TORONTO, Dec. 18 /PRNewswire-FirstCall/ -- Generex Biotechnology Corporation , a leader in the area of buccal drug delivery, today announced that it has engaged Kinexum LLC, a prominent life sciences organization, to manage the development of the Company's new clinical and regulatory departments, which will spearhead the Company's clinical development activities in all therapeutic areas. Kinexum's initial responsibilities will be to establish a team of clinical and regulatory experts to assist Generex in an intensive global development and registration program for the Company's proprietary Oralin(TM) oral insulin spray formulation (and other drugs based on the same proprietary drug delivery platform). This team will assist the Company in completing its Phase IIB clinical trials and the initiation of Phase III clinical trials as soon as authorized by FDA and other regulatory authorities.
"We are extremely excited to form this major alliance with Generex, which holds one of the most promising and versatile drug delivery technologies under development today," said Dr. Alexander Fleming, Kinexum President and CEO. "I am particularly gratified that our initial focus is a treatment that could benefit millions of people with diabetes mellitus, a leading cause of death and disability throughout the world. Oralin(TM) consists of human insulin delivered to the oral cavity. This easily accessible targeted absorption tissue substantially reduces the complexity involved in demonstrating the safety of Oralin(TM) compared with other alternate delivery approaches."
About Kinexum
Kinexum, LLC is a prominent life sciences consulting firm led by Dr. Fleming, former senior physician at FDA and recognized expert in diabetes therapeutic development, and Lisa Jansa, former senior manager in several established and start-up health product companies. Kinexum's team includes select industry veterans with expertise in regulatory affairs, clinical development, pharmaceutical sciences, drug manufacturing, business development and health product marketing. Kinexum specializes in providing client services aimed at dramatically reducing the time and resources required for biotechnology companies to advance their clinical development programs and enhance their product portfolio. Kinexum also offers InterKinex(TM) and CogNexum(TM), internet-based information services designed for knowledge assimilation. InterKinex(TM) facilitates its clients' presentation of their critical scientific, regulatory, patent and financial information in a media-rich web environment that is simple, time-efficient and focused. CogNexum(TM) is a scientifically grounded approach to understanding and resolving complex issues in diverse situations, particularly among healthcare industry partners, providers and patients.
About Generex
Generex is engaged in the research and development of drug delivery systems and technology. To date, it has focused on developing a platform technology for the buccal delivery -- delivery to the oral cavity for absorption through the inner mouth mucosa -- of drugs that historically have been administered only by injection. Generex's buccal delivery technology has application to a large number of drugs.
This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Generex Biotechnology Corporation