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Lipoxen and Serum Institute of India start Phase II trial for ErepoXen

Lipoxen’s (AIM: LPX) clinical development partner, the Serum Institute of India, has begun the expanded Phase II trial of ErepoXen. The ErepoXen product candidate is a treatment for anaemia, caused by kidney failure or chemotherapy. Dosing of the 30 patients with anaemia, across 6 trial centres in India, is now underway and the trial results are scheduled for Q3 2010.

"The commencement of our Phase II ErepoXen trial with the Serum Institute under European regulations in India is a very exciting step forward. EPO is a currently $9B drug and is injected 1-3 times per week”, Lipoxen CEO M. Scott Maguire commented. “Our EPO is designed to last for one month so we are very excited about moving this potential blockbuster candidate into patient trials having had a successful Phase I trial”. 

ErepoXen uses Lipoxen's PolyXen platform technology to attach polysialic acid (NYSE:PSA), a natural biodegradable sugar, to protein drugs, resulting in an enhanced polysialylated form of erythropoietin (EPO), a hormone produced by the kidneys to maintain red blood cell production.

The trial’s primary endpoints are the improved red blood cell count, reticulocytes, hemoglobin and hematocrit, while secondary endpoints will measure safety, a reduced frequency of injections versus current EPOs, and immunogenicity.

Bangalore-based contract research organization Clinigene International is conducting the trial on behalf of the partnership.  Results on this trial are scheduled to be reported early Q3 this year.

“Not only will the trial measure the potential benefits of our enhanced EPO product candidate, but positive results will assist Lipoxen to execute further licensing deals that combine our versatile PolyXen platform technology with existing protein drugs", Maguire added.

Lipoxen’s proprietary PolyXen platform is a versatile protein drug delivery technology. The technology is essentially based on a polymer of sialic acid which is naturally found in the body. 

The polymer is attached to a drug, which generates several positive attributes. Firstly, as the polymer is a natural substance, it effectively hides the drug from the body’s immune system.  Secondly, the polymer acts like a tail on the drug, substantially increasing its life once administered. This means the drug dose frequency required is greatly reduced as the drug is released over a longer time frame. PolyXen polymers also improve the stability and water solubility.

Lipoxen in November 2009 signed a collaboration deal with Russian private research-based pharmaceutical company Pharmasynthez ZAO to apply its ImuXen and PolyXen proprietary technologies to a broad range of six drug and vaccine candidates. Pharmsynthez will apply Lipoxen's ImuXen technology to create three enhanced vaccine candidates for secondary progressive multiple sclerosis, HIV and non-Hodgkin's lymphoma. Similarly, Lipoxen's PolyXen technology will be applied to active compounds to create three pharmaceutical candidates for treatment of cystic fibrosis, acute myeloid leukaemia, non-Hodgkin's lymphoma and type 2 diabetes.

Disclosure: The author holds no positions in the company