PEDIATRIC STUDY COMPLIMENTS ONGOING ADULT PROGRAM IN
COMBINATION WITH CHEMOTHERAPY.
Berkeley Heights, NJ September 04, 2002
- Genta Incorporated (Nasdaq: GNTA) today announced the initiation
of a new, multicenter clinical trial with its lead drug, Genasense
TM
, in children with cancer. The study will involve the treatment of
children with solid tumors who have failed standard therapy or who
have illnesses for which no therapy currently exists. The U.S.
National Cancer Institute (NCI) will sponsor the study, pursuant to
Genta's Cooperative Research and Development Agreement (CRADA). The
trial will be conducted by the Children's Oncology Group and will
be led by Dr. Peter Adamson, Associate Professor of Pediatrics at
the University of Pennsylvania.
"Although significant advances have been made in
the treatment of children with solid tumors, there are few
alternatives for children who relapse following frontline therapy,"
commented Dr. Adamson, who is also Chairman of Developmental
Therapeutics for the Children's Oncology Group and Chief of the
Division of Clinical Pharmacology and Experimental Therapeutics at
The Children"s Hospital of Philadelphia. "With such a tremendous
need for novel treatment approaches, we look forward to this first
pediatric clinical trial of Genasense
TM
."
"As a Company led by oncologists, we have long
believed that it is critically important to extend Genasense
TM
applications to children as soon as possible," commented Dr.
Loretta M. Itri, Executive Vice President and Chief Medical Officer
of Genta. "Each year, more than 12,000 children are diagnosed with
cancer. The preclinical synergy with other anticancer drugs that's
been repeatedly documented, plus the clinical safety profile
established in adults, makes Genasense
TM
an ideal candidate for early testing in pediatrics."
The new trial will evaluate escalating doses of
Genasense
TM
in combination with doxorubicin and cyclophosphamide, two
standard chemotherapy drugs. The Children's Oncology Group, the
world's largest pediatric cooperative group, is devoted exclusively
to cancer research in children and adolescents. The NCI-supported
group develops and coordinates cancer clinical trials at 238 member
institutions, which include cancer centers at major universities
and teaching hospitals in the U.S. and Canada, as well as sites in
Europe and Australia. Group members include over 5,000 cancer
researchers dedicated to saving the lives of children with
cancer.
Genta intends to use the current protocol as the
first step towards an application for Pediatric Exclusivity with
the Food and Drug Administration (FDA). Under terms of the Food and
Drug Modernization Act of 1997, the FDA may grant a drug an
additional six months of marketing exclusivity if a company
conducts clinical studies in certain pediatric populations. This
provision is designed to encourage more investigation into the
unmet needs of the pediatric population.
