Bioniche Life Sciences Inc announced that it has had three new patents issued for the Company's core technology.
The new patents relate to the Company's proprietary product, Mycobacterial Cell Wall-DNA Complex (MCC), which has been demonstrated to act as an immune stimulant as well as inducing apoptosis (programmed cell death) in cancer cells.
The new patents (one in the U.S. and two in Europe) are: Composition and Method for Inducing Apoptosis in Prostate Cancer Cells (US6794368); Chemotherapeutic Composition and Method (EP01135161B1); Composition for the Treatment of Inflammation" (EP1135164B1).
"It is extremely gratifying to be able to further extend our already significant patent coverage for MCC," noted Dr. Nigel Phillips, CSO for Bioniche Life Sciences. He added, "These patents not only protect the core platform, but also the scope of application of the technology."
MCC has undergone successful phase I and II clinical trials as a treatment for carcinoma in-situ, a particularly dangerous form of bladder cancer. The protocol for the phase III clinical trial is being developed. This will be a multi-centre, international (North America and Europe) trial involving regulatory approval in both jurisdictions before it can proceed. MCC for the phase III trial is being produced at Bioniche's manufacturing facility in Montreal. This 27,000 square foot facility was acquired in 2001 and was upgraded and validated to manufacture the bladder cancer clinical trial material to cGMP standards.
MCC, in combination with hyaluronic acid (HA), has been trialed as a treatment for prostate cancer. A phase I clinical trial was completed earlier this year.
"Bioniche invests a substantial amount of its resources in research and development," Graeme McRae, president & CEO noted adding, "A well-developed intellectual property portfolio such as ours will ensure that we will be well-protected in key therapeutic areas and will be able to provide the best possible return on our R&D investment."
Bioniche has a family of proprietary, patented mycobacterial cell wall technologies. These are immunomodulators derived from Mycobacterium phlei with the known ability to enhance non-specific immunologic responses of the host. Their anti-microbial and anti-tumor effects have been documented. Mycobacterial Cell Wall-DNA Complex (MCC) is one of these technologies. MCC acts as an immune stimulant and as a cell cycle arresting/proliferation-inhibiting and apoptosis (programmed cell death)-inducing agent for cancer cells. MCC contains mycobacterial DNA, which has demonstrated that it is responsible for both of these activities, the release added.