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- Jun 7, 2006
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- 173
There has been some issues during the CJC clinical trails resulting in what appears to be a temporary hault in the trail. It seems very likely that the trail will be resumed but Innovative Research has decided to hold off on distributing this product for the time being.
Here is the news direct from the pharmaceutical company’s (ConjuChem) press release after the incident
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.
The only information released so far by ConjuChem, which stopped the
study on July 17th, is that the participant who died was attending a
study site in Argentina. An unconfirmed, anecdotal report from a trial
participant at a Canadian study site, suggests that the individual
concerned was a man who died a few hours after receiving his eleventh
CJC-1295 injection.
Here is the results of the investigation regarding the death of the man participating in the trail.
ConjuChem provides findings of DAC(TM):GRF HIV Lipodystrophy trial investigation
ConjuChem Biotechnologies Inc. provided findings of its investigation into the death of a patient that occurred in its Phase II clinical trial of DAC(TM):GRF in HIV Lipodystrophy.
MONTREAL, Canada | Aug 08, 2006 | ConjuChem Biotechnologies Inc. (TSX:CJB) provided findings of its investigation into the death of a patient that occurred in its Phase II clinical trial of DAC(TM):GRF in HIV Lipodystrophy. The Company had previously reported on July 14 that a death occurred of a patient in the trial at a clinical site in Argentina. The trial was an international multi-center, randomized, placebo-controlled, double-blind study which had completed enrollment with 192 patients.
Patients were to be administered once-weekly dosing of DAC(TM):GRF for 12 weeks followed by a 6-week follow-up. The deceased patient received the 11th weekly dose on July 13 and approximately two hours later, the patient complained of chest discomfort and an ECG confirmed an acute myocardial infarction; death occurred approximately one hour later.
There is no evidence of any cardiotoxic effects of DAC(TM):GRF in previous preclinical or clinical studies. The attending physician stated that his most likely explanation for the event was the patient had asymptomatic coronary artery disease with plaque rupture and occlusion.
ConjuChem indicated it has terminated the Phase II study and is further evaluating the clinical development strategy of DAC(TM): GRF.
As you can see, it appears that the CJC-1295 peptide had nothing to do with death of the man in the trial. He was an obese AIDs patient as all the other participants. The autopsy showed positive ECG results for the heart attack and further investigation confirmed large amounts of plaque in the arteries as said above leading to the eventual heart attack. It happens everyday unfortunately, especially in the overweight population.
The CJC peptide and the GRF from which it is derived have shown no potential risk factors, and no cardio toxic effects. In fact a competing company was doing a similar study and has continued it trail right through the incident. That alone should show the confidence that this was a totally random, isolated and unrelated incident from the clinical trail of the CJC-1295 peptide. It is still however the wishes of Innovative Research to hold off on releasing the product at least for a short period of time.
Here is the news direct from the pharmaceutical company’s (ConjuChem) press release after the incident
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.
The only information released so far by ConjuChem, which stopped the
study on July 17th, is that the participant who died was attending a
study site in Argentina. An unconfirmed, anecdotal report from a trial
participant at a Canadian study site, suggests that the individual
concerned was a man who died a few hours after receiving his eleventh
CJC-1295 injection.
Here is the results of the investigation regarding the death of the man participating in the trail.
ConjuChem provides findings of DAC(TM):GRF HIV Lipodystrophy trial investigation
ConjuChem Biotechnologies Inc. provided findings of its investigation into the death of a patient that occurred in its Phase II clinical trial of DAC(TM):GRF in HIV Lipodystrophy.
MONTREAL, Canada | Aug 08, 2006 | ConjuChem Biotechnologies Inc. (TSX:CJB) provided findings of its investigation into the death of a patient that occurred in its Phase II clinical trial of DAC(TM):GRF in HIV Lipodystrophy. The Company had previously reported on July 14 that a death occurred of a patient in the trial at a clinical site in Argentina. The trial was an international multi-center, randomized, placebo-controlled, double-blind study which had completed enrollment with 192 patients.
Patients were to be administered once-weekly dosing of DAC(TM):GRF for 12 weeks followed by a 6-week follow-up. The deceased patient received the 11th weekly dose on July 13 and approximately two hours later, the patient complained of chest discomfort and an ECG confirmed an acute myocardial infarction; death occurred approximately one hour later.
There is no evidence of any cardiotoxic effects of DAC(TM):GRF in previous preclinical or clinical studies. The attending physician stated that his most likely explanation for the event was the patient had asymptomatic coronary artery disease with plaque rupture and occlusion.
ConjuChem indicated it has terminated the Phase II study and is further evaluating the clinical development strategy of DAC(TM): GRF.
As you can see, it appears that the CJC-1295 peptide had nothing to do with death of the man in the trial. He was an obese AIDs patient as all the other participants. The autopsy showed positive ECG results for the heart attack and further investigation confirmed large amounts of plaque in the arteries as said above leading to the eventual heart attack. It happens everyday unfortunately, especially in the overweight population.
The CJC peptide and the GRF from which it is derived have shown no potential risk factors, and no cardio toxic effects. In fact a competing company was doing a similar study and has continued it trail right through the incident. That alone should show the confidence that this was a totally random, isolated and unrelated incident from the clinical trail of the CJC-1295 peptide. It is still however the wishes of Innovative Research to hold off on releasing the product at least for a short period of time.
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