Berkeley Heights, NJ - September 18, 2003-
TM
Cancer-related hypercalcemia is a life-threatening elevation of
blood calcium that can occur in up to 50% of patients with advanced
cancer. The disorder is usually caused by the release of factors
from tumor cells, which markedly accelerate the loss of calcium
from bone. Hypercalcemia is particularly common in patients with
cancers of the lung, breast, head and neck, and kidney, and
multiple myeloma.
"In several randomized double-blind clinical trials, Ganite has
proven to be effective against hypercalcemia in patients with a
variety of cancers," noted Dr. Christopher R. Chitambar, Professor
of Medicine at the Medical College of Wisconsin. Dr. Chitambar, who
is also an investigator for an ongoing Ganite clinical trial
stated, "Ganite's increased availability now represents a promising
treatment alternative for my patients."
"Today's action by the FDA reinforces the capabilities,
experience, and skills of many teams within Genta," stated Bruce
Williams, Senior Vice-President for Sales and Marketing. "While
we've previously supplied the drug to individual patients who
failed to respond to conventional treatment, today's approval marks
our transition from development to commercialization. Our
oncology-focused sales team covers 18 territories in the U.S., and
we plan to leverage this marketing, sales, and reimbursement
expertise to future products from Genta."
Patient Assistance Program
Genta has established a patient assistance program called
GentaCARESTM (Creating Access to Reimbursement Expertise
Solutions). Reimbursement services include benefit verification,
prior authorization, claims tracking, appeals, and a patient
assistance program for qualifying uninsured patients. A call center
will be staffed by experienced reimbursement specialists from 8:30
a.m. to 8:00 p.m. EST to answer calls from patients, physicians,
and payers in order to provide assistance to patients and providers
for the reimbursement of Genta products. For more information on
the GentaCARES program please visit
http://www.gentacares.com/
About Ganite
Ganite was originally developed by the National Cancer Institute
(NCI) as a cancer chemotherapy drug. A separate series of studies
showed that the drug markedly reduced the loss of calcium from bone
- an observation that suggested the drug may be useful in
hypercalcemia, as well as other conditions associated with loss of
bone mass.
Ganite has proven safe and effective in normalizing high levels
of blood calcium by inhibiting calcium resorption from bone. In a
double-blind clinical trial that compared Ganite with calcitonin (a
commonly used anti- hypercalcemia drug), 50 patients were
randomized to receive either Ganite at a dosage of 200 mg/m2/day
for 5 days, or calcitonin at a dosage of 8 IU/kg four times per day
for 5 days. Normalization of calcium (normocalcemia) was achieved
in 75% of patients who received Ganite, compared with 27% of
patients treated with calcitonin (p value = .0016). Ganite appeared
to be useful in treating hypercalcemia associated with many
different types of cancer, irrespective of the initial severity of
the disorder.
Important Safety Information about Ganite
TM
(gallium nitrate injection)
Ganite is contraindicated in patients with severe renal
impairment (serum creatinine > 2.5 mg/dL). While Ganite was
generally well tolerated by patients who received the drug in
clinical trials, concurrent use of Ganite with other potentially
nephrotoxic drugs like aminoglycosides and amphotericin B may
increase the risk for developing severe renal insufficiency in
patients with cancer-relapsed hypercalcemia. If use of a
potentially nephrotoxic drug is indicated during Ganite therapy,
Ganite should be discontinued and hydration is recommended for
several days.
Please see accompanying full Prescribing Information in the
Package Insert or on the Ganite website at
www.ganite.com
Ongoing Clinical Trials
In 2002, Genta filed a new Investigational New Drug (IND)
exemption with the Division of Oncology Drug Products for Ganite to
be evaluated in a variety of oncologic indications. Genta is
currently conducting a multi-center clinical trial to evaluate the
efficacy of Ganite as a treatment for patients with relapsed or
refractory low- or intermediate-grade NHL. For more information,
please visit
http://www.genta.com/
.
About Genta
Genta Incorporated is a biopharmaceutical company with a
diversified product portfolio that is focused on delivering
innovative products for the treatment of patients with cancer. The
Company's research platform is anchored by two major programs that
center on DNA/RNAbased medicines and small molecules. Genasense
TM
(oblimersen sodium) is the Company's lead compound from its
oligonucleotide program and is currently undergoing late-stage,
Phase 3 clinical testing. The leading drug in Genta's small
molecule program is Ganite
TM
(gallium nitrate injection), which under today's approval from the
FDA, will be marketed for the treatment of cancer-related
hypercalcemia that is resistant to hydration. For more information
about Genta, please visit our website at:
http://www.genta.com/
.
This press release contains forward-looking statements with
respect to business conducted by Genta Incorporated. By their
nature, forward-looking statements and forecasts involve risks and
uncertainties because they relate to events and depend on
circumstances that will occur in the future. There are a number of
factors that could cause actual results and developments to differ
materially. For a discussion of those risks and uncertainties,
please see the Company's Annual
Report/Form 10-K
for 2002
.
SOURCE: Genta Incorporated
