FDA Removes Partial Clinical Hold on CytRx Corporation's Brain Cancer Trials
January 20, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
CytRx Corporation today announced that the U.S. Food and Drug Administration (FDA) has removed its partial clinical hold on the company’s clinical trials of cancer drug aldoxorubicin for patients with soft tissue sarcoma, glioblastoma, Kaposi's sarcoma, and small cell lung cancer. In the wake of the announcement, share prices of CytRx shot up 11 percent in premarket trading, according to Bloomberg.
The stock price closed yesterday at $3.32, opened this morning at $3.65, but was trading at $3.23 as of 11:10 a.m. today eastern standard time.
Now that the Institutional Review Boards (IRBs) of the study sites have approved CytRX’s revised trial protocols, enrollment in the trial and dosing of patients can resume.
“CytRx developed modified study parameters intended to avoid potential risks, while allowing the company to evaluate the therapeutic impact of aldoxorubicin for patients with soft tissue sarcoma, glioblastoma, Kaposi's sarcoma, and small cell lung cancer, among other trials,” said Steven Kriegsman, the chairman and chief executive officer of CytRx, in a statement. “Our staff worked closely with the FDA Oncology Division to resolve all partial clinical hold issues as rapidly as possible. We expect enrollment and dosing in the ongoing clinical trials to be back underway soon.”
The FDA placed a partial clinical hold on the study in November 2014, reported BioSpace. The basis for the partial hold was a reported death of a patient with advanced-stage cancer. The patient was not a part of the study, but had been given aldoxorubicin under a “compassionate use” program. In the wake of the patient’s death, the FDA requested that CytRx add more patient screening assessments to the inclusion/exclusion criteria of possible study participants. In addition, the FDA requested the company perform an evaluation of serum electrolytes on study participants before administering them aldoxorubicin.
A combination cancer medication, aldoxorubicin combines doxorubicin with a novel single-molecule linker. “The linker molecule directly binds to circulating albumin. Specific types of tumors concentrate albumin, so the new medication increases delivery of the drug to those tumors,” reported Biospace at the time. “Studies have indicated this allows for 3.5 to 4 times the doses of doxorubicin to be administered with lower toxic side effects.”
CytRx plans to complete enrollment in its ongoing Phase III trial in second-line soft tissue sarcoma by the end of 2015 and estimates that unblind clinical data will be available by mid-2016. Subject to FDA approval, CytRx’s market launch of aldoxorubicin for second line soft tissue sarcoma is projected for 2017.
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