cGMP Manufacturing Contract Signed by Proteon Therapeutics, Inc., and QSV Biologics, Ltd., for PRT-201 Clinical Phase I Material Supply
August 10, 2006
EDMONTON, Aug. 10 /CNW/ - QSV Biologics, Ltd (QSV), a North American based biologics CMO located in Edmonton, Canada, and Proteon Therapeutics, Inc, of Waltham, Massachusetts and Kansas City, Missouri, announced today the signing of a contract for the cGMP manufacturing of PRT-201, Proteon's lead drug candidate. QSV will be responsible for cGMP manufacture of phase I clinical trial material in their licensed cGMP manufacturing facility. PRT-201 is a novel recombinant human protein produced from yeast. In pre-clinical studies conducted thus far, PRT-201 treatment leads to permanent dilation of blood vessel segments.
Graeme Macaloney PhD, PEng, QSV President & CEO said: "This is our second contract with Proteon. We are very excited to be manufacturing their yeast-based vasodilation drug which has the potential to rapidly progress from currently planned phase I trials through later stages of clinical development".
Timothy P. Noyes, Proteon President & CEO commented: "We are excited to broaden our relationship with QSV, and view this next step as an important extension of the ongoing process development program. QSV has demonstrated expertise and an understanding of our business that makes them a great CMO partner for Proteon".
Proteon Therapeutics, Inc., is a privately held biotechnology company developing novel, first-in-class pharmaceuticals to address the critical, rapidly expanding medical needs of patients with renal and vascular diseases. The company is leveraging a unique understanding of tissue remodeling to develop a pipeline of proprietary therapeutics. For more information about Proteon, please visit: www.proteontherapeutics.com.
QSV Biologics, Ltd., based in Edmonton, Canada, is an international cGMP biologics contract manufacturer (CMO) providing microbial fermentation, mammalian & insect cell culture, and purification services. QSV's facility has a 10 year track-record including an Establishment License from Health Canada, for manufacturing clinical trial and commercial biologics. QSV was the sole recipient of the prestigious international Frost & Sullivan "Customer Value Enhancement Award" in 2005. QSV's clientele, spanning three continents, are firms who develop protein therapeutics, monoclonal antibodies, vaccines & diagnostics. As a dedicated CMO with no competing products of its own, QSV builds value for its clients by producing quality products in a timely manner. Hence its acronym: QSV: Quality & Speed build Value. For more information, please visit: www.qsvbiologics.com.
For further information:
Richard Hetrick
Director of Business Development
QSV Biologics, Ltd.
(780) 438-5722
Timothy P. Noyes
President & CEO
Proteon Therapeutics, Inc.
(781) 890-0102
