CytRx Corporation (CYTR) fell 3.8% after the company announced that it has received a written notice from the FDA that studies evaluating its oncology candidate, aldoxorubicin, have been placed on partial clinical hold. We note that the company had received prior verbal communications from the FDA regarding the same.
As per the FDA’s notice, the patients already enrolled in these studies may continue to receive treatment with aldoxorubicin or comparator drugs as per study protocols but new patients cannot be enrolled until the partial clinical hold is lifted.
The FDA has asked the company to amend all the protocols related to the aldoxorubicin studies to include appropriate inclusion/exclusion criteria, additional patient screening assessment and an evaluation of serum electrolytes before administration of aldoxorubicin. CytRx is working with the FDA to lift the partial hold and resume patient enrollment in the studies.
The company stated that the partial hold is expected to be resolved and will not affect enrollment rates and timelines for its ongoing trials.
CytRx plans to report preliminary results from two phase II studies on aldoxorubicin for the treatment of Kaposi's sarcoma and glioblastoma multiforme in the first half of 2015. The company also expects to complete patient enrollment in a pivotal phase III study on aldoxorubicin for second-line soft tissue sarcoma by the end of 2015.
Additionally, CytRx is evaluating aldoxorubicin for other indications including small cell lung cancer (phase IIb), in combination with Bristol-Myers Squibb Company’ (BMY) Ifex (ifosfamide) for soft tissue sarcoma (phase Ib) and in combination with Eli Lilly and Company’s (LLY) Gemzar (gemcitabine) for metastatic solid tumors.
We are concerned about the partial hold on the company’s key pipeline candidate aldoxorubicin.
Investors looking for well-placed stocks in the pharmaceutical sector may consider AMAG Pharmaceuticals, Inc. (AMAG) carrying a Zacks Rank #2 (Buy).
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