Today, CytRx Corporation announced that US health regulators removed a partial clinical hold on its late-stage cancer trials, causing shares to jump ten percent.
The company said that the US Food and Drug Administration (FDA) has removed the partial clinical hold on its aldoxorubicin clinical trials, and enrollment and dosing of new patients is permitted once study sites’ Institutional Review Boards (IRBs) approve the revised trial protocols. In November, CytRx had been ordered to halt enrollment following the death of a patient taking the drug under compassionate use rules.
The company said that it modified its research so it could avoid risks to patients and still assess the drug’s impact on several forms of cancer. However, CytRx did not provide information on what exactly these modifications were.
The company believes that the delay will not significantly alter its development timeline. CytRx expects to complete enrollment in its ongoing Phase III trial in second-line soft tissue sarcoma by the end of 2015 and unblind the clinical data by mid-2016. If successful and approved, the company estimates market launch of aldoxorubicin for second line soft tissue sarcoma in 2017. The company is also evaluating the drug in a Phase IIb clinical trial in small cell lung cancer, a Phase II clinical trial in HIV-related Kaposis’s sarcoma, a Phase II clinical trial in patients with late-stage glioblastoma, a Phase Ib trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase Ib trial in combination with gemcitabine in subjects with metastatic solid tumors.
“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 A. Kriegsman, Chairman and CEO of CytRx. “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.”
Aldoxorubicin is a modified form of the widely used chemotherapeutic agent doxorubicin. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Aldoxorubicin is designed to release the drug into the tumor, while staying benign in healthy cells. This allows for greater doses of doxorubicin to be administered while reducing its toxic side effects.
Source: CytRx Corporation