Boston Life Sciences Files Investigational New Drug Application for Axosine -Inosine- for Stroke Recovery.

BOSTON -- Company plans to initiate human Phase I study with Axosine therapy previously shown to stimulate brain re-wiring and to enhance motor function recovery after stroke in animals

Boston Life Sciences, Inc. (NASDAQ: BLSI) announced that the Company has filed an Investigational New Drug (IND) application with the FDA for the use of Axosine(TM) to enhance motor function recovery after stroke. The IND includes a proposed human Phase I study protocol to test the safety of Axosine administered to stroke patients for 28 days by continuous infusion into one of the fluid compartments of the brain (intracerebral ventricle; ICV). Pre-clinical efficacy and safety animal testing has shown that Axosine, when administered in this manner, is safe, well-tolerated, and highly effective in promoting motor function recovery after experimentally-induced strokes in rats. The results of these efficacy studies, as well as studies demonstrating compensatory axon growth in experimental spinal cord injury, have been published in numerous prestigious scientific journals during the last few years. The Company believes that Axosine is the first in a class of small molecule (nonpeptide) axonal growth factors to enter commercial clinical development for this indication. The Company hopes to initiate its Phase I study following a 30 day FDA review of the IND, although the Company cautions that the FDA may have questions or concerns that require a response or additional preclinical studies to be performed prior to initiating the Phase I study.

The proposed Phase I study has been designed to enroll 27 moderate-severe stroke patients in up to 3 academic stroke centers in the greater Boston area. The study design calls for a dose-escalation of Axosine given to three groups of stroke patients (nine patients in each dose group). The highest dose given will be the estimated human equivalent of the effective dose given to rats. All patients will be maintained on their initial dose of Axosine for the full 28 day study period. Axosine will be administered via an implantable subcutaneous pump and ICV catheter system that potentially allows the patient to leave the hospital at the same approximate time that they otherwise would have after such a stroke. In addition to safety monitoring, efficacy monitoring will also be performed, but the small number of patients and the short duration of treatment will probably preclude statistically valid efficacy conclusions to be drawn. Formal efficacy testing will be the purpose of a Phase II study, which will follow the Phase I study if there are no significant safety concerns raised by the Phase I study.

"Filing this IND is an important and exciting milestone for the Company and hopefully for stroke patients as well," stated Dr. Marc Lanser, President of BLSI. "Axosine is truly unique in a number of important ways. Axosine is neither a neuroprotective agent, nor is it a thrombolytic (clot-dissolving) agent (such as TPA) and thus, does not need to be given within hours after symptoms of stroke occur. Axosine does not work by limiting or reversing the brain damage caused by the interruption of arterial blood flow that results in stroke, but instead stimulates brain re-wiring after the stroke is complete. This means, among other things, that the so-called 'treatment window' is markedly extended with Axosine; though for how long we do not yet know. Our studies have shown that rats can begin Axosine treatment up to 24 hours after the completed stroke and still recover motor function. In contrast, thrombolytic and neuroprotective treatments must be given within a few hours of stroke onset (in rats or humans) for there to be any benefit. Clinically, neuroprotective and thrombolytic approaches have failed when given after the stroke is 'complete'; i.e., after there has been significant brain cell death and a functionally important region of the brain has been definitively destroyed by stroke. In contrast, Axosine promotes motor function recovery through the formation of new axonal branches and connections (rewiring) in the brain and spinal cord after the stroke is complete. We believe that Axosine has the potential to change the current clinical treatment paradigm for stroke and other Central Nervous System (CNS) injuries. If we are successful in treating stroke, we will then move on to the treatment of spinal cord injury and traumatic brain injury, two additional indications that could potentially benefit from Axosine treatment," added Dr. Lanser.

Boston Life Sciences, Inc. (BLSI) is a development stage biotechnology company engaged in the research and development of novel therapeutic and diagnostic solutions for central nervous system diseases (CNS) and cancer. In addition to AXOSINE(TM), BLSI's products in development include: ALTROPANE(R) and FLUORATEC(TM), radioimaging agents for the diagnosis of PD and ADHD; AF-1, a nerve growth factor for the treatment of acute and chronic CNS disorders; Troponin I, a naturally-occurring anti-angiogenesis factor for the treatment of solid tumors; and novel therapies for the treatment of PD and ADHD.

Statements made in this press release other than statements of historical fact 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 (including the timing of the initiation of the Phase I Axosine study), 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, delays in the regulatory or development processes, results from clinical and pre-clinical trials, regulatory decisions, market acceptance of the Company's products, the ability to obtain intellectual property protection, the outcome of discussions with potential partners 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.