Vancouver, B.C.–(Business Wire)– biOasis Technologies Inc. (TSX:V.BTI) announces today positive results of a preliminary toxicity evaluation of test animals that formed part of its xenograft model study, the results of which were announced September 5, 2012. That study showed that BT211, biOasis conjugate of trastuzumab (Herceptin®) designed to treat brain metatastsis of HER2+ breast cancer halted the growth of tumors in an animal xenograft model of human breast carcinoma.
The xenograft study was conducted by Biopharmaceutical Research, Inc., (BRI) Vancouver, British Columbia, Canada and was designed to assess the antitumor activity of BT2111. A secondary component of the study was a preliminary look at potential tissue toxicity of BT2111. As such, the heart, kidneys and liver of test animals were collected and submitted to Bellingham WA based Nova Pathology for histopathological evaluation by light microscopy. The analysis was conducted by Michael J. Tomlinson, D.V.M., Ph.D. The histopathology analysis looked at organs from forty female mice that had been assigned to four treatment groups (n=10 per group) as follows: PBS (saline) control; Herceptin®; Transcend; and, Transcend-Herceptin® conjugate (BT2111). The mice had been administered these test compounds by intraperitoneal injections twice per week over a 40 day period. The histologic findings were assigned semi-quantitative severity scores based on the following scheme: Minimal = 1, Mild = 2, Moderate = 3, Marked = 4. The histologic findings in animals dosed with Transcend, Herceptin® or conjugated Transcend-Herceptin® conjugate (BT2111) were consistent with findings in naïve mice and were not different from the control group. The report concluded that “Under the conditions of this study, there were no test article-related histopathology findings”.
In addition to the benign histopathology findings, BRI reported that the body weights of animals in Herceptin®; Transcend; and, Transcend-Herceptin® conjugate (BT2111) groups were not statistically different from control animals during the course of the treatment phase. This observation further suggests that BT2111 was well tolerated under the conditions of this study.
“This microscopic examination of tissue from animals that had been administered BT2111 over a 40 day period was our first opportunity to look for any preliminary evidence of drug-related tissue damage in selected organs”, said Rob Hutchison, Chairman and CEO. “We were extremely pleased to see that in this animal study, BT2111 did not cause any apparent organ toxicity, which is obviously a very important observation going forward. As we continue to advance the BT2111 program, extensive and rigorous toxicity studies will need to be conducted to clearly establish the safety of this compound. However, we are very encouraged by the findings to date.”
ABOUT BT2111 – BT2111 is a conjugate between biOasis’ Transcend brain delivery vector and trastuzumab (trade name of Herceptin®), a humanized monoclonal antibody used clinically in the treatment of HER2+ breast cancer. It is reported that up to 30% of HER2+ breast cancer patients develop brain metastasis for which therapeutic options are limited. Because of its ability to cross the blood-brain barrier, biOasis is researching the potential of BT2111 for treatment of HER2+ metastatic breast cancer in the brain.
Herceptin® is a registered trademark of Roche/Genentech.
biOasis Technologies Inc. is a biopharmaceutical company headquartered in Vancouver, Canada. Based on Transcend, biOasis proprietary brain delivery platform, the Company is focused on creating new drugs that can cross the blood-brain barrier to address unmet medical needs in the treatment of brain diseases such as neurodegeneration, metastatic cancer and metabolic diseases. biOasis trades on the TSX Venture Exchange under the symbol “BTI”. For more information about the Company please visit www.bioasis.ca.
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On Behalf of the Board of Directors
Robin Hutchison Chairman & CEO