EPIX is up 16% today at $10 3/4. H&Q maintains its $17 potential. Here are the Phase II results. Phase III is not considered a minor hurdle. The announcement came out after the market closed....
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EPIX Medical and Mallinckrodt Announce Results from Phase II
Clinical Trial for Ms-325 Magnetic Resonance Contrast Agent
Agent Demonstrates 82% Accuracy for Identifying Clinically Significant Stenosis
CAMBRIDGE, Mass., July 16 /PRNewswire/ -- EPIX Medical, Inc. (Nasdaq: EPIX - news) and Mallinckrodt Inc.
(NYSE: MKG - news) today jointly announced that MS-325, an injectable magnetic resonance imaging (MRI) contrast
agent, demonstrated 82% accuracy for identification of clinically significant stenosis in a recently completed Phase II
clinical trial. The multi-center trial was a double-blind, dose-ranging study, designed to compare MS-325 MRI with
x-ray angiography, evaluating its safety and diagnostic efficacy for the detection of non-coronary atherosclerotic
occlusive disease, commonly known as peripheral vascular disease (PVD). PVD affects arteries throughout the body,
and results in approximately 500,000 strokes, 600,000 vascular operations and 100,000 amputations in the more than
two million people afflicted with the disease in the U.S. alone.
The primary endpoints of the study were the identification and location of clinically significant stenoses, defined as
>70% stenosis in the carotid arteries and >50% stenosis in the femoral and iliac arteries. The results for identification of
stenoses, combining all doses (0.01, 0.03 and 0.05 mmol/kg), indicate that MS-325 demonstrated an accuracy of 82%,
sensitivity of 80% and specificity of 82% in the peripheral vasculature (including the carotid, femoral and iliac arteries),
as compared to x-ray angiography. The 95% confidence intervals for accuracy, sensitivity and specificity were 73-90%,
68-92% and 70-95%, respectively. The study also demonstrated that the accuracy for determining the location of
stenoses for carotid, iliac and femoral arteries was 100%, 72% and 86%, respectively, again combining all doses. The
study further indicates that MS-325 is well tolerated by patients at all dose levels, with no serious side effects reported
during the trial.
With these Phase II results in peripheral MR angiography, EPIX and Mallinckrodt intend to seek a meeting with the
U.S. Food & Drug Administration to discuss plans for a Phase III trial to confirm MS-325 safety and efficacy.
X-ray angiography is the current reference standard for the diagnosis of PVD, with an estimated 1.9 million peripheral
vascular procedures performed annually in the U.S. It is a highly invasive procedure, with significant complications --
including limb loss and renal failure -- and requires a substantial commitment of hospital resources. By enabling high
resolution imaging, EPIX believes that MS-325 will provide radiologists with a minimally invasive means of visualizing
the peripheral vasculature early in the patient work-up, potentially aiding clinicians in making definitive diagnoses and
planning surgery.
Michael D. Webb, President and CEO of EPIX, said, ''Phase II studies represent a critical juncture in the development
of a new imaging agent, and these data suggest that MS-325 may be a very valuable tool for the non- invasive diagnosis
of peripheral vascular disease, streamlining the diagnostic pathway. What we hope to provide is a diagnostically
equivalent exam with less patient discomfort and a significantly reduced risk of serious side effects. We also expect
MS-325 to substantially reduce the costs currently associated with diagnosing peripheral vascular disease.''
''We expect that MS-325 will play a major role in expanding our MR imaging business. It will complement our current
agents, GastroMARK(R), which is marketed to facilitate delineation of the bowel from other structures during
abdominal studies, and OptiMARK(TM), a development stage product designed for general MRI use,'' said James C.
Carlile, President of Mallinckrodt's Imaging Group.
Examples of the Phase II MS-325 MRI images can be viewed via the Internet by accessing EPIX Medical's web site
(www.epixmed.com). |
