A Sampling of Published Reports
Choline Supplementation With a Structured Lipid in Children With Cystic Fibrosis: A Randomized Placebo-Controlled Trial
J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):618-26. doi: 10.1097/MPG.0000000000001004.
"Children with CF had higher liver fat than healthy children and depleted calf muscle choline at baseline. Muscle choline concentration increased in LXS and was associated with improvement in plasma choline status."
CONCLUSIONS: "LXS had improved choline intake, plasma choline status, and muscle choline stores compared with placebo group. The choline-rich supplement was safe, accepted by participants, and improved choline status in children with CF."
EFFECT OF ORAL LIPID MATRIX SUPPLEMENT ON FAT ABSORPTION IN CYSTIC FIBROSIS: A RANDOMIZED PLACEBO-CONTROLLED TRIAL.
J Pediatr Gastroenterol Nutr 2016 Mar 31. Epub 2016 Mar 31.
Lym-X-Sorb™ was associated with increased fatty acid and linoleic acid (LA) absorption in children with FA and LA insufficiency and was associated with better growth status. "In children with CF and PI, daily oral supplementation with this easily absorbable phospholipid - and triglyceride- rich lipid matrix was safe and effective, as indicated by increased fasting plasma FA and 6% increase in stool CFA."
According to the study conclusion, "Increased total FA and LA absorption may support better growth status in school aged children. Based on these results and clinical experience, LXS has potential to reduce fat malabsorption in CF clinical care."
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.