Just a little behind
8K Dated November 29, 2018
Item 8.01 Other Events
The Company is halting enrollment in its Phase I clinical trial of Prolanta for the treatment of ovarian cancer as a result of injection site reactions at the current dose level. No other adverse effects or signs of toxicity have been observed for the drug.
Two subjects enrolled in the second dosing group, 1 mg per kg of body weight, have experienced inflammation and edema at the injection sites that resulted in their withdrawal from the study. Prolanta is injected subcutaneously daily during the treatment period. The Company believes that a reformulation or alternative dosing method of the drug will be required to continue the clinical evaluation of the drug, and such changes may require additional preclinical toxicity studies and additional clearance by the U.S. Food and Drug Administration. The Company does not have the financial resources at this time to conduct such additional studies.
The Company will evaluate its development plans, including accelerating its development timelines for CycloSam, its other product candidate.
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