CytRx Corporation (CYTR) jumped 15.8% after announcing encouraging interim results from a phase II study on aldoxorubicin. The candidate is being developed for the treatment of unresectable glioblastoma multiforme (GBM).
The open-label, multisite study will be evaluating the preliminary efficacy and safety of the candidate in patients whose tumors have progressed even after treatment with surgery, radiation and Merck & Co. Inc.’s (MRK) Temodar (temozolomide). Only patients who haven’t been treated with Roche’s (RHHBY) Avastin are eligible for the study.
Interim results from the study showed prolonged stable disease and tumor shrinkage in several patients. Moreover, one patient under aldoxorubicin treatment showed complete response demonstrating no microscopic evidence of tumor when the tissue was examined after resection.
The main objective of the study is to determine progression-free survival at 6 months and overall survival in recurrent GBM patients. CytRx intends to provide more definitive data in the first half of this year.
CytRx has been struggling with aldoxorubicin lately. In Nov 2014, the FDA informed the company that a partial clinical hold has been placed for all studies on aldoxorubicin. The FDA’s decision was due to the death of an advanced-stage cancer patient who had received aldoxorubicin treatment under CytRx’s compassionate use program despite being ineligible for participation in any of the ongoing trials (read more: CytRx Falls on Partial Study Hold on Oncology Candidate).
Concerns were raised further when last month the company announced that it received a written notice from the FDA stating that new patients cannot be enrolled until the partial clinical hold is lifted. However, patients already enrolled in ongoing studies may continue to receive aldoxorubicin treatment or comparator drugs as per study protocols (read more: CytRx Falls on Written FDA Notice for Aldoxorubicin Study).
Our Take
Favorable interim results from the phase II study on aldoxorubicin at this point of time are a major positive for the company. CytRx is evaluating the candidate in several oncology indications like small cell lung cancer (phase IIb) and soft tissue sarcoma (phase Ib).
Yet, the partial hold on aldoxorubicin remains a concern given that this is the company’s key pipeline candidate. We expect investor focus to remain on the candidate going forward.
Investors looking for favorably ranked stocks in the health care sector may consider AMAG Pharmaceuticals, Inc. (AMAG) carrying a Zacks Rank #1 (Strong Buy).
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