Acetylon Begins Phase 2 Study Of Ricolinostat With Pomalyst

Acetylon Pharmaceuticals, Inc., the leader in the development of selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes, today announced the initiation of a Phase 2 study of ricolinostat (ACY-1215), a selective HDAC6 inhibitor, in combination with Pomalyst® (pomalidomide, Celgene) for the treatment of relapsed-and-refractory multiple myeloma. The Phase 2 segment of the trial follows successful completion of a Phase 1b segment earlier this year, involving dose escalation of ricolinostat. The study, ACE-MM-102, is the second trial of ricolinostat in combination with one of Celgene's IMiD® (immunomodulatory drug) compounds. Ricolinostat is also being evaluated in an ongoing Phase 1b/2 study in combination with Revlimid® (lenalidomide, Celgene). “Our collaboration with Celgene has permitted our clinical investigators and their patients to access ricolinostat in combination with best-in-class IMiD drugs for multiple myeloma. Based on early signs of clinical activity with ricolinostat in combination with Revlimid, and supported by our preclinical results presented at ASH in December 2013 (Quayle and Jones), we believe that ricolinostat has the potential to demonstrate synergistic effects with Pomalyst as well,” said Walter C. Ogier, President and Chief Executive Officer and co-founder of Acetylon. “We are additionally encouraged by the excellent tolerability which ricolinostat has demonstrated thus far in combination with the IMiD class of drugs. In other clinical trials of non-selective HDAC inhibitors, their combination with other anti-cancer drugs has been associated with dose-limiting levels of gastrointestinal, hematologic and cardiac toxicity and fatigue.” The Phase 2 study of ricolinostat in combination with Pomalyst and low-dose dexamethasone is a multicenter, open-label trial to evaluate the safety and efficacy of the drug combination in patients with relapsed-and-refractory multiple myeloma. The primary endpoint of the Phase 2 study is overall response rate. Ricolinostat is being administered orally in the Phase 2 portion of the trial per an optimized schedule determined during the Phase 1b portion, involving daily dosing for the first 21 days of each 28 day treatment cycle. The Phase 2 trial is being conducted at 20 leading cancer treatment centers for multiple myeloma in the United States and Canada, with expansion to sites in Europe planned for early 2015. Additional information about the clinical trial including participating medical centers is available at https://clinicaltrials.gov/ct2/show?term=ricolinostat&rank=4.