Pharmaleads' Lead Candidate For Pain, PL37, Enters Phase I

Main Category: Pain / Anesthetics
Also Included In: Neurology / Neuroscience;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 04 Oct 2008 - 0:00 PDT

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Pharmaleads has obtained from the French Medicine Agency (AFSSAPS) the authorization to perform a single ascending dose Phase I study with PL37, its lead compound for oral treatment of neuropathic pain.

Neuropathic pain is a major chronic pain condition, with an estimated prevalence in the world's population of up to 6%, according to the most recent surveys, with many causes such as shingles, herpes, diabetes, antiviral or antitumor chemotherapy surgery, or low back disorders. Neuropathic pain does not respond well to usual painkillers. Worldwide market for neuropathic pain is estimated to reach 5 billion USD by 2010.

This compound originates from the work of Pharmaleads' chief scientists, Professors Bernard P. Roques and Marie-Claude Fournie-Zaluski, and is a dual inhibitor of both enzymes responsible for the rapid degradation of enkephalins, the endogenous opiates. It therefore elicits an analgesic effect wherever enkephalins are produced as a response to a painful stimulus, and maintains a high level of these natural analgesic substances by preventing their rapid degradation.

According to Thierry Bourbie, Chairman and CEO of Pharmaleads, "PL37 is Pharmaleads' first compound to enter clinical development and the first representative of a totally new class of painkillers, hence confirming the validity of our science and chemistry, as well as our capabilities as a drug development company. Neuropathic pain remains poorly treated and there is an urgent need to develop and bring to patients and doctors a specific oral treatment that would be really active and well tolerated. This looks very promising."

Bernard P. Roques, Vice-President and CSO of Pharmaleads explains: "The inhibition of both enzymes, responsible for the inactivation, in the body, of naturally present opiates, enhances their analgesic properties. PL37 physiological action in all areas where pain is present leads to very promising properties in peripheral neuropathic disorders."

Michel Wurm, M.D., Director of Corporate Development at Pharmaleads stated: "Pre-clinical studies have demonstrated the safety and efficacy of PL37 across all known models for neuropathic pain. The bioavailability of this oral compound is remarkable, as is its safety margin. We hope to complete Phase I in less than a year, including early pharmacodynamic testing in healthy volunteers."

The pre-clinical program was financed with the support of OSEO, the French Public Research Financing Institution.

About Pharmaleads:

Pharmaleads is a pharmaceutical company focusing on research and early development of small molecules. Headquartered in Paris, France, Pharmaleads was founded in 2001 by Professors Bernard P. Roques, pharmacist and PhD in chemistry, Member of the French Academy of Sciences, and Marie-Claude Fournie-Zaluski, PhD in chemistry, both of them inventors of drugs (2 on the market). They were joined in 2004 by Thierry Bourbie, alumnus from Polytechnique and Mines, PhD from Stanford, (former Deputy General Manager, Suez Group) and Jean-Pierre Rogala, PhD from Agro, MBA from MIT (IBM, Suez Group). They were able to bring in their first rank international business expertise to fully unleash the world-class capabilities of the company in pharmacology and medicinal chemistry. In 2006, Michel Wurm, M.D. joined and added his extensive experience in drug and business development.

Pharmaleads
http://www.pharmaleads.com