Dec 16 2009
Makefield Therapeutics, Inc., an emerging therapeutics company, today announced that it has obtained an exclusive license from Albert Einstein College of Medicine of Yeshiva University to patent applications covering Makefield's biodegradable Hybrid Nanoparticles™, a versatile new drug delivery platform. Makefield Therapeutics is utilizing two different topical formulations of the nitric oxide (NO)-containing nanoparticles in its therapeutic development programs: an antimicrobial for the treatment of drug resistant skin and soft tissue infections; and a topical treatment for Erectile Dysfunction (ED) in men unresponsive or dissatisfied with currently available oral drug treatments.
“Nitric oxide, Science Magazine’s 1992 ‘Molecule of the Year,’ has been the focus of immense medical and scientific exploration,” said Robert Towarnicki, president and chief executive officer of Makefield Therapeutics “Until now, however, the difficulty of conveniently and effectively delivering the gas to targeted tissues has limited the therapeutic application of nitric oxide. The inventors at Einstein, led by Joel Friedman, MD, PhD, have developed a novel method for storing and delivering nitric oxide in a therapeutically relevant manner, through the use of biodegradable nanoparticles constructed of ‘Generally Recognized as Safe’ (GRAS) components. We are very pleased to gain access to this promising drug delivery platform, for which the inventors have already published proof-of-concept in several very high value applications.”
Mr. Towarnicki noted that multiple, published peer-reviewed articles have demonstrated in animal models the therapeutic potential of the nitric oxide-containing nanoparticles, both as a broad-spectrum antimicrobial and as a topical treatment for erectile dysfunction. Makefield Therapeutics plans to develop these two lead indications commercially and expand the uses of the technology to address other therapeutic applications where the Hybrid Nanoparticle™ technology platform can be enabling.
Hybrid Nanoparticles™ have for the first time enabled the practical delivery of therapeutic amounts of nitric oxide gas (NO) in a local, controlled, and sustained manner. The platform is also capable of delivering peptides, nucleic acids and traditional small molecule pharmaceuticals, both as single therapeutic entities and in combination treatments as well.
Multiple routes of administration including transdermal/topical, oral, intravenous, intraperitoneal, and instillation are possible utilizing this technology. The delivery system is capable of providing for immediate, pulsatile and sustained controlled drug release both locally and systemically.
The delivery system is biodegradable and utilizes excipients that are Generally Recognized as Safe (GRAS), USP-NF listed or previously utilized in medical applications. All of the components of the drug delivery system are commercially available in pharmaceutical grade and the methods of preparation use well-known pharmaceutical unit operations that easily lend themselves to scale up and manufacture.
Makefield Therapeutics, Inc., founded in July 2009, is a privately held therapeutics company with two development programs addressing large market opportunities in anti-infectives and the treatment of erectile dysfunction. Both programs are based on an innovative nanoparticle drug delivery platform with the potential to generate a pipeline of additional novel therapeutics.