Our US based client established a company based on research from a university affiliated with a federally certified national aging center, that quantifies a unique protein/protein complex in cerebrospinal fluid (CSF) and serum that identifies AD subjects including those early in disease progression. Levels of the complex show significant disease progression related correlations with both mental status examination scores and measures of neuropathology. In addition, the complex is not significantly altered in subjects with other neurologic disorders.
The company expects, based on data gathered to date, that the specificity and selectivity measures will be high enough for an FDA approval of a serum screen for mild cognitive impairment and optional CSF draw for diagnosis.
Stock Offering
The company is offering preferred shareholder investment in the company. The investment is eligible for a match from their State economic authority. A minimum investment for a strategic partner is $50,000 and the maximum is $100,000. There is an open seat on the board and a qualified member would require unanimous consent. The offer expires on March 31, 2009. A $100,000 investment would yield approximately a 3% share.
Our clients will consider a variety of partnership agreements from out-licensing to co-development. Ideally a partner would actively co-direct NIH Phase II work on site and offer full direct support of regulatory filings. The company could reimburse a portion of these costs through matching state programs. The company is willing to risk share through early milestones and operate under a structured buy-out when commercialization is achieved.
The protein complex discovered is fully characterized by the company and the preliminary research indicates that the complex is central to the mechanisms involved in the pathology of dementia. Accordingly, the company believes that the findings will lead to drug candidate trials in the near term. Drug developers could license the underlying IP at any stage of development with or without joint development.