Prolor Biotech

 

The creation of a successful, non-toxic and non-immunogenic long-lasting therapeutic protein is a very "tricky" process. The more changes that are made in an effort to increase persistence, the more likely these differences will introduce an unintended toxicity. Of particular concern is the fact that the body may recognize the altered protein as a foreign substance that it should fight off, and develop an immune response against the molecule, rendering it useless.

 

 

CTP is a small peptide naturally found in the body as a portion of the protein hCG. hCG, a female hormone that helps maintain pregnancy, has a much longer life-span than that of the hormone LH, which assists in helping females get pregnant and males to produce testosterone, and is identical to hCG except for the CTP portion. hCG is a natural part of the female system, and males are exposed to it during the 9-month pregnancy period. Therefore, CTP has strong potential to be non-toxic and non-immunogenic to humans when attached to other proteins, while still getting the job done: prolonging the life-span of many other hormones, enzymes and peptides. Merck & Co., a leading pharmaceutical company, and PROLOR, have the exclusive license from Washington University to utilize the CTP. PROLOR's License Agreement is exclusive for human therapeutics, with the right to sub-license, for all therapeutic proteins and peptides, of natural or non-natural sequence, other than four endocrine proteins - LH, FSH, TSH and hCG, previously licensed to Merck & Co. The phase III human clinical trials conducted by Merck with FSH-CTP have shown no adverse effects of toxicity or immunogenicity. Merck's FSH-CTP requires only one injection, compared to the seven injections required for the regular FSH. On January 28, 2010 the European Commission (EC) gave Merck & Co. marketing approval with unified labeling valid in all European Union Member States for FSH-CTP, now branded as ELONVA. 

 

CTP can readily be attached to a wide array of existing therapeutic proteins, stabilizing the therapeutic protein in the bloodstream and greatly extending its life span without additional toxicity or loss of desired biological activity. Moreover, CTP-modified proteins can be manufactured using established recombinant DNA techniques in widely used mammalian protein expression systems. The benefits of the CTP technology are substantial.

 

The CTP technology has distinct competitive advantages over other methods used to extend the life of therapeutic proteins. PROLOR's solution is based on a naturally-occurring human peptide that may be readily used for any therapeutic protein without causing any loss of desired biological activity or any toxicity. It offers an elegant, generally applicable solution to improving protein and peptide half-life, and does not increase manufacturing complexity or cost.