Cytogen and Draxis Announce First Clinical Use of BrachySeed for Prostate Cancer Therapy in U.S. and Canada; ProstaScint Images Used to Guide Placement of Second-Generation Radiation Implants Updated: Monday, December 18, 2000 07:01 AM ET PRINCETON, N.J., and MISSISSAUGA, Ontario, Dec. 18 /PRNewswire/ -- Cytogen Corporation (Nasdaq: CYTO, news, msgs) and Draxis Health, Inc. (Nasdaq: DRAX, news, msgs; Toronto: DAX) announced today the first clinical use of BrachySeed(TM), a new type of iodine-125 brachytherapy implant, in both the U.S. and Canada. For the first time, physicians at major medical centers in both countries implanted the second-generation radioactive-iodine seeds in patients with prostate cancer.
"Our first case with BrachySeed went very well," said Rodney J. Ellis, M.D., Director of Brachytherapy, University Hospitals of Cleveland. Dr. Ellis used two Cytogen products to perform the implant procedure. He combined ProstaScint images with CT (computer tomography) scans to locate the areas of highest tumor burden within the prostate gland and implanted additional BrachySeeds areas as required. "The implants provided superior coverage of the target volume of the prostate, with fewer required millicuries of radioactivity. The seed design is excellent, with good visualization by both ultrasound and fluoroscopy. Additionally, the cost for the procedure was reduced through a decrease in the required number of seeds."
The first implantation in Canada was carried out by Eric Vigneault, M.D. at the Centre Hospitalier Universitaire de Quebec. Dr. Vigneault stated, "BrachySeed permitted the use of 11% lower activity seeds to achieve the same therapeutic dose." The use of BrachySeed permits either a reduction in seed activity or seed quantity, which is an advantage over the current market leader.
"BrachySeed now makes it possible for patients to receive a second- generation product for the treatment of their prostate cancer," said Terence S. Novak, Cytogen's Vice President of Marketing and Sales. "The use of image- guided therapy employing both ProstaScint and BrachySeed underscores the complementary nature that our products play in the diagnosis and treatment of prostate cancer."
"As part of the pre-launch plan, Cytogen recently hosted an opinion leader workshop to introduce BrachySeed and image-guided therapy to radiation oncologists, physicists and urologists," continued Mr. Novak. "We were excited by the interest BrachySeed received from the key thought leaders in prostate cancer therapy. We believe that our implants will become a popular choice for many prostate cancer patients and their physicians and that ProstaScint will play an increasingly important role in prostate cancer therapy."
Under the terms of a 10-year arrangement with DRAXIMAGE, a wholly owned subsidiary of Draxis, Cytogen will market and distribute BrachySeed in the U.S. DRAXIMAGE will supply radioactive seeds to Cytogen for sale in the U.S. and will market the product in Canada.
Dr. Martin Barkin, President and Chief Executive Officer of Draxis Health stated, "We are very encouraged by the early feedback regarding BrachySeed, which serves to confirm Draximage's position as a quality provider of innovative radiopharmaceutical products, both diagnostic and therapeutic, to the global marketplace. BrachySeed I-125 is the first of the major new products under development to emerge from DRAXIMAGE's pipeline, and over the next few years the Company expects to bring other products to commercialization."
BrachySeed is a second-generation implant therapy that the companies believe demonstrates a number of important innovations over currently available technology, including double encapsulation for additional patient safety and near perfect dosimetry to reduce "cold spots." Cold spots are areas within the target organ not reached by radiation, that may occur when seeds do not provide symmetrical and spherical fields of radiation.
While brachytherapy has been available since the 1970s, it has only started to gain prominence and greater acceptance within recent years, coinciding with the development of advanced technologies to aid seed placement. Brachytherapy is the fastest growing treatment for early stage prostate cancer and offers a number of potential benefits compared to alternative treatments such as prostatectomy, including: rapid patient recovery, lower costs and reduced incidence of complications such as impotency and incontinence. Given this improved side-effect profile, the market for brachytherapy seeds has grown by 95% over the last three years. By 2003, the companies estimate that approximately half of all newly diagnosed prostate cancer patients will opt for brachytherapy, while radical prostatectomies will be performed on less than 15% of patients. Independent estimates place the current brachytherapy market at $220 million in the U.S. and growing by approximately $100 million in three years. |