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FDA Gives Orphan Drug Designation to CytRx Corp. (CYTR) Pancreatic Cancer Treatment

Apr. 28, 2011 2:32 PM ETLADXD
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Oncology-focused biotech company CytRx Corp. today announced that its tumor-targeting pro-drug candidate INNO-206 has been approved for orphan drug designation for the treatment of patients with pancreatic cancer by the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA), giving the company leverage to advance into phase II clinical trials.

CytRx holds the exclusive worldwide development and commercialization rights to INNO-206, which is designed to control the release of commonly prescribed chemotherapeutic doxorubicin and to preferentially target tumors. The company said it believes INNO-206 may make it more effective and less toxic in cancer patients than doxorubicin.

“This designation represents an important and exciting step in the overall development program for INNO-206. We are delighted with the FDA’s decision to grant INNO-206 this special status, particularly given that treatment with INNO-206 resulted in a statistically significant, three-fold reduction in the average primary tumor size in an animal model of pancreatic cancer,” Steven A. Kriegsman, president and CEO of CytRx stated in the press release.

Kriegsman noted that INNO-206 is one of few drugs demonstrating positive results as a pancreatic cancer treatment.

“Only a handful of drugs have shown any benefit for the treatment of patients suffering from this rapidly progressing, deadly cancer, and INNO-206 outperformed both doxorubicin and the current standard of care gemcitabine in the animal trial. We are now arranging advancement of INNO-206’s development for pancreatic cancer in a phase II clinical trial,” he stated.

CytRx is currently conducting a phase Ib safety and dose escalation study with INNO-206 in patients with advanced solid tumors who have failed standard therapies. The company said it plans on moving into phase II clinical testing in the second half of this year.

For more information visit www.cytrx.com

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