CytRx Announces Partial Clinical Hold On Main Drug' Big Buying Opportunity For Investors

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.

Today's fall is a great buying opportunity considering that the risk-reward  is now even more attractive. The company can apply its linker technology to many different types of currently approved chemotherapeutic compounds that could improve efficacy while keeping toxicity to a minimum. The company has already displayed that its Aldoxorubicin compound can perform efficiently. For instance in a trial with patients with soft tissue sarcoma the company reported an improved progression-free survival. Patients treated with Aldoxorubicin achieved progression-free survival with an average of 6.4 months which compared historically with placebo only achieving 3 months. Progression-free survival is the amount of time a patient lasts in the clinical trial taking an experimental drug without advancing their cancer to a worsening state.

We think that investors should take a look into the prospects of this biotech and consider initiating a position after this partial clinical hold placed by the FDA. As with every biotech stock there will always be associated risks but this drop has created  a nice buying opportunity.

Disclosure: no position any stocks mentioned

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