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SAFESCIENCE'S LECTIN INHIBITOR STABILIZES PSA IN ADVANCED STAGE CANCER PATIENTSSafeScience Accelerates Clinicals Studies of GBC-590 in Prostate and Pancreatic Cancer PatientsBoston, MA, June 24, 1999/ WiredBird/ -- SafeScience, Inc. (NASDAQ: SAFS), today announced the completion of a PhaseI/II clinical study of the anti-cancer compound GBC-590 at M.D. Anderson Cancer Institute in Houston, Texas. The results show that the compound is well tolerated and effective in reducing or stabilizing PSA (prostate specific antigen) levels in 18 out of 22 relapsing prostate cancer patients that are resistant to standard therapy. As a result, the Company will commence Phase II studies for prostate cancer at M.D. Anderson Institute and a number of other leading cancer centers. SafeScience will also initiate a Phase I/II study for pancreatic carcinoma at the Beth Israel Deaconess Medical Center, a major teaching hospital of Harvard Medical School. "We believe this is the first time a well-tolerated compound has shown to affect PSA levels at this magnitude, potentially offering patients promise in being able to treat this disease without compromising quality of life. The few approved treatments that are available today such as chemotherapy drugs, hormonal therapy and radiation therapy have significant side effects and in many cases do not provide therapeutic benefits," stated Clark Springgate, M.D., Ph. D, Chief Medical Officer of SafeScience, Inc. GBC-590, SafeScience's leading therapeutic compound, is a designed carbohydrate molecule representing a new generation of the cancer therapies that block the spread (or metastatic cascade) of cancer. "We are extremely pleased to be able to report these unprecedented results during Prostate Cancer Awareness Month." "The Phase I study for relapsing prostate cancer has indicated that GBC-590 is well-tolerated at the administed doses," stated Dr. Christopher Logothetis and Dr. D. Daliani of the Genito Urinary Oncology Department at the M.D. Anderson Cancer Institute in Houston, Texas. "We observed interesting qualitative changes in the kinetics of PSA subsequent to administration of GBC-590 that included stabilization of the PSA level, as well as increasing PSA levels after the administration of GBC-590 was terminated. We look forward to participating in the Phase II trial for GBC-590." "The SafeScience mission is to make chemical safety a lifestyle choice," stated David Platt, Ph.D., Chairman and Chief Executive Officer of SafeScience, Inc. "GBC-590 is the most dramatic example of how we are creating products that are chemically safe and effective." New Class of Cancer DrugsDr. Platt continued, "GBC-590 is a designed carbohydrate that represents a new class of drugs called 'lectin inhibitors', which competitively bind to unique lectins (protein-based receptors that that exist in all living cells including plants) on cancer cells and disrupt that metastatic process. GBC-590's affinity for these cancer cell lectins is the core reason for the unprecedented biological activity and specificity that we have seen in our clinical and preclinical trials on multiple forms of cancer." To date, no dose limiting GBC-590-related toxicities have been observed in clinical and preclinical trials, and GBC-590 has shown that it can shrink tumors as well as arrest tumor growth in preclinical studies on the PANC-1 human pancreatic cancer model and the LNCaP human prostate carcinoma model. GBC-590 and Prostate CancerProstate cancer is the most common cancer in American males. In 1998, over 180,000 men were diagnosd with prostate cancer and there were over 38,000 deaths directly attributed to the disease. There is an urgent need for safe and effective alternative treatments for advanced prostate cancer patients. In the May 5, 1999 issue of the Journal of the American Medical Association it was reported that over 50% of patients who experience metastatic relapse after radical prostatectomy will die within 5 years and there are no approved therapeutic treatments, including cytotoxic drugs, that have proven to improve survival of these patients. The understanding of the biology of human prostate cancer is leading to the evaluation of new therapies including stimulation of the immune system, differentiation of malignant cells and those designed to block specific points in the metastatic cascade. In this recently completed Phase I/II study, 18 of 22 relapsing prostate cancer patients that are resistant to standard therapy experienced a reduction or stabilization of their PSA (prostate specific antigen) levels. No dose limiting toxicities were observed for hematologic, renal, hepatic or other end organ functions. The preclinical evaluation of GBC-590 in prostate cancer showed that when administered as monotherapy, GBC-590 produced a significant response, including complete tumor shrinkage and arrest of tumor growth, in the LNCaP human carcinoma xenograft animal model. >GBC-590 and Pancreatic CancerPancreatic cancer is the fifth leading cause of death by cancer. The American Cancer Society predicts that 29,000 people will be diagnosed with pancreatic cancer -- and that 28,900 people will die as a result of the disease -- in the coming year. With a 1-year mortality rate of approximately 90%, and a 5-year mortality rate of more than 99%, pancreatic cancer has the lowest survival rate of any cancer. Usually occuring in people between 60 and 70 years old, the cancer is one of the most difficult to detect because the patients remain asymptomatic until late in the progression of the disease. Preclinical results on GBC-590 in the PANC-1 human pancreatic cancer model, reported at a conference in November 1998, demonstrated exceptional efficacy in the reduction of tumor size and stabilization of tumor growth. Forty-four percent of mice treated with GBC-590 as a single agent showed a significant response and survived the 90 day experiment: in 33%, the tumor was completely erdicated, while 11% showed a stabilization of tumor size over the 90 days. No mice in control groups that were administered saline or gemcitabine (the most commonly used drug for treating pancreatic cancer patients) survived past 43 days, with a mean survival time of less that 30 days. About SafeScienceSafeScience is developing and in-licensing a portfolio of pharmaceutical, agricultural and consumer products to be marketed under the SafeScience world brand. The SafeScience brand represents a new category of products that offer consumers, for the first time, chemically-safe alternative that perform as well as, if not better than, chemically-harsh products. SafeScience Safe Harbor StatementAny statements contained in this release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties, including, but not limited to, risks of product nonapproval or product development and market acceptance risks, the impact of competitive products and pricing, the results of current and future licensing and other collaborative relationships, the results of financing efforts, developments regarding intellectual property rights and litigation, and other risks identified in the Company's Securities and Exchange Commission filings. Actual results, events or performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as the date hereof. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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