoactive effects," said Professor Udo Schneider, who led the team of researchers at Hannover Medical School. "This trial provides valuable research-based evidence about the benefits of an agonist that appears to affect specific receptors, other than those currently known, that are involved in mediating analgesic and anti-inflammatory effects."
An IND (investigational new drug application) for IP 751 has been filed with the U.S. Food and Drug Administration (FDA). An initial Phase I clinical trial designed to assess the safety of IP 751 showed that it was well tolerated. Indevus is currently determining the optimal clinical and regulatory plan for advancing IP 751 as a therapy for pain and inflammatory disorders.
Indevus Pharmaceuticals licensed exclusive, worldwide rights to IP 751 from Atlantic Technology Ventures, Inc. (OTC BB: ATLC.OB - News).
Indevus Pharmaceuticals is engaged in the development and commercialization of a portfolio of products and product candidates, including multiple compounds in late-stage clinical development. The Company's lead products under development include trospium for overactive bladder, pagoclone for panic/anxiety disorders, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for pain and inflammation, citicoline for stroke and dersalazine for inflammatory bowel disease.
Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: uncertainties relating to clinical trials, regulatory approval and commercialization of our products, including trospium; the early stage of products under development; need for additional funds and corporate partners, including for the development of pagoclone and citicoline; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; dependence on third parties for manufacturing and marketing; competition; risks associated with contractual arrangements; limited patent and proprietary rights; and other risks.
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Contact:
Indevus Pharmaceuticals, Inc.
Michael W. Rogers or William B. Boni, 781/861-8444 |
