New Liposomal Formulation of Major Breast Cancer Drug Is Equally Effective With Reduced Incidence of Severe Side-Effects
PR Newswire - May 20, 1998 07:17
EVACET(TM) Results Presented at ASCO - New Drug Application to be Filed in 1998 -
LOS ANGELES, May 20 /PRNewswire/ -- EVACET(TM), a liposomal formulation of doxorubicin, significantly reduces the incidence of severe side-effects of the parent molecule and has similar clinical efficacy for the treatment of the disease. Conventional doxorubicin is the preferred drug therapy for the treatment of advanced-stage breast cancer.
Clinicians conducting a 288-patient Phase III clinical study of The Liposome Company's (Nasdaq: LIPO), EVACET(TM) product, presented midpoint interim results at the 34th Annual Meeting of the American Society of Clinical Oncology (ASCO). The Liposome Company expects to file a New Drug Application with the U.S. Food and Drug Administration for permission to market EVACET(TM) in the second half of 1998.
Metastatic breast cancer afflicts approximately 60,000 women annually in the U.S. and is the cause of 38,000 fatalities. Doxorubicin has been used as a chemotherapeutic agent for 36 years but presents several debilitating side effects, including irreversible damage to the heart, sometimes resulting in congestive heart failure (CHF), severe nausea and vomiting, ulcers of the lining of the mouth, esophagus and intestines, and bone marrow suppression. The risk of cardiotoxic side effects increases significantly among patients who have received cumulative lifetime doses of more than 550 mg/m2. EVACET(a) is manufactured with a liposomal formulation that enhances the delivery and release of the drug to the specific targeted site, thereby reducing side effects.
Lindsay Harris, M.D. of Duke University Medical Center reported a midpoint analysis from a randomized comparative study of the response rates of EVACET(a) versus conventional doxorubicin therapy. One hundred forty four patients received doses of 75 mg/m2 with either EVACET(a) or doxorubicin for at least six weeks. The response rates for EVACET(a) versus conventional doxorubicin were assessed according to World Health Organization criteria to be essentially equivalent. Additionally, Dr. Harris reported that patients treated with EVACET(a) versus those treated with conventional doxorubicin experienced a reduction in the incidence of certain side effects, including nausea and vomiting (10% vs. 25%), stomatitis and mucositis (9% vs. 15%) and fever and infection (7% vs. 16%).
In a separate report, Gerald Batist, M.D. of McGill University in Montreal, Canada, reported results demonstrating a significant reduction in the risk of cardiotoxicity of EVACET(a) compared to conventional doxorubicin. Dr. Batist reported that of the 144 patients evaluated at the midpoint of the study, 27% (20 of 75 patients) of the patients that received conventional doxorubicin had experienced a cardiac event compared to 16% (11 of 69 patients) of those patients receiving EVACET(a) therapy. This was a statistically significant difference (p-value = 0.0034). Three patients receiving conventional doxorubicin developed CHF after going off the study. No patient on EVACET(a) experienced CHF, either on or off the study.
"The large single-agent study we are conducting is the purest indicator of the safety and efficacy of EVACET(a) in comparison to conventional doxorubicin," said Dr. James A. Boyle, Senior Vice President, Medical and Regulatory Affairs at The Liposome Company. "The data we are seeing are strong, and the results in a second comparative Phase III study where EVACET(a) and doxorubicin are each used in combination with another chemotherapeutic agent are consistent with these findings. We are very pleased by the safety and efficacy data for EVACET(a)," Dr. Boyle continued. "We believe that, if approved, EVACET(a) has the potential to replace doxorubicin as a first-line treatment for metastatic breast cancer, and will reduce the suffering of thousands of women being treated for late stage breast cancer."
The Liposome Company is a biopharmaceutical company developing and marketing therapeutic products to treat cancer and related diseases. ABELCET(TM) (Amphotericin B Lipid Complex Injection), which has been approved in 19 countries, is marketed in the United States for the treatment of severe, systemic fungal infections in patients who are refractory to or intolerant of conventional therapy and is the leading lipid-based formulation of amphotericin B in this country. The Company's product pipeline includes TLC ELL-12 and bromotaxol for the treatment of various cancers and programs focused on the development of new cancer therapies and vehicles for the delivery of gene therapy.
Except for historical information, this press release contains forward- looking statements that involve risks and uncertainties, including but not limited to statements regarding the successful completion of clinical trials of EVACET(a), the timing and approval of the NDA filing and other filings for marketing authorization of EVACET(a), and the likelihood that EVACET(TM), or any other product, can be successfully developed and commercialized. While these statements reflect the Company's best current judgment, they are subject to risks and uncertainties that could cause actual results to vary, including the risk factors identified in the Registration Statement on Form S-3 dated October 29, 1997 and from time to time in the Company's other SEC filings. This press release and other information are available at lipo.com and noonanrusso.com
SOURCE Liposome Company, Inc.
/CONTACT: Larry Hoffman, Chief Financial Officer of The Liposome Company,
Inc., 609-452-7060; or Ernie Knewitz, media, 212-696-4455, ext. 204, or
Barbara Lindheim, investor, ext. 237, both of Noonan-Russo Communications,
Inc., for The Liposome Company, Inc./
/Web site: lipo.com |
