Hot Watch List (comments).
PROLOR Biotech`s core technology bases on using of a short, naturally occurring amino acid sequence (CTP) to slow the removal of therapeutic proteins from the body without increasing toxicity or altering the overall biological activity.
In simple words with this technology virtually all known therapeutics proteins and peptides may be fused (genetically) with the heavily glycosylated C-terminal peptide region of the human chorionic gonadotropin beta subunit. This region (CTP) is important to maintain the prolonged plasma half-life of human CG dimer.
January 03, 2011 by BiotechInvest
PBTH has phase II clinical trial with
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)
Primary Outcome Measures:
* 1. Safety and Tolerability [ Time Frame: Following 4 weeks of MOD-4023 treatment ] [ Designated as safety issue: Yes ]
Adverse events (AE's), vital signs, electrocardiogram (ECG), laboratory tests, local reaction
* Maintenance of normal Insulin-like-Growth-Factor-1 (IGF-1)levels in GHDA [ Time Frame: Following 4 weeks MOD-4023 treatment ] [ Designated as safety issue: No ]
The primary efficacy endpoint will be the mean time interval of IGF-I levels that lay within ±1.5 SDS after the last dose administration expressed in hours.
Secondary Outcome Measures:
* Change of IGF-I levels over time expressed in absolute and SDS values [ Time Frame: Following 4 weeks of MOD-4023 treatment ] [ Designated as safety issue: No ]
* Change of IGF-BP3 over time expressed in absolute and SDS values [ Time Frame: Following 4 weeks of MOD-4023 treatment ] [ Designated as safety issue: No ]
If trial show positive results it will prove that PBTH technology is working and can be applied to numerous therapeutic proteins and peptides. In this case PBTH could be the potential acquisition target for big pharmas.
Strongly recommended for investment in 2011 (starting from Q I-II). High risk, high reward.
Disclosure: I'll open the positions in PBTH in this month.
January 17, 2011 by BiotechInvest
The entire PBTH pipeline is based on CTP-link technology:
PROLOR Biotech is currently developing long-lasting versions for the following existing therapeutic proteins and peptides:
* MOD-4023: hGH-CTP – $2.7 billion current market, no available long-lasting therapeutics
* MOD-9013: IFN-ß-CTP – $4.7 billion current market, no available long-lasting therapeutics
* MOD-5023: Factor VIIa-CTP – $1.2 billion current market, no available long-lasting therapeutics
* MOD-7023: EPO-CTP - $10 billion current market, available long-lasting therapeutics
* MOD-1001: GLP-1-CTP – $1.0 billion estimated potential market, no available long-lasting therapeutics
* MOD-1002: OBES-CTP – $5.0 billion estimated potential market, no available long-lasting therapeutics
Actually the success of PBTH technology is already proved:
Merck & Co., a leading pharmaceutlcals company (NSYE: MRK) has used the CTP technology to extend the life of FSH. The long-acting FSH is named corifollitropin alfa (FSH-CTP).
On July 8, 2008 Schering-Plough, a division of Merck & Co, announced successful top-line data from its Phase III ENGAGE trial demonstrating that women receiving a single injection of FSH-CTP achieved the same pregnancy rates as women receiving seven consecutive daily injections of FSH, a primary endpoint of the study. This 1,509 patient trial was the largest double-blind fertility trial ever conducted.
On December 31, 2008 Schering-Plough announced European submission of FSH-CTP. 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®.
Follicle Stimulating Hormone ("FSH") is a hormone that naturally exists in females. Women who have fertility problems may get supplemental FSH to increase the likelihood of pregnancy. Women have to be injected daily, for seven days, with FSH, at around ovulation time. The FSH market is significant, with more than $1.0 billion in 2009.
February 04, 2011 by BiotechInvest
Recent news again support the huge potential of PBTH technology.
PROLOR Biotech Announces Positive Preclinical Results From Long-Acting Factor IX Comparative Study
Factor IX-CTP May Provide Hemophilia Patients Prolonged Protection from Bleeding and Enable Reduction in Number of Required Injections to Once-Weekly or Less
PROLOR Biotech, Inc., (NYSE Amex: PBTH), today reported positive results from a comparative study of its biobetter longer-acting version of the hemophilia drug Factor IX (Factor IX-CTP) in Factor IX-depleted hemophilic mice. The study was designed to measure the potential increase in clotting activity and duration of therapeutic effect of PROLOR's long-acting CTP-modified Factor IX when compared with commercially available recombinant Factor IX. Factor IX is indicated for the treatment of acute bleeding episodes and as therapy for prevention of bleeding in hemophilia B patients.
In the study, Factor IX-CTP, when compared with commercially available Factor IX, demonstrated a significantly longer duration of clotting activity in the hemophilic mice model. Bleeding episodes were also significantly shorter and less intense for the group treated with Factor IX-CTP. In addition, none of the animals treated with Factor IX-CTP had any spontaneous re-bleeding events, compared with a 50% incidence of re-bleeding events for the group treated with commercial Factor IX and an 83% incidence of re-bleeding events for the untreated group.
The new study results support previous preclinical studies that demonstrated significant improvements in the half-life of Factor IX-CTP compared to commercially available Factor IX.
One can say: It's just animal study, who care about hemophilic mice?
Well, FDA sent CRL to several companies because of drug-linked "rat cancer" (ARNA, XNPT).
I'm really surprising by fact that PBTH is still not acquired by some big pharma. CTP-based half-life prolongation of therapeutic proteins and peptides is a simple and cheap approach. This innovative approach has huge potential to improve numerous biologics products. Once-weekly injections of GLP-1, PTH, calcitonin and other biologics are real with CTP technology.
But it seems like that big pharma strategy is just unthinkable.
Eli Lilly buys Avid Radiopharmaceuticals and its Alzheimer’s test
Eli Lilly and Co. has completed its previous announced acquisition of Avid Radiopharmaceuticals. Philadelphia biotechnology company Avid is developing a compound to diagnosis Alzheimer’s disease earlier than now possible.Under the terms of the agreement, Eli Lilly (NYSE:LLY) of Indianapolis made an upfront payment of $300 million to Avid’s owners, who stand to receive an additional $500 million if Avid’s Florbetapir product achieves undisclosed regulator and commercial milestones.
Was it wise acquisition (almost $1B!)? Well, if you have a cure for AD may be it is. But if you don't have even a lead how to treat Alzheimer's disease, why you need the early diagnosis?
Recently one LLY late clinical trial for AD was terminated because the preliminary results showed the drug did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. That left solanezumab as the company's only late-stage candidate for Alzheimer's.
But recently Eli Lilly is reporting that one patient enrolled in a study of Alzheimer's drug solanezumab experienced temporary brain swelling; however, it's not clear yet whether the subject was receiving the drug or a placebo. The patient was able to resume treatment after the issue had subsided. About 2,000 patients are enrolled in two late-stage trials of the drug.
Johnson & Johnson and Pfizer are developing a rival drug, called bapineuzumab, and have also reported incidents of brain swelling. Bapineuzumab is designed to facilitate the clearance of amyloid plaque, which researchers believe contributes to the onset of Alzheimer's.
Gloomy picture... It seems like that big pharma R&Ds are just clueless about how to approach the AD treatment. They failed one by one. So, everybody at age 30-40 now have a very high probability to meet with this terrible disease. I hate this disease because it take the most valuable thing: cognition.
I know that AD is a hard target. I even tried to do something in this are and sent the project to NSF (National Science Foundation). And read what they answered:
"During the initial consideration of submitted grant proposals one of the
issues that we examine is the disease- or medical-relatedness of the
project. As noted in the Proposal and Award Policies and Procedures
Guide (NSF 09-02)
"Research with disease-related goals, including work on the etiology,
diagnosis or treatment of physical or mental disease, abnormality, or
malfunction in human beings or animals, is normally not supported."
Your above-referenced proposal is clearly medically-related as
illustrated by the following quotations from the Project Summary:
"The proposed work is an effort to find primary triggers that initiate
"Understanding the structure and function of A-beta channel could be
useful in clarifying of the mechanisms of A-beta amyloid neurotoxicity.
If discovered, the raft-associated A-beta channels can be a potential
therapeutic target for disease-modifying strategy in AD. The new results
gained from this study could become a novel strategy for the development
of therapeutics designed to cure Alzheimer's disease."
In addition the "Background and Significance" section of your proposal
makes strong connections between your proposed work and Alzheimer's
Therefore, regrettably, I have little alternative but to recommend that
this proposal be returned to you without review."
Funny! I was trying to do something useful, may be find some lead to AD mechanisms, but NSF provides grants only for abstract science. They don't care that big pharma R&D just can't find any leads to cure AD. They have big money for R&D but even big money can't inspire non-enthusiastic scientists to think and generate bright innovative ideas like CTP approach that actually was invented at academy:
"PROLOR Biotech`s core technology was developed by Professor Irving Boime of Washington University in St. Louis, while investigating the female hormone human Chorionic Gonadotropin ("hCG"), which facilitates pregnancy by maintaining production of progesterone and stimulating development of the fetus.
hCG has a long life span of up to 2 days, meaning that the body is slow to break it down. LH (Luteinizing Hormone) is another female hormone having a chemical composition (amino acid sequence) very close to that of hCG. LH has a very short life span of 20 minutes.
Prof. Boime discovered that the only difference between hCG and LH is a short amino-acid sequence present in hCG and not LH which he called "CTP".
Bravo, Professor! Perfect discovery that will help many people.