To all: manufacturing completed for phase III RRP trial
Stressgen Biotechnologies completes manufacture of HSPE7 for use in RRP Phase III clinical study
SAN DIEGO, CA, June 21 /CNW/ - Stressgen Biotechnologies ("The Company") (TSX: SSB) announced today that it has completed the manufacture of HspE7, which will allow for the release of HspE7 for use in the RRP Phase III clinical study in the next several months. As a result, the Company plans to begin a Phase III study in recurrent respiratory papillomatosis (RRP) in the first quarter of 2006, pending review by the U.S. Food and Drug Administration (FDA).
The study will include multiple doses to assess the safety and efficacy of HspE7 in patients with RRP. Efficacy will be measured by increases in intersurgical interval. Because of the change in the biological profile of the newly manufactured HspE7, the Company does not expect to gain concurrence from the FDA under a Special Protocol Assessment (SPA).
In addition, the Company will be developing an additional HspE7 product that incorporates the reformulation of the compound with an adjuvant. The Company expects to be prepared to begin a Phase I/II proof-of-concept study with this product in the first quarter of 2006.
"We are extremely pleased with the outcome of the manufacturing work accomplished by our project team, who resolved our manufacturing issues. We look forward to the release of our HspE7 product for our RRP Phase III trial," stated Gregory M. McKee, President and Chief Executive Officer of Stressgen. "In addition, we have established a plan for the development of HspE7 and HspE7 combined with an adjuvant. HspE7 plus adjuvant has demonstrated increased potency in relevant animal models, suggesting expanded utility of HspE7 and our CoVal(TM) fusion technology platform."
Financial Update
Over the next several months, the Company will continue to dedicate its strategic and financial resources to support the further advancement of HspE7. The Company needs to raise additional funds to begin and continue to conduct the necessary trials and will focus on partnering activities as the primary source of new capital to fund the HspE7 programs.
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