| Repros Therapeutics [NASDAQ:RPRX] may run a new Proellex trial |
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| Biotechnology Companies | |||
| Written by Hugh McManus | |||
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There's news today that Repros Therapeutics may run a new, escalting dose trial on Proellex. The small molecule drug is the subject of clinical trials to address uterine fibroids and endometriosis. The company voluntarily suspended clinical trials on the drug on August 3 last year as a result of safety concerns about elevated liver function, which triggered adverse events. Earlier in the year, there were positive reports about the efficacy of the drugs; woman taking Proellex reported reduced chronic pelvic pain and the requirement for pain killing drugs. The results were published after Repros reported its phase 2 clinical trial results on the drug. Earlier this month, Repros requested the FDA to lift the clinical hold on the drug. It was reported that if Repros modified the scope of the clinical trial on the drug, the FDA would consider the request. An escalating dose study would address the concerns raised by the FDA. In this type of trial, small doses (amounts) of material are administered to the patient population; all major system functions are monitored; the dose is then slowly increased. If the trial can identify the dose at which the onset of problems is likely to occur. It is possible that a low dose regime would have efficacy and the requisite safety profile, thus allowing marketing approval. At this point there is still much risk: the FDA might actually decline permission to run this new trial. In any event, investors seem hopeful. Shares of the company which traded in the $0.76 to $0.88 reached a high of $1.13 (as of 1205 ET) today. The stock has traded as high as $46 back in 1997.
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