Long Lasting HGH is near

[DanB]

I seen this on another board a few weeks ago and forgot to post it until now when I just came back aross it

Its currently about to begin phase 3 trials in America according to their website, please form an orderly queue to sign up for these trials lol.


http://finance.yahoo.com/news/prolor...123000668.html


NES-ZIONA, Israel, Jan. 18, 2012 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH) today announced positive top-line results from a post-Phase II clinical study of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone deficient adults. The data show that two injections of hGH-CTP per month have the potential to replace 30 consecutive daily injections of currently marketed human growth hormone.

"We believe that the findings from this experiential study are very promising for adult patients in need of growth hormone therapy," said Dr. Avri Havron, Chief Executive Officer of PROLOR. "The Phase II results we reported last year showed that hGH-CTP can potentially provide a safe and effective new therapeutic option for adults with growth hormone deficiency when injected once-weekly, versus the daily injections of conventional hGH that are currently required. The results from this new pilot study indicate that hGH-CTP may be able to achieve an even better administration regimen—requiring injections just twice per month. This is encouraging news for growth hormone deficient patients who would like to minimize their injection regimen."

In the experimental pilot study, 12 patients were switched from daily injections of conventional hGH to a regimen of just two injections of hGH-CTP over a period of 30 days. The two injections of hGH-CTP contained either 15% or 50% of the total cumulative dose of hGH the patients would usually inject over the 30-day period. Patient IGF-1 levels, a well-accepted biomarker for assessing the activity of growth hormone therapy, were tracked in the study and served as a measure of efficacy.

Dr. Havron continued, "We believe that these results demonstrate significant potential, especially in view of the limitations of this pilot study. First, the study duration was only 30 days, thus not allowing sufficient time for patients to adjust fully to the new injection regimen. Second, patients received only 15% or 50% of their regular cumulative hGH dose. Third, the patients did not go through the dose titration procedure that physicians usually employ to optimize hGH dosing. Despite this, there was a clear correlation between dose and IGF-1 response, and patients receiving the 50% dose showed promising IGF-1 response to the twice-monthly hGH-CTP injection regimen. We look forward to further study of the twice-monthly regimen while we also advance our ongoing clinical program for hGH-CTP administered once-weekly."

[marcus300]

I reported another lab who have one coming out over 12 months ago here http://forums.steroid.com/showthread...eek&highlight=

Looks like everyone is jumping on the wagon

[DanB]

Haha I assummed you were already well clued up on this Marcus, your probably participating in the trials

But the all important question will be, what is the cost?

I imagine it will be more complex to make and therefore more expensive. . . . .

But this could force regular HGH pharm companys to lower their prices to try and retain some sort of marketshare? Should be interesting whenever it comes out

[marcus300]

Haha I assummed you were already well clued up on this Marcus, your probably participating in the trials

But the all important question will be, what is the cost?

I imagine it will be more complex to make and therefore more expensive. . . . .

But this could force regular HGH pharm companys to lower their prices to try and retain some sort of marketshare? Should be interesting whenever it comes out

I don't know much about it DanB only what I posted 12 months ago but it does sound very interesting
Not sure what they would do with the price of it, weather they price it to what it would normally cost you to inject that many iu's anyway or if they price it cheap. But I am sure it would bring down the price of Pharm grade gh when there is a one weekly shot hgh to contend with

[Flier]

Love it!
Admin. HRT will probably become rapidly easier.
I look forward to easier Test supp. as well.

[Razor]

I wonder if it will still be as effective as daily dosing

[ScotchGuard02]

This is really interesting. I'd love to read some clinical trials. I too wonder if the absorption is steady state over a two week period or it peaks and ebbs slowly.

[muscleport]

There is camp of experience HGH user that believe it is the "pulse" (the jump above the base line) that produces the sighnificant biological effect, any long lasting version may get your body used to a high base line and got an effect of "hGH" tolerance.

Well, ultimately, the clinical trial should brought more strong evidence on whether long lasting version being effective or not .

[DanB]

This is really interesting. I'd love to read some clinical trials. I too wonder if the absorption is steady state over a two week period or it peaks and ebbs slowly.

hGH-CTP Phase II Data

The three main cohorts in the trial received a single weekly dose of hGH-CTP for a period of four weeks, containing 30%, 45% or 100% of the equivalent cumulative commercial hGH dose these patients would usually inject each day over the course of seven days (referred to as the “30%,” “45%” and “100%” cohorts, respectively.) The top-line data reflect results from 39 patients, with 13 patients in each cohort comprised of 11 males and two females.

Efficacy for the three main cohorts receiving a single weekly injection of hGH-CTP was defined by measuring daily insulin -like growth factor 1 (IGF-1) levels within the desired therapeutic range over a period of seven days during the last week of treatment in the study. The desired therapeutic range is defined as an IGF-1 level that is between +2 standard deviations through -2 standard deviations from the average IGF-1 levels expected in a normal population stratified by age group and gender. In addition, the trial measured IGF-1 levels within a narrower range of +/- 1.5 standard deviations from the average normal population IGF-1 levels, for the purpose of learning more about the variance of patients within the normal range.

Phase II Trial Top-Line Data Analysis

As shown in the table below, the study data show that patients in all three cohorts (the “30%,” “45%” and “100%” cohorts) achieved average IGF-1 levels that were within the normal range on 100% of the days when they were assessed. In addition, the data show that patients in each of the cohorts achieved average IGF-1 levels within the narrow definition of the normal range on many or most of the days when they were assessed, indicating a favorable variance profile within the normal range.

hGH-CTP demonstrated excellent safety and tolerability in all patients across all trial cohorts, with no apparent issues. In addition, there were no indications that hGH-CTP can induce excessive levels of IGF-1 in patients above the normal range when used in high doses.

Cohort


% Days Within Normal Range (+/- 2 SD)


Avg. Cmax (preferred below +2 SD)


Variance Measure: % Days Within Narrow Normal Range
(+/-1.5 SD)

30%


100%


-0.9


57%

45%


100%


0.1


100%

100%


100%


0.4


86%



· The table shows the average percent of days within the normal therapeutic range (+/- 2 SD), average percent of days within a narrower normal therapeutic range (+/- 1.5 SD), and average Cmax (highest concentration level) of IGF-1 for males, measured during the last treatment week, expressed in standard deviations from the mean IGF-1 levels expected in the normal population.

http://www.modigeneinc.com/?CategoryID=231

[DanB]

damn the table didnt like the copy and paste attempt, just follow the link if you want to see it