LipoMedics, Inc. To Update Its Development Of Next-Generation Abraxane At 7th International Nanomedicine Conference And At CLINAM

FORT WORTH, Texas, June 20, 2016 /PRNewswire-iReach/ -- Paclitaxel is a highly effective chemotherapeutic drug which disrupts the ability of cancer cells to divide and thus cease the growth or spread of tumors. It is being successfully used to treat mainly breast, lung and ovarian cancers. The challenge lies in creating a soluble/injectable form of paclitaxel since it is hydrophobic in nature. Previous attempts have included the use of albumin (Abraxane® Celgene, Corp.) and chemical polymers (Cynviloq NantPharma) to develop soluble paclitaxel nanoparticles. We have reported earlier on our success in formulating a phospholipid-lysophospholipid stabilized paclitaxel nanoparticle. Here, we report on the advances we have made in an alternative approach, employing cholesteryl ester.  A comparison of the drug loading and stability profile of the two approaches is also included.                                                                             

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Title: "LM-102-An Injectable Phospholipid-Cholesteryl Ester Nanoformulation of Paclitaxel: Comparison of Drug Loading and Stability with Phospholipid-Lysophospholipid Formulation (LM-101)"

Venue: 7th International Nanomedicine Conference 2016, Sydney, Australia

Location: Ocean Ballroom, Crown Plaza Hotel, Coogee Beach, Sydney, Australia

Date and Time: Tuesday, June 28, 2016 5:30 pm - 7:30 pm

Authors: Gary Williams2, Shradha Prabhulkar2, Steve Miller2, Zachary Yim1, Walter McConathy1, Tapas De1

Institutions: 1LipoMedics Inc.;  2Autotelic Inc.

(LipoMedics Inc. is a participant company in the University of North Texas Health Science Center Acceleration Lab, Fort Worth, Texas)

This poster will report on the formulation parameters including the type of phospholipids and fatty acid chain lengths in cholesteryl ester, combination of phospholipid and cholesteryl esters, and amount of drug. The process parameters such as temperature of water for thin film hydration were studied and their impact on drug loading, particle size and physical stability were evaluated.  The short-term stability evaluation of nanoparticles prepared with different cholesteryl esters demonstrated that 1-10% (w/w) of cholesteryl esters produced nanoparticle with a loading of about 42% paclitaxel with a particle size of less than 275 nm. The formulation is found to be stable for 24 hours at 4°C. The stability of the formulation was also evaluated at different temperatures before lyophilization with different amounts of drug loading. The optimization of different parameters like drug amount, temperature of water for rehydration for stability of the formulations were performed and compared to the stability of the phospholipid-lysophospholipid formulations (LM-101) made in our lab. A phospholipid-cholesteryl ester nanoparticle formulation of paclitaxel was successfully manufactured at the lab scale stage.

Title: "Third Generation Abraxane®:  LM-101 - An Injectable Phospholipid-coated Nanoparticles Loaded with Paclitaxel:Composition and Method of Preparation, Electrochemical Characterization and Dissolution Studies."

Venue: 9th CLINAM conference and exhibition 2016, Basel, Switzerland

Location:  Foyer, Congress Center, Messeplatz 21, 4058, Basel, Switzerland

Date and Time: June 27 -29, 2016

Authors:Tapas De1, Shradha Prabhulkar2, Gary Williams2, Steve Miller2, Zachary Yim1, Walter McConathy1, Vuong Trieu

Institutions:  1LipoMedics Inc., 2Autotelic Inc.

This poster will report on a one-pot synthesis method developed to formulate paclitaxel nanoparticles using phospholipids which retains the desired plasma dissolution characteristics of Abraxane® (1st-generation) and the PBS stability of Genexol®-PM (2nd-generation). Due to the use of naturally occurring phospholipids in this 3rd-generation Abraxane®, hypersensitivity (observed in Genexol®-PM) should not be an issue.

Process parameters such as temperature of rehydration were optimized to obtain stable nanoparticles suitable for development. The nanoparticles produced had a size of ~100 nm and a drug entrapment efficiency of more than 80%. The electrochemical and zeta potential characteristics of nanoparticles were tested and found to be distinctive of the method of preparation used.  

Contact :info@autotelicinc.com

About LipoMedics Inc.

LipoMedics Inc. is developing personalized paclitaxel therapy based on our proprietary Therapeutic Drug Monitoring (TDM) device and our platform for delivery of water insoluble drugs including paclitaxel. The company's platform technology is the phospholipid paclitaxel nanoparticle that upon injection disperses paclitaxel in the plasma compartment. This paclitaxel/phospholipids formulation represents the "Next Generation of Paclitaxel Nanomedicine". More information is available at www.lipomedics.com

About Autotelic Inc.

Autotelic works through our partners to transform how medications are being delivered. The Autotelic Inc. platform is our Therapeutic Drug Monitoring (TDM) device which allows PK guided dosing, reducing the toxicity from overmedication and increasing the efficacy from under-medication. Current dosing schemes result in either too much drug exposure or too little drug exposure because of individual pharmacokinetic variations. Autotelic's pipeline includes TDM devices for management of oncology, hypertension and pain. More information is available at www.autotelicinc.com

Forward-LookingStatements

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Words such as "plans," "believes," "expects," "anticipates," and "will," and similar expressions, are intended to identify forward-looking statements. We caution you that any forward-looking information provided by or on our behalf is not a guarantee of future performance. Forward-looking statements include: (I) changes in domestic and foreign economic or non-economic conditions, (II) the effect of federal, state and foreign FDA regulations, (III) Intellectual property and other claims, (IV) the effect of our clinical and non-clinical trial, (V) the impact on our branding strategy and other factors. All such forward-looking statements are current only as of the date on which such statements are made. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.  Should one or more of these risks or uncertainties materialize, or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of the companies may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statement. The companies above neither intend, nor assume any obligation, to update or revise these forward-looking statements in light of developments which differ from those anticipated.

Media Contact: Tapas De Ph.D. Chief Executive Officer, LipoMedics Inc, 818-575-9505, info@autotelicinc.com

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SOURCE LipoMedics Inc

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