Mr. Rob Hutchison reports

BIOASIS INITIATES MPS II STUDY WITH RENOWNED LYSOSOMAL STORAGE DISEASE EXPERT DR. MAURIZIO SCARPA AND THE BRAINS FOR BRAIN FOUNDATION

Bioasis Technologies Inc. will initiate a study to investigate the ability of its Transcend BBB (blood-brain barrier) 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 (Mucopolysaccharidosis type 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 co-ordinated by Dr. Rosella Tomanin.

The human enzyme to be administered in the study, idursulphase (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's 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 (melanotransferrin-derived Transcend peptide) 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 buildup of GAG (glycosaminoglycan) 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 financed in 2007 by Dr. 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's chief executive officer, 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 buildup of toxic byproducts 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 MPS II, is a rare genetic disorder that occurs when the I2S enzyme is either missing or does not function properly. The enzyme deficit impairs the breakdown of GAG in the lysosomes, and results in GAG buildup in harmful amounts in certain cells and tissues. The buildup, 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's 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's ultrasmall MTfp vector that has the ability to shuttle a wide variety of therapeutics and biologics into the brain with the 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.

We seek Safe Harbor.