Repros Therapeutics has suspended dosing in all clinical trials of its Phase III drug Proellex, which is being investigated as a treatment for symptoms of uterine fibroids. The company is concerned about clinically significant increases in liver enzymes in patients given two dose levels of the drug; of 500 study subjects given Proellex, seven experienced liver enzyme elevation severe enough to be reported to the FDA as serious adverse events. Advice from a panel of liver experts also factored into the company's decision to suspend the trial. Earlier this month, Repros dropped the 50 mg dose after researchers found that a small percentage of women in the trial experienced a dose-dependent increase in liver enzymes, a key marker of toxicity.
"Job one for us is ethical patient safety, and by removing the 50 mg dose [1] earlier this month we achieved that," said CEO Joseph Podolski in an interview with FierceBiotech. "I think it's important for us to talk to the FDA." At the end of September, Repros is scheduled to meet with the agency and discuss the next steps for Proellex.
Repros also said it is exploring financing alternatives to meet its short term liquidity needs. Podolski noted that in addition to patient safety, all biotech companies have to keep an eye on their financials, particularly when running costly Phase III trials. "By stepping back at this moment we do both," he explained. If funding cannot be secured, Repros will consider reducing its expenses, licensing some or all of its assets, the sale of the company or bankruptcy.
- here's Repros' release [2]
- see the Reuters write-up [3]
Related Article:
Repros drops top dose for late-stage study [1]
Links:
[1] http://www.fiercebiotech.com/story/repros-drops-top-dose-late-stage-study/2009-07-01
[2] http://www.fiercebiotech.com/press-releases/repros-therapeutics-inc-rprx-suspends-dosing-proellex-and-provides-update-financial-s
[3] http://www.reuters.com/article/rbssHealthcareNews/idUSBNG49622020090803