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New Sitris Resveratrol News


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#1 mikeinnaples

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Posted 17 April 2008 - 01:16 PM


http://biz.yahoo.com...05169.html?.v=1

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT - News), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat diseases of aging such as Type 2 Diabetes, today announced positive top-line data from its twice-daily dosing study of SRT501, the company’s proprietary formulation of resveratrol. The Phase 1b clinical trial, which tested either 1.25 or 2.5 grams of SRT501 given twice daily to Type 2 Diabetic patients, found that the patient group receiving 2.5 grams twice a day had significantly lower blood glucose levels as determined through an oral glucose tolerance test (OGTT) at the test’s two-hour time point, as compared with the placebo group.
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At 2.5 grams twice daily, the study also found that SRT501 had a statistically significant lowering of both fasting blood glucose and glucose levels after meals, known as the postprandial period, an important timeframe for Type 2 Diabetics who need better control of blood sugar levels after eating. While not at the level of statistical significance, this dose level also showed a strong trend in lowering postprandial insulin levels.

At 1.25 grams given twice daily, SRT501 also showed strong trends. While not at statistical significance, SRT501 at 1.25 grams given twice per day lowered fasting and postprandial glucose, and glucose when challenged with an OGTT at the two-hour time point on day 27 of the trial as compared to the placebo group. The data suggest a dose response.

The company plans to present the full data at the American Diabetes Association annual meeting in June.

“With this study, and the Phase 1b once daily dosing study data that we announced in January of this year, we have now observed a lowering of glucose in Type 2 Diabetic patients in two clinical trials with SRT501,” says Peter Elliott, Ph.D., Senior Vice President of Development at Sirtris. “The two Phase 1b clinical trials tested SRT501 at different dosage levels and dose time points. While the primary focus of each study was safety and blood levels of SRT501, by developing the studies as we did, we are also able to see signs of efficacy and dose response.”

“Our clinical trial program with SRT501 further validates our approach in targeting the SIRT1 enzyme for the development of a potential new treatment for Type 2 Diabetes,” says Christoph Westphal, M.D., Ph.D., CEO and Vice Chair of Sirtris. “Today’s Phase 1b announcement is the second time we’ve seen a translation of the positive results from preclinical studies carry over to humans.”

The current multi-center, blinded and randomized Phase 1b study included approximately 100 Type 2 Diabetic patients divided into three groups. The first patient group received 1.25 grams of SRT501 twice daily for a total daily-dose level of 2.5 grams. The second patient group received 2.5 grams twice daily for a total daily-dose level of 5.0 grams. The third group received placebo twice daily.

The study was designed to assess the safety, tolerability and pharmacokinetics of twice-daily, orally administered dosing of SRT501 at 2.5 and 5.0 total grams. In both patient cohorts receiving SRT501, the drug was found to be safe and well-tolerated, with no evidence of drug accumulation. The study also indicates that suitable pharmacokinetics, a measure of drug levels in the blood, was achieved.

In January of this year, Sirtris announced positive Phase 1b trial results of its once-daily dosing of SRT501 at 2.5 and 5.0 grams. In that study, SRT501 was also found to be safe and well-tolerated and to significantly lower glucose as compared to the placebo group in an OGTT at the two-hour time point as part of the 28 day trial of patients with Type 2 Diabetes.

SRT501 is currently being tested in patients with Type 2 Diabetes in a Phase 2a study in combination with metformin, the current first-line therapy for Type 2 Diabetes. Results from this trial are expected in the second-half of this year.

Sirtris has also identified new chemical entities (NCEs) that are chemically distinct from resveratrol, and in in-vitro tests are up to 1,000 times more potent. In preclinical models of Type 2 Diabetes, Sirtris’ NCEs have lowered glucose and improved sensitivity.

About Sirtris Pharmaceuticals

Sirtris Pharmaceuticals is a biopharmaceutical company focused on discovering and developing proprietary, orally available, small molecule drugs with the potential to treat diseases associated with aging, including metabolic diseases, such as Type 2 Diabetes. Our drug candidates are designed to mimic certain beneficial health effects of calorie restriction, without requiring a change in eating habits, by activation of sirtuins, a recently discovered class of enzymes that control the aging process. The company's headquarters are in Cambridge, Massachusetts.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, the potential therapeutic effects of SIRT1 activators including SRT501 for diseases of aging, such as Type 2 Diabetes, the progress and results of pre-clinical and clinical studies of SIRT1 activators, the potential therapeutic effects of SRT501 and other SIRT1 activators, and the potential of sirtuin modulators and activators to receive regulatory approval. These forward-looking statements about future expectations, plans and prospects of Sirtris Pharmaceuticals involve significant risks, uncertainties and assumptions, including risks related to the lack of results that would provide a basis for predicting whether any of the Company’s product candidates will be safe or effective, or receive regulatory approval, the possibility that results of pre-clinical studies are not necessarily predictive of clinical trial results, the Company's potential inability to initiate and complete pre-clinical studies and clinical trials for its product candidates, the fact that none of the Company's product candidates has received regulatory approvals, the potential inability of the Company to gain market acceptance of the Company's product candidates, and those other risks factors that can be found in the Company's filings with the Securities and Exchange Commission. Actual results may differ materially from those Sirtris Pharmaceuticals contemplated by these forward-looking statements. Sirtris Pharmaceuticals does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release.



Contact:
Investor and Media:
Sirtris Pharmaceuticals, Inc.
John Lacey, 617-252-6920
Associate Director of Corporate Communications
or
Pure Communications
Sheryl Seapy, 949-608-0841


Edited by mikeinnaples, 17 April 2008 - 01:16 PM.


#2 TianZi

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Posted 18 April 2008 - 07:53 AM

I was just about to post this, then saw your thread.

We can conclude from this study, assuming it's accurate, that humans need much more resveratrol to achieve clinically significant results than many had hoped, at least in a relatively short time frame, and at least as regards diabetes treatment.

5 grams daily is a lot, and extremely expensive at present. That's a bottle every 6 days of 500 mg 99% potency caps w/ 60 to a bottle, and 5 bottles monthly.

Is anyone even selling t-res at 99% potency above 1 gram per capsule?

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#3 maxwatt

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Posted 18 April 2008 - 12:50 PM

I was just about to post this, then saw your thread.

We can conclude from this study, assuming it's accurate, that humans need much more resveratrol to achieve clinically significant results than many had hoped, at least in a relatively short time frame, and at least as regards diabetes treatment.

5 grams daily is a lot, and extremely expensive at present. That's a bottle every 6 days of 500 mg 99% potency caps w/ 60 to a bottle, and 5 bottles monthly.

Is anyone even selling t-res at 99% potency above 1 gram per capsule?


The capsule would be more than a little large. One gram would just about fit into a size "000" capsule, which is too big for a significant portion of the population to swallow without difficulty.

Using a powder can bring the cost down considerably, especially purchasing a kilogram at a time.
Powder can be taken with milk or with whey protein, which bring it into solution in a liquid. The binding is not a problem for bioavailability.
Miralax (PEG3350) an also be used as a dispersant to solublize resveratrol. This is more effective if the resveratrol is first stirred into some alcohol, Everclear or vodka or whiskey. Not for everyone. The SRT501 formulations that have been published in the Methods section in one of Sinclair's papers, all use HPMC as a dispersant in liquid. I am currently taking several grams of resveratrol at a time in half a cup of water using HPMC as a dispersant. It doesn't take much, just a smidgeon (less than 1/64th of a teaspoon, about 120 milligrams.) HPMC dissolves better in cold water. I stir it in first, then add resveratrol powder and stir.

There are different kinds of HPMC; the degree of polymeriation is indicated by a numerical suffix. HPMC 4000 is used as a thikener for low-fat salad dressing. HPMC 15 is used as a food coating, and to prevent sugar crystalization in sugar coatings. HPMC 4000 works, but I found HPMC 05 dissolves more readily than 4000. The 4000 tended to form a gel, but still worked. HPMC-05 was easier to stir in. Anthony suggested HPMC 50.

Edited by maxwatt, 18 April 2008 - 01:02 PM.


#4 Anthony_Loera

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Posted 18 April 2008 - 02:20 PM

Maxwatt,

Wow, that post contained so much good info on mixing resveratrol, in such a short post...
I consider that post a gold nugget! The only thing left out was beta-lactoglobulin in the milk as the protein that resveratrol binds to, but otherwise I would consider your post right on the mark for folks wondering what the latest info is on mixing resveratrol.

(oh yeah, that and your nice chocolate preparation) :)

A

Edited by Anthony_Loera, 18 April 2008 - 02:23 PM.


#5 Hedgehog

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Posted 18 April 2008 - 03:39 PM

At 1.25 grams given twice daily, SRT501 also showed strong trends. While not at statistical significance, SRT501 at 1.25 grams given twice per day lowered fasting and postprandial glucose, and glucose when challenged with an OGTT at the two-hour time point on day 27 of the trial as compared to the placebo group. The data suggest a dose response.
The study was designed to assess the safety, tolerability and pharmacokinetics of twice-daily, orally administered dosing of SRT501 at 2.5 and 5.0 total grams. In both patient cohorts receiving SRT501, the drug was found to be safe and well-tolerated, with no evidence of drug accumulation. The study also indicates that suitable pharmacokinetics, a measure of drug levels in the blood, was achieved.


By my calculation that is

1.25grams = ~400mg of resveratrol.
2.5grams = ~700mg resveratrol
5grams = ~1.7 grams resveratrol

I need to recheck the math but you get the idea.

Edited by Hedgehog, 18 April 2008 - 03:42 PM.


#6 malbecman

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Posted 18 April 2008 - 04:12 PM

Right, TianZi, keep in mind that Sirtris is using 5 grams per day of their 501 formulation, not 5 grams of t-res. The t-res is only a fraction of that as Hedgehog showed in his calculation. But, their formulation does help a lot in the absorption of the compound (bioavailability) which is what Maxwatt was showing with his very detailed and helpful post on the solubility of t-res.


(edit added)
Still, for anyone concerned about potential adverse effects at high doses, I think this further proves how safe t-res is in humans.


I was just about to post this, then saw your thread.

We can conclude from this study, assuming it's accurate, that humans need much more resveratrol to achieve clinically significant results than many had hoped, at least in a relatively short time frame, and at least as regards diabetes treatment.

5 grams daily is a lot, and extremely expensive at present. That's a bottle every 6 days of 500 mg 99% potency caps w/ 60 to a bottle, and 5 bottles monthly.

Is anyone even selling t-res at 99% potency above 1 gram per capsule?


Edited by malbecman, 18 April 2008 - 04:14 PM.


#7 TianZi

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Posted 18 April 2008 - 07:15 PM

I am unaware of Sirtris having disclosed the % of resveratrol per gram in their proprietary compound. Have they?

Edited by TianZi, 18 April 2008 - 07:17 PM.


#8 Hedgehog

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Posted 18 April 2008 - 08:10 PM

I am unaware of Sirtris having disclosed the % of resveratrol per gram in their proprietary compound. Have they?


IMO it is clearly stated in a patent. I have all the compounds needed to make it but it would cost a lot of money to actually formulate it. I bought a large amount and if people want to try to make it home I would be happy to give/sell you the ingrediants.

PM if you would like.

#9 TianZi

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Posted 19 April 2008 - 03:19 AM

What patent has been issued to Sirtris for this compound? You must have the patent number as published by the US PTO to have reviewed the compound's components; please post it.

#10 TianZi

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Posted 19 April 2008 - 03:28 AM

A few other things:

1. Regarding the efficacy of mixing resveratrol with shots of pure alcohol, I don't know of any human studies demonstrating improved bioavailability from this. And it's a safe bet that Sirtris is not adding any alcohol to a compound used to treat diabetes sufferers! At any rate, a shot or two of pure alcohol daily is likely to have deleterious effects on the body, over time. It's not at all like a glass or two of red wine.

2. While there is a (single) study showing increased bioavailability of resveratrol when mixed with whey, there isn't one showing increased bioavailabilty when mixed with milk, and there's reason to be concerned that casein would bind with resveratrol in a way that would decrease its bioavailability. At least, that is my understanding.

3. That Sirtris uses a two treatment per day dosing method should end, for now, the debate on these boards about whether the ideal daily dose should be taken all at once or spread out over the day. There are no posters on these boards who have the qualifications of any of the researchers at Sirtris, or at least, none have so identified themselves.

#11 Shepard

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Posted 19 April 2008 - 03:34 AM

At any rate, a shot or two of pure alcohol daily is likely to have deleterious effects on the body, over time.


Why?

3. That Sirtris uses a two treatment per day dosing method should end, for now, the debate on these boards about whether the ideal daily dose should be taken all at once or spread out over the day.


Diabetics vs. healthy people. Not the same thing.

#12 TianZi

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Posted 19 April 2008 - 04:01 AM

At any rate, a shot or two of pure alcohol daily is likely to have deleterious effects on the body, over time.


Why?

3. That Sirtris uses a two treatment per day dosing method should end, for now, the debate on these boards about whether the ideal daily dose should be taken all at once or spread out over the day.


Diabetics vs. healthy people. Not the same thing.


1. According to the US National Institute of Health, the maximum safe level of daily alcohol consumption for the average adult is 1 "drink" per day for women and men over age 65, and 2 "drinks" per day for men under the age of 65. The definition of what constitutes a "drink" is dependant on the percentage of alcohol in it. As regards spirits with a *40%* alcohol content, a "drink' is defined as 1.5 oz., a standard shot glass (although shot glasses may have a capacity up to 2.7 oz.).

There is also a significant percentage of adults who shouldn't consume any alcohol due to special health concerns.

Drinking a single straight shot of 100% alcohol daily will place you over the limit for safe alcohol consumption.

2. Yes, they are diabetics. Your point? Show me a human study conducted by Sirtris or anyone else reputable that included alcohol in the resveratrol compound. To my knowledge, there have been no human studies conducted using resveratrol in conjunction with alcohol.

Edited by TianZi, 19 April 2008 - 04:03 AM.


#13 niner

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Posted 19 April 2008 - 04:33 AM

1. Regarding the efficacy of mixing resveratrol with shots of pure alcohol, I don't know of any human studies demonstrating improved bioavailability from this. And it's a safe bet that Sirtris is not adding any alcohol to a compound used to treat diabetes sufferers! At any rate, a shot or two of pure alcohol daily is likely to have deleterious effects on the body, over time. It's not at all like a glass or two of red wine.

Studies? We don't need no Steenkin' Studies! (We do know that micronization improves the bioavailability of resveratrol, and since we're using ethanol with an antisolvent as a micronization method, this scheme is not entirely baseless.)

2. While there is a (single) study showing increased bioavailability of resveratrol when mixed with whey, there isn't one showing increased bioavailability when mixed with milk, and there's reason to be concerned that casein would bind with resveratrol in a way that would decrease its bioavailability. At least, that is my understanding.

I should let Maxwatt answer this, but I'm here, so... Casein binding of polyphenols is apparently largely a function of gallate groups, which would be a potential problem with EGCG, but since resveratrol doesn't have any, this shouldn't be a problem.

3. That Sirtris uses a two treatment per day dosing method should end, for now, the debate on these boards about whether the ideal daily dose should be taken all at once or spread out over the day. There are no posters on these boards who have the qualifications of any of the researchers at Sirtris, or at least, none have so identified themselves.

In this post, I presented an analysis of Boocock's data which suggests that the largest AUC (Area Under the plasma concentration/time Curve) per gram of resveratrol will occur with doses in the vicinity of 1 - 1.5 gram. The more resveratrol you take at a time, the higher your plasma concentrations will be, but if you are interested in the most efficient use, and you are taking very large doses, you might want to go with multiple doses. This would not be the case if you were taking a total dose of less than about a gram and a half. In that case, I would just take it all at once. Sirtris has experimented with both one and two per day dosing schedules.

As for the qualifications of posters on this forum, there are some here with PhDs in relevant fields and with experience in the pharmaceutical industry, including more than one person who has been personally involved in the development of formulations, so I think as a group we have some significant expertise. We just don't brag about it.

#14 niner

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Posted 19 April 2008 - 04:41 AM

1. According to the US National Institute of Health, the maximum safe level of daily alcohol consumption for the average adult is 1 "drink" per day for women and men over age 65, and 2 "drinks" per day for men under the age of 65. The definition of what constitutes a "drink" is dependant on the percentage of alcohol in it. As regards spirits with a *40%* alcohol content, a "drink' is defined as 1.5 oz., a standard shot glass (although shot glasses may have a capacity up to 2.7 oz.).

We aren't using all that much alcohol. I was using 25-30 cc of 95% ethanol, so in terms of alcohol content, this is less than 2 "drinks".

There is also a significant percentage of adults who shouldn't consume any alcohol due to special health concerns.

Yeah, some of us don't want to drink that much even if it's technically Ok. We've been looking at other formulations.

#15 Shepard

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Posted 19 April 2008 - 05:57 AM

1. According to the US National Institute of Health, the maximum safe level of daily alcohol consumption for the average adult is 1 "drink" per day for women and men over age 65, and 2 "drinks" per day for men under the age of 65.


A shot of Everclear (1.5 ounces) is right around 40g of ethanol if my math is right.

40 grams doesn't seem so bad:

http://www.nature.co...l/1601459a.html
http://www.ncbi.nlm....Pubmed_RVDocSum
http://www.ncbi.nlm....Pubmed_RVDocSum


2. Yes, they are diabetics. Your point?


Controlling the effects of diabetes as far as glucose/insulin fluctuations are concerned is a completely different ballgame than a longevity perspective. The same approach might be appropriate, might not be. To assume it is just because a pharmaceutical company designed their trial that way is shortsighted.

#16 TianZi

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Posted 19 April 2008 - 06:15 AM

1. According to the US National Institute of Health, the maximum safe level of daily alcohol consumption for the average adult is 1 "drink" per day for women and men over age 65, and 2 "drinks" per day for men under the age of 65.


A shot of Everclear (1.5 ounces) is right around 40g of ethanol if my math is right.

40 grams doesn't seem so bad:

http://www.nature.co...l/1601459a.html
http://www.ncbi.nlm....Pubmed_RVDocSum
http://www.ncbi.nlm....Pubmed_RVDocSum


2. Yes, they are diabetics. Your point?


Controlling the effects of diabetes as far as glucose/insulin fluctuations are concerned is a completely different ballgame than a longevity perspective. The same approach might be appropriate, might not be. To assume it is just because a pharmaceutical company designed their trial that way is shortsighted.


Again as regards alcohol consumption, I'll simply refer to the NIH guidelines, and leave it at that.

My point is not that alcohol can't improve bioavailability of resveratrol--it is simply that there have been no human trials demonstrating this (to my knowledge). And where resveratrol in almost any amount you'd be likely to consume seems completely safe for anyone (to date), this certainly isn't true of alcohol.

I believe human trials for diseases other than diabetes will be underway soon, if they aren't already (?). It will be instructive to see if alcohol is added to the mixture in such studies. Shall we bet that it won't be?

#17 Hedgehog

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Posted 19 April 2008 - 06:30 AM

1. According to the US National Institute of Health, the maximum safe level of daily alcohol consumption for the average adult is 1 "drink" per day for women and men over age 65, and 2 "drinks" per day for men under the age of 65.


A shot of Everclear (1.5 ounces) is right around 40g of ethanol if my math is right.

40 grams doesn't seem so bad:

http://www.nature.co...l/1601459a.html
http://www.ncbi.nlm....Pubmed_RVDocSum
http://www.ncbi.nlm....Pubmed_RVDocSum


2. Yes, they are diabetics. Your point?


Controlling the effects of diabetes as far as glucose/insulin fluctuations are concerned is a completely different ballgame than a longevity perspective. The same approach might be appropriate, might not be. To assume it is just because a pharmaceutical company designed their trial that way is shortsighted.


Again as regards alcohol consumption, I'll simply refer to the NIH guidelines, and leave it at that.

My point is not that alcohol can't improve bioavailability of resveratrol--it is simply that there have been no human trials demonstrating this (to my knowledge). And where resveratrol in almost any amount you'd be likely to consume seems completely safe for anyone (to date), this certainly isn't true of alcohol.

I believe human trials for diseases other than diabetes will be underway soon, if they aren't already (?). It will be instructive to see if alcohol is added to the mixture in such studies. Shall we bet that it won't be?


Why would Alcohol been in the protocol? Their formulation already separates resveratrol on a molecule to molecule basis (you can't get better then this). There is no need to add OH to the clinical trial it might actually hurt their formulation. Adding OH will give you a quick plasma spike just like SRT501 probably not as good but pretty freaking close. It all a numbers game....

#18 graatch

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Posted 19 April 2008 - 12:35 PM

1. According to the US National Institute of Health, the maximum safe level of daily alcohol consumption for the average adult is 1 "drink" per day for women and men over age 65, and 2 "drinks" per day for men under the age of 65.


You won't go far simply taking the word of these conservative organizations.

Up to 3 "drinks" daily presents no health issues on average.

Beyond that there is deleterious effects.

I wouldn't call it "unsafe".

Edited by graatch, 19 April 2008 - 12:36 PM.


#19 Mind

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Posted 19 April 2008 - 02:59 PM

5 grams per day resveratrol! What about the side effects? Some users of high doses are reporting Achilles tendonitis. I think we have a thread about it here at Imminst.

#20 maxwatt

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Posted 19 April 2008 - 03:06 PM

5 grams per day resveratrol! What about the side effects? Some users of high doses are reporting Achilles tendonitis. I think we have a thread about it here at Imminst.


I believe at least some of those posters later decided their tendinitis was dut to other causes. If such effects had appeared in Siritris' trials, I would think thy would have been reported.

#21 stephen_b

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Posted 19 April 2008 - 04:18 PM

5 grams per day resveratrol!

That's 5 grams a day of SRT-501, which Hedgehog thinks would be about 1.7 grams of transresveratrol, taken in two doses of 0.85 grams. For my 99% powder, that's about 3/8 teaspoon twice daily, quite doable IMO.

I'm starting to move away from using the alcohol. I just mix the t-res into dissolved soy lecithin and then put whey into that. It seems to me that you can just take a little more resveratrol (perhaps 25%, just a guess, would be nice to have firmer numbers) to make up for the slightly smaller particle size with ethanol.

Stephen

#22 s'Jon Piranha

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Posted 27 April 2008 - 06:50 PM

Forgive me for being so new, but I work in Animal Research.

Anyway, one of the studies I am directly involved with includes a 1-shot oral dose cure for Type 2 diabetes. And I mean "cure" in the full sense of the word. To date, 46 out of 47 pigs given the dose were cured (one died of pneumonia within 1 hour of the dose being given, so we believe that is an outliar), and 4 out of 4 macak monkeys have been cured. We are currently focusing on getting away from pigs (because they are so unclean) and focusing on NHPs, who can be equally unclean, but easier to put into a metabolic chamber to limit their access to their own feces, etc.

The dose given is about 40ml, injected directly into the stomach of the animal, usually through endoscopy.

I post this news here because someone was mentioning alcohol interference with diabetics, in regards to taking resveratrol. I expect this drug will move to human studies within 5 years.


Best wishes,
s'Jon

#23 Hedgehog

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Posted 27 April 2008 - 10:22 PM

Forgive me for being so new, but I work in Animal Research.

Anyway, one of the studies I am directly involved with includes a 1-shot oral dose cure for Type 2 diabetes. And I mean "cure" in the full sense of the word. To date, 46 out of 47 pigs given the dose were cured (one died of pneumonia within 1 hour of the dose being given, so we believe that is an outliar), and 4 out of 4 macak monkeys have been cured. We are currently focusing on getting away from pigs (because they are so unclean) and focusing on NHPs, who can be equally unclean, but easier to put into a metabolic chamber to limit their access to their own feces, etc.

The dose given is about 40ml, injected directly into the stomach of the animal, usually through endoscopy.

I post this news here because someone was mentioning alcohol interference with diabetics, in regards to taking resveratrol. I expect this drug will move to human studies within 5 years.


Best wishes,
s'Jon


Can you be more specific when you mean "cure". What is the mechanism of action. I think resveratrol just helps in opening the gateway for glucose uptake. Best of luck.

#24 Hedgehog

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Posted 28 April 2008 - 02:41 AM

5 grams per day resveratrol!

That's 5 grams a day of SRT-501, which Hedgehog thinks would be about 1.7 grams of transresveratrol, taken in two doses of 0.85 grams. For my 99% powder, that's about 3/8 teaspoon twice daily, quite doable IMO.

I'm starting to move away from using the alcohol. I just mix the t-res into dissolved soy lecithin and then put whey into that. It seems to me that you can just take a little more resveratrol (perhaps 25%, just a guess, would be nice to have firmer numbers) to make up for the slightly smaller particle size with ethanol.

Stephen


Hey Stephen,

In the clinical trial they are trying to help w/ diabetes. Resveratrol seems to target many different proteins. One of which it inhibits in the very low nM range. It may take more or less depending on what effects we want to achieve. Maybe diabetes only needs 1gram of resveratrol to be effective.... maybe cancer needs 5grams... Life span????

#25 niner

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Posted 28 April 2008 - 03:19 AM

Forgive me for being so new, but I work in Animal Research.

Anyway, one of the studies I am directly involved with includes a 1-shot oral dose cure for Type 2 diabetes. And I mean "cure" in the full sense of the word. To date, 46 out of 47 pigs given the dose were cured (one died of pneumonia within 1 hour of the dose being given, so we believe that is an outliar), and 4 out of 4 macak monkeys have been cured. We are currently focusing on getting away from pigs (because they are so unclean) and focusing on NHPs, who can be equally unclean, but easier to put into a metabolic chamber to limit their access to their own feces, etc.

The dose given is about 40ml, injected directly into the stomach of the animal, usually through endoscopy.

I post this news here because someone was mentioning alcohol interference with diabetics, in regards to taking resveratrol. I expect this drug will move to human studies within 5 years.


Best wishes,
s'Jon

hey s'Jon P, thanks for posting. This is kind of huge, should it pan out... Is there any possible mechanistic connection between the drug and the pheumonia? Like was it an anaphylactic reaction or somesuch, or was the pig sick before hand? I'd tend to think the former... Anyway, pretty major thing. Is this big pharma or biotech/startup?

#26 inawe

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Posted 28 April 2008 - 03:36 PM

Anyway, one of the studies I am directly involved with includes a 1-shot oral dose cure for Type 2 diabetes. And I mean "cure" in the full sense of the word. To date, 46 out of 47 pigs given the dose were cured (one died of pneumonia within 1 hour of the dose being given, so we believe that is an outliar), and 4 out of 4 macak monkeys have been cured. We are currently focusing on getting away from pigs (because they are so unclean) and focusing on NHPs, who can be equally unclean, but easier to put into a metabolic chamber to limit their access to their own feces, etc.

The dose given is about 40ml, injected directly into the stomach of the animal, usually through endoscopy.
Best wishes,
s'Jon

Is this a stand-alone, conventional type of drug; or is it an autologous process?

#27 s'Jon Piranha

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Posted 28 April 2008 - 07:53 PM

Hedgehog: I can't really talk about the specifics of it, I'm sure you understand why.

Niner: Actually we think it was the latter - specifically that the farm the pig came from (Country Valley Farms, I think) had a small occurance with pneumonia. Usually we keep our animals for a couple weeks of observation, but in recent months we've been sidestepping that by keeping animals from different farms/sources in different rooms. So to clarify, we think the pig had pneumonia when it arrived at our facility. We have seen two others since with the same thing, but never did the procedure on them, so as to not mess up our results. And as to your second question, it's none of those - University research. *Although* I would expect that our PI might go the way of startup or just plain old selling out should things continue to go so well. We'll see.

Inawe: The islet cells involved are harvested from another pig's pancreas, then mixed with our drug, and then the concoction injected into the stomach of the Type 2 pig. The reversal of diabetes is usually within 12 hours after the injection. We've seen as soon as 8 hours, and as late as 19 hours.

#28 inawe

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Posted 28 April 2008 - 08:15 PM

Inawe: The islet cells involved are harvested from another pig's pancreas, then mixed with our drug, and then the concoction injected into the stomach of the Type 2 pig. The reversal of diabetes is usually within 12 hours after the injection. We've seen as soon as 8 hours, and as late as 19 hours.

So it doesn't have to be autologous. For humans you can develop lines
of stem cells that differentiate into islet cells. Then you mix it
with your drug.
It's about the most exciting thing I heard in a long
time.

#29 jmcarvas

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Posted 02 May 2008 - 10:46 PM

I was just about to post this, then saw your thread.

We can conclude from this study, assuming it's accurate, that humans need much more resveratrol to achieve clinically significant results than many had hoped, at least in a relatively short time frame, and at least as regards diabetes treatment.

5 grams daily is a lot, and extremely expensive at present. That's a bottle every 6 days of 500 mg 99% potency caps w/ 60 to a bottle, and 5 bottles monthly.

Is anyone even selling t-res at 99% potency above 1 gram per capsule?


The capsule would be more than a little large. One gram would just about fit into a size "000" capsule, which is too big for a significant portion of the population to swallow without difficulty.

Using a powder can bring the cost down considerably, especially purchasing a kilogram at a time.
Powder can be taken with milk or with whey protein, which bring it into solution in a liquid. The binding is not a problem for bioavailability.
Miralax (PEG3350) an also be used as a dispersant to solublize resveratrol. This is more effective if the resveratrol is first stirred into some alcohol, Everclear or vodka or whiskey. Not for everyone. The SRT501 formulations that have been published in the Methods section in one of Sinclair's papers, all use HPMC as a dispersant in liquid. I am currently taking several grams of resveratrol at a time in half a cup of water using HPMC as a dispersant. It doesn't take much, just a smidgeon (less than 1/64th of a teaspoon, about 120 milligrams.) HPMC dissolves better in cold water. I stir it in first, then add resveratrol powder and stir.

There are different kinds of HPMC; the degree of polymeriation is indicated by a numerical suffix. HPMC 4000 is used as a thikener for low-fat salad dressing. HPMC 15 is used as a food coating, and to prevent sugar crystalization in sugar coatings. HPMC 4000 works, but I found HPMC 05 dissolves more readily than 4000. The 4000 tended to form a gel, but still worked. HPMC-05 was easier to stir in. Anthony suggested HPMC 50.



You guys are all demented! You have no clue of what is scientific reasearch or how to interpret a scientif article. You can not distinguish between science and a money making company like Sirtris. Just stop for one moment and THINK!!! Do not take the word of the people directly involved in the business....

Informative note: I buy resveratrol from Sigma for my experiments. That I'm sure it is 99% pure. It has an usable life of 1 year and it has to be kept at -20°C. The lab pays 100Euros for 100mg!!

Click HERE to rent this advertising spot to support LongeCity (this will replace the google ad above).

#30 niner

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Posted 03 May 2008 - 01:46 AM

You guys are all demented! You have no clue of what is scientific reasearch or how to interpret a scientif article. You can not distinguish between science and a money making company like Sirtris. Just stop for one moment and THINK!!! Do not take the word of the people directly involved in the business....

Informative note: I buy resveratrol from Sigma for my experiments. That I'm sure it is 99% pure. It has an usable life of 1 year and it has to be kept at -20°C. The lab pays 100Euros for 100mg!!

I have some very high purity resveratrol that has a usable life in excess of a year, and can be stored at room temperature. Because you are an imminst poster, I will sell you 10 grams for a mere 5000 Euros. This is HALF what you are paying now, for a superior product! Just PM me if you want to make a deal. Warning: I am demented.




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