Publications:

Benefits of LYM-X-SORB, a Highly Absorbed Structured Lipid Compound, in Children with Cystic Fibrosis and Pancreatic Insufficiency with Varying Degrees of Malabsorption

Conclusions: Subjects with CF and PI at higher risk for fat malabsorption had a dramatic improvement in CFA with LXS treatment, accompanied by improved EFA and growth status. This suggests that LXS may help those with CF and other pancreatic diagnoses in need of optimizing nutritional status and avoiding unintentional weight loss. Funding Sources Supported by NIH.

Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial

Subjects with CF, PI and more severe fat malabsorption experienced greater improvements in CFA, FA and growth after three months of Encala™ treatment. Encala™ was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.

Cystic Fibrosis News Today: Encala Improves Fat Absorption in CF Patients With Pancreatic Insufficiency, Study Shows

Old drug yields new ways to fight childhood cancers

From 2006 to 2008, 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."

Reports Outline Clinical Trials Research Study Results from National Cancer Institute

2011 JUN 13 — "The synthetic retinoid fenretinide (N-(4-hydroxyphenyl)retinamide, 4-HPR) has shown promising anticancer activity in preclinical studies, but its limited oral bioavailability has hindered clinical assessment. A novel lipid matrix, Lym-X-Sorb (LXS), was evaluated to improve fenretinide bioavailability and attain higher plasma concentrations," investigators in Bethesda, United States report.

Activity of fenretinide/Lym-X-Sorb oral powder combined with the oral microtubule inhibitor ABT-751 against multidrug-resistant neuroblastoma xenografts.

Conclusions: 4-HPR + ABT-751 is a well-tolerated oral drug combination that is highly active in vivo against multiple recurrent neuroblastoma xenograft models and warrants clinical trials...enhanced mouse survival.

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). Based on pharmacokinetic data, a recommended Phase II dose and schedule is 1700 mg/m2/day x 7days every 3 weeks.

Scientists find new chemo form: Two USC researchers part of team that developed a powder chemotherapy drug.

"Developing the new powder form seemed to be a simple solution to comfort", Reynolds said. "(The Fenretinide can be) mixed with food or drinks to make it easy for children to take," Maurer said. "Prior to the new powder form, patients of chemotherapy had the choice of either intravenous or a prescription of 24 large capsules a day", Reynolds said. "A past problem with Fenretinide has been that its large capsules are difficult for children to swallow and hard for the body to absorb," Maurer said.

The new formulation has fatty gloves, trademarked as Lym-X-Sorb, surrounding each cancer-fighting molecule. This helps to flow the drug into the bloodstream and allows more of the drug to be absorbed.

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

Carbon 13 Lipids, Oral Absorption in Cystic Fibrosis

Going Down Easy

Controlled Release Society Newsletter Volume 20 - Number 2 - 2003 Spotlight Article

A Spoonful Of Sugar Aids Chemo

The new fenretinide formulation was awarded the 2004 Eurand Award Grand Prize for Novel Approaches in Oral Drug Delivery at the 31st Annual Meeting and Exposition of the Controlled Release Society in Honolulu in June.



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