Are these two legal in the US?
For now. But eventually FDA will ruin it for everybody.
dumb question, but I’ve never heard of CJC-1295–what is it?
Dumb question? Yet you dont know what cjc-1295 is lol at you
oops sorry read that wrong
Yeah, I’ve never heard of CJC-1295 either…
[quote]sota123 wrote:
For now. But eventually FDA will ruin it for everybody.[/quote]
…and here is why:
[i]
Lipodystrophy study halted after patient death
A Phase II study of a lipodystrophy treatment developed by Canadian
biotech company, ConjuChem, has been halted after the death of a study
participant. The cause of death and its relationship to the study drug -
CJC-1295, a chemically modified version of growth hormone releasing
factor (GRF) also known as DAC:GRF - is currently being investigated.
However, a Phase III study of another Canadian-developed GRF-based
lipodystrophy treatment, Theratechnologies’ TH-9507, is continuing.
The multicentre, randomised, placebo-controlled, double-blind Phase II
study of CJC-1295 had only completed enrolling a total of 192
participants with HIV-related visceral obesity at various sites in North
and South America last month. Participants were randomised to receive
once-weekly injections of either a three-week escalating low dose of
CJC-1295 (at 60, 90, 120mcg/kg); a three-week escalating high dose (at
60, 120, 240mcg/kg); or a placebo, and then continue for a further nine
weeks.[/i]
One death out 192 (over less than 9 weeks) may not seem like many, but it is important to the drug approval process…and to you, if you are that one.
So an obese person with HIV died and the immediate conclusion is to blame the CJC? That seems stupid.
^^^^ It also seams normal and run of the mill for the gear haters.
Oh ya is ifg-1 worth it? Is it cost efective?
[quote]Inner Hulk wrote:
So an obese person with HIV died and the immediate conclusion is to blame the CJC? That seems stupid. [/quote]
No. I disagree. I don’t know the facts, but I suggest you read the little article again.
Yes, they have HIV and no they are not necessarily fat (lipodystrophy is a different thing altogether and is one of the indications for HGH or GHRH analogues).
Second, it is a randomized study, so some subjects were on salt-water injections. In such trials, all the patients are deemed healthy enought to survive some period of time (like 2 or 3 or 6 months). If there were a death, attributable to the agent, it may achieve statistical significance, and end the trial right there. Then, no legal drug.
The judgment hinges on details: cause of death and when it occurred in the course of the trial.
What would be stupid is if the agent was approved and you died…that would be real stupid.
Anyone want to hear the real story of thalidomide?
Hm that CJC peptide is interesting, haven’t read about it until now. Looks like ConjuChem just put out a new paper about it as well, detailing structural information. The peptide has a thiol reactive chemical linker (maleimide) appendage that is supposed to function to covalently link the GHRH peptide to albumin. This binding to albumin is designed to enhance the half life of the peptide to days or more. They say in the paper:
“The predominant free thiol group available for binding after parenteral administration is the single unpaired cysteine (cysteine 34) in serum albumin. At least 90% of CJC-1295 binds covalently to albumin in this fashion, with trace amounts found bound to fibrinogen and IgG. No other chemical species have been found bound to DAC-GRF after administration (data on file, ConjuChem, Inc.).”
From: http://jcem.endojournals.org/cgi/reprint/91/3/799.pdf
I would like to see the data and how they tested it. I have read about maleimides reacting with lysine and arginine residues under certain conditions. (I have also used it in many PEG reactions.) I also doubt that the free C34 cysteine on albumin is the only place this peptide attaches itself to. This is major cause for concern.
Bottom line is that this chemistry is very dicey and I would not want to inject this into my own body!
The Theratechnologies GHRH analogue (TH-9507) that is a 1x/daily dose peptide proved safe in the HIV anti-lipodystrophy test mentioned above. They published results a few months ago. The HIV patients did well, losing significant fat mass over a 1 year period.
[quote]DrSkeptix wrote:
sota123 wrote:
For now. But eventually FDA will ruin it for everybody.
…and here is why:
[i]
Lipodystrophy study halted after patient death
A Phase II study of a lipodystrophy treatment developed by Canadian
biotech company, ConjuChem, has been halted after the death of a study
participant. The cause of death and its relationship to the study drug -
CJC-1295, a chemically modified version of growth hormone releasing
factor (GRF) also known as DAC:GRF - is currently being investigated.
However, a Phase III study of another Canadian-developed GRF-based
lipodystrophy treatment, Theratechnologies’ TH-9507, is continuing.
The multicentre, randomised, placebo-controlled, double-blind Phase II
study of CJC-1295 had only completed enrolling a total of 192
participants with HIV-related visceral obesity at various sites in North
and South America last month. Participants were randomised to receive
once-weekly injections of either a three-week escalating low dose of
CJC-1295 (at 60, 90, 120mcg/kg); a three-week escalating high dose (at
60, 120, 240mcg/kg); or a placebo, and then continue for a further nine
weeks.[/i]
One death out 192 (over less than 9 weeks) may not seem like many, but it is important to the drug approval process…and to you, if you are that one.[/quote]
According to a later released report concerning the death in the CJC-1295 trial, it was concluded that the heart attack suffered by the participant was unrelated to the drug course, and that CJC-1295 exhibited no effects leading to cardiac toxicity.
Apparently the drug was unavailable for a time during this investigation, but became available again with it’s conclusion.
Does this mean it’s totally safe? Who knows. At the 3mg per week dosage that’s been found to be effective in the literature, it’s also quite cost prohibitive, as 2mg is around $75.
all i know is that i wouldn’t want free maleimide groups floating around in my body… that’s akin to free radicals floating around that can just react with whatever they come into contact with
Ya the cj3-1295 is for sale again.
I am still wondering about igf-1 though. Is it legal?
Is it cost effective>?
[quote]Cup wrote:
Ya the cj3-1295 is for sale again.
I am still wondering about igf-1 though. Is it legal?
Is it cost effective>?[/quote]
Yes it’s legal and better yet it works.
[quote]2thepain wrote:
Yes it’s legal and better yet it works.[/quote]
Pain, do you have any additional info on this like dosage, during cycle or PCT? Any additional info would be great.
there’s info all over the net about IGF-1. there is less regarding growth hormone releasing hormone analogues (such as CJC-1295) because GHRH analogues that have bioavailabilities beyond the ~10 minutes of the native hormone are just beginning to emerge for sale on various markets.