biOasis Announces Positive Anti-Tumour Efficacy Data
biOasis Transcend-Herceptin® Conjugate (BT2111) Significantly Reduces the Number and Size of Metastatic HER2+ Breast Cancer Tumors in the Brain
VANCOUVER, BRITISH COLUMBIA--(Marketwire - Feb. 7, 2013) - biOasis Technologies Inc. (TSX VENTURE:BTI) announced today that its Transcend-Herceptin® Conjugate (BT2111) product candidate (a proprietary conjugate of Roche's anti-cancer antibody trastuzumab (Herceptin®) and Transcend, biOasis brain delivery vector) reduced the number of metastatic human HER2+ breast cancer tumors in the brains of test animals by 68% when compared to untreated control animals. The tumors that remained after treatment were 57% smaller than those in the untreated control animals. In contrast, Herceptin alone had no effect on reducing the number of tumors and was associated with only a slight (15%) reduction in tumor size when compared to untreated control animals. These results provide clear evidence of the potential of the biOasis Transcend-Herceptin® Conjugate (BT2111) for treating brain metastasis.
The results reported here are from studies performed at Texas Tech University Health Sciences Center School of Pharmacy under the direction of Dr. Paul Lockman - a recognized expert on drug transport across the blood-brain barrier and on metastatic brain tumors. The study was intended to assess the effect of BT2111 and Herceptin® alone in animals that were inoculated with a human "brain-seeking" breast cancer cell line that overexpresses HER2. Within 21 days the cells migrate to the brain and establish clinically relevant tumors. Animals were then treated twice per week with Herceptin® alone, or the BT2111 conjugate or saline (untreated control) to day 35. Following treatment the number and size of the metastatic tumors were then determined. At day 35, the average number of tumors in the brains of untreated control animals was 85. Herceptin® treatment showed no statistically significant reduction in this number. In contrast, the animals treated with BT2111 had on average 28 tumors, a highly statistically significant reduction over both Herceptin®-treated and untreated controls. Furthermore, BT2111 resulted in a 57% reduction in the size of the tumors that remained after treatment when compared to both Herceptin®-treated and untreated controls. This improvement observed in the BT2111 treatment group was also highly statistically significant compared to Herceptin® treatment where the average tumor size was slightly reduced (15%) when compared to untreated controls.
"The treatment model that Dr. Lockman and his team have developed at Texas Tech is at the leading edge of research for assessing drug therapies for metastatic brain cancer. The highly statistically significant reductions in the number and size of HER2+ metastatic breast cancer tumors due to BT2111 treatment that biOasis is reporting today forms part of a massive and rigorous effort to assess the potential of Transcend Conjugates to traverse the blood-brain barrier and treat diseases of the brain," said Dr. Wilf Jefferies, inventor of the Transend technology and Founding Scientist of biOasis.
"These studies build on the positive results that we have reported previously," added Rob Hutchison, biOasis CEO. "In September 2012 we announced that BT2111 and Herceptin® were equally effective in arresting the growth of breast cancer tumors that were implanted subcutaneously in test animals. Today we announce the exciting benefit of BT2111 over Herceptin® - that is, the ability to transport this important anticancer agent into the brain at levels which are efficacous against metastatic breast carcinomas. Our mission as a company is to advance the development of BT2111 with the goal of potentially one day treating this devastating disease that affects so many women."
About Brain Metastases of HER2+ Breast Cancer - 20% of human breast cancers over- express a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. The standard of care for treatment of these HER2+ cancers is the monoclonal antibody trastuzumab (Herceptin®), which specifically targets HER2, kills the cancer cells and decreases the risk of recurrence. Unfortunately, brain metastases of breast cancer occurs in approximately 35% of women treated with Herceptin® for advanced HER2+ breast cancer. The high incidence of HER2+ metastatic brain disease results from the combination of the inability of Herceptin® to cross the blood-brain barrier and a predilection of breast cancers that overexpress HER2 to metastasize to the brain. The prevention and treatment of brain metastasis from HER2-overexpressing breast tumors represents a major challenge and there is an urgent medical need for the development of new treatment strategies.
About Transcend-Herceptin® Conjugate (BT2111) - BT2111 is a conjugate between biOasis' Transcend brain delivery vector and trastuzumab (Herceptin®), a humanized monoclonal antibody used clinically in the treatment of HER2+ breast cancer. It is reported that up to 35% of HER2+ breast cancer patients develop brain metastasis for which therapeutic options are limited. Because of its ability to deliver Herceptin®, across 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.
Certain statements in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments express or implied by such forward-looking statements or information. Such factors include, among others, our stage of development, lack of any product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: we may not be able to successfully develop and obtain regulatory approval for p97 as a Physician's Aid to Diagnose Alzheimer's, or future products in our targeted corporate objectives ; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and the costs of launching our products may be greater than anticipated; we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in our filings with the Canadian securities regulatory authorities at www.sedar.com. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward- looking statements and information to reflect subsequent events or circumstances, except as required by law.
On Behalf of the Board of Directors
Rob Hutchison, Chairman & CEO
"Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release."
biOasis Technologies Inc.
Chairman & CEO