CytRx Announces Favorable Study for New Drug to Treat Soft Tissue Sarcoma
CytRx, a biopharmaceutical company based in Los Angeles that specializes in oncology, has announced favorable outcomes from an early study for aldoxorubicin for the treatment of relapsed advanced soft tissue sarcoma. The company will present the results at the Connective Tissue Oncology Society (CTOS) 17th Annual Meeting on November 15th in Prague.
Soft Tissue Sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body. Although tumors can form anywhere, they are most common in the arms and legs. Because the tumors are difficult to diagnose, the often metastasize to other parts of the body before a person even knows they have cancer. At Stage III cancer, a sarcoma patient’s 5-year survival rate is only 56%.
Aldoxorubicin (formerly INNO-206) has been granted orphan drug designation by the US Food and Drug Administration for the treatment of patients with STS and pancreatic cancer. An orphan drug is one that has been specifically developed to treat a rare medical condition. Based on National Cancer Institute statistics from 2007-2009, 0.33% of men and women born today will be diagnosed with a cancer of the soft tissue during their lifetime.
The drug is a novel, tumor-targeted conjugate of a commonly prescribed chemotherapeutic agent known as doxorubicin. Doxorubicin is the standard treatment for a variety of cancers and is used either alone or in combination with other chemotherapy agents. Aldoxorubicin is designed to concentrate the chemotherapy agent within the tumor, so it minimizes the damaging effects on healthy tissue.
In a Phase 1 clinical trial, Aldoxorubicin was able to deliver a dose up to six times greater than doxorubicin without increasing side effects normally seen with chemotherapy.
In a 2b international trial, 13 patients with soft-tissue sarcomas given INNO-206 tolerated the drug with 5 achieving tumor shrinkage of more than 30% and seven showing prolonged stable disease. No cardiac toxicities were observed; heart concerns are considered a major dose-limiting factor when delivering standard chemotherapy drugs such as doxorubicin. The most common adverse effect was neutropenia, a decrease in white blood cells.
Dr. Sant Chawla MD, FRACP, the study’s principal investigator, is a world renowned expert in the treatment of soft tissue sarcomas and the Director of the Sarcoma Oncology Center in Santa Monica, Calif.
“We are excited to share the powerful data from our aldoxorubicin clinical trial with experts from the international oncology community at this preeminent sarcoma conference, as well as at the upcoming ESMO 2012 Congress in Vienna, Austria," said Steven A. Kriegsman, CytRx President and CEO. "The results from this clinical trial are impressive, especially given that these patients had failed prior chemotherapy regimens."