Investigation of Collategene(TM), HGF Plasmid for Ischemic Disease Treatment Designated as the Fast Track Development Program by the FDA

Source Press Release
Company AnGesVicalSoseiEi 
Tags USA, Priority Review, Gene Therapy, Cardiovascular
Date September 17, 2010

AnGes  MG Inc. announced today that its US subsidiary,  AnGes , Inc’s investigation to develop Collategene(TM) as a treatment for Critical Limb Ischemia (CLI) has been designated as a Fast Track development program by the Food and Drug Administration. (FDA) 

Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological product means that the FDA will take actions as appropriate to expedite the development and review of the application for approval of such product. 

Request for Fast Track designation was submitted by AnGes , Inc. in July 2010. This designation enables AnGes  to acquire timely advice from the FDA to facilitate the development. Furthermore, the FDA may evaluate for filing and commence review of portions of an application for approval of a Fast Track product under certain conditions.  

As previously announced, since our phase 3 global clinical study protocol has received SPA approval from the FDA, provided that we obtain robust positive data from the pending clinical study, it is possible that Collategene(TM) will be granted Priority Review. 

Dr. Ei  Yamada, CEO of  AnGes  MG commented, “The fact that Collategene(TM) obtained Fast Track status in addition to reaching agreement on SPA, reflects the unmet medical need and the CLI patients’ high expectation for this new treatment option. In particular, because of the higher prevalence, the need for a new treatment in this field is greater in the US as well as in Europe, compared to Asian nations. It is our expectation to expedite the initiation of the global phase 3 clinical trial.”  

The impact of this event on AnGes ’ annual financial projection is as announced separately. It is our expectation to contribute to the improvement of our AnGes ’ financial status in the long run. 

Source: Evaluate™
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