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Astellas/Vical Start TransVax Phase III Study

Zacks Equity Research

Astellas Pharma Inc. (ALPMY) and its partner Vical Inc. (VICL) 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 (1:1), 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 Roche’s (RHHBY) Valcyte is approved for the prevention of CMV disease in patients who have undergone a heart, kidney, or kidney-pancreas transplant.

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, Jazz Pharmaceuticals (JAZZ) looks well positioned with a Zacks Rank #1 (Strong Buy).

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