CytRx Corporation (CYTR) received good news when the FDA removed the partial clinical hold on its oncology candidate aldoxorubicin.
The company received a notice last month from the FDA about the partial clinical hold. As per the FDA’s notice, patients already enrolled in these studies were allowed to continue receiving treatment with aldoxorubicin or comparator drugs as per study protocols but new patients could not be enrolled until the partial clinical hold was lifted.
The FDA 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 the administration of aldoxorubicin.
The company worked closely with the FDA’s Oncology Division to resolve all partial clinical hold issues. Consequently, CytRx may now resume enrollment and dosing of new patients once study sites' Institutional Review Boards approve the revised protocols.
As per CytRx, enrollment rates and timelines for its trials will remain materially unchanged. The company expects to complete enrollment in its ongoing phase III trial on aldoxorubicin for second-line soft tissue sarcoma by the end of 2015. Data from the study is expected by mid-2016. Upon FDA approval, CytRx plans to launch aldoxorubicin for second-line soft tissue sarcoma in 2017.
Our Take
The investors will be relieved with the removal of partial clinical hold as aldoxorubicin is company’s key pipeline candidate. CytRx is evaluationg aldoxorubicin for soft tissue sarcoma, glioblastoma, Kaposi's sarcoma and small cell lung cancer.
The candidate is also in a phase Ib trial in combination with Ifex (ifosfamide) for soft tissue sarcoma, and a phase Ib trial in combination with Eli Lilly and Company’s (LLY) Gemzar (gemcitabine) for the treatment of metastatic solid tumors.
Hence, we expect investor focus on further updates from the pipeline.
Investors looking for favorably placed stocks in the pharmaceutical sector may consider Biodel Inc. (BIOD) and Shire (SHPG). While Biodel sports a Zacks Rank #1 (Strong Buy), Shire is a Zacks Rank #2 stock. (Buy).
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