PARIS, October 2 Pharmaleads has obtained from the FrenchMedicine Agency (AFSSAPS) the authorization to perform a single ascendingdose Phase I study with PL37, its lead compound for oral treatment ofneuropathic pain.
Neuropathic pain is a major chronic pain condition, with an estimatedprevalence in the world's population of up to 6%, according to the mostrecent 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 marketfor 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 dualinhibitor of both enzymes responsible for the rapid degradation ofenkephalins, the endogenous opiates. It therefore elicits an analgesic effectwherever enkephalins are produced as a response to a painful stimulus, andmaintains a high level of these natural analgesic substances by preventingtheir rapid degradation.
According to Thierry Bourbie, Chairman and CEO of Pharmaleads, "PL37 isPharmaleads' first compound to enter clinical development and the firstrepresentative of a totally new class of painkillers, hence confirming thevalidity of our science and chemistry, as well as our capabilities as a drugdevelopment company. Neuropathic pain remains poorly treated and there is anurgent need to develop and bring to patients and doctors a specific oraltreatment that would be really active and well tolerated. This looks verypromising."
Bernard P. Roques, Vice-President and CSO of Pharmaleads explains: "Theinhibition of both enzymes, responsible for the inactivation, in the body, ofnaturally present opiates, enhances their analgesic properties. PL37physiological action in all areas where pain is present leads to verypromising properties in peripheral neuropathic disorders."
Michel Wurm, M.D., Director of Corporate Development at Pharmaleadsstated: "Pre-clinical studies have demonstrated the safety and efficacy ofPL37 across all known models for neuropathic pain. The bioavailability ofthis oral compound is remarkable, as is its safety margin. We hope tocomplete Phase I in less than a year, including early pharmacodynamic testingin healthy volunteers."
The pre-clinical program was financed with the support of OSEO, theFrench Public Research Financing Institution.
Pharmaleads is a pharmaceutical company focusing on research and earlydevelopment of small molecules. Headquartered in Paris, France, Pharmaleadswas founded in 2001 by Professors Bernard P. Roques, pharmacist and PhD inchemistry, Member of the French Academy of Sciences, and Marie-ClaudeFournie-Zaluski, PhD in chemistry, both of them inventors of drugs (2 on themarket). They were joined in 2004 by Thierry Bourbie, alumnus fromPolytechnique and Mines, PhD from Stanford, (former Deputy General Manager,Suez Group) and Jean-Pierre Rogala, PhD from Agro, MBA from MIT (IBM, SuezGroup). They were able to bring in their first rank international businessexpertise to fully unleash the world-class capabilities of the company inpharmacology and medicinal chemistry. In 2006, Michel Wurm, M.D. joined andadded his extensive experience in drug and business development.For further information, please contact: PHARMALEADS YUCATAN Michel Wurm, MD, Annie-Florence Loyer Director, Corporate Development +33-1-53-63-27-29 +33-1-440-670-04 [email protected] [email protected]