Genta Announces Reactivation of New Drug Application (NDA) For Ganite(TM) and Initiation of CMC Regulatory Filings Submissions Intended to Enable Product Launch during 2003
BERKELEY HEIGHTS, N.J., Jan 3, 2003 /PRNewswire via COMTEX/ -- Genta
Incorporated today announced that the Company received notice from the Food and
Drug Administration (FDA) of the formal reactivation of the New Drug Application
(NDA) for Ganite(TM) (Gallium Nitrate Injection). In addition, the Company
announced that it has submitted to the FDA the first of two planned regulatory
supplements related to the chemistry, manufacturing, and controls (CMC) portion
of the Ganite NDA. These submissions, which are expected to be completed by the
end of the first quarter, should enable the Company to launch Ganite for its
approved indication later this year.
Ganite has been approved in the U.S. as an intravenous treatment for patients
with cancer-related hypercalcemia. Hypercalcemia is a potentially
life-threatening elevation of blood calcium that can occur in patients with
advanced cancer. Gallium nitrate was originally developed by the U.S. National
Cancer Institute (NCI) as a form of cancer chemotherapy, and the activity of the
drug on calcium metabolism was originally discovered in these trials.
Preclinical and clinical studies have also suggested the drug may have direct
anticancer activity in various diseases, including non-Hodgkin's lymphoma (NHL).
In 2002, Genta filed an Investigational New Drug (IND) exemption with the
Division of Oncology Drug Products and initiated a clinical trial to evaluate
the drug's activity in relapsed patients with NHL.
"I am delighted to announce the commencement of our regulatory filings for
Ganite with the Metabolism and Endocrine Division at FDA," commented Dr. Raymond
P. Warrell, Jr., Genta's Chairman and Chief Executive Officer. "This first CMC
submission updates information related to the drug substance, and the second
filing will address the final drug product. We have been advised by FDA that
both submissions will be treated as manufacturing updates, which imply a
four-month review process, thereby enabling the Company to achieve its goal of
launching Ganite during the current year."
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), 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, as
well as an anticancer series of DNA-based compounds called "decoy aptamers". For
more information about Genta, please visit our website at: www.genta.com. |
