FDA Grants Orphan Drug Designation To Pentacea For Small Cell Lung
Cancer
MORRIS PLAINS, N.J. -- March 9, 2000 -- IBC
Pharmaceuticals, LLC, a joint venture between Immunomedics, Inc. and Beckman
Coulter Corporation announced that the Office of Orphan Products Development of
the U.S. Food and Drug Administration has granted orphan drug designation for
its lead product, Pentacea(TM), for the treatment of small cell lung cancer
(SCLC). In addition to certain tax benefits, orphan drug designation provides
U.S. marketing exclusivity for seven years following the drug's marketing
approval.
SCLC is the most aggressive
form of lung cancer and there is currently no effective therapy. The majority of
these patients succumb to their disease within 12-18 months. Pentacea(TM) is
currently in Phase I/II clinical trials for the treatment of small cell lung
cancer and is the first commercial drug to be developed using the Company's
proprietary platform technology based on 2-step bispecific antibody
pretargeting.
With Pentacea(TM),
patients first receive an injection of bispecific antibody. One arm of the
bispecific antibody binds to the patient's tumor. After allowing time for tumor
targeting and clearance of unbound bispecific antibody from the body, the
radiation attached to its carrier, is injected. The carrier with the radiation
binds to the other half of the bispecific antibody, allowing for specific and
high tumor uptake. Radiation that does not bind to pretargeted bispecific
antibody is rapidly eliminated from the body, thus limiting the patient's
exposure to radiation and allowing high doses to be
administered.
The Company's Executive
Vice President, Dr. John Reno, remarked: "We are excited about the prospects of
this latest method of selective delivery of radiation for cancer therapy, since
it holds promise for repeated therapies without evoking major immune responses.
Our first products using this technology showed excellent therapeutic results in
preclinical studies, as well as encouraging therapeutic responses in patients
with small-cell lung cancer."
IBC
Pharmaceuticals is developing radiopharmaceutical products for the treatment of
cancer based on its proprietary pretargeting technology. Pentacea(TM) binds to
CEA positive tumors. CEA is expressed on most of the major solid tumors
including those of the colon, breast and lung.
Related Links: IBC
Pharmaceuticals, Immunomedics, Inc. and Beckman Coulter
Corporation.
