Repros Therapeutics (NasdaqGM:RPRX) today announced that the Company has entered into an amendment with the National Institutes of Health (NIH) to its existing exclusive license for Proellex® that revises the existing milestones and dates for performance to provide additional time to lift the current clinical hold on Proellex or select a second generation molecule for further development from the family of anti-progestational agents covered by the license.
Previously the Company announced in early August 2009 that it had voluntarily suspended dosing of all patients in its Proellex clinical trials. The FDA subsequently notified Repros that the Proellex program was placed on full clinical hold due to the observation of increased liver enzymes in a number of patients treated with Proellex.
The clinical hold on Proellex affected a variety of benchmark milestones used by the NIH to enforce its license. The Company believes the new agreed amendment between Repros and the NIH allows Repros sufficient time to determine whether it is possible to lift the clinical hold on Proellex. The Company is addressing the deficiencies noted by the FDA and hopes to submit pharmacokinetic data as soon as possible to the Agency that would be supportive of the safety of lower doses that could be tested in short duration trials that would be suggestive of clinical efficacy. However, there can be no assurances that the FDA will view such data as sufficient for lifting the current full clinical hold.