LEP-ETUTreatment for Ovarian Cancer
NeoPharm Announces LEP-ETU Project Update
Bioequivalency Study Meets Endpoint Development For NDA Submission via 505(b)(2) Pathway Planned
LAKE FOREST, Ill., September 29, 2005 - NeoPharm, Inc. (Nasdaq:NEOL) today announced that, based on the results of its recently completed bioequivalence study, the Company's NeoLipid drug candidate LEP-ETU (Liposome Entrapped Paclitaxel "Easy to Use") has met the study criteria, established by FDA, for demonstrating bioequivalence. LEP-ETU is NeoPharm's easy-to-use liposomal formulation of paclitaxel (Taxol), which is a widely-used and approved treatment for advanced cancers, including ovarian, breast, and lung cancer. Based on this initial bioequivalence study, NeoPharm is accelerating the clinical program of LEP-ETU to support submission to FDA of a 505(b)(2) New Drug Application (NDA) for marketing approval.
The Company is currently preparing to submit an abstract in December of the bioequivalence study data to the American Society of Clinical Oncology (ASCO) for consideration for the program of the 2006 ASCO Annual Meeting in Atlanta, Georgia, June 2-6, 2006.
"We are pleased that our LEP-ETU drug candidate has demonstrated bioequivalence to Taxol," said Ronald G. Eidell, NeoPharm's President and Chief Executive Officer. "According to written guidance provided by the FDA, after completion of a 100-patient comparator study, we may be able to file an NDA for LEP-ETU as early as the fourth quarter of 2007."
Under the 505(b)(2) pathway, and guidance from the FDA on LEP-ETU, in addition to the bioequivalence study, the Company will need to initiate a 100-patient comparator study in metastatic breast cancer. The Company estimates the 100-patient comparator study, in which 50 patients would receive LEP-ETU and 50 patients would receive Taxol, will take approximately eight to ten months to enroll with a six-month treatment period. The Company is finalizing preparations for such a study to expedite patient enrollment, and currently expects to commence enrollment in the first quarter of 2006.
The rationale for developing a liposomal formulation of paclitaxel is to attempt to improve the safety profile of paclitaxel by eliminating the drug formulation component polyoxyethylated castor oil (Cremophor EL), which is associated with toxicities, while maintaining or enhancing efficacy.
In addition to the LEP-ETU comparator study, a Phase II study for another of the Company's NeoLipid drug candidates, LE-SN38 for colorectal cancer, is being planned with the Cancer and Leukemia Group B (CALGB), an NCI funded clinical study group, with protocol submission and acceptance to NCI CTEP and FDA, currently anticipated in the fourth quarter of this year.
LEP-ETU is the Company's NeoLipid liposomal formulation of the widely used cancer drug, paclitaxel. Paclitaxel has been approved in the U.S. as Taxol. Common side effects of this approved anticancer agent include nausea, vomiting, hair loss, and nerve and muscle pain. In addition, Taxol cannot be introduced into the body unless it is first formulated in a mixture of castor oil (Cremophor EL) and ethanol, which can lead to another set of debilitating side effects including hypersensitivity reactions. NeoLipid technology eliminates the need for Cremophor. As a result, LEP-ETU may overcome many of the current limitations of Taxol treatment for cancer patients and may limit the adverse side effects.
Posted: September 2005
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