MIME-Version: 1.0 Server: WebSTAR/2.1 ID/32304 Message-ID: Last-Modified: Tue, 01 Jul 1997 00:19:58 GMT Content-type: text/html Content-length: 3377 MS-325 Development Program


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MS-325 Development Program

EPIX submitted an IND application for MS-325 to the FDA on July 22, 1996 and commenced a Phase I clinical trial in September 1996. Vital signs, blood chemistries and other biological and physical markers were monitored in all subjects. Based on preliminary results, no clinically significant adverse effects have been reported. The Company anticipates that the final audit of the Phase I data will be completed by April 1997. Assuming successful completion of the Phase I clinical trial, the Company intends to conduct concurrent but separate Phase II and Phase III clinical trials for different cardiology and radiology indications.

In addition to the diagnosis of CAD and PVD, the Company intends to pursue the use of MS-325 for additional clinical indications, including thrombosis, commonly referred to as "blood clots." EPIX believes that MRI with MS-325 could eliminate the need for selected ultrasound and nuclear medicine studies of thrombosis while providing, noninvasively, diagnostic information which is clinically equivalent to that provided by peripheral X-ray angiography.

Based on the physical properties of MS-325 and preclinical studies, MS- 325 may also have potential application as part of a noninvasive imaging procedure that would enable physicians to discriminate between malignant and benign breast masses in patients with indeterminate mammograms or palpable lumps. Another potential application for MS-325 in the diagnosis of breast cancer is in defining the size of malignant lesions. EPIX believes that an MRI breast exam using MS-325 could allow better determination of eligibility for breast-conserving therapy.


© 1997, EPIX Medical, Inc.

E-mail us at info@epixmed.com