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Phase 1 Trial Of All-Oral Ricolinostat-Revlimid-Dexamethasone Combo Begins – Acetylon Pharmaceuticals announced last week the initiation of a Phase 1b clinical trial of ricolinostat (ACY-1215) in combination with Revlimid (lenalidomide) and dexamethasone (Decadron) for the treatment of patients with relapsed or refractory multiple myeloma. Ricolinostat is an oral treatment that belongs to a family of anti-cancer drugs called HDAC inhibitors. Other HDAC inhibitors under investigation for multiple myeloma include Zolinza (vorinostat) and panobinostat. Acetylon believes that ricolinostat could produce fewer side effects than other non-specific HDAC inhibitors, as it selectively inhibits the enzyme HDAC6. The primary aim of the trial is to establish an optimal dose of ricolinostat over a 28-day treatment cycle and to assess the potential anti-myeloma activity of the three-drug combination. In addition, Acetylon is enrolling patients for a Phase 1/2 trial of ricolinostat in combination with Velcade (bortezomib) and dexamethasone in patients with relapsed or refractory myeloma. For more information on both trials, please see the Acetylon press release and the U.S. clinical trial registry.

Lucatumumab Shows Modest Activity As Single Agent In Relapsed/Refractory Myeloma – Results from a recent Phase 1 study indicate that lucatumumab, an antibody developed by Novartis, is well tolerated in relapsed or refractory myeloma patients; however, the compound only showed modest activity in the study participants. Specifically, 4 percent of patients maintained a partial response for a period of eight months or longer, and 43 percent maintained stable disease. The most common severe side effects included anemia (7 percent), chills (7 percent), and fever (7 percent). Side effects severe enough to limit drug dosage were seen in about 10 percent of patients. Based on these results, the researchers recommend that lucatumumab be tested in combination with other anti-myeloma drugs. For more information, please see the study in the British Journal of Hematology (abstract).

Viracept-Velcade Combo Kills Myeloma Cells Better Than Either Drug Alone – Researchers at the National Cancer Institute have found that a combination of the anti-HIV drug Viracept (nelfinavir) and Velcade kills myeloma cells better than either drug alone in a preclinical study. Viracept belongs to a class of drugs called protease inhibitors and was approved by the FDA to treat HIV in 1997. Both Viracept and Velcade limit a cell’s ability to chop up and discard unwanted proteins. Simultaneous treatment with both drugs resulted in an accumulation of such unwanted proteins in the cell, eventually resulting in cell death. For more information, please refer to the study in Cell Death and Disease.