Shares of CytRx Corporation (CYTR) fell as low as 10% on the day as the company received notice that the FDA would place a partial clinical hold on its Aldoxorubicin drug, which is being used in patients with multiple types of cancer. This type of news has brought the share price down for CytRx today, but it is a great buying opportunity for investors because it is not a full clinical hold. What it means is that the FDA has stated that patients can continue with the Aldoxorubicin treatment that are currently enrolled in the clinical trial, but as of now the company has to temporarily suspend enrollment until they receive further feedback from the FDA.

The partial clinical hold was based on the fact that one patient with advanced stage cancer, who was not enrolled in the clinical trial itself, had died. The patient was using Aldoxorubicin under the “compassionate use” program from the FDA. The “Compassionate Use” program was established by the FDA to allow people to take an experimental drug that would treat their unmet medical need despite that patient not being enrolled in the clinical study itself. CytRx says that it can easily address the FDA’s concerns in a timely manner and should have no problem having the partial clinical hold lifted. As soon as the clinical hold is lifted the company will be able to resume enrollment in the clinical trials using Aldoxorubicin.

The company is currently running multiple clinical trials with Aldoxorubicin and has one late stage phase 3 trial treating patients with Soft Tissue Sarcoma. Other clinical trials utilizing Aldoxorubicin include NSCLC — non-small cell lung cancer , glioblastoma — brain cancer, and other types of cancers. The company uses a currently marketed chemotherapeutic agent known as Doxorubicin but have attached their own acid sensitive linker that combines the drug compound into Aldoxorubicin. What this linking does is increase the efficacy of the drug while at the same time reducing the known adverse effects it has on patients. As the drug is already approved and with the known reduction of safety risks we believe that CytRx should be able to resolve this matter efficiently with the FDA.

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