Genta Initiates Clinical Trial of Genasense(TM) in Children with Cancer
Pediatric Study Complements Ongoing Adult Program in Combination with Chemotherapy
BERKELEY HEIGHTS, N.J., Sept. 4 /PRNewswire-FirstCall/ -- 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 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 an ideal candidate for early testing in pediatrics."
The new trial will evaluate escalating doses of Genasense 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.
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. Genta aims to become a direct marketer of its pharmaceutical products in North America. For more information about Genta, please visit our website at: genta.com.
The statements contained in this press release that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the expectations, beliefs, intentions or strategies regarding the future. Without limiting the foregoing, the words "anticipates," "believes," "expects," "intends," "may" and "plans" and similar expressions are intended to identify forward-looking statements. The Company intends that all forward-looking statements be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the Company's views as of the date they are made with respect to future events, but are subject to many risks and uncertainties, which could cause the actual results of the Company to differ materially from any future results expressed or implied by such forward-looking statements. For example, the results obtained in pre-clinical or clinical studies may not be indicative of results that will be obtained in future clinical trials, and delays in the initiation or completion of clinical trials may occur as a result of many factors. Further examples of such risks and uncertainties also include, but are not limited to: the obtaining of sufficient financing to maintain the Company's planned operations; timely development, receipt of necessary regulatory approvals, and acceptance of new products; the successful application of the Company's technology to produce new products; the obtaining of proprietary protection for any such technology and products; the impact of competitive products and pricing and reimbursement policies; and changing market conditions. The Company does not undertake to update forward-looking statements. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurances that the Company's expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement and other factors detailed in the Company's reports filed with the Securities and Exchange Commission.
MAKE YOUR OPINION COUNT - Click Here
tbutton.prnewswire.com
SOURCE Genta Incorporated
CO: Genta Incorporated
ST: New Jersey
SU: CHI
prnewswire.com
09/04/2002 08:02 EDT |
