Here's one that could take off.
CTIC on news of cancer drug trials. Could really go as news gets out.
Monday November 23, 8:46 am Eastern Time
Company Press Release
Leading Prostate Cancer Centers and Cell Therapeutics Initiate Efficacy Trial of New Treatment for Prostate Cancer
SEATTLE--(BW HealthWire)--Nov. 23, 1998--Leading U.S. prostate cancer centers and Cell Therapeutics Inc. (cti) (Nasdaq:CTIC - news) are initiating an efficacy trial of CT-2584, the company's novel anticancer drug, among patients with advanced prostate cancer who have previously failed treatment with conventional chemotherapy.
Approximately 90 percent of the more than 700,000 cancer patients who receive chemotherapy in the U.S. each year are either resistant to or develop resistance to conventional anti-cancer therapies. Once resistance develops, the chances for cure become remote. No effective agents for treating chemotherapy resistant cancers are on the market today.
The majority of conventional chemotherapy agents kill cells by interfering with the genetic machinery necessary for cell replication. CT-2584 represents a new class of anticancer drug, which, unlike conventional chemotherapeutic agents, kills cancer cells by a process associated with altering their phospholipid composition. Because of differences in lipid metabolism between tumor cells and normal cells, tumor cells are more sensitive than normal cells to the effects of CT-2584. By altering their phospholipid composition, CT-2584 is active against a broad variety of cancers including those that are resistant to conventional chemotherapeutic drugs, without the toxicities that commonly accompany treatment with those agents.
Approximately 317,000 men are diagnosed each year in the U.S. with prostate cancer with more than 34,000 deaths annually attributable to advanced disease. While hormonal therapy is effective in managing the symptoms of patients with advanced prostate cancer, more than 40,000 patients each year grow resistant to the effects of hormonal treatment and fail subsequent attempts at treatment with conventional chemotherapeutic agents.
''We are encouraged by the results of our two Phase I trials,'' said Carolyn Paradise, M.D., Head of Medical Affairs at Cell Therapeutics Inc. Patients in the Phase I studies had a variety of chemotherapy refractory progressive cancers for which no curative therapies were available. In those trials, approximately 30 percent of the 52 patients with advanced prostate, soft tissue sarcoma/mesothelioma, ovarian and renal cancers, experienced stable disease or better with CT-2584 treatment. Fifteen patients remained free from progression for at least three months. Two patients with advanced hormone refractory prostate cancer, who had failed prior chemotherapy experienced a decrease in PSA levels following treatment with CT-2584, with one patient being free from disease progression for 5.5 months. Four of nine mesothelioma patients had stable disease or better with a partial response lasting six months while a patient with advanced ovarian cancer remains free of disease progression at eight months. CT-2584 was well tolerated with some patients experiencing flushing or mild nausea. The dose limiting side effect was fatigue. One patient on the first dose level had an anaphylactic reaction. There was no bone marrow suppression or hair loss observed, or death related to CT-2584 treatment. ''Compared to Phase I results reported for chemotherapy drugs currently on the market, the activity seen with CT-2584 in our Phase I efforts provides a sound basis to move forward into randomized efficacy trials,'' Dr. Paradise noted.
''CT-2584 has exceeded our expectations demonstrating broad anti-tumor activity in chemotherapy resistant cancers and few of the toxicities associated with conventional chemotherapeutic drugs,'' noted James A. Bianco, M.D., the company's President and CEO. ''While our initial efficacy trials are targeting single agent applications such as prostate cancer and sarcoma, CT-2584's anticipated lack of overlapping toxicities with conventional chemotherapeutic agents makes it an ideal candidate for use in combination therapy for a variety of cancer types. We are fortunate to be faced with the prospect that CT-2584 will become cti's second attractive near term commercial product,'' he noted.
The new trial is an open label efficacy study among patients with advanced prostate cancer who have failed therapy with hormonal agents and at least one conventional chemotherapeutic agent. Eighty patients will be randomized to either the best dose and regimen determined in the Phase I Memorial Sloan Kettering trial (455mg/M2 daily for 3 days once every 21 days) or to the same total dose administered once weekly for 3 weeks. Slowing of the rate of disease progression is the primary endpoint of the study. Enrollment is expected to be completed next year. A consortium of 8 leading prostate cancer research and treatment centers in the United States will conduct the trial.
In addition to its evaluation in advanced prostate cancer, CT-2584 is expected to enter an additional efficacy study in refractory soft tissue sarcoma later this quarter.
Cell Therapeutics Inc. is dedicated to the discovery, development and commercialization of small molecule drugs that selectively regulate the metabolism of oxidized lipids and phospholipids relevant to the treatment of life-threatening diseases.
This announcement includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of cti's products under development includes risks associated with preclinical and clinical development in the biotechnology industry in general and of cti 's products under development in particular (including, without limitation, the potential failure of CT-2584, lisofylline, PG-TXL and related compounds to prove safe or effective for treatment of disease), determinations by regulatory, patent, and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing, and selling cti's products under development, and the risk factors listed or described from time to time in the company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent Registrations on Forms 10-K, 8-K, and 10-Q.
Contact:
Cell Therapeutics Inc.
James A. Bianco, 206/282-7100 or 800/664-CTIC
invest@ctiseattle.com
www.cticseattle.com
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