Phase III Generx trial for Myocardial Ischemia on track-Cardium Therapeutics

Cardium Therapeutics has received encouraging initial findings from its clinical Phase III registration study (ASPIRE) that is evaluating Generx (Ad5FGF-4) in patients with Myocardial Ischemia due to Arteriosclerosis. ASPIRE is a randomized, multi-center study with two parallel arms, and is being conducted at leading medical centers in Moscow and Novosibirsk to supplement previously-obtained data in other countries including the United States.

Preliminary clinical data from the initial phase of the current study suggests that a one-time non-surgical administration of Generx can induce substantial improvements in cardiac blood flow (myocardial perfusion) as measured quantitatively using SPECT imaging. These findings are consistent with and further supportive of results observed in the Generx AGENT 2 clinical study that was conducted by Schering AG, from which Cardium obtained the product rights prior to Schering's acquisition by Bayer Healthcare. The Company intends to accelerate the Aspire study, and believes it will be in a position to provide an interim analysis in the first half of 2014.