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Serum Institute begins clinical studies on Lipoxen’s long-acting EPO drug ErepoXen in India

Monday, March 1, 2010, 17:02 This news item was posted in Biotech category and has 0 Comments so far.

ErepoXen will be a once-a-month injection  as against other EPO drugs which are injected 1-3 times a week

The Serum Institute of India in partnership with Lipoxen Inc of USA has started clinical studies for anemia treatment ErepoXen in India.

The expanded Phase II trial of ErepoXen will evaluate the efficacy the drug candidate to treat  anaemia caused by kidney failure or chemotherapy.

Clinigene International, the contract research organization arm of the Bangalore-based Biocon is conducting the trial across India.

Clinigene has already begun dosing of the 30 patients with anaemia, across 6 trial centres in India. The trial results are scheduled to be reported early Q3 this year.

“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.

ErepoXen is designed to last for one month and so Lipoxen expects the drug could well be a  potential blockbuster candidate.

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

ErepoXen trial’s primary endpoints are improvement in red blood cell count, reticulocytes, hemoglobin and hematocrit.

The secondary endpoints of the trial will measure safety, a reduced frequency of injections versus current EPOs, and immunogenicity.

The ErepoXen trials will aslo measure the positive results will assist Lipoxen to execute further licensing deals that combine PolyXen platform technology with existing protein drugs.

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.

In November 2009, Lipoxen 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.

Lipoxen is a leading UK based biopharmaceutical company providing specialist delivery solutions to improve the efficacy and performance of drugs and vaccines.

Lipoxen is working with some of the largest pharmaceutical organisations in the world in the development of a whole new generation of drugs and vaccines.

The Pune, Maharashtra-based serum institute also produces hundreds of millions of doses of the measles, mumps and rubella group of vaccines annually. Serum Institute meets 100 % requirements for measles vaccine of the Government of India and also the global requirements.

Serum’s manufacturing facilities conform to WHO current Good Manufacturing Practice (cGMP) requirements and are approved by WHO, Geneva. The unique large bioreactors for DTP group of vaccines have a huge batch size to produce millions of doses.

Serum Institute of India Ltd. has established it self as the world’s largest producer of measles and DTP group of vaccines. It is estimated that two out of every three children immunized in the world is vaccinated by a vaccine manufactured by Serum Institute. Serum’s products have been used in 140 countries across the globe.

Serum Institute of India was founded in 1966 to manufacture life-saving immuno-biologicals, which were in shortage in the country and imported at high prices. Thereafter, several life-saving biologicals were manufactured at affordable prices.

Serum made India self-sufficient for tetanus anti-toxin and anti-snake venom serum, followed by DTP (Diphtheria, Tetanus and Pertussis) group of vaccines and then later on MMR (measles, mumps and rubella) group of vaccines.

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