Bioasis Breaking Through With the World's First Blood Test ForAlzheimer's
November 11, 2010 08:10 am
After years of research, a smallCanadian biotech company is on the verge of commercializing two"holy-grail" technologies in the field of central nervous system(CNS) disorders. The first is the long sought-after simple blood test for diagnosing Alzheimer's disease (AD). The second is acarrier of therapeutics across the blood-brain barrier (BBB), the primaryobstacle to treating many diseases including inoperable brain tumors andParkinson's.
The potential of both thesetechnologies to deliver breakthroughs in fight against some of the worstdiseases plaguing humanity today is immeasurable. The CNS disorders market isalready one of the biggest, valued at more than US$98 billion per annum with an8% annual growth. Yet many of the CNS diseases cannot be treated either due tolack of a suitable diagnosis method or due to inability of 95% of drugs tocross the BBB.
AD is one of the most cruel and costliestdiseases plaguing our society today. This incurable, degenerative, and fataldisease is affecting roughly 30 million people worldwide, 5.3 million of themin the US. With an aging population this number is expected to double every 20years.
Based on the recently released World Alzheimer Report 2010: The GlobalEconomic Impact of Dementia the totalsocietal cost of AD in 2010 is estimated at $360 billion. That is almost ashigh as the 2009 GDP of the oil producing giant - Saudi Arabia.
Not only is there no cure for AD, there isn't even a reliabletest for diagnosing it. Even today, the only definitive diagnosis can bereached after the patient dies and the brain is examined for plaques andtangles, two of the main features of AD.
After decades of research and over 500 clinical trials we don't have adrug to halt or even delay progression of the disease. Lack of simple test is amajor obstacle, so much so that this summer a New York Times article praised as revolutionary the newopportunities to diagnose the disease with the aid of MRIs, brain scans, andspinal taps. These methods are costly and time consuming making themimpractical.
Bioasis Technologies' Cognitest is a simple blood test for AD.After years of development and several successful proof of concept studies, thecommercial version of the product is in the final stages of development incollaboration with the UK-based Fleet BioProcessing. Once complete, the testwill be validated by scientists at the prestigious King's College London. And,if things go according to plan, Bioasis expects to gain European Unionregulatory approval in early 2011.
Validating study will be animportant indicator of how effective Cognitestwill be. Data from the independent study suggests that the test will be veryaccurate for AD patients at the possible and probable stages of the disease. Thisis vitally important in diagnosing AD versus other forms of dementia, somethingmost clinicians struggle with on a daily basis.
Where the test can make a drasticimpact is if it can detect AD before any symptoms of the disease becomeobvious. Benefits of this are that people who know they will be developing ADin a few years time can try preventive therapies such as Vitamin B12 injectionsand enrollment in AD clinical trials.
Crossing the Blood Brain Barrier
TheWorld Health Organization has identified CNS disorders as the major medicalchallenge of the 21st Century. Despite the large market segment, most CNSdisorders do not have an adequate treatment today. This is due to thecomplexity of the brain and the BBB.
Theblood brain barrier acts as a protector of the CNS, and while effectivelyprotecting the brain from many common bacteria and infections, the BBB alsoseverely limits the movement of potential medicines into the brain.
Transcend is a carrier fordelivery of therapeutic agents across the BBB. It is based on p97, a naturallyoccurring protein that is able to cross the BBB. Studies have shown that Transcend is capable of delivering arange of different molecules across the BBB and accumulating the same in thebrain parenchyma.
Transcend's ability to transport a wide range of drugs across theBBB is of interest to every major pharmaceutical company, as well as to anumber of mid-size CNS specialty companies such as Lundbeck.
Thecompany has already initiated internal development programs with a selecttarget of drug candidates. Results from these programs should be available in2011.
InMay of 2009, a major US biotech company has engaged in testing of Transcend for possible collaborationwith Bioasis. It is expected that there will be a progress update announcement by Q1 of 2011.
Itis rare to see such an incredible potential in any market. Bioasis is now inthe final stretch towards commercialization where, within a few months, severalkey developments will shape this company's future.
Cognitest may soon become ahousehold name with Bioasis featured on Dr. Oz's show with their ground-breakingachievement.
Thecompany is estimating that the revenues from Cognitest royalties, to Bioasis, would start in 2011, growing to$20M-$30M annually by 2016.
Transcend is targeting one ofthe most lucrative pharmaceutical market segments where the top 10 CNS drugs haverevenues between $2B-$5B per annum. Foreach drug that Transcend is combinedwith 100s of millions of dollars can be expected in royalty payments toBioasis. Ilove investing in well managed, early stage companies with huge upsidepotential. Bioasis is one such company. With only 28M shares out, anexperienced management team, 35% ownership by the management and insiders, andtwo ground-breaking products, I believe Bioasis Technologies has the potentialto be a ten bagger within the next 12-18 months.