Financial figures for the 2008/2009 fiscal year
• Liquid funds including marketable securities were up 2.8 million euros compared with the previous year to 22.3 million euros as a result of the capital increase completed in November 2008. Long-term financial liabilities amounting to 8.0 million euros resulted from a loan that will not become payable until 2015.
• Net loss for the 2008/2009 fiscal year amounts to 10.3 million euros compared with -6.3 million euros in the previous year.
• Revenues remain virtually unchanged at 0.4 million euros (0.5 million euros in the 2007/2008 fiscal year).
• Operational expenditure increased to 11.2 million euros (2007/2008: 7.8 million euros) and reflects the significant increase in R&D activities.
About the Phase IIa trial in type C viral hepatitis (IPH 1101-203):
IPH 1101-203 was a multicenter, open label Phase IIa clinical trial designed to evaluate the effect on the viral load of IPH 1101 treatment with and without IL-2, as well as its tolerance and pharmacodynamics in chronically infected hepatitis C patients who are either treatment naïve or have relapsed after one course of standard of care treatment.
The rationale of this trial was based on the known role of ?d T cells in anti-infectious immunity in general and in stimulating the production of certain cytokines in particular.
The primary efficacy endpoint of the trial was a decrease in the viral load of at least 0.5 log10 in at least 6 patients out of 13 evaluable patients in each arm.
The protocol called for the treatment of 26 patients (divided into 2 groups receiving IPH 1101 (750 mg/m²) with and without IL-2 (2 MIU) respectively) for two treatment cycles three weeks apart. 28 patients were included in the trial and evaluable for safety. 25 patients were evaluable for efficacy (for technical reasons, 3 patients could not have their viral load assessed).
Five of the 13 evaluable patients in Arm A (38%) and 7 of the 12 evaluable patients in Arm B (58%) had a viral load decrease of more than 0.5 log10. The objective for the primary endpoint was therefore met in Arm B. The viral load decrease after injection was rapid and lasted for up to three days. Ten of the 19 genotype 1 HCV patients and 2 out of the 3 genotype 4 HCV patients (the two most difficult-to-treat genotypes) had viral load decreases of more than 0.5 log10. About type C chronic hepatitis (“HCV”):
According to data from the World Health Organization (WHO), 170 million people may be chronically infected by HCV worldwide. There are probably about 3 or 4 million new cases of hepatitis C per year (Source: UNAIDS and WHO, 2005). Hepatitis C is known to be a major cause of cirrhosis and primary liver cancer (hepatocellular carcinoma). Furthermore, 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 provides long-lasting control of the disease and prevents complications in about 50% of genotype 1 and 4 patients and about 80% of genotype 2 and 3 patients. Moreover, the length of the course of treatment (6 to 12 months) and the presence of side effects mean that only the most active forms of hepatitis C are treated. About IPH 1101:
IPH 1101, Innate Pharma’s most advanced drug candidate, is a chemical agonist of unconventional ?9d2 T lymphocytes. It is a small-molecule, structural analogue of bacterial unconventional phospho-antigens.
IPH 1101 very specifically activates populations of unconventional ?9d2 T lymphocytes. In oncology indications, it potentiates the direct cytotoxic activity of V?9Vd2 T cells against a large number of tumor cell lines and triggers the synthesis of pro-inflammatory cytokines - thus inducing the recruitment of other cell effectors and facilitating implementation of an adaptive response. The addition of very low-dose IL-2 then enables amplification of the ?d T cell population.
Among the cytokines released upon IPH1101 stimulation, several bear a well characterized activity against viral replication and others can allow the improvement of an adaptive immune response against the virus.
IPH 1101 is being tested in a Phase IIa program in oncology and infectious disease indications (www.innate-pharma.com, section product / IPH 1101). IPH_HCV IPH 1101 About Innate Pharma:
Innate Pharma S.A. ("the company”) is a clinical-stage biopharmaceutical company developing first-in-class immunotherapy drugs for cancer and other severe diseases. The company was incorporated in 1999 and listed on NYSE-Euronext in Paris in 2006.
The company has significant expertise in identifying new targets and bringing novel drug candidates through to clinical proof-of-concept trials. It currently has seven proprietary drug candidates in development (two of which are in clinical trials with lead compound in Phase II clinical trial) and two programs out-licensed to Novo Nordisk A/S. Innate Pharma is based in Marseilles, France, and had 88 employees as at March 31, 2009. Learn more about Innate-Pharma at www.innate-pharma.com.