GTx (GTXI) Submits Complete Response to FDA for Capesaris Following Clinical Hold
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GTx, Inc. (Nasdaq: GTXI) has submitted to the U.S. Food and Drug Administration (FDA) a complete response to the FDA’s letter regarding the previously announced Full Clinical Hold of the Company’s clinical trials evaluating Capesaris (GTx-758) for primary (first line hormonal) androgen deprivation therapy for advanced prostate cancer and secondary (second line) hormonal therapy.
The FDA’s letter specified the information required by the FDA for the Company to resolve the safety related clinical hold deficiency seen in its recent clinical studies before the Company can initiate further clinical studies of Capesaris.
The Company’s response provides the information requested by the FDA and includes its development plans for Capesaris as a secondary hormonal therapy for advanced prostate cancer at doses lower than those previously tested by the Company. Assuming the FDA determines the Company’s response to be a Complete Response to its Full Clinical Hold letter by adequately addressing the FDA’s request for information to resolve the clinical hold deficiency, the FDA has stated that it will provide the Company a decision whether to lift the clinical hold on further Capesaris development within thirty (30) days of the Company’s submission.
The FDA’s letter specified the information required by the FDA for the Company to resolve the safety related clinical hold deficiency seen in its recent clinical studies before the Company can initiate further clinical studies of Capesaris.
The Company’s response provides the information requested by the FDA and includes its development plans for Capesaris as a secondary hormonal therapy for advanced prostate cancer at doses lower than those previously tested by the Company. Assuming the FDA determines the Company’s response to be a Complete Response to its Full Clinical Hold letter by adequately addressing the FDA’s request for information to resolve the clinical hold deficiency, the FDA has stated that it will provide the Company a decision whether to lift the clinical hold on further Capesaris development within thirty (30) days of the Company’s submission.
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