VANCOUVER, British Columbia, May 11, 2011 (GLOBE NEWSWIRE) -- biOasis Technologies Inc. (TSX-V:BTI) announced today the initiation of its first Transcend therapeutic development program directed towards developing treatments for the neurological effects of lysosomal storage disorders ("LSD"). This strategic decision is based on recently announced results from the National Research Council of Canada demonstrating that intravenously administered Transcend is delivered into brain cell lysosomes and data from the company showing that brain lysosomal enzyme activity can be restored and enhanced in animals when linked to Transcend. These properties of Transcend offer the possibility of enhancing the brain delivery of specific lysosomal enzymes as replacement therapies to address the neurological manifestations of lysosomal storage diseases.
Lysosomal storage disorders are inherited metabolic disorders caused by a deficiency in lysosomal enzymes, of which approximately fifty have been described to date. As a consequence of these deficiencies, cells are unable to breakdown and metabolize lipids, glycoproteins and mucopolysaccharides. The diseases which result from the accumulation of these molecules in the cells of various tissues and organs usually affect children, many of whom die within several years of birth following years of suffering from symptoms that may include developmental delay, movement disorders, seizures, dementia, deafness and blindness.
The most effective therapeutic strategy for LSDs is to replace the missing enzyme. Enzyme replacement therapy (ERT) provides relief from some of the systemic symptoms of LSDs. However, because of the blood-brain barrier, no effective ERT is currently approved to treat central nervous system manifestations. Despite the limitations of existing products, market revenues have exceeded $2 billion for each of the past three years.
As proof-of-concept of the potential of Transcend in LSD therapy, earlier animal studies demonstrated that intravenous Transcend increased the brain delivery of the lysosomal enzyme iduronidase by approximately 4-fold compared to the level achieved by administrating the enzyme alone. A human recombinant form of this enzyme, marketed by Genzyme under the trade name Aldurazyme®, accounts for annual worldwide sales of $167 million, and is the leading enzyme replacement therapy for the non-neurological effects of Mucopolysaccharidosis I (MPS I), a progressive, debilitating and life-threatening disease.
"There is a major unmet medical need for therapies that can address the devastating neurological effects of many of these lysosomal storage diseases," said Rob Hutchison, CEO. "With the knowledge we now have in hand, we are commencing our LSD Transcend program for enzyme replacement therapy. These may include those that are currently marketed or in development to treat non-CNS symptoms of LSDs. In parallel we continue to evaluate other disease areas including oncology and neurodegenerative diseases where we believe our Transcend therapeutic delivery vector may provide solutions to improve the health of people."
ABOUT THE BLOOD-BRAIN BARRIER
Overcoming the difficulty of delivering therapeutic agents to specific regions of the brain presents a major challenge to treatment of most brain disorders. In its neuroprotective role, the blood–brain barrier functions to hinder the delivery of many potentially important diagnostic and therapeutic agents to the brain. Therapeutic molecules and genes that might otherwise be effective in diagnosis and therapy do not cross the BBB in adequate amounts. It is widely reported that over 95% of all Therapeutic molecules do not cross the blood-brain barrier.
ABOUT TRANSCEND
biOasis is developing a proprietary carrier for the transport of therapeutic and imaging agents across the blood-brain barrier - Transcend. Current initiatives within the Transcend program include production of materials for preclinical studies and conjugation to a range of small molecule and biologic therapeutics. To address the unmet clinical need to transport drugs across the blood brain barrier biOasis intends to license Transcend to multiple corporate partners.
ABOUT BIOASIS:
biOasis Technologies Inc. is a biopharmaceutical company engaged in the development and commercialization of products for the diagnosis and treatment of neurological diseases and disorders. Its products and technologies are intended for use within the healthcare and life science research markets. The Company is currently developing Cognitest™, a blood test for the diagnosis of Alzheimer's disease. biOasis is also developing Transcend, a proprietary molecular carrier intended to transport drugs across the Blood-Brain Barrier for treatment of a wide range of neurological, oncological and infectious disease applications.
Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC
Forward Looking Statements
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
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