JAMA Publishes Positive Results from Phase II Clinical Trial in Neuropathic Pain with Cannabinoid Compound under Development By Indevus
Tuesday September 30, 4:07 pm ET
LEXINGTON, Mass.--(BUSINESS WIRE)--Sept. 30, 2003--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced the publication of data by the Journal of the American Medical Association showing that a novel synthetic anti-inflammatory and analgesic cannabinoid compound known as IP 751 (also as CT-3) significantly reduced the degree of neuropathic pain in a Phase II clinical trial without causing psychoactive adverse events (JAMA 2003; 290(13): 1757-1762).
The two-week crossover design trial was conducted by a team of investigators at the Hannover Medical School in Germany led by Matthias Karst, M.D., Ph.D. The 21 patients in this trial had chronic neuropathic pain syndromes as a result of previous spinal or peripheral nerve injuries, despite receiving standard pain medication therapy that continued during the trial. 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 receive placebo or IP 751, 20 milligrams given twice a day during the first four days and 40 milligrams twice a day during the remaining three days of the first treatment week. After a washout period of one week, patients were crossed over to the alternative therapy for another week.
The degree of pain experienced by patients, as measured by visual analog scores (VAS), decreased significantly during periods of treatment with IP 751 (p=0.02). In addition, no significant differences were observed between IP 751 and placebo with respect to measurements of cognitive function and prototypic subjective experiences, thereby demonstrating a lack of psychoactive effects accompanying the administration of IP 751 in this trial. IP 751 was therefore shown to be effective in reducing chronic neuropathic pain and was well tolerated, with no major adverse psychological or physical effects observed.
"These results represent an important clinical demonstration of the benefits of a cannabinoid compound in patients with poorly controlled, chronic pain resistant to standard therapy," said Dr. Karst. "These benefits were experienced without the cognitive, psychomotor and physical impairment reported anecdotally or in previous experimental treatments with cannabinoids such as tetrahydrocannabinol (THC). Since this study showed the potential effectiveness of IP 751 in a chronic pain syndrome, with no observed clinically relevant psychoactive adverse events, and since previous animal studies showed no signs of dependency after withdrawal of the drug, additional, longer-term clinical testing of this promising compound is warranted."
"We believe this trial may represent a significant step forward in the evolution of an innovative pain therapy," said Bobby W. Sandage, Jr., Ph.D., executive vice president of research and development at Indevus. "The encouraging results of this study will be the catalyst for a broader clinical development program, involving larger numbers of patients, which will confirm whether or not treatment with this innovative compound can deliver the medical benefits seen with cannabis administration and simultaneously avoid the unwanted psychoactive side effects that currently limit its applicability. The medical and patient community is clearly in need of alternatives to existing pain therapies that have limited efficacy and harmful side effects."
Background
IP 751, a new chemical entity, is a non-psychoactive synthetic cannabinoid. Its principal mechanism of action 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.
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 conducted in Europe and designed to assess the safety of this compound showed that it was well tolerated. Indevus is currently continuing development activities, including preparation for the initiation of further clinical trials with IP 751 in 2004.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the development and commercialization of a diversified portfolio of pharmaceutical product candidates, including multiple compounds in late-stage clinical development. The Company currently has six compounds in development: trospium for overactive bladder, pagoclone for panic and generalized anxiety disorders, citicoline for ischemic stroke, IP 751 for pain and inflammatory disorders, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, and aminocandin for systemic fungal infections.
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: dependence on the success of trospium; the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly trospium; risks associated with contractual agreements; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the commercialization of trospium and for the development of pagoclone and citicoline; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.
Contact:
Indevus Pharmaceuticals
Exec. VP, Research and Development
Bobby W. Sandage, Jr., 781-861-8444
or
VP, Corp. Communications
William B. Boni, 781-861-8444
Source: Indevus Pharmaceuticals |
