Regulatory Approval for Aneustat (OMN54) Phase I Clinical Trial
Genyous Biomed International (Genyous) announced today that it has received regulatory approval to conduct a Phase I clinical trial of the Company's lead cancer therapy, Aneustat™ (OMN54).
Aneustat (OMN54) represents a new class of therapies designed to address the heterogeneous nature of cancer. Genyous' Multifunctional Multitargeted (MFMT™) therapies are formulated to provide multiple therapeutic effects in parallel in a manner that is both safe and efficacious.
Pre-clinical in vitro and in vivo studies of Aneustat (OMN54) suggest that:
- Aneustat™ can be delivered orally and is well-tolerated (no harmful side effects at therapeutic doses)
- Aneustat™ inhibits tumor growth (human tumor tissue xenografts in mice) of some lung and prostate cancers on par with standard combination chemotherapy regimens
- Aneustat™ inhibits cancer through multiple genomic targets to induce apoptosis and impede metastasis
- Aneustat™ has strong cancer inhibition synergy with leading chemotherapies, potentially enhancing efficacy and/or lowering toxicity
- Aneustat™ regulates the cancer cell cycle in a manner that suggests that Aneustat may serve as an enhancer to increase efficacy of chemo or radiation therapy
- Aneustat™ can be used as an adjuvant therapy or combination pharmaceutical
The Phase I clinical study is planned to take place at the BC Cancer Agency in Vancouver, British Columbia.
"The approval of our phase I clinical trial application by Health Canada is a major milestone for us. We are grateful for their cooperation and diligence in providing a swift review of our clinical trial application," said James Dao, Chairman & CEO of Genyous. "The decision to conduct the first clinical trial of Aneustat (OMN54) at the BC Cancer Agency was a natural choice given the long history of collaboration between Genyous and the BC Cancer Agency. Most of the pivotal efficacy and safety studies of Aneustat (OMN54) took place at the BC Cancer Agency. We are honored that Dr. Karen Gelmon has agreed to serve as the principal investigator in this study. Her expertise in Phase I oncology studies is extremely valuable."
About Genyous Biomed International Genyous Biomed International was founded in 2000 with a mission to reduce mortality due to chronic diseases such as cancer. Genyous' proprietary Multifunctional Multitargeted (MFMT™) therapies are particularly well-suited to address the heterogeneous nature of cancer by delivering multiple therapeutic effects in parallel. More information can be found at www.genyous.com.
Aneustat and MFMT are trademarks of Genyous Biomed International, Inc.