Afexa Life Sciences Inc.

Afexa Life Sciences Inc.

July 18, 2011 08:00 ET

Afexa Announces U.S. FDA IND Clearance for Clinical Trial of AFX-2 in Patients With Chronic Lymphocytic Leukemia

EDMONTON, ALBERTA--(Marketwire - July 18, 2011) - Afexa Life Sciences Inc. (TSX:FXA) today announced the U.S. Food and Drug Administration (FDA) authorization of a Phase 1B clinical trial of AFX-2 (CVT-E002™) as an Investigational New Drug (IND) in adults with Chronic Lymphocytic Leukemia (CLL).

The successful completion of this milestone for AFX-2 marks the initiation of the Company's strategy to obtain FDA approval as one of the first medicines in the polymolecular botanical drug category. The FDA clearance of this important initial step affirms the Company's regulatory, scientific, and quality capabilities in developing novel polymolecular medicines.

Although numbers vary, current estimates suggest approximately 130,000 individuals in the United States suffer from CLL. CLL is the most common type of leukemia, representing roughly one third of all leukemia cases in the U.S. It is primarily a disease afflicting adults older than 65 years of age, and incidence is expected to grow with the increasing aging demographic. Although it is the most common leukemia, CLL meets the definition of an orphan disease. Accordingly, AFX-2 has the potential to be developed as an orphan drug and play an important role in providing a new option for these patients.

The Company is currently evaluating the strategy of developing AFX-2 as orphan drug in CLL as a potential first step in the strategy to obtain approval for use in a generally healthy population for colds and flu. Significant advantages of the general orphan drug pathway include reduced development requirements and expedited FDA review, enabling market approval at a substantially reduced cost and timeline. The initial assessment of the U.S. market potential for AFX-2 in CLL is approximately $250 to $300 million per year. Obtaining first approval as a CLL therapeutic potentially covering multiple indications, including reduction of acute respiratory infection (ARI), has the potential to enable more rapid approval in generally healthy adults with reduced development costs.

This new Phase 1B trial will be building on the recently announced encouraging results of the previous independent National Cancer Institute (NCI) approved multi-centre, randomized, double-blind, placebo-controlled clinical trial involving 293 CLL patients led by Wake Forest Baptist Medical Centre, Winston-Salem, North Carolina. The results of the previous trial, awaiting final peer review, showed that 400 mg/d of AFX-2 for at least four months over the cold and flu season was associated with a statistically significant reduction in the incidence of moderate to severe ARI symptoms and a trend of reduced incidence of moderate to severe ARI versus placebo. There was no significant difference shown for patients with mild ARI symptoms, average number of ARI days or antibiotic use. AFX-2 intake was also associated with greater seroconversion (antibody levels) against nine common upper respiratory viral pathogens, suggesting a potential enhanced antibody response in immunocompromised CLL patients. A favourable safety-related effect of significantly reduced relative risk of Serious Adverse Events (SAEs) was also shown in the AFX-2 group.

The dose used in this previous clinical trial (400 mg/d) was selected based on the dose of CVT-E002 approved for use in Canada for ARI reduction in generally healthy adults. However, the findings suggest that this dose may have been insufficient in the CLL population and that further dose-finding studies are warranted. This new trial will examine the safety and immunological effects of doses ranging from 400-3200 mg/d. Discussions and planning have been on-going with multiple U.S. clinical centers and the new trial is expected to be initiated by the end of 2011.

About Afexa Life Sciences Inc. (TSX:FXA)

Afexa Life Sciences Inc., founded in 1992, strives to deliver the most trusted health brand on the planet through pioneering evidence-based natural medicines that empower people to achieve their health potential. The Company's patented ChemBioPrint® discovery and standardization technology enables the development of effective and safe medicines from complex natural sources, while ensuring reliable health benefits and batch-to-batch consistency. COLD-FX®, a ChemBioPrint product, is the Company's flagship product and Canada's leading over-the-counter (OTC) cold and flu remedy. It is officially indicated in Canada to help reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system. COLD-FX has a product license (NPN) and is supported by scientific evidence, including randomized, double-blind, placebo-controlled clinical trials. The Company recently launched COLDSORE-FX in Canada and has a range of polymolecular drugs at various clinical and pre-clinical development stages. This product pipeline includes COLD-FX pediatric, AFX-2 for Chronic Lymphocytic Leukemia, Dilexaponan for cholesterol management, HT-1001 for Oxidative Stress and a product for blood glucose management.

Advisory Regarding Forward-looking Statements:

This news release contains certain forward-looking statements and information within the meaning of applicable securities laws, which reflect current expectations of the management of Afexa Life Sciences Inc. (the "Company") regarding future events or the Company's future performance. All statements other than statements of historical fact contained in this news release may be forward-looking statements. The forward-looking information included in this document does not guarantee future performance and should not be unduly relied upon. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information, including, without limitation comments that could be impacted by competition, the incidence of cold and flu, consumer confidence and spending levels, general economic conditions, interest and currency exchange rates, unseasonable weather patterns, the cost and availability of capital and grants/funding, product development uncertainties, labour market challenges, consumer acceptance of Afexa's products in other markets. The Company believes that the expectations and assumptions reflected in the forward-looking information contained herein are reasonable but no assurance can be given that these expectations and assumptions are correct or that that the results, performance or achievements expressed in, or implied by, forward-looking statements herein will occur, or if they do, that any benefits may be derived from them. The Company can give no assurance that new product development initiatives will lead to new product commercialization or that this U.S. clinical trial in CLL patients will lead to a commercialized product. The Company assumes no duty to update or revise forward looking information, except as may be required pursuant to applicable laws. All forward-looking information is expressly qualified in its entirety by this cautionary statement. Further information regarding risks and uncertainties relating to the Company and its securities can be found in the disclosure documents filed by the Company with the securities regulatory authorities, available at The Company claims exemption under U.S. SEC Rule 12g3-2(b).

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