Boston Life Sciences' Proprietary Protein-Production Process to be Used by Manufacturing Partner to Supply Anti-Angiogenic Troponin.

Business Editors/Health and Medical Writers

BIOWIRE2K

BOSTON--(BW HealthWire)--Feb. 28, 2001

Boston Life Sciences, Inc. (NASDAQ: BLSI) has developed a "breakthrough" advance in protein manufacturing process for use in production of its anti-angiogenic agent, Troponin. The Company believes that this process will yield reliable production of highly active, pure, GMP material for clinical trials and commercialization. Troponin is an extremely potent, naturally occurring protein that suppresses and inhibits angiogenesis (blood vessel formation) that is vital to sustain primary and metastatic tumor growth.

"Complex proteins like Troponin can be made efficiently through conventional biotech processes in bacteria. However, such bacterially-expressed protein often has diminished or even no biological activity and, therefore, does not yield the required therapeutic results. Tumors are not suppressed or, at best, the effect is very inconsistent. Much more expensive alternative manufacturing systems are then required, which significantly increase manufacturing costs and thus render commercial production impractical," commented Dr. Marc Lanser, the Company's Chief Scientific Officer.

"The cause of the decreased activity of such conventional bacterial-expressed proteins is most often due to the requirement that these proteins be structurally `unfolded' in order to purify them when using traditional biotech techniques. These proteins must then be `re-folded' into their original configuration (through a complex, tightly controlled process). This is very often exceedingly difficult to achieve. BLSI, however, has developed internally, a proprietary method of purifying bacterial-produced proteins like Troponin without the need for the critical `unfolding-refolding' step. This process, which has been scaled-up and transferred to our manufacturing partner, Marathon Biopharmaceuticals, results in efficient production of highly biologically active Troponin. Our method produces Troponin that is several times more potent than the material we used in previously published studies. Consequently, our agent may be more than a hundred times more potent than other anti-angiogenic products currently under development or in clinical trials," added Dr. Lanser.

"Anti-angiogenic, naturally-occurring proteins (found within the human body) like Troponin, have several potential advantages over conventional pharmaceutical small chemical molecules: (1) they are more specific to their targets; (2) they should exhibit little or no toxicity; and (3) they should not cause autoimmune reactions. However, their clinical development within the biotech community has been considerably hindered by the difficulties inherent in developing a scale-up manufacturing process for complex therapeutic proteins," stated Dr. Lanser.

"The achievement of this manufacturing milestone (two years in the making) and our recently announced production contract with Marathon Biopharmaceuticals will enable us to go into our human clinical program with great confidence in the product," noted David Hillson, the Company's President and CEO. "We believe that the high potency and solubility of Troponin may allow us to use in human trials, for the first time in the anti-angiogenic arena, a low-dose, constant infusion of Troponin via an indwelling intravenous catheter. Consequently, Troponin has the potential to be delivered continuously and automatically via an implanted reservoir/pump," continued Mr. Hillson.

"Depending on the results of our ongoing stability studies, the pump reservoir may require as little as bi-weekly refilling. The relatively infrequent clinical visits that we are considering for patients in our prospective cancer trial are in sharp contrast to the multiple visits per week required for anti-angiogenic proteins under development elsewhere. Troponin could, therefore, have a great potential advantage over these other agents, since cancer patients will most likely need long-term treatment. The high potency resulting from our proprietary manufacturing process means that the weekly cumulative dose of Troponin may be as little as one percent of that being tested with other anti-angiogenic proteins. In terms of manufacturing requirements, our process makes commercialization of Troponin look very feasible from a financial and technological prospective," added Mr. Hillson.

BLSI is developing novel diagnostics and therapeutics for Parkinson's Disease (PD) and Attention Deficit Hyperactivity Disorder (ADHD) as well as treatments for cancer, autoimmune disease, and central nervous system disorders. BLSI's products in development include: Altropane and Fluorotec, radioimaging agents for the diagnosis of PD and ADHD; Troponin, a naturally-occurring anti-angiogenesis factor for the treatment of solid tumors; AF-1 and Inosine, nerve growth factors for the treatment of acute and chronic CNS disorders; novel therapies for the treatment of PD and ADHD; and transcription factors that may control the expression of molecules associated with autoimmune disease and allergies.

Statements made in this press release other than statements of historical fact may represent forward-looking statements. Such statements include, without limitation, statements regarding expectations or beliefs as to future results or events, such as the expected timing and results of clinical trials, discussions with regulatory agencies, schedules of IND, NDA and all other regulatory submissions, the timing of product introductions, the possible approval of products, and the market size and possible advantages of the Company's products. All such forward-looking statements involve substantial risks and uncertainties, and actual results may vary materially from these statements. Factors that may affect future results include: the availability and adequacy of financial resources, the ability to obtain intellectual property protection, delays in the regulatory or development processes, results of scientific data from clinical trials, the outcome of discussions with potential partners, regulatory decisions, market acceptance of the Company's products, and other possible risks and uncertainties that have been noted in reports filed by the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K.