Implantable wafer is first treatment to deliver chemotherapy directly to tumor site.
COLLEGEVILLE, PA., AND BALTIMORE, MD; SEPTEMBER 24, 1996
Rhone-Poulenc Rorer Inc.(NYSE:RPR) and Guilford Pharmaceuticals Inc. (NASDAQ:GLFD) announced today that the Gliadel Wafer (polifeprosan 20 with carmustine implant), the first commercially available brain cancer treatment to deliver chemotherapy directly to the tumor site, has received clearance from the US Food and Drug Administration (FDA) for use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme (GBM) for whom surgical resection is indicated.
GBM is one of the most rapidly progressive and universally fatal of all cancers. There are approximately 20,000 primary brain tumors diagnosed in the United States each year and GBM is the most common type.
Clearance was granted based on data from a landmark study involving 222 patients undergoing surgery for recurrent malignant glioma. This Phase III double-blind, placebo-controlled clinical study showed that Gliadel Wafer increased survival at six-months by more than 50 percent (from 36% with placebo to 56% with Gliadel) in patients with GBM, and is the first study of its kind in the oncology field.
"Gliadel is the first new drug to clearly demonstrate survival benefits in patients with recurrent glioblastoma multiforme. It is also the first new approved treatment for brain cancer in more than 20 years," said Jon Weingart, M.D., Assistant Professor of Neurosurgery at the Johns Hopkins Hospital. "This new approach slows disease progression by delivering drug directly to the tumor site in high concentrations and locally destroying cancer cells."
Gliadel Wafer, a new approach to the treatment of recurrent GBM, is a biodegradable wafer, implanted at the time of surgery, that delivers chemotherapy directly to the tumor site, minimizing drug exposure to other areas of the body. Gliadel Wafer complements other standard therapies for brain cancer, such as surgery, radiation and traditional intravenous injection.
Previously, chemotherapeutic agents for brain malignancies were typically administered intravenously. Because these agents have difficulty crossing the blood-brain barrier, therapeutic concentrations at the tumor site were difficult to achieve, while systemic side effects such as depletion of white blood cells were common. In animal studies, Gliadel Wafer was shown to deliver up to 1,000 times more carmustine to the tumor site than can be delivered by intravenous injection.
In practice, up to eight wafers (each approximately a quarter of an inch in diameter) are implanted into the cavity created when a brain tumor is surgically removed. After implantation, the wafers slowly erode, delivering carmustine over a two-to-three week period directly into the tumor site and minimizing drug levels elsewhere in the body. As a result, Gliadel Wafer is effective without causing the serious or debilitating systemic side effects associated with intravenous carmustine administration.
In Phase III studies, local side effects that were more common with Gliadel Wafer versus placebo included healing abnormalities, brain edema, and local infections. Although the incidence of seizures was the same in the placebo and Gliadel groups, patients receiving Gliadel Wafer had a much earlier onset of seizures. The spectrum of adverse events observed in patients who received Gliadel Wafer or placebo was consistent with that encountered in patients undergoing surgery for malignant gliomas.
"Brain tumor is a disease for which many more effective treatment options are needed," said Michael McKechnie, Executive Director of the National Brain Tumor Foundation in San Francisco. "We applaud the development of this new treatment that will offer the patient an expanded choice in the battle for survival." (To reach the Foundation call 1-800-934-CURE.)
On June 14, 1996, Rhone-Poulenc Rorer Inc. and Guilford Pharmaceuticals Inc. entered into a strategic agreement to develop oncology products using Guilford's proprietary biodegradable polymer implant technology. This agreement gives RPR the rights to market Gliadel Wafer worldwide, except in Scandinavian countries.
"Gliadel Wafer is an important new treatment option that makes the surgical treatment of recurrent glioblastoma more effective. Receiving FDA approval within eight months of submitting our NDA is an outstanding accomplishment for Guilford," commented Craig Smith, M.D., President and Chief Executive Officer of Guilford.
"As the first new drug to clearly demonstrate survival benefits in a randomized, placebo-controlled, double-blind study, Gliadel Wafer should have a positive impact on thousands of patients treated every year for recurrent glioblastoma multiforme, " said Glenn Mattes, Vice President and General Manager of RPR's Advanced Therapeutics and Oncology Division. "We are committed to making Gliadel Wafer available to these patients as soon as possible."
Gliadel Wafer is expected to be available by January 1997. Until that time, it will remain available to patients under an existing treatment protocol for investigational new drugs (TIND). For information on obtaining Gliadel Wafer, physicians and patients can call 1-800-RX TRIAL.
Rhone-Poulenc Rorer Inc., whose commitment to the field of oncology is well established with the development of innovative anticancer agents, including Taxotere and Oncaspar, is a global pharmaceutical company dedicated to improving human health. The company invested $826 million (pro forma) in research and development in 1995.
Guilford Pharmaceuticals Inc. is a biopharmaceutical company engaged in the development of polymer-based therapeutics for cancer, and novel products for the diagnosis and treatment of neurological disorders.
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