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Clinical Trials

Date: 2011-05-31

Type of information:

phase: 2a

Announcement: results

Company: Hybrigenics (France)

Product: inecalcitol

Action mechanism: Inecalcitol is a synthetic chemical derivative of calcitriol, the naturally active form of vitamin D.

Disease: castrate-resistant prostate cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

Hybrigenics announces that the complete positive results of clinical tolerance Phase IIa study of daily oral inecalcitol in castrate-resistant prostate cancer patients, in combination with the standard 3-weekly Taxotere® chemotherapy regimen, will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 5th in Chicago. At the ASCO meeting, Hybrigenics will report a completely new aspect relating to the fast onset of action of the combination treatment: 43% of the patients showing a Prostate-Specific Antigen (PSA) decline of at least 30% within 3 weeks (i.e. before the second injection of Taxotere®). In addition to the previously reported high maximum tolerated dose (4 milligram per day) and excellent total response rate (85% of the patients showing a PSA decline of at least 30% within 3 months), this fast onset of action justifies the preparation of the next step of development: the start of a phase IIb study.
Given its excellent safety profile and strong presumption of efficacy, inecalcitol can proceed to a clinical efficacy Phase IIb study in the same therapeutic indication as soon as pharmaceutical or financial partners have been secured. Other diseases such as hormone-dependent prostate cancer and severe psoriasis will be considered as additional indications for inecalcitol, to take advantage of its strong anti-proliferative potency.

 

Is general: Yes