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.
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