FDA grants Celsion Corp. orphan drug designation
COLUMBIA, Md. The Food and Drug Administration has given orphan drug designation to a cancer drug.
Celsion Corp. announced Monday that it received the designation for ThermoDox (doxorubicin), a heat-activated drug for treating primary liver cancer. The drug is undergoing an international phase 3 trial involving 600 patients under a special protocol assessment with the FDA.
“We look forward to working with the FDA and other regulatory agencies to make ThermoDox available to patients as soon as possible,” Celsion president and CEO Michael Tardugno stated.
The FDA gives orphan drug designation to drugs in development meant to treat serious and life-threatening illnesses that affect 200,000 people or fewer in the United States.
AstraZeneca, BioDuro to expand partnership
BEIJING AstraZeneca and BioDuro announced Monday that they would expand their collaboration to find new drugs to treat respiratory and inflammatory diseases.
BioDuro, a life science outsourcing company with 580 employees in Beijing, said it would provide research services in discovery chemistry and biology, as well as drug metabolism and pharmacokinetics and absorption, distribution, metabolism, excretion and toxicity services to help drug-discovery efforts.
“BioDuro is pleased to build upon this existing collaboration and work closely with the experienced team at AstraZeneca to develop new clinical compounds for respiratory and inflammatory indications,” BioDuro CEO John Oyler said in a statement. “This partnership demonstrates the strength of our innovation, quality and our fully integrated R&D service platform.”
Study discovers additional use for breast cancer antibody
BASEL, Switzerland A study involving almost 600 patients has shown that adding a monoclonal antibody normally used to treat breast cancer to standard chemotherapy prolongs the lives of patients with HER2-positive stomach cancer.
The international phase 3 study, dubbed ToGA, enrolled 594 patients. Patients were randomly placed into two groups, one that received chemotherapy alone and one that received chemotherapy with Roche’s Herceptin (trastuzumab).
“The ToGA study shows for the first time that Herceptin extends the lives of patients in a cancer other than breast cancer,” stated Roche Pharmaceuticals Division CEO William Burns. “Advanced stomach cancer is a devastating disease for which there are currently few treatment options.”
Genentech, which recently agreed to be acquired by Roche, markets Herceptin in the United States. Chugai markets it in Japan, and Roche markets it elsewhere.