Marseilles, October 22, 2007 -- Innate Pharma SA, a biopharmaceutical company developing first-in-class drugs targeting the innate immune system, today announced that it has received approval from the French authorities to start an exploratory Phase II (“Phase IIa”) clinical trial in chronic myeloid leukaemia (“CML”) with IPH 1101, the lead drug candidate of its ?d T cell platform. This trial (the “IPH 1101-204” study) is the drug candidate’s fourth exploratory Phase II clinical trial and its third in an oncological indication.
IPH 1101 is already in a Phase IIa clinical trial in metastatic renal cell carcinoma (“mRCC”), a Phase I/II in follicular lymphoma (“fNHL”) and a Phase IIa in Type C viral hepatitis (“HCV”). As previously indicated by Innate Pharma, a fifth exploratory Phase II clinical trial with IPH 1101 (administered in combination with a cytotoxic agent) is being prepared in a solid tumour indication. The application for this latter trial should be filed at some point in Q4 2007 (see the summary of ongoing Phase II clinical trials attached to this release and also available on the Company’s website at www.innate-pharma.com).
The first results from the Phase IIa trial in metastatic renal cell carcinoma (mRCC) should be available during the first part of 2008. The initial data from the other Phase I/II or Phase IIa clinical trials are expected in 2008 and 2009.
Completion of the final safety, pharmacology and efficacy database from the ongoing IPH 1101 trials is expected as of 2010.
“Our clinical development strategy with IPH 1101, the leading drug candidate of our ?d T cell platform, is focused on obtaining clinical proof of concept for a new immunotherapy targeting the ?d T cells”, says Hervé Brailly, CEO of Innate Pharma. He adds: “The launch of this new clinical trial is one of the objectives we had set for 2007 and disclosed at the time of our IPO. We are focussed on executing our plan and are now working on the launch of a fifth exploratory Phase II clinical trial, in line with our stated schedule”.
“We are very pleased to be launching this trial since it offers a favourable setting for an immunotherapy strategy, specifically a residual stage of the disease and a biological marker with a documented prognostic value” points out Patrick Squiban, CMO of Innate Pharma.
