) recently enrolled the first patients for two phase II studies
of its candidate SRM003 (formerly Vascugel), which is being
developed for treating patients suffering from end-stage renal
disease (ESRD). The patients are undergoing arteriovenous access
creation for hemodialysis.
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We note that SRM003 is being developed by Shire for its
Regenerative Medicine (RM) business. The company obtained the
rights to the candidate following its acquisition of Pervasis
Therapeutics in Apr 2012.
AVF01-SRM003, the first of the two phase II studies, is designed
to evaluate the efficacy and safety of SRM003 in improving the
rate of arteriovenous fistula (AVF) maturation. In addition, it
will also be evaluated for usage in patients with ESRD who are
undergoing surgery for the creation of an AVF to aid hemodialysis
AVG01-SRM003, the second study, will evaluate the efficacy and
safety of SRM003 for extending the duration of primary patency
after placement of an arteriovenous graft (AVG) in ESRD patients.
SRM003 has been granted orphan drug designation in the US and the
EU. In addition, SRM003 has received a Fast Track designation
from the US Food and Drug Administration (FDA).
Diabetes is the root cause of ESRD. Shire aims to develop SRM003
to help patients suffering from diabetes.
Successful development and commercialization of SRM003 would
boost the top line at Shire significantly since the diabetes
market offers great commercial potential. We remind investors
that Shire's Regenerative Medicine business already has
Dermagraft in its portfolio. The product is approved for the
treatment of diabetic foot ulcers in the US, Canada, Mexico,
Israel, and Malaysia.
Shire currently carries a Zacks Rank #3 (Hold). Pharma stocks,
which currently look better placed include
Furiex Pharmaceuticals Ltd.
Avanir Pharmaceuticals Inc