Major Israeli Institution Selected to Lead Human Clinical Trials for Revolutionary Alpha Radiation Cancer Therapy
NEW YORK, Oct. 31, 2011 /PRNewswire/ — Althera Medical Ltd. announced today that it intends to perform a First-in-Human study for its revolutionary treatment of cancer tumors with alpha radiation at Israel’s eminent Rabin Medical Institute. Professors Benjamin Corn, M.D., Chairman of Radiation Oncology at the Sourasky Medical Center and Althera’s Chief Medical Officer, and Aron Popovtzer, M.D., Chief of the Head and Neck Tumor Service at Rabin’s Beilinson Hospital will lead the study.
Althera’s alpha radiation delivery system is expected to offer hope to patients suffering from head and neck, colon, pancreatic, sarcoma, brain, melanoma and lung cancer. Althera’s Chairman, C. Leonard Gordon, a lawyer and entrepreneur with previous in-depth experience in successfully bringing medical devices through the FDA approval process and to market, believes that Althera’s technology could be made available to these patients rapidly under the FDA’s Compassionate Use policy.
Althera’s therapy delivers alpha radiation using tiny needles called DaRT(TM) (Diffusing Alpha-emitters Radiation Therapy) invented by Professor Itzhak Kelson of Tel Aviv University.
Professor Michael J. Zelefsky, Chief of Memorial Sloan Kettering’s Brachytherapy Service, said, “The advantages of alpha over beta and gamma radiation are expected to be shown in these studies. Althera’s unique method of alpha radiation delivery is expected to minimize side effects.”
Dr. Steven Evans, Chief Executive Officer of Althera Medical, said that the use of alpha radiation to treat cancer has been the ‘holy grail’ of radiation therapy. Prior to Althera’s breakthrough technology, alpha therapy was not able be delivered safely and efficaciously. DaRT(TM) solved this problem. Althera is now moving to regulatory approval to treat recurrent Head & Neck cancer.
The primary goal of the First-in-Human clinical study is to establish the safety of the device. Tumor shrinkage and relief of pain will also be evaluated. The study requires 15 patients and is a prerequisite to larger FDA and European regulatory studies and Compassionate Use treatments.
DaRT(TM) is expected not only to be more efficacious but also more affordable and easier to administer than traditional radiation therapy. DaRT(TM) does not require heavy equipment, specially shielded rooms or lead vests, and the entire dosage can be delivered in a single session.
Alpha radiation causes double-stranded DNA breaks, hindering cancer cells from repairing themselves and reducing the possibility of radiation-resistance in tumors. The market for radiation exceeds $6 Billion annually worldwide.
The First-in-Human Study is expected to start in several months, if not delayed by financing which has been difficult in the face of the recession. It is expected that the financing will now be successful as DaRT(TM) is close to human clinical studies.
Althera Medical is an Israeli Company with its headquarters co-located in New York City’s Harlem and in Tel Aviv. Its Advisory Board members are eminent Interventional Radiologists, Brachytherapists and Radiation Oncologists at Memorial Sloan Kettering, Johns Hopkins, and at major hospitals in Israel and Europe.
SOURCE Althera Medical Ltd.