CytRx Corporation’s (CYTR) shares lost 8.7% immediately after the company announced that it has received a notice from the FDA informing the company about a partial clinical hold on all studies on its primary candidate, aldoxorubicin. The company stated that until the clinical hold is lifted, new patients cannot be enrolled in these studies.
However, patients already enrolled in the studies may continue to receive treatment with aldoxorubicin or comparator drugs as per study protocols.
The FDA mentioned in the notice that it had placed all aldoxorubicin studies on partial hold, owing to the death of an advanced-stage cancer patient who had received aldoxorubicin treatment under CytRx’s compassionate use program despite being ineligible to participate in any of the ongoing trials.
The FDA has asked CytRx to amend all the protocols related to the aldoxorubicin studies. This amendment should include appropriate inclusion/exclusion criteria, additional patient screening assessment and an evaluation of serum electrolytes before administration of aldoxorubicin.
CytRx said that it is working with the FDA to lift the partial hold and resume patient enrollment in the studies.
We note that the company has assured that the partial hold on the studies will not affect patient enrollment rates. Moreover, timelines involved in the ongoing studies will not be materially impacted.
CytRx intends to announce preliminary results from two phase II studies on aldoxorubicin for the treatment of Kaposi's sarcoma and glioblastoma multiforme in the second quarter and first half of 2015, respectively. Meanwhile, the company 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 in a phase IIb study for small cell lung cancer and two phase Ib studies – one for soft tissue sarcoma (aldoxorubicin plus ifosfamide) and the other for metastatic solid tumors (aldoxorubicin plus Gemzar).
The partial hold on the aldoxorubicin studies is concerning since it is the primary candidate in CytRx’s pipeline.
Investors looking for well-placed stocks in the pharmaceutical sector may consider AMAG Pharmaceuticals, Inc. (AMAG), Lannett Company, Inc. (LCI) and ANI Pharmaceuticals, Inc. (ANIP). All these stocks carry a Zacks Rank #1 (Strong Buy).
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