Genta Completes FDA Submission of New Drug Application for Ganite(TM) (gallium nitrate injection)
BERKELEY HEIGHTS, N.J., Apr 1, 2003 /PRNewswire via COMTEX/ -- Genta announced
today that the Company had filed its completed supplemental New Drug Application
(sNDA) submission to the U.S. Food and Drug Administration's (FDA), for
Ganite(TM) (gallium nitrate injection). The sNDA was submitted to FDA's
Metabolism and Endocrine Division for the treatment of cancer-related
hypercalcemia that has not responded to hydration, a life-threatening elevation
of blood calcium that occurs in up to 20% of cancer patients. The Company has
been advised that the sNDA will be reviewed as a manufacturing supplement and
will be subject to a 4-month review period.
Separate from the sNDA filing, the Company also announced the it has submitted
several new patent applications related to the manufacturing and use of
gallium-containing compounds to the U.S. Patent and Trademark Office.
"Completion of this high-quality submission is a great tribute to our clinical
and regulatory teams," stated Dr. Raymond P. Warrell Jr., Genta's Chief
Executive Officer. "Assuming there are no delays in the review process, the
anticipated launch of Ganite in the 2nd-half of this year will represent the
first product commercialized by Genta in its 15-year history. The teams are now
engaged in their next assignment, which is pulling together to meet timelines
for our anticipated filing of Genasense later this summer."
About Ganite(TM)
Gallium nitrate was originally developed by the U.S. National Cancer Institute
(NCI) as a form of cancer chemotherapy. More than 1,000 patients were patients
were treated in a variety of Phase1 and Phase 2 trials sponsored by NCI. Several
published reports showed that gallium nitrate appeared to be active in
non-Hodgkin's lymphoma, bladder cancer, and certain other diseases. A separate
series of studies showed that the drug also was a potent treatment for
hypercalcemia, and the first NDA for gallium nitrate was granted under the trade
name Ganite(TM) for the treatment of cancer-related hypercalcemia. In 2002,
Genta filed an Investigational New Drug (IND) exemption with the Division of
Oncology Drug Products for Ganite as a treatment for patients with NHL who have
failed prior therapy. NHL, with approximately 54,000 cases diagnosed each year,
is a group of several closely related cancers that affect the lymphatic system.
The incidence of NHL has nearly doubled within the last three decades and has
become the fifth most common form of cancer in the United States.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product
portfolio that is focused on anticancer therapy. The Company's research platform
is anchored by oligonucleotide chemistry, particularly applications of antisense
and decoy aptamer technology. Genasense(TM) (oblimersen sodium), the Company's
lead compound, is being developed in collaboration with Aventis and is currently
undergoing late-stage, Phase 3 clinical testing in several clinical indications.
Genta's pipeline also comprises a portfolio of small molecules, including
gallium-containing compounds and Androgenics compounds for prostate cancer. For
more information about Genta, please visit our website at: www.genta.com. |
