CTP tech boosts interferon beta potential several times, cuts down dosage: Prolor

Prolor Biotech’s new CTP-technology boosts the potential therapeutic proteins like interferon beta, Factor Vll and Factor lX by several times so that the dosages of these drugs could be cut down limiting their exposures, according to pre-clinical studies data released by the company.

The preclinical data includes an update on Prolor’s preclinical development program for its CTP-enhanced version of interferon beta (IFN-Beta), a widely used drug for the treatment of multiple sclerosis (MS).

In January 2010, the company reported positive results from a study in primates comparing intravenous injections of commercial IFN-Beta with Prolor’s CTP-enhanced version of IFN-Beta.

Prolor’s new data includes the results of experiments comparing IFN-Beta-CTP with commercially available IFN-Beta administered by subcutaneous injection.

The preclinical data showed that the AUC (overall drug exposure) of Prolor’s CTP-modified IFN-beta administered subcutaneously was more than 200 times greater than an equivalent dose of commercial IFN-Beta.

The new data is an expansion on the results in the January study, which showed that CTP-modified IFN-Beta administered intravenously had 55 times greater overall drug exposure compared to commercial IFN-Beta.

CTP-modified IFN-Beta also demonstrated strong biological potency as measured by several well-validated biomarkers, in both studies.

The results further validate the potential of IFN-Beta-CTP to significantly reduce the current dose level and dosing frequency of interferon beta for the treatment of MS, potentially also reducing the associated side effects.

Prolor’s preclinical data on its programs for CTP-enhanced Factor Vll and Factor lX, potential drugs for the treatment of blood clotting disorders also showed that the durability of the CTP-enhanced compounds was increased approximately three to six-fold compared to commercially available Factor VII and Factor IX.

The company also has data on its novel anti-obesity peptide showing that the durability of its biobetter version is 100 times greater than the durability of the naturally-occurring anti-obesity peptide.

“These promising new data from four different Prolor drug development programs add to our confidence that our technology has the potential to significantly increase the duration of effect and reduce the dosing frequency for a wide variety of therapeutic proteins,” stated Abraham Havron, Ph.D., CEO of Prolor.

Prolor plans to advance its anti-obesity candidate and Factor VII and Factor IX biobetter compounds into clinical trials during 2011. Phase II trials with its proprietary biobetter version of human growth hormone will begin this year, Mr Havron added.

Prolor’s CTP technology, which was discovered by researchers at Washington University in St. Louis, is based on a short amino acid sequence that occurs naturally in humans, the carboxyl terminal peptide (CTP).

When attached to a therapeutic protein, CTP extends the time that the protein is active in the body, reducing the required frequency of administration.

The potential utility of the technology has been demonstrated by Merck, which licenses the CTP technology for fertility applications only.

Early this year, Merck received European Commission authorization to market its fertility drug Elonva a CTP-enhanced version
of recombinant follicle stimulating hormone (FSH). A single injection of the recommended dose of Elonva is indicated to replace the first seven injections of daily FSH for ovarian stimulation in infertility patients.

Prolor is using the same CTP technology to extend the duration of action of human growth hormone, interferon beta and other therapeutic proteins.  It has an exclusive license from Washington University to the CTP technology for use with all therapeutic proteins and peptides except for the four endocrine hormones licensed to Merck.

Prolor Biotech, Inc. is a biopharmaceutical company primarily to develop longer-acting, biobetter, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales.  The CTP technology is applicable to virtually all proteins and Prolor is currently developing long-acting versions of human growth hormone, which is in clinical development, and interferon beta, factor VII, factor IX and erythropoietin, which are in preclinical development, as well as GLP-1 and other therapeutic peptides