Date: 2012-10-03
Type of information: Initiation of preclinical development
phase: 2
Announcement: initiation of the trial
Company: Ipsen (France) Active Biotech (Sweden)
Product: tasquinimod
Action
mechanism: immunomodulator/immunotherapy product. TASQ (tasquinimod, ABR-215050) binds to a molecule called S100A9 which is expressed in the white blood cells involved in the regulation of immune responses. S100A9 interacts with two known pro-inflammatory receptors (Toll like receptor 4 (TLR4) and receptor of advanced glycation end products (RAGE)) and this interaction is inhibited by TASQ (Björk et al PLoS Biology, April 2009).
Disease: metastatic castrate-resistant prostate cancer
Therapeutic area: Cancer - Oncology
Country: Europe
Trial
details: A global, 2:1 randomized, placebo controlled, double-blind Phase II trial investigating up to 1 mg/day of taquinimod versus placebo in 150 metastatic castrate resistant prostate cancer (mCRPC) patients who have not progressed after a first line docetaxel based chemotherapy. The primary endpoint of the study is radiological progression free survival. The study will be recruited across about 50 centers in Europe.
Latest
news: * On October 3, 2012, Ipsen and Active Biotech have announced the initiation of a new phase II proof of concept clinical trial, evaluating the activity of tasquinimod in advanced metastatic castrate resistant prostate cancer patients. The study aims at establishing the clinical efficacy of tasquinimod used as maintenance therapy in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have not progressed after a first line docetaxel based chemotherapy.
Karim Fizazi, Head of the Cancer Medicine Department of the Institut Gustave Roussy (IGR) in France and Principal investigator of the study said: "In current clinical practice, metastatic castrate-resistant prostate cancer patients with non-progressive disease after docetaxel treatment are not proposed any medication as no reference/standard treatment exists. These patients remain untreated until disease progression. Prolongation of the response to first line chemotherapy (consolidation) represents an unmet need for which patients and physicians request further therapeutic options. 'Switch maintenance' therapy with manageable safety profile such as tasquinimod could be one strategy to prolong treatment response, without significantly compromising quality of life.\"
The "switch maintenance" trial is part of the initial agreement with Active Biotech to enhance tasquinimod's data package beyond the ongoing phase III placebo-controlled study in men with bone-metastatic CRPC, which has been adequately powered to detect an OS improvement.
The phase III study will include about 1,200 patients in more than 250 centers. Recruitment is proceeding according to plan with top line results expected by the end of 2013.
Today the development of tasquinimod is principally focused on the treatment of prostate cancer. It was announced in December 2009 that the primary endpoint of the Phase II clinical study, to show a higher fraction of patients with no disease progression during the six-month period of treatment using tasquinimod, had been met. Phase II results were published in Journal of Clinical Oncology in September 2011. In June, 2012, overall survival (OS) data was presented at ASCO (American Society of Clinical Oncology).
