Astellas Pharma Inc.
) and its partner
) recently commenced a multinational phase III registration study
of TransVax to control cytomegalovirus (CMV) in hematopoietic
cell transplant (HCT) recipients. TransVax is the first CMV
vaccine to reach the phase III stage.
The randomized (1:
), double-blind, placebo-controlled study will be performed in
CMV seropositive patients undergoing HCT procedures. This study
is divided into two parts -- the first part will enroll around
100 patients with the primary endpoint being overall survival,
and the second part will enroll roughly 400 patients with the
primary endpoint either survival or a composite endpoint
including survival and some other variables.
Vical has a licensing agreement with Astellas for the
development and commercialization of TransVax. Vical received a
$25 million upfront payment from Astellas in 2011 and a $10
million milestone payment in 2012.
Vical and Astellas intend to commence a phase II study of
TransVax in solid organ transplant (SOT) recipients in the latter
half of 2013.
TransVax has orphan drug designation in the US and Europe for
HCT and SOT patients.
We note that
) Valcyte is approved for the prevention of CMV disease in
patients who have undergone a heart, kidney, or kidney-pancreas
Another candidate that is currently being studied for the
treatment of CMV infections in transplant recipients is
maribavir, which is in two phase II studies. The studies are
being conducted in Europe and the US.
Vical carries a Zacks Rank #3 (Hold) while Astellas and Roche
carry a Zacks Rank #4 (Sell). Right now,
) looks well positioned with a Zacks Rank #1 (Strong Buy).
ASTELLAS PHARMA (ALPMY): Get Free Report
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
ROCHE HLDG LTD (RHHBY): Get Free Report
VICAL INC (VICL): Free Stock Analysis Report
To read this article on Zacks.com click here.