Studies:
A Sampling of Published Reports
CF: EFFECT OF CHOLINE SUPPLEMENTATION ON MUSCLE.
Conclusion: Muscle choline content was 1)lower at baseline in CF subjects compared to controls; 2) increased after 12 months of LYM-X-SORB® supplements in CF subjects; 3) was associated with better growth status. Daily choline supplements can improve choline status.
SERUM AMINO ACID PROFILES IN CHILDREN WITH CF RECEIVING SUPPLEMENTAL CALORIES, FAT AND CHOLINE
Conclusions: Supplementation with extra calories & fat for 18 mo. decreased serum AAA and improved BCAA:AAA in subjects with CF, suggesting improved hepatic protein metabolism. The additional choline did not result in further changes to the AA profile.
Normalization of the Absorption of Lipids and of Vitamin A from the Matrix Lym-X-Sorb® with Added Retinyl Palmitate in CF Patients:
CONCLUSIONS: Lym-X-Sorb holds promise as a vehicle for fat and fat-soluble vitamins in CF.
Improved Oral Delivery of N-(4-Hydroxyphenyl)Retinamide with a Novel LYM-X-SORB Organized Lipid Complex (Clin Cancer Res. 2007):
LYM-X-SORB matrix increased fenretinide levels. ...CONCLUSIONS: 4-HPR/LYM-X-SORB oral powder is a novel, oral drug delivery formulation, suitable for pediatric use, which warrants further development for the delivery of fenretinide in the treatment of cancer. A phase I clinical trial in pediatric neuroblastoma is in progress.
Phase I study of fenretinide (4-HPR) oral powder in patients with recurrent or resistant neuroblastoma: New Approaches to Neuroblastoma Therapy (NANT) Consortium trial:
Conclusions: 4-HPR/LXS oral powder was well tolerated, obtained 2 - 5 fold higher 4HPR plasma levels than fenretinide capsules on the same dose and schedule (P < 0.01), and showed anti-tumor activity (complete responses in 4/15 patients at DL4-8).
Fenretinide metabolism in humans and mice: utilizing pharmacological modulation of its metabolic pathway to increase systemic exposure:
Complete responses were observed in 4 of 18 neuroblastoma patients at the highest five dosing levels tested with an improved oral powder formulation [4-HPR/Lym-X-Sorb (LXS)™ oral powder]
Old drug yields new ways to fight childhood cancers:
Lym-X-Sorb fenretinide was tested in a Phase I trial, which helped establish safe levels for drug delivery. The results exceeded expectations...
"We had four complete responses, which is where a tumor completely goes away," Reynolds says. "I'd never seen four complete responses in a neuroblastoma Phase I trial, so we're very excited."
Organized Lipid Eutectic for Drug Delivery:
This is a non-liposomal lipid-based drug delivery system composed of lysophosphatidylcholine (LPC), monoglycerides (MG), and fatty acids (FA). LPC interacts with MG and FA to form a eutectic mixture. The system is compatible with a large number of diverse drug structures, especially water-insoluble drugs. The system has lamellar structure in the absence of water and adopts inverse hexagonal phase upon absorption of water. It binds one mole of drug per monomeric structure. Many drugs such as, cyclosporin, insulin, nifedipin, hydrochorthiazide, progesterone, etc., have been shown to be compatible with the system. The key advantages of this technology are—improved solubilization, stability, and bioavailability of drugs. Bioavailability of 300mg of fenretinamide in corn oil with surfactant formulation was the same as 65mg drug in the system.