biOasis Technologies Inc.
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OTCQX : BIOAF

biOasis Technologies Inc.

September 18, 2014 09:30 ET

biOasis Initiates MPS II Study with Renowned Lysosomal Storage Disease Expert Dr. Maurizio Scarpa and The Brains for Brain Foundation

One of the most challenging aspects of treating Lysosomal Storage Diseases is the transport of the required enzymes across the Blood-Brain Barrier and into the Central Nervous System.

VANCOUVER, BRITISH COLUMBIA--(Marketwired - Sept. 18, 2014) - BIOASIS TECHNOLOGIES INC. (TSX VENTURE:BTI)(OTCQX:BIOAF), the pioneering biopharmaceutical company focused on the delivery of therapeutic drugs across the blood-brain barrier ("BBB"), announces a study to investigate the ability of its Transcend BBB transport platform technologies to deliver to the Central Nervous System of a knockout animal model, the therapeutic enzyme required to correct the neurological disorder, MPS II, or Hunter Syndrome. The study will be conducted by way of a biOasis grant to the Brains for Brain Foundation ("B4B") of Padova, Italy, headed by renowned Lysosomal Storage Disease expert, Dr. Maurizio Scarpa, Founder and President of the Foundation. The study will be performed at the "Diagnosis and Therapy of Lysosomal Disorders" research facility of the University of Padova, and will be coordinated by Dr. Rosella Tomanin.

The human enzyme to be administered in the study, Idursulfase (I2S), is missing or functionally deficient in human sufferers of Hunter Syndrome. The study will use a knockout animal model that has shown the same characteristics as in the human form of MPS II. The study will demonstrate whether a therapeutic quantity of I2S can be delivered in the animal's brain using biOasis' fusion proteins, MTf-I2S and the Transcend peptide-based MTfp-I2S, and whether the proteins can restore normal I2S function after intravenous administration.

Through the mechanism of Receptor Mediated Transcytosis, the biOasis fusion proteins, MTfp-I2S and MTf-I2S, are designed to cross the BBB and to allow the I2S to localize in the lysosomes of brain cells. The study will allow biOasis and B4B to not only study the effects of the fusion MTfp and MTf proteins on the restoration of enzymatic activity, but also the effect of the proteins' administration in brain parenchyma cells and in cells from various other tissues. Preliminary experiments using this animal model of MPS II have suggested that Enzyme Replacement Therapy with recombinant I2S may be effective in reducing the build-up of GAG stores that result from the I2S enzyme deficiency.

The results of the study will be used to support the design of clinical studies to evaluate the efficacy of MTfp-I2S and MTf-I2S in MPS II patients.

"The delivery of enzymes to the brain in a safe and efficient manner would offer clinicians a way to treat patients suffering from this dreadful disease," said Dr. Scarpa, President of B4B. "A number of invasive techniques have been deployed to deliver these enzymes into the brain and these techniques have demonstrated in humans that when the enzymes get there, they can be effective. The biOasis technology that we are going to study may offer a non-invasive, broad solution to the disorders."

The Brains for Brain Foundation was founded and also funded in 2007 by Dr. Maurizio Scarpa and the Foundation's Vice-President, Dr. David Begley. B4B's stated mission is the following: "B4B aims to develop new and innovative therapeutic strategies to cross the Blood-Brain Barrier, a capillary system which shields and defends the CNS from circulating neurotoxin compounds. It has a very important filtering protective function but unfortunately also prevents access to the brain by most candidate therapeutic drugs under development for CNS diseases. B4B mission consists of the promotion of an International Network of health professionals in rare disorders, specifically in the field of rare neurological paediatric diseases. The purposes of the Foundation are to support the following activities in the field of rare Neurological Disorders: scientific research, knowledge dissemination, social and socio-medical assistance and health assistance."

Rob Hutchison, biOasis' CEO, commented, "biOasis chose to work with Dr. Scarpa and the B4B Foundation he founded for a number of reasons. Dr. Scarpa has dedicated his career to helping children fight these dreadful diseases. He and Dr. Begley of the Foundation are world leading experts in the field. Dr. Scarpa, together with Dr. Tomanin, also guides a research facility at the University of Padova and they have several years of expertise with this animal model. We expect to have this study completed later this year with evaluation of data to follow."

About Lysosomal Storage Diseases

Lysosomal Storage Diseases form a group of more than 50 distinct diseases that cause physiological and neurological deterioration, predominantly in children. An LSD develops when a particular enzyme is missing or produced in insufficient quantities, resulting in the cellular build-up of toxic by-products that cause disease pathologies throughout the body, including, in their severe forms, in the Central Nervous System.

About Hunter Syndrome (MPS II)

Hunter Syndrome, also known as Mucopolysaccharidosis type II (MPS II), is a rare genetic disorder that occurs when the Idursulfase (I2S) enzyme is either missing or does not function properly. The enzyme deficit impairs the breakdown of glycosaminoglycan (GAG) in the lysosomes and results in GAG build-up in harmful amounts in certain cells and tissues. The build-up, which usually begins in early childhood, eventually causes permanent, progressive damage affecting appearance, mental development, organ function and physical abilities.

About The Transcend Program

The Transcend Program consists of biOasis' proprietary platforms for the delivery of therapeutics across the blood-brain barrier to address a wide spectrum of unmet medical needs. The program includes biOasis' ultra-small Melanotransferrin-derived Transcend peptide vector ("MTfp") that has the ability to shuttle a wide variety of therapeutics and biologics into the brain with their transport not being limited by the sizes of the transported therapeutics or their compositions.

The transport of therapeutics across the BBB represents the single greatest challenge in the treatment of neurological disorders. The ability to effectively permeate the BBB offers researchers the opportunity to test promising new therapeutics as well as the potential to develop new and more effective formulations of already-approved therapies, thus expanding the commercial value and patent life of the underlying intellectual property.

About biOasis

biOasis Technologies Inc. is a biopharmaceutical company headquartered in Vancouver, Canada and is focused on the delivery of therapeutic drugs across the blood-brain barrier. The company is developing and commercializing proprietary brain delivery technology platforms to address unmet medical needs in the treatment of central nervous system disorders. biOasis trades on the OTCQX under the symbol "BIOAF" and on the TSX Venture Exchange under the symbol "BTI". For more information about the company please visit www.bioasis.ca.

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: products that we develop may not succeed in preclinical or clinical trials, 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."

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