Moppy1
New member
Been researching IGF-1 and IGF-1 LR3 and what has been used in humans in various clinical trials versus what has caught on in BB circles, and as usually there is a huge discrepancy
1) First, realize that your IGF-1 or IGF-LR3 has to be made recombinantly in E. coli, just like HGH is made, or it will never work. Peptide synthesis companies do not make bioactive IGF-1 LR3.
2) Second, the average dosage of IGF-1 used in humans in well over 5 clinical trials is 4-8 mg a day, per injection, 2x a day!!! (average dosage is 0.1mg/kg/day). IGF-1 LR3 is more potent with a longer half life, so you could probably get away with 2-3x lower dosage, but that is still like 3-4 mg per day, which is like 3-4 full kits with of Igtropin, for a single injection!!! Hence, no one in the BB community is using IGF-1 correctly, at a dosage that will work clinically
Here is a summary from the FDA on 5 previous clinical trials with IGF-1:
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Silver Spring, MD 20993
FDA Summary of Controlled Clinical Data for
Human IGF-1 in Treatment of Patients with
Amyotrophic Lateral Sclerosis
FDA is aware of 5 sources of controlled clinical
data evaluating recombinant human IGF-1 (rhIGF-1, or
IGF-1) for treatment of patients with Amyotrophic Later
al Sclerosis (ALS or Lou Gehrig’s disease). The
data from these sources are summarized below.
The first 2 data sources are controlled clinical trials
that were submitted by Cephalon in support of their
New Drug Application (NDA) for the use of IGF-1
(proposed Tradename Myotrophin) in ALS. FDA has
not approved IGF-1 for treatment of ALS.
Study 1200 was a multi-center clinical trial perfo
rmed in the United States and Canada in which 266
patients with ALS were randomized to receive eith
er IGF-1 0.05 mg/kg/day, IGF-1 0.1 mg/kg/day, or
placebo, each given in a twice-daily regimen by subc
utaneous injection. Patients were to be treated for 9
months, or until they reached one of 2 pre-specifie
d endpoints: an Appel ALS Scale (AALS) score of 115,
or a Forced Vital Capacity (FVC) of <39%. The
Appel ALS Scale consists of 5 subscales (Bulbar
Function, Respiratory Function, Overall Muscle Strength, Upper Extremity, and Lower Extremity Function)
with scores ranging from 30 (Normal) to 164 (Maxim
al Dysfunction). Patients with a baseline AALS score
of between 40 and 80 were eligible for inclusion in
the trial. Approximately 90 patients were randomized
to each treatment group.
Study 1202 was a multi-center clinical trial performed in
Europe using a protocol very similar to that used
for Study 1200. Study 1202 differed from Study 1200 in
the inclusion of only two treatment groups; 0.1
mg/kg/day IGF-1 and placebo, and the primary outcome measure was the total AALS score. The trial
duration and pre-specified study endpoints
were the same as in Study 1200.
A total of 124 patients were randomized to IGF-1,
and 59 to placebo. There was no statistically significant difference on the primary outcome meas
ure between drug- and placebo-treated patients. A
total of 15% of the drug-treated group, and 8% of
the placebo-treated patient
s, died during double-blind
treatment. This was a multi-center clinical tr
ial in which patients with ALS were randomized to receive IGF-1, 0.1
mg/kg/day or placebo given twice-daily for 2 years. T
here were a total of 330 pati
ents at 20 centers in the
United States. The primary outcome measure was t
he rate of change in the averaged manual muscle
testing score (MMT). The MMT assesses strength in
34 muscle groups, and individual groups are scored
on a 10 point scale. There was no
statistically significant differenc
e between treatment groups on the
primary outcome, and no difference in mortality between the 2 groups.
Cephalon Treatment IND
The trial permitted
patients who were 18 years old or olde
r with a diagnosis of ALS to enter a lottery with the possibility of
receiving IGF-1 0.1 mg/kg/day (given in a twice daily
regimen). The sponsor proposed a lottery because
they did not have sufficient supply of drug to make it
available to all who wanted it. Those patients who
entered the lottery and did not receive drug were continued to be followed in order to obtain mortality data
in both the treated and untreated groups. For each pa
tient who received drug, 10 were untreated.
Japanese Study
(unpublished data submitted to FDA by Cephalon)
A study was performed in Japan by Kyowa Hakko,
a partner of Cephalon. This was a randomized,
placebo-controlled, parallel-group, clinical trial in
which patients with ALS (AALS scores of 40-80 at
screening) were randomized to receive IGF-1, 0.1 mg
/kg/day (given twice daily) or placebo. The study
duration was 9 months, and stopping rules were as in
the Cephalon studies described above. FDA does
not know what the pre-specified primary outcome me
asure was for this trial, but AALS score and “ALS
Severity” were assessed, as well as “Overall Therap
eutic Effects”. There was an open label extension
after patients completed the randomized portion of th
e trial, and based on an interim report of survival
data, Kyowa Hakka apparently voluntarily discontinued treatment. The
results of the mortality data for the
controlled trial are given below
1) First, realize that your IGF-1 or IGF-LR3 has to be made recombinantly in E. coli, just like HGH is made, or it will never work. Peptide synthesis companies do not make bioactive IGF-1 LR3.
2) Second, the average dosage of IGF-1 used in humans in well over 5 clinical trials is 4-8 mg a day, per injection, 2x a day!!! (average dosage is 0.1mg/kg/day). IGF-1 LR3 is more potent with a longer half life, so you could probably get away with 2-3x lower dosage, but that is still like 3-4 mg per day, which is like 3-4 full kits with of Igtropin, for a single injection!!! Hence, no one in the BB community is using IGF-1 correctly, at a dosage that will work clinically
Here is a summary from the FDA on 5 previous clinical trials with IGF-1:
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Silver Spring, MD 20993
FDA Summary of Controlled Clinical Data for
Human IGF-1 in Treatment of Patients with
Amyotrophic Lateral Sclerosis
FDA is aware of 5 sources of controlled clinical
data evaluating recombinant human IGF-1 (rhIGF-1, or
IGF-1) for treatment of patients with Amyotrophic Later
al Sclerosis (ALS or Lou Gehrig’s disease). The
data from these sources are summarized below.
The first 2 data sources are controlled clinical trials
that were submitted by Cephalon in support of their
New Drug Application (NDA) for the use of IGF-1
(proposed Tradename Myotrophin) in ALS. FDA has
not approved IGF-1 for treatment of ALS.
Study 1200 was a multi-center clinical trial perfo
rmed in the United States and Canada in which 266
patients with ALS were randomized to receive eith
er IGF-1 0.05 mg/kg/day, IGF-1 0.1 mg/kg/day, or
placebo, each given in a twice-daily regimen by subc
utaneous injection. Patients were to be treated for 9
months, or until they reached one of 2 pre-specifie
d endpoints: an Appel ALS Scale (AALS) score of 115,
or a Forced Vital Capacity (FVC) of <39%. The
Appel ALS Scale consists of 5 subscales (Bulbar
Function, Respiratory Function, Overall Muscle Strength, Upper Extremity, and Lower Extremity Function)
with scores ranging from 30 (Normal) to 164 (Maxim
al Dysfunction). Patients with a baseline AALS score
of between 40 and 80 were eligible for inclusion in
the trial. Approximately 90 patients were randomized
to each treatment group.
Study 1202 was a multi-center clinical trial performed in
Europe using a protocol very similar to that used
for Study 1200. Study 1202 differed from Study 1200 in
the inclusion of only two treatment groups; 0.1
mg/kg/day IGF-1 and placebo, and the primary outcome measure was the total AALS score. The trial
duration and pre-specified study endpoints
were the same as in Study 1200.
A total of 124 patients were randomized to IGF-1,
and 59 to placebo. There was no statistically significant difference on the primary outcome meas
ure between drug- and placebo-treated patients. A
total of 15% of the drug-treated group, and 8% of
the placebo-treated patient
s, died during double-blind
treatment. This was a multi-center clinical tr
ial in which patients with ALS were randomized to receive IGF-1, 0.1
mg/kg/day or placebo given twice-daily for 2 years. T
here were a total of 330 pati
ents at 20 centers in the
United States. The primary outcome measure was t
he rate of change in the averaged manual muscle
testing score (MMT). The MMT assesses strength in
34 muscle groups, and individual groups are scored
on a 10 point scale. There was no
statistically significant differenc
e between treatment groups on the
primary outcome, and no difference in mortality between the 2 groups.
Cephalon Treatment IND
The trial permitted
patients who were 18 years old or olde
r with a diagnosis of ALS to enter a lottery with the possibility of
receiving IGF-1 0.1 mg/kg/day (given in a twice daily
regimen). The sponsor proposed a lottery because
they did not have sufficient supply of drug to make it
available to all who wanted it. Those patients who
entered the lottery and did not receive drug were continued to be followed in order to obtain mortality data
in both the treated and untreated groups. For each pa
tient who received drug, 10 were untreated.
Japanese Study
(unpublished data submitted to FDA by Cephalon)
A study was performed in Japan by Kyowa Hakko,
a partner of Cephalon. This was a randomized,
placebo-controlled, parallel-group, clinical trial in
which patients with ALS (AALS scores of 40-80 at
screening) were randomized to receive IGF-1, 0.1 mg
/kg/day (given twice daily) or placebo. The study
duration was 9 months, and stopping rules were as in
the Cephalon studies described above. FDA does
not know what the pre-specified primary outcome me
asure was for this trial, but AALS score and “ALS
Severity” were assessed, as well as “Overall Therap
eutic Effects”. There was an open label extension
after patients completed the randomized portion of th
e trial, and based on an interim report of survival
data, Kyowa Hakka apparently voluntarily discontinued treatment. The
results of the mortality data for the
controlled trial are given below
