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Perifosine Approved For Phase III Trial

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Perifosine Approved For Phase III Trial

Found this article about new anti-cancer drug on http://www.myelomaforums.com/:

The U.S. Food and Drug Administration has announced approval for a Phase 3 clinical trial evaluating perifosine in relapsed and refractory multiple myeloma patients. Perifosine, also known as KRX-0401, is an oral anti-cancer agent produced by Aeterna Zentaris and licensed in the U.S., Canada, and Mexico by Keryx Biopharmaceuticals. The trial, entitled “A Phase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib,” will evaluate the safety and efficacy of perifosine, compared to placebo, when added to a Velcade (bortezomib) and dexamethasone (Decadron) regimen. To participate, patients must have already received treatment with Velcade and either Revlimid (lenalidomide) or thalidomide (Thalomid). Though the study is not yet enrolling, the trial will involve approximately 400 patients. As its primary objective, the study will assess whether perifosine extends progression-free survival, and it will also evaluate overall response rate, survival, and safety. In previous clinical trials, perifosine has demonstrated significant anti-cancer activity. Acting through a novel mechanism, perifosine inhibits the (PI3K)/Akt cellular pathway – thereby preventing cancerous cell growth and maturation. In addition, it regulates a number of other key cellular processes, including the JNK and MAPK pathways, which are associated with programmed cell death, growth, differentiation and survival. Through these multiple effects, perifosine helps inhibit tumor growth and encourages cancer cells to die. “Perifosine has shown considerable activity when combined with [Velcade] and dexamethasone in heavily pre-treated patients with relapsed and refractory disease,” explained Dr. Paul Richardson, the clinical director of the Jerome Lipper Multiple Myeloma Center, Dana Farber Cancer Institute, and the study chairman for the upcoming trial. “We are hopeful that the upcoming Phase 3 trial will demonstrate clinical benefit for our patients with less advanced myeloma.”

Anyone familiar with this? It didn’t come up during our Millennium Drug Company meetings in Boston. Guess that makes sense, since it is produced by another company, even though trial uses in along with Velcade.
Feel good and keep smiling! Pat