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Diatos announces start of the preclinical toxicology program of DTS-108


Paris, France, 17 October 2007 - Diatos SA, an international biopharmaceutical company focusing on the research, development and commercialization of targeted anti-cancer drugs, announced today the start of its regulatory toxicology program of DTS-108, with a Phase I trial planned in the first half of 2008. DTS-108 is a Vectocell® based prodrug of SN38, the active metabolite of irinotecan that is currently used for the treatment of colon and lung cancer.

Preclinical data suggest that DTS-108 could significantly improve on the therapeutic benefit provided by irinotecan. DTS-108 improves the anti-tumoral efficacy and safety compared to irinotecan as a result of an efficient and non-hepatic mode of activation. This results in significantly higher circulating levels of the active metabolite with reduced gastrointestinal toxicity. In addition, it is anticipated that DTS-108 will bypass the inter-patient variability which is a major limitation in the therapeutic use of irinotecan.

Commenting on today's announcement, John Tchelingerian, Ph.D, President & CEO of Diatos, said: 'DTS-108 is the first drug utilising our Vectocell® technology platform to reach the clinic. For Diatos, this is an important validation of our technology platform and further demonstrates the ability of our in-house Research and Development team to push new compounds into the clinic. If these encouraging preclinical observations are reproduced in the clinic, then we will have a second generation irinotecan that will provide a significantly improved patient treatment option in the areas of colon and lung cancer. In addition, clinical studies may indicate other potential novel indications where DTS-108 can be effective, and where irinotecan can not been used.'

- ends -

Notes to Editors

About DTS-108

DTS-108 is an oncology drug product consisting of SN38 (the active metabolite of irinotecan, CPT-11, Campto®, Camptosar®) conjugated through a chemical linker to a Vectocell® peptide. DTS-108 aims to safeguard the efficacy of SN38 while reducing the toxic effects of irinotecan.

Irinotecan is a soluble prodrug of SN38 that is the standard of care for the treatment of metastatic colorectal cancer, however, only a small proportion (2 to 8%) of irinotecan is converted into SN38, mainly by liver carboxylesterase I and/or II. The complex hepatic metabolism of irinotecan results in the accumulation of high SN38 concentrations in the intestine, which leads to severe diarrhoeas, particularly late-onset grade 3 or 4 diarrhoeas that are observed in 30 to 40% of patients. Such patients require hospitalization, dose reductions and/or treatment interruptions (fatal events during single-agent irinotecan treatment have been reported with a prevalence of up to 5.3%). This complex metabolism results in significant variability in terms of both safety and efficacy, which often results in these regimens being relegated to second-line therapy. Nevertheless, the overall survival benefit of irinotecan for patients with metastatic disease can be excellent and dose intensification (when possible) results in improved therapeutic responses (Van Cutsem et al., Br J Cancer 28 (92), 1055-62, 2005). A drug delivery system that would allow efficient and non-hepatic release of SN38 would resolve irinotecan's main drawbacks and result in a safer and more effective drug.

To efficiently deliver SN38 with minimal variability and toxicity Diatos has conjugated a Vectocell® peptide to SN38. Vectocell® peptides (or DPVs for Diatos Peptide Vectors) are proprietary 15- to 23-residue peptide sequences. Their physico-chemical properties make them particularly convenient tools to greatly enhance the aqueous solubility, together with altering pharmacokinetic and tissue distribution characteristics of small therapeutic molecules. This has been found to result in an improved therapeutic index in a number of cases (Meyer-Losic et al., J. Med. Chem., 49 (23), 6908 -6916, 2006).

DTS-108 has v


Publisher Contact Information:

Diatos SA
+ 33 (0)1 53 80 93 81
Jtchelingerian@diatos.com

Company profile of Diatos SA
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