Looking for that next biotechnology company that has the potential for incredible growth soon to spring upon us can be tedious. I ran across one that I believe is worth an investor's time to take a look at. The name of the company is PROLOR Biotech, which trades on both the AMEX and Tel-Aviv Stock Exchanges. It has a new technology platform and promises more effective drugs with less maintenance on existing marketable drugs. And one of its key creations is due to enter a Phase III study very soon!
There is a pituitary disorder that results in shorter stature for children and the onset of other physical ailments in both children and adults. This "Growth Hormone Deficiency" or (GHD) is presently treated with recombinant hGH-long term, in both children and adults with growth failure. In children it treats growth hormone deficiency, kidney disease, Prader-Willi Syndrome, and Turner Syndrome.
Adults are treated for replacement of endogenous growth hormone and AIDS-induced weight loss. Unfortunately, these (Recombinant hGH) proteins must be injected, since they are absorbed through the gastrointestinal cycle. Injections must be given regularly to keep therapeutic levels where they need to be, for these proteins are broken down once they enter the blood stream.
What do you think would happen to a publicly traded biotechnology company if it came up with a way to prolong the life of a patented therapeutic protein so that injections could be reduced from say once a day to twice a month? Do you think this company could capture a nice piece of the revenue in this $96 billion industry?
CTP Technology Platform
PROLOR has a patented technology it uses in its research with previously approved therapeutic proteins. These are recombinant which means they are genetically altered to produce certain types of proteins that replace deficiencies in blood borne growth factors. The new versions of these proteins remain active longer so fewer injections are needed and therapeutic results can be optimized!
Dr. Fuad Fares, Chief Science Officer with PROLOR (PBTH) was involved in the early stages of this technology. While studying the half lives of two different reproductive hormones-(LH) and (hGC), it was observed that both were very similar but the human body broke down one much slower than the other. The (hGC) lasted two days while the lasted but 20 minutes-so further investigation took place to discover why. The only difference between the two was the (CT Peptide) which we will refer to as (CTP). Further study lead to learning how to attach to other therapeutic proteins in use, prolonging their lives! This opened up a whole new technology! It uses what is known as Carcoxyl Terminal Peptide (CTP Technology) sequence that has an effect of slowing the removal from the body of the therapeutic protein to which it is attached.
PROLOR's CTP Technology is developing proprietary versions of existing therapeutic proteins with longer life spans. Imagine a significant reduction in the number of injections needed to achieve the same results from a required dosage without increasing the risk of toxicity of losing therapeutic effectiveness. A company can extend its patent protection as proprietary new formulas of existing therapies. The commercialization process is faster and less expensive than those normally associated with a new therapeutic protein with a typical (industry standard) biotechnology-based protein production process. This is where a huge market exists for PROLOR.
Finding Promise in a CTP Version of hGH (hGH-CTP)
PROLOR is presently planning a third phase of research on its very promising (hGH-CTP) for adults later this year and Phase II development in children also
In its initial pilot study, it acquired promising results from a "twice monthly" dosage schedule of (hGH-CTP). This could have a huge impact upon treatment with existing growth hormone products that require daily injections. PROLOR reported in January of this year that in this study, 12 patients were switched from daily injections of conventional hGH to a controlled system of two injections of (hGH-CTP) over a 30 day period. In these two injections patients were given the (hGH-CTP) that contained 15% or 50% of the total dose (hGH) they would normally receive for a month.
These assessments were centered on stimulating the production of an insulin-like growth factor-1 (IGF-1). It is a hormone that plays an important role in childhood growth. In summary, Phase 1 data showed that the drug is a very potent hGH preparation, with a t1/2 seven times longer than commercial hGH. There was a clear correlation between dosage (IFG-1) response with the 50% showing promising response to the twice per month (hGH-CTP) injection plan. This provided enough data to support further development of the growth hormone.
In 2010, worldwide sales of therapeutic proteins tipped the scale at $96 billion. With many proteins on the market in danger of losing certain patent claims in the next 15 years, PROLOR Biotech's internal product development program is currently focused on extending the life span of several such therapeutic proteins, which together address an established market in excess of $15 billion. CTP Technology will be applicable to many currently marketed therapeutic proteins and should attract new partners who are interested in extending the rights of their proteins that are new patent expiration. PROLOR's potential growth looks bright and is a good stock to research further as a personal investment.