Aronex Pharmaceuticals Reports Data on Platar Cancer Agent at ASCO
Monday May 17, 100 pm Eastern Time
Company Press Release
SOURCE Aronex Pharmaceuticals, Inc.
THE WOODLANDS, Texas, May 17 /PRNewswire/ -- Aronex Pharmaceuticals, Inc. (NasdaqARNX - news) today announced the presentation of preliminary Phase II results for its novel chemotherapeutic agent Platar in a presentation at the American Society for Clinical Oncology (ASCO) meeting in Atlanta. Investigators described Platar's favorable safety and anti-tumor activity in treating cancer patients afflicted with mesothelioma, many of whom have failed prior chemotherapy. Platar is a liposomal formulation of a novel platinum drug designed to overcome the toxicity and drug resistance that currently limit the usefulness of platinum, a chemotherapeutic agent widely used in the treatment of solid tumors.
Commenting on the preliminary Phase II clinical trial results, Roman Perez-Soler, M.D., Associate Director of Clinical Oncology at the Kaplan Comprehensive Cancer Center in New York, said, ``This study was initiated to evaluate Platar's effectiveness, when administered intrapleurally, in treating malignant mesothelioma. We are encouraged by the drug's safety profile, and the high rate of pathological response as shown in these preliminary data. We will continue to accrue patients in this trial, and we believe Platar could be a promising therapeutic approach in the treatment of this disease.''
In the reported ASCO data, Platar was given to 17 patients with malignant pleural mesothelioma. The dose was 450 mg/m2, and treatments were given every three to four weeks. Platar was well tolerated with no significant hematologic, renal or neurologic toxicities. A pathologic complete response based on biopsy and cytology was seen in 61% and 73% of the patients, respectively. In contrast, currently available therapies provide no more than a 10% to 15% response rate.
The Phase II clinical trial is being conducted at the Kaplan Comprehensive Cancer Center and The University of Texas M.D. Anderson Cancer Center in Houston under an institutional Investigational New Drug application (IND). The trial is funded by the Office of Orphan Drug Products at the Food and Drug Administration.
"Platar's potential lies in its possible utilization against a number of solid tumors, whether delivered as a systemic or intracavitary therapy,'' said Geoffrey F. Cox, Ph.D., Chairman and CEO of Aronex Pharmaceuticals, Inc. ``We are in the process of implementing a broad clinical development program for this product, utilizing both systemic and intracavitary administration.''
Mesothelioma is a rare form of lung cancer, with a history of asbestos exposure reported in a majority of all cases. In addition to its use in the treatment of mesothelioma, Platar is being evaluated at M.D. Anderson under an Institutional IND funded by Aronex Pharmaceuticals in a Phase II clinical trial for the treatment of renal cell carcinoma.
Aronex Pharmaceuticals, Inc. is a biopharmaceutical company that develops and commercializes proprietary innovative medicines to treat cancer and infectious diseases. Aronex Pharmaceuticals currently has five products in clinical development, two of which (ATRAGEN® and NYOTRAN®) are in an advanced stage, as well as a pipeline of additional products. In late 1998, the Company filed a New Drug Application for ATRAGEN (an injectable form of all-trans-retinoic acid or tretinoin) for the treatment of patients with acute promyelocytic leukemia for whom therapy with tretinoin is necessary but for whom an intravenous administration is required. In 1998, the Company licensed NYOTRAN, its novel antifungal agent, to Abbott Laboratories, providing them with exclusive worldwide rights to market and sell this product.
Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including but not limited to those relating to product demand, pricing, market acceptance, the effect of economic conditions, intellectual property rights and litigation, clinical trials, governmental regulation, competitive products, risks in product and technology development, the ability to raise additional capital when needed and on acceptable terms, and other risks identified in the Company's Securities and Exchange Commission filings. No representation is given concerning the ultimate outcome of pending Platar clinical trials for mesothelioma or any other indication, or when or whether the FDA would approve such drug for commercial sale.
For more information:
* Kaplan Comprehensive Cancer Center, New York City: (212) 263-8043 or
(212) 263-6485;
Email: lyj01@kccc.med.nyu.edu
* M.D. Anderson Cancer Center, Houston, Texas: (713) 792-6161
ext. 6516
At the M.D. Anderson Medical Center in Houston, Texas, a phase II study
of mesothelioma with pleural decortication, LNDDP (Platar), and
radiotherapy is currently open for pleural mesothelioma, and the phase
I of intraperitoneal LNDDP is still open for accrual. Patients with
peritoneal mesothelioma are welcome. For pleural mesothelioma,
call (713)792-6363 and have patients speak with Dr. Shin, and for
peritoneal mesothelioma call Dr. Claire Verschraegen at
(713)792-7959.
** POSTED MAY 20, 1999 **
Note: Intraperitoneal PLATAR suspended at MD Anderson,
9/7/99
We just received news that that the Platar trial at MD Anderson in
Houston, Texas has been suspended due to toxicity. The trial in New
York for pleural mesothelioma is continuuing. I have contacted Dr.
Verschraegen at MDAnderson to confirm this report. More to follow.
RGW
** POSTED SEPETMBER 9, 1999 **