This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration. Need a new registration confirmation email? Click here
MORRIS PLAINS, N.J., June 9, 2014 (GLOBE NEWSWIRE) --
Immunomedics, Inc., (Nasdaq:IMMU) today announced that IMMU-132, the Company's antibody-drug conjugate (ADC) for solid cancer therapy, has received orphan drug status from the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
"This is the second orphan designation from FDA for IMMU-132, which has demonstrated activity in patients with advanced pancreatic cancer, as well as partial responses in 5 other types of solid cancer," commented Cynthia L. Sullivan, President and Chief Executive Officer.
As recently reported by the Company at the American Association for Cancer Research Special Conference on Pancreatic Cancer: Innovations in Research and Treatment, 13 pancreatic cancer patients who had failed 1-5 prior therapies showed a median time-to-progression of 12.7 weeks (range 4.3-21.4 weeks) after receiving repeated doses of IMMU-132. This compared favorably with the median 8.0 weeks (range 4-36 weeks) estimated from the patients' last prior therapy.
IMMU-132 has also been designated an orphan drug by FDA for the treatment of patients with small-cell lung cancer. In an ongoing Phase I/II clinical study, IMMU-132 has resulted in partial responses in patients with colorectal cancer, esophageal cancer, triple negative breast cancer, and small-cell and non-small-cell lung cancers.
Orphan drug status is granted by FDA to a drug or biological product to treat a rare disease or condition upon request of a sponsor. Orphan drug designation qualifies the Company for various development incentives, including tax credits for qualified clinical testing, a waiver from FDA's application User Fee for marketing application, and a seven-year period of marketing exclusivity in the United States for IMMU-132, if it is approved by FDA for the treatment of patients with pancreatic or small-cell lung cancer.
The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.