BioMolecular Products, Inc. (BMP), a Massachusetts corporation, has formed two limited liability corporations in order to focus the LYM-X-SORB™ (LXS™) technology for specific but different business targets.
LYM-DRUG PRODUCTS, LLC licenses the LXS™ technology for drug delivery. Briefly, an included drug within the LXS™ eutectic complex will result in enhanced oral drug bioavailability in animals and humans, for example, ca. 15% to 90%.
LYM-MED NUTRITIONAL PRODUCTS, LLC exploits the readily oral absorbability of the eutectic complex without the need for enzymatic digestion in the intestine of humans. This product has been successfully evaluated and has improved the clinical well-being of Cystic Fibrosis subjects (See J Pediatr 2002;141;178-85) and is the focus of a new SBIR Phase II grant.
Additional uses of LYM-X-SORB™ exploit the lower surface tension of LYM-X-SORB™ in relation to skin surfaces. An included drug/LXS™ aqueous formulation will spread easily and thinly on the skin, such that the moisture is quickly evaporated to provide a cooling sensation. Physical properties of LYM-X-SORB™ are ideally suited for application to biological surfaces. In addition, this cutting edge platform LYM-X-SORB™ technology has many applications for cosmetic formulations.
The strengths of LYM-X-SORB™ (LXS) in these diverse markets are:
1. Patented technology in North America and World Wide through 2022
2. Multiple applications in numerous markets with high return potential
3. Clear and defined advantages over competing products
4. Rapid growth potential
5. Well-developed and researched technology
Financial Opportunity in BMP:
We have years of development and research behind this product and are months, not years, away from launch of products in a number of fields. The company is unencumbered by third-party debts and is seeking licensing, marketing, investing, etc., agreements. The short time-frame to launch, the large upside potential, and diverse market applications make this an attractive financial opportunity.
UPDATED INFORMATION:
The NIH, National Diabetes and Digestive and Kidney Disease Division has awarded funding, March 14, 2006, for this application (2 R44 DK060302-02A1 entitled Organized Lipid Matrix: Fatty Acids and Choline in Cystic Fibrosis). This three year program (6 million dollars) will conduct a randomized placebo-controlled double-blinded study to evaluate the effectiveness of the next generation LYM-X-SORB™ with improved palatability and mixing characteristics on fatty acid and choline status of 78 children, ages 6.0 to 17.9 years, with Cystic Fibrosis (CF) and pancreatic insufficiency (PI). We will also explore whether LYM-X-SORB™ supplementation will improve fat soluble vitamin status, bile composition, incidence of fatty liver, inflammatory cytokines, resting energy expenditure and respiratory quotient over 12 months and improve pulmonary function, growth status, body composition and overall health status over 18 months. Participants in this study are Walter Shaw, Ph.D. (Avanti Polar Lipids, Inc.), Virginia Stallings, MD (Children's Hospital of Philadelphia) and David Yesair, Ph.D. (LYM-MED NUTRITIONAL PRODUCTS, LLC).
A Phase I Study of Fenretinide (4-HPR, NSC 374551) formulated in LYM-X-SORB™ (LXS) as an oral powder will be evaluated in patient with recurrent or resistant neuroblastoma (NEW APPROACHES TO NEUROBLASTOMA THERAPY (NANT) CONSORTIUM, 7/8/05). The coordinating center is Children's Hospital Los Angeles/NANT Operation Center and Barry J. Maurer, MD PhD of CHLA is the protocol chairperson. There are 14 participating institutions. The primary aim will determine the maximum tolerated dose of 4HPR/LXS oral powder given orally, BID, for seven consecutive days every three weeks, in patient with recurrent and/or resistant neuroblastoma. A secondary aim will determine the response rate to 4HPR/LXS oral powder in patients with recurrent and/or resistant neuroblastoma within the confines of a Phase 1 study.
LYM-X-SORB™ as the novel lipid-based drug delivery for its formulation and its enhanced oral bioavailability of the investigation anti-cancer drug Fenretinide (4-HPR) was named the Eurand Award Grand Prize winner. Walter Shaw of Avanti Polar Lipids in collaboration with Barry Maurer of Children's Hospital of Los Angeles and David Yesair of BioMolecular Products reported that the 4HPR/LXS formulation achieved an approximate 5 fold increase in bioavailability. Further investigation is underway as a NANT CONSORTIUM.