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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by glenn on December 1, 2003, at 5:11:24
This was posted about a year ago:
http://www.ksl.com/dump/news/cc/series/blues.htm
Since then I have heard nor been able to find anything more about it!
Maybe everybody in the trial turned into a frog!
I have wondered if it was a hoax, but the docs are genuine, as is the pharmacology research clinic who carried out the trials!
Any thoughts!!Glenn
Posted by JonW on December 1, 2003, at 8:05:26
In reply to Was this a joke? or is it so good we can't have it, posted by glenn on December 1, 2003, at 5:11:24
> This was posted about a year ago:
>
> http://www.ksl.com/dump/news/cc/series/blues.htm
>
> Since then I have heard nor been able to find anything more about it!
> Maybe everybody in the trial turned into a frog!
> I have wondered if it was a hoax, but the docs are genuine, as is the pharmacology research clinic who carried out the trials!
> Any thoughts!!Check out:
"We currently have a number of Phase 2 / 3 clinical trials underway, which will generate a portion of the data required by the FDA in order to obtain approval to market Nemifitide. We plan to commence large scale, Phase 3 clinical trials of Nemifitide within the first or second quarter of 2003, to submit a New Drug Application (NDA) to the FDA in 2005, and to commercialize the compound in 2006. Our research plans include clinical studies to be conducted in the United States and in Europe under internationally established protocols that will yield results suitable for submission to regulatory authorities in all important world marketplaces."
Posted by Larry Hoover on December 1, 2003, at 8:51:31
In reply to Re: Was this a joke? or is it so good we can't have it » glenn, posted by JonW on December 1, 2003, at 8:05:26
> Check out:
>
> http://www.innapharma.com/
>
> "We currently have a number of Phase 2 / 3 clinical trials underway, which will generate a portion of the data required by the FDA in order to obtain approval to market Nemifitide. We plan to commence large scale, Phase 3 clinical trials of Nemifitide within the first or second quarter of 2003, to submit a New Drug Application (NDA) to the FDA in 2005, and to commercialize the compound in 2006. Our research plans include clinical studies to be conducted in the United States and in Europe under internationally established protocols that will yield results suitable for submission to regulatory authorities in all important world marketplaces."Thanks for the link. It let me find the drug ID, which simplified my searching immensely.
I have three significant concerns. One, the obvious one, is that this substance must be injected, and it has a daily dose regime. That makes it very impractical, IMHO. Two, pharmacological responsivity is substantially dependent on blood concentrations, and we don't know why people differ on that, at the same dose....so do you not only have to have injections every day, but daily blood draws? Expensive, expensive. Three, we know nothing about the long-term effects of exogenous (from outside) administration of neuroactive peptides (think brain hormones). Playing with fire, methinks.
Anyway, here are so relevant research abstracts (published by the company....no chance of publication bias, eh?):
Int Clin Psychopharmacol. 2001 Nov;16(6):345-52.
Double-blind, placebo-controlled study of INN 00835 (netamiftide) in the treatment of outpatients with major depression.Feighner JP, Ehrensing RH, Kastin AJ, Patel A, Sverdlov L, Hlavka J, Abajian HB, Noble JF, Nicolau G.
Innapharma Inc., Park Ridge, NJ 07656, USA.
This study was designed to determine the safety, efficacy and pharmacokinetics of the antidepressant netamiftide (previously designated name: INN 00835) after 5 or 10 daily doses administered to patients diagnosed with major depression. Netamiftide was administered subcutaneously at a fixed dose of 18 mg/patient per day. Of the 55 enrolled patients, 22 were dosed for 10 days with drug, 11 for 5 days with drug followed by 5 days with placebo and 22 for 10 days with placebo only. The effect of treatment with netamiftide was evaluated by the following psychometric tests: Hamilton Depression Rating, Montgomery-Asberg Depression Rating Scale, Carroll Self-Rating Depression and Clinical Global Impression scales. None of the patients experienced significant adverse effects. A pharmacodynamic correlation (P < 0.05) was found between plasma drug concentrations and response to treatment. Highest plasma concentrations (Cmax) of netamiftide averaging 45.7 ng/ml were observed at 0.25 h after dosing. There were 89% responders in the group with Cmax > or = 45.7 ng/ml (minimum therapeutic concentration) versus 40% in the group with Cmax < 45.7 ng/ml. Onset of action was observed within 48 h after treatment, peak effect was observed at approximately 1 week after treatment and efficacy lasted during a 4-week follow-up period. Netamiftide is a promising antidepressant with rapid onset of action and with an excellent safety profile.
J Affect Disord. 2000 Dec;61(1-2):119-26.
A double-blind, placebo-controlled, efficacy, safety, and pharmacokinetic study of INN 00835, a novel antidepressant peptide, in the treatment of major depression.Feighner JP, Ehrensing RH, Kastin AJ, Leonard BE, Sverdlov L, Nicolau G, Patel A, Hlavka J, Abajian H, Noble JF.
The Feighner Research Institute, San Diego, CA, USA.
BACKGROUND: INN 00835 is a synthetic pentapeptide with a potential for rapid onset of action as an antidepressant. Its efficacy was investigated in a pilot study in patients diagnosed with major depression. METHODS: Fifty two patients received either active drug - INN 00835 (26 patients) - or placebo (26 patients), subcutaneously at 0.2 mg/kg for 5 consecutive days. The patients were evaluated for an additional 4 weeks after treatment. Efficacy was evaluated by the following psychiatric rating scales: HAMD, MADRS, CSRS, CGI, and VAS. The effect of treatment was also evaluated by using a biochemical marker: changes in blood platelet serotonin (5HT) uptake rates in drug-treated patients compared to those in the placebo group. Plasma concentrations of INN 00835 were measured by LC/MS. RESULTS: Statistical analysis indicated a strong pharmacodynamic correlation between plasma drug concentrations at 1 h after dosing and the reduction in the severity of depression as measured by the psychiatric rating scales. A minimum effective plasma concentration (MEC) of INN 00835 was 5 ng/ml. Statistically significant differences in response to treatment (P<0.05) were found between patients with plasma concentrations above MEC and those in the placebo group, as well as between subjects with plasma concentrations above and below the MEC. The peak effect was observed after the 5-day treatment and the response to treatment persisted during the 4-week follow-up period. The change of 5HT uptake rates after treatment was significantly larger in the drug-treated group than in the placebo group. Limitations: This was a pilot study conducted in a relatively small population (52 patients) and the limited number of blood sampling times did not allow a comprehensive pharmacokinetic analysis. There was a relatively large placebo response. The results have to be confirmed in future, large scale studies. CONCLUSIONS: INN 00835 appears to be a promising drug for the treatment of major depression.
Posted by glenn on December 1, 2003, at 11:39:12
In reply to Re: Was this a joke? or is it so good we can't have it » JonW, posted by Larry Hoover on December 1, 2003, at 8:51:31
Thankyou for the info , if this is the same stuff then I now know where it is at. I have emailed the director of Pharmacology research just to be sure, will let you know what Dr Ferguson says if he gets back to me.
I have ano0ther one for you, try the post below regarding that naughty amygdala, might be an alternative for the gentleman who wanted his surgically removed!!Glenn
Posted by stjames on December 1, 2003, at 20:34:12
In reply to Re: Was this a joke? or is it so good we can't have it » JonW, posted by Larry Hoover on December 1, 2003, at 8:51:31
>Three, we know nothing about the long-term effects >of exogenous (from outside) administration of >neuroactive peptides (think brain hormones). >Playing with fire, methinks.
Dr Frankinstein, I think. We have not begun to
understand a) How NT's work b) how they relate in mental illness. So it is not a safe leap, to me,
to consider exogenous administration of a substance to "fix" all this. We know something is broken but we don't know how it works. Seems to me then we don't know how to fix it.> There was a relatively large placebo response.
Really ! I have often felt the clinical setting
of a study causes a larger placebo response.
"Hey, they are shooting me up with X, must be good."Since this is phase 2, even if it does make it through stage 3 and to market, we are talking a decade.
Post some stuff that is through with stage 3,
and then we can discuss something that might be here in a year or 5.
This is the end of the thread.
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