The News
Innate Pharma has received approval for its phase II trial with IPH 1101 in HCV in France
21/06/2007
Following the last April 26 announcement by Innate Pharma S.A. (the “Company”), a biopharmaceutical company developing new drug classes targeting innate immunity, of its filing of an application for a Phase II clinical trial with IPH 1101 in Type C viral hepatitis C (“HCV”), the Company announced today that it has received approval from the French authorities to start this trial, Innate Pharma’s first clinical trial outside the field of oncology. IPH 1101 is already in Phase II clinical trial in metastatic renal cell carcinoma (trial IPH 1101- 201) as well as in a Phase I/II in follicular lymphoma (trial IPH 1101-202).
About IPH 1101:
IPH 1101 is the most advanced drug candidate generated by the T?d platform - one of Innate Pharma's three product platforms currently under development and which consists of a family of non-conventional T?9d2 lymphocyte agonists. IPH 1101 is a chemically-synthesized structural analog of non-conventional bacterial phosphoantigens which specifically activate the V?9Vd2 Tlymphocyte subset. The compound has been developed for intravenous delivery in association with subcutaneous, low-dose interleukin 2 (IL-2). IPH 1101 potentiates the direct cytotoxic activity of ?9d2 T cells against a large number of tumor cell lines and also triggers the synthesis of pro-inflammatory cytokines - thus inducing the recruitment of other cell effectors and facilitating implementation of an adaptive response. It has also been shown that V?9Vd2 Tlymphocytes are able to exert clear activity against various types of virus.
About the HCV trial:
The planned Phase II viral hepatitis C study (IPH 1101-203) is a multicenter trial aimed at evaluating the safety and efficacy on viral load of IPH 1101 (alone or combined with IL-2) in patients who are chronically infected by the hepatitis C virus. The study rationale is based on the well-established involvement of ?d T cells in anti-infection immunity. The treatment's safety and efficacy will be evaluated in HCV antiviral treatment-naive patients with respect to their immune response and the potential effect on viral load. The protocol specifies the inclusion of 30 patients who will be randomized into two groups- one receiving IPH 1101 alone and the other receiving IPH 1101 and IL-2.
About the target indication:
The worldwide infectious disease market was estimated at 44.5 billion USD in 2005 (source: CHA Advanced Report) and is expected to double by 2010. According to WHO data, 170 million people may be chronically infected by HCV worldwide. This can be considered in light of the 40 million HIV-infected people worldwide. Hepatitis C is also known to be a major cause of cirrhosis and primary liver cancer (hepatocellular carcinoma). Worldwide, there are probably about 3 or 4 million new cases of hepatitis C annually (Source: UNAIDS and WHO, 2005). In the US, hepatitis C is now the most frequent long-term hematological infection, with 4.1 million people infected (1.6% of the total population, of whom 3.2 million are chronically infection) and between 8,000 and 12,000 deaths per year (source: Center of Disease Control and Prevention).
In addition, decompensated HCV-related cirrhosis is the leading cause of liver transplantation in Europe (source: Direction Générale de la Santé, France). The standard treatment is based on a combination of interferon a and ribavirin - both of which are aimed at blocking viral replication. This combination can provide long-lasting control on the disease and prevent complications in about 50 % of all cases.
About Innate Pharma:
Founded in 1999 and funded by reference venture capitalists up to its IPO on Euronext in Paris in 2006, Innate Pharma S.A. (Euronext Paris: FR0010331421 – IPH) is a biopharmaceutical company developing first-in-class* drugs targeting innate immunity. The pioneering work of Innate Pharma’s scientific founders and research groups has led to the development of three product platforms (gamma delta T cells, NK cells and TLR), each directly or indirectly validated in clinical oncology settings. Besides cancer, Innate Pharma’s drug candidates have development potential in the treatment of infectious disease and chronic inflammation. The company's most advanced molecule is in Phase II clinical trials in cancer. With its strong scientific position in innate immunity pharmacology, its robust intellectual property portfolio and its R&D expertise, Innate Pharma intends to become a leading player in the rapidly growing market of immunotherapeutics.
Based in Marseilles, France, Innate Pharma had 74 employees as at March 31, 2007.
Practical Information about Innate Pharma shares:
ISIN code
Ticker code
FR0010331421
IPH
Disclaimer:
This press release, and the information contained herein, does not constitute an offer to sell or a solicitation of an offer to buy or subscribe for shares in Innate Pharma in any country.
For any additional information, please contact:
Innate Pharma Alize Public Relations
Stéphane Boissel, EVP and CFO Caroline Carmagnol
Tel. : +33 (0)4 96 19 05 58 Tel. : +33 (0)6 64 18 99 59
stephane.boissel@innate-pharma.fr caroline.carmagnol@wanadoo.fr
* with new mechanisms of action.
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