CytRx Announces Plan To Initiate A Phase 2 Clinical Trial With INNO-206 In Patients With Advanced Soft Tissue Sarcomas

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials
Article Date: 25 Nov 2009 - 15:00 PST

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CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, today announced plans to initiate a multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a treatment for patients with advanced soft tissue sarcomas who have failed surgery and radiation. Soft tissue sarcomas are cancers that are formed in the muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body.

In the open-label Phase 2 clinical trial, 50 patients will receive INNO-206 once every three weeks for four consecutive cycles. The study will be conducted in approximately 25 study centers in the U.S., Europe and India. Following trial initiation, patient enrollment is expected to be completed in approximately 12 months. These patients will be evaluated on an ongoing basis for overall tumor response and progression-free survival.

"Our decision to move into Phase 2 clinical testing in advanced soft tissue sarcomas was largely based on positive clinical and preclinical trial results with INNO-206," said CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D. "In animal testing, INNO-206 was safely administered at higher levels than doxorubicin, demonstrating superior antitumor efficacy of this widely used chemotherapeutic agent. Phase I trial results showed that INNO-206 was safe when administered at six times the standard dosing of doxorubicin and produced objective clinical responses in patients with sarcoma, breast and lung cancers."

CytRx President and CEO Steven A. Kriegsman said, "Patients with advanced soft tissue sarcomas who can no longer be treated with surgery have a poor prognosis. Progression-free survival for this group is around six to seven months, and median overall survival is approximately 18 months with less than one-third of these patients living past three years. Combinations of the chemotherapy drugs ifosfamide and doxorubicin appear to offer the highest response rates and longest time to progression in these patients; however, these regimens have not significantly improved survival. The ability to administer INNO-206 at a higher dose than doxorubicin without potentially increasing side effects could enhance these patients' quality of life and potentially prolong survival."

About INNO-206

CytRx holds the exclusive worldwide rights to INNO-206, a prodrug derivative of the commonly prescribed chemotherapeutic agent doxorubicin. INNO-206 is designed to reduce adverse events by controlling drug release and preferentially targeting tumors. In a Phase 1 clinical trial, INNO-206 was administered in doses at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. In the Phase 1 clinical trial of 35 patients with various cancers treated with INNO-206, three patients showed a partial tumor reduction and 20 patients showed stable disease over the course of the trial. All three of the partial responses occurred at the higher dose ranges of the dose-ranging safety study. Animal studies conducted by INNO-206 inventor Dr. Felix Kratz, Department of Medical Oncology, Clinical Research, at the Tumor Biology Center in Freiburg, Germany, demonstrated statistically significant results in breast, ovarian, pancreatic and small cell lung cancers. Results of these studies were published in the peer-reviewed journal Investigational New Drugs.

About Soft Tissue Sarcomas

Soft tissue sarcomas comprise a group of relatively uncommon tumors that may arise in a variety of sites that include soft tissues, skin muscle and internal organs. The extremities (50%), trunk and retroperitoneum (40%) or head and neck (10%) account for the sites where these tumors develop. The three major types of soft tissue sarcomas are leiomyosarcomas, malignant fibrous histiocytomas and liposarcomas. Most tumors arise in the soft tissues, including the heart, skin, uterus and retroperitoneum.

Approximately 25,000 new cases of soft tissue sarcomas will be diagnosed and nearly 10,000 deaths will be attributed to this cancer worldwide this year. Incidence rates rise exponentially with age with a modest peak in childhood due primarily to the increased development of embryonal rhabdomyosarcoma. Peak rates of other soft tissue sarcomas occur in individuals 75 years and older, except for uterine leiomyosarcomas, which reach peak incidence in women between ages 40 and 50 years. In general, African-Americans have a higher rate of soft tissue sarcoma development than Caucasians.

Source
CytRx Corporation