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Oops...better not let the FDA get ahold of this...they'll shut er down!
The company, which was previously known as Star Scientific, had been marketing its Anatabloc product for the treatment of ulcerative colitis, multiple sclerosis, and Alzheimer’s disease. A Nov. 17th presentation by Megha Varma will address the “Effects of anatabine on Alzheimer’s disease (AD) like pathology, neuroinflammation and behavior in transgenic mouse model of AD.”
Roskamp makes breakthrough in Alzheimer's research
http://www.bradenton.com/2014/10/29/5440603/roskamp-makes-breakthrough-in.html
By RICHARD DYMOND
rdymond@bradenton.comOctober 29, 2014
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MANATEE -- It's just one of scores of molecules that talk to each other in the human brain, helping make the brain one of the most complex and efficient structures in the universe.
But scientists at the Roskamp Institute in Manatee/Sarasota have honed in on one of these "intelligent" molecules called the SYK protein and discovered that, along with its other roles in the brain, it involves itself in three of the main problems that cause Alzheimer's disease.
"This molecule was known before," medical genetics scientist Dr. Fiona Crawford, of the Roskamp Institute, said Tuesday. "But it wasn't known that it was involved in inflammation, accumulation of amyloid protein, and modulation of the 'tau' protein -- all of which are responsible for damage to the brain's nerve cells."
When word got out Tuesday of Roskamp's discovery about the SYK protein,
the phone at the nonprofit biomedical research facility, which specializes in Alzheimer's research, started ringing.
The discovery could mean a cure for Alzheimer's is on the horizon, Crawford added.
"Absolutely, this could lead to a cure," Crawford said. "Now, we need lots of people exploring. What is exciting here is that in contrast to previous approaches that target one symptom, this tackles all three. We hope that other scientists out there will now say to themselves, 'I wonder if I have something in my toolbox that can hit that therapeutic target and be safe.'"
The finding is the result of more than 10 years of work by more than a dozen scientists and clinicians on the research team here. Alzheimer's has been the subject of intensive research for more than 20 years.
"We've been working on this a long time, but we just submitted the data at the end of August," said Crawford, referring to a paper published Oct. 20 in the online edition of the Journal of Biological Chemistry (www.jbc.org).
The full study is set to be published in the December edition of Journal of Biological Chemistry.
"These studies suggest there is a single drug target to inhibit all the three key pathologies of Alzheimer's disease," says neurobiologist Daniel Paris, lead researcher for the study.
The discovery stemmed from work at Roskamp with a drug called Nilvadipine that is used to treat high blood pressure in Europe and Japan, Crawford said.
In working out how the drug works to reduce amyloid protein accumulations, Roskamp researchers realized the drug also had positive effects on neuroinflammation and the tau protein. The scientists retraced the molecular steps leading to these three factors and discovered they all led back to the SYK protein.
Paris then went on to show that drugs blocking SYK activity in the brain could represent a new strategy for treating Alzheimer's.
Alzheimer's is the most prevalent form of dementia in the elderly. Currently, the disease affects 5.2 million Americans, or 1 in 9 adults over the age of 65.
"Our studies have revealed that the spleen tyrosine kinase (SYK) enzyme is at a crossroad from which all three of the brain abnormalities known to be associated with Alzheimer's disease diverge," said Dr. Michael Mullan, senior author of the study. "Hopefully, academic or industry researchers can now develop new drugs to inhibit SYK which are suitable for clinical trials in Alzheimer's disease."
Richard Dymond, Herald reporter, can be reached at 941-745-7072 or contact him via Twitter@RichardDymond.
Read more here: http://www.bradenton.com/2014/10/29/5440603/roskamp-makes-breakthrough-in.html#storylink=cpy
A search on "Roskamp" at the upcoming Neuroscience Conference Web page turns up the following:
Presentation Session
Sat, Nov 15, 1:00 - 5:00 PM
41.07/D32 - Beneficial effects of anatabine in a mouse model of tauopathy
*D. PARIS1, D. BEAULIEU-ABDELAHAD1, G. AIT-GHEZALA1, V. MATHURA1, M. VERMA1, A. E. ROHER2, F. CRAWFORD1, M. MULLAN1,3;
1Roskamp Inst., SARASOTA, FL; 2The Longtine Ctr. for Neurodegenerative Biochem., Banner Sun Hlth. Res. Inst., Sun City, AZ; 3Rock Creek Pharmaceuticals, Sarasota, FL Poster
041. Alzheimer's Disease: Tau Animal Models
Sat, Nov 15, 1:00 - 5:00 PM
Sun, Nov 16, 8:00 AM - 12:00 PM
134.12/E11 - Dissecting the critical period of estrogen replacement therapy: Brain proteomic analysis
*J. CUI, J. REED, G. CRYNEN, F. CRAWFORD, R. LI;
Roskamp Inst., Sarasota, FL Poster
134. Alzheimer's Disease: APP Abeta In vivo Models I
Sun, Nov 16, 8:00 AM - 12:00 PM
Sun, Nov 16, 8:00 AM - 12:00 PM
135.15/G12 - Thalidomide regulates cerebral vessel normalization through a specific signal transduction in a mouse model of Alzheimer’s disease
*H. YAO1, P. HE1, R. LI2, Y. SHEN1;
1Ctr. for Advanced Therapeut. Strategies for Brain Disorders, 2Ctr. for Hormone Advanced Sci. and Educ., Roskamp Inst., SARASOTA, FL Poster
135. Alzheimer's Disease: Experimental Therapeutics II
Sun, Nov 16, 8:00 AM - 12:00 PM
Mon, Nov 17, 8:00 AM - 12:00 PM
307.17/D63 - Effects of anatabine on Alzheimer's disease (AD) like pathology, neuroinflammation and behavior in a transgenic mouse model of AD
*M. VERMA;
Roskamp Inst., Sarasota, FL Poster
307. Alzheimer's Disease: APP Abeta Tau Interactions I
Mon, Nov 17, 8:00 AM - 12:00 PM
Mon, Nov 17, 8:00 AM - 12:00 PM
371.07/VV53 - Proteomic profiling of the cns in a mouse model of pyridostigmine bromide and permethrin exposure reveals mitochondrial dysfunction
*Z. ZAKIROVA1,2,3, M. TWEED1,2,3, J. REED1,3, G. CRYNEN1,2, A. HART1, P. VALLABHANENI1, F. CRAWFORD1,2,3, M. MULLAN1,3, V. MATHURA1,2, G. AIT-GHEZALA1,2,3;
1Roskamp Inst., Sarasota, FL; 2The Open Univ., Milton Keynes, Buckinghamshire, United Kingdom; 3James A. Haley Veteran’s Hosp., Tampa, FL Poster
371. Bioinformatics
Mon, Nov 17, 8:00 AM - 12:00 PM
Mon, Nov 17, 1:00 - 5:00 PM
408.13/H10 - Influence of ApoE on LRP1 function
*B. SHACKLETON, F. CRAWFORD, C. BACHMEIER;
Roskamp Inst., Sarasota, FL Poster
408. Alzheimer's Disease: APOE and Cholesterol
Mon, Nov 17, 1:00 - 5:00 PM
Mon, Nov 17, 1:00 - 5:00 PM
423.03/Y28 - Omic approaches identify lipid disturbances in mice exposed to Gulf War agents at a chronic 16 months post-exposure time-point
*L. ABDULLAH1,2, J. EVANS1, J. REED1, G. CRYNEN1, H. MONTAGUE1, A. GONZALEZ1, M. CROCKER1, S. BAUMANN3, Z. ZAKIRVA1, T. EMMERICH1, R. PELOT1, G. AIT-GHEZALA1,2, M. MULLAN1, F. CRAWFORD1,2;
1Roskamp Inst., SARASOTA, FL; 2James A. Haley VA Hosp., Tampa, FL; 3Agilent Technologies, Santa Clara, CA Poster
423. Nerve Agents and Warfare Illness
Mon, Nov 17, 1:00 - 5:00 PM
Tue, Nov 18, 8:30 - 8:45 AM
483.03 - Proteomic analyses reveal altered hippocampal protein expression in a rat model of Alzheimer’s disease
*S. DO CARMO1, G. CRYNEN2, A. DUCATENZEILER1, F. CRAWFORD2, A. CUELLO1;
1Pharmacol. and Therapeut., McGill Univ., Montreal, QC, Canada; 2Roskamp Inst., Sarasota, FL Nanosymposium
483. Modeling APP and Abeta Pathology in Animals
Tue, Nov 18, 8:00 - 10:15 AM
Tue, Nov 18, 8:15 - 8:30 AM
486.02 - Delayed treatment with Anatabine after repetitive mild TBI normalizes spatial memory impairment
*S. FERGUSON1,2, B. MOUZON1,2, L. ABDULLAH1,2, G. CRYNEN1, V. MATHURA1, M. MULLAN1,2, F. CRAWFORD1,2;
1Roskamp Inst., Sarasota, FL; 2James A Haley Veteran's Hosp., Tampa, FL Nanosymposium
486. Traumatic Brain Injury: Therapeutic Strategies I
Tue, Nov 18, 8:00 - 11:30 AM
Tue, Nov 18, 10:45 - 11:00 AM
486.12 - Microglia polarization dynamics in a mouse model of single and repetitive mtbi
*B. C. MOUZON1,2, G. AIT-GHEZALA1,2, O. OJO1, C. BACHMEIER1,2, S. FERGUSON1,2, M. MULLAN1, F. CRAWFORD1,2;
1The Roskamp Inst., Sarasota, FL; 2James A. Haley Veterans Hosp., Tampa, FL Nanosymposium
486. Traumatic Brain Injury: Therapeutic Strategies I
Tue, Nov 18, 8:00 - 11:30 AM
Wed, Nov 19, 8:00 AM - 12:00 PM
703.20/S4 - Omic profiling identifies distinct genetic, protein and lipid biomarker profiles correlating with MRI in military service members with TBI and PTSD
*T. E. EMMERICH1,2,3, F. CRAWFORD1,2,3, L. ABDULLAH1,3, J. EVANS1,3, G. CRYNEN1,2, A. HART1, A. GONZALEZ1, T. DENNEYJR.4, J. ROBINSON4, J. KATZ4, G. DESHPANDE4, M. DRETSCH5,6, J. REED1,3, M. MULLAN1,3,2;
1Roskamp Inst., Sarasota, FL; 2The Open Univ., Milton Keynes, United Kingdom; 3James A. Haley Veterans’ Hosp., Tampa, FL; 4AU MRI Res. Ctr., Auburn, AL; 5Natl. Intrepid Ctr. of Excellence, Bethesda, MD; 6US Army Aeromedical Res. Lab., Fort Rucker, AL Poster
703. Traumatic Brain Injury: Human Studies
Wed, Nov 19, 8:00 AM - 12:00 PM
Wed, Nov 19, 1:00 - 5:00 PM
788.15/D4 - Temporal sequence of TBI-dependent post translational modifications of Tau in a mouse model of concussion
*R. C. PELOT1,2,3, J. REED1,3, G. CRYNEN1,2, C. BACHMEIER1,2,3, J. EVANS1, L. ABDULLAH1, F. CRAWFORD1,2,3;
1Roskamp Inst., Bradenton, FL; 2The Open Univ., Milton Keynes, United Kingdom; 3The Veteran's Admin., Tampa, FL Poster
788. Alzheimer's Disease: Tau Biochemistry
Wed, Nov 19, 1:00 - 5:00 PM
Wed, Nov 19, 1:00 - 5:00 PM
789.20/D33 - Exploiting the pathogenic inter-relationship between TBI and AD in mouse models using proteomic and lipidomic technology
*J. O. OJO1, J. M. REED1, J. EVANS1, G. CRYNEN1, L. ABDULLAH1, M. MULLAN1, F. CRAWFORD1,2;
1The Roskamp Inst., Sarasota, FL; 2James A Haley Veterans' Hosp., Tampa, FL Poster
789. Alzheimer's Disease: APP Abeta In Vivo Models II
Wed, Nov 19, 1:00 - 5:00 PM
Wed, Nov 19, 1:00 - 5:00 PM
792.03/F5 - Mitigation of tau pathology with CD40 receptor deficiency in a mouse model of neurodegeneration
*M. TWEED1,2,3, Z. ZAKIROVA1,2,3, D. PARIS1,2,3, F. CRAWFORD1,2,3, M. MULLAN1, G. AIT-GHEZALA1,2,3;
1Roskamp Inst., Sarasota, FL; 2The Open Univ., Milton Keynes, United Kingdom; 3James A. Haley Veterans' Hosp., Tampa, FL Poster
792. Alzheimer's Disease: Tauopathy
Wed, Nov 19, 1:00
Interesting. You can download full article...then do "word search" on article. Anatabine appears a few times in notes 37 and 42 in the article.
Yes, was thinking the same thing. Seems the big question is "how much more effective/"safe" is Anatabine vs. others, including nivaldipine, at disrupting/targeting the single enzyme, syk." The concerning thing is that it appears that Anatabine perhaps is not completely unique in that other compounds can be effective as well. On the other hand, it is interesting that RCPI/Roskamp are choosing to present on all of these topics at upcoming conference based on their testing with Anatabine, not some other compound (including nilvadipine).
Thanks to the "court reporters" and all the great input here! EOM
Purely procedural paperwork. RCPI removed Anatabloc from retail availability so the FDA no longer has an immediate issue with them.
Great post...thanks! Enjoyed hearing Dr. Crawford speak.
I agree that NukeJohn posts usually ring "hollow" for me...usually filled with often repeated hyperbole. IMO, he did make a good observation about the potential for RCPI to NOT be delisted from NASDAQ based on new, more lenient requirements (potentially getting a 180 day extension even being below $1/per share). I would also question your position that "luck" plays a huge role in whether or not RCPI is successful. Sure, some luck is needed and appreciated, but if their science proves valid, then considerably less "luck" will be required. More of concern to me is the protection/defensibility of their patents and the ultimate effectiveness of their IND for the treatments that they are applying for...so it will either be wildly effective, midly effective, or not effective...and/or somewhere in between. Then you factor in $ and time required to get to these conclusions recognized by the FDA/Europe, and ultimately the public.
Joe Namath speaking on TBI and treatments (he's pushing some kind of therapy) on CNBC....
There are alot of prescribing doctors out there than can't spell worth a damn. I figure the same might be expected of a cross section of Anatabloc users.
I signed it...but chose not to have my name published. Thought they would have published my "comments" but did not see them.
Completing additional pre-clinical studies by November, 2014.
Presentation mentions this as means of addressing FDA questions on IND filing. Wonder what they are studying?...my guess, and only a guess, is that perhaps it is related to time release. Would like to see others' speculation on this...
Would be great to hear his presentation...if for no other reason, to see/hear how Dr. Mullan boils his presentation down to 9 minutes...which I believe is all the time he gets. What he emphasizes as being most critical...and what new, if anything, will be revealed. Any other time I have seen videos of him presenting the case for Abloc, presentation is much more lengthy.
2 bottles of Anatabloc just went for $292 on eBay. I think there are a few people who believe this stuff works!
Watched the bidding go up all day long...
You didn't ask me, but I will weigh in...
I take it more for as longterm health maintenance than anything else...
I have had a CT scan of heart with fantastic results of vascular health, great cholesterol readings, etc. all since being on Anatabloc regularly for several years.
Dr. Mullan has 9 minutes to present at BioPharm Conference...
He is going to need to be very, very succint in his presentation, to say the least!
Next Generation | 11:10 am, Wednesday, September 24 | Level 3 | Room Suffolk
Not much volume...so I really don't believe alot of accumulation going on. As one retail investor, I HAVE been buying. ~ 10K shares per day over last few days. Good news I suppose that long time holders are not selling...but I am a bit surprised that people are not buying more at these levels. You really have to "hold your nose" on the price/share and buy to bring the avg cost down. I am sympathetic with those that no longer have more to give...but if you believe in the long term story, it's damn cheap if your expectations are that they will ultimately make it to trials in US and/or Europe...hopefully both...and with at least some partner backing. As long as the stuff works (and we KNOW it DOES) and those who are currently running the show lose significantly with a bunkruptcy declaration, why else who but a manipulater (aka the shorts and naked shorts) would be selling at this juncture?
Ah yes...the old de-listing warning. Right out of the basic playbook. Seriously, don't think contemplation even comes into play prior to Phase 1 go forward in USA and/or approval in Europe to move into trials...
Am I the only one still buying here? Yes, I am way under...but have my major holdings down to 1.15 avg cost. I certainly understand that many are "tapped out" but still will not sell down here as believers in the company. But at this price, if you still believe in management and the potential, a great way to bring avg cost down.
Frankly, I cannot imagine much additional "bad news" to come out...the only thing I can imagine is additional lawsuits...but to me, RCPI has reasonable justification for claiming that they were entitled to sell the neutraceutical in the first place (at least in a court of law).
Yes, read through that. Mostly a bunch of beuracratic "junk" that suggests more study is required. In the "real world" it comes down to can/will the FDA look unfavorably upon RCPI for making the product available under a "compassionate use" justification?...I would think that they indeed WOULD look unfavorably upon this...and as long as FDA is necessary for approvals into the various stages of IND progress in USA, I suspect RCPI will elect not to even touch such a justification.
The baseball analogy would be Pete Rose...he may not have bet on baseball since his banishment, but hanging out in casinos (and admitting that he did bet on the Reds to win) since his banishment has hurt his case for reinstatement.
BTW, have not seen anyone claim that Anatabloc is "life saving" with alternatives being unavailable.
That said, I am plenty upset that I will run out of Abloc and will not have accesss to it. I credit it for my healthier heart stats and low cholesterol.
Much up in the air. Which is understandable, under the current circumstances. Interesting to me,
RCPI now giving themselves until end of year to file for European IND?...originally, this was by end of Q3. So, is RCPI keeping its options open since the FDA has not provided approval yet for first condition treatment phase 1? That would be my guess. Perhaps you go for Osteoarthritis now in Europe?
Thoughts?
And, what is the hope for strategy on neutraceutical by end of year?...are they just buying time, or is this still a possibility for pursuit in Europe...or somehow still here in US?
Thoughts?
Upcoming BioPharm Conference - The Fierce 15
Wonder if there is any chance at all that RCPI might receive Fierce 15 designation?
<<A major draw to precede Monday's Keynote address is the live announcement of the Fierce 15 by John Carroll, Editor-in-Chief of FierceBiotech. The Fierce 15 is a hunt that involves the biggest ideas in biotech, the most daring characters in biopharma, and entrepreneurs doing things that haven't been done before. The result is fifteen privately held drug developers or platform biotechs with the potential to have a huge impact on the treatment of human diseases. A LIVE Stream announcement of the Fierce 15 will take place during BioPharm America™ 2014 on partnering360:Insight LIVE on September 22, 2014 at 10:45 am EST.>>
I am buying (stock) today. Ultimately, while I am concerned in the short term as a loyal Abloc user, I consider this a potential step forward as resolution/progress for shareholders.
"The letter of the law"...
Is sometimes used as an excuse to hide "inconveniences". RCPI has argued, I believe credibly, that they WERE following the letter of the law with respect to anatabine being an ingredient that they could lawfully sell as a neutraceutical. So the FDA disagreed, OK.
BTW, there are many instances of the "letter of the law" not being followed...check immigration for instance. Oh well, another "inconvenience" for the one who is supposed to be the chief enforcer of our laws.
Well, perhaps this will ultimately make RCPI "more richer" or perhaps just the grammatically correct, "richer".
FDA in essence stating...
We are going to further punish you, RCPI, by not approving your initial drug application because the stats that you reference for safety were gained from selling your "drug" as a neutraceutical. Even though the evidence of safety far exceeds that of other new drug applications that we regularly approve. Because our process and interests (especially those of our big drug company benefactors) trump anything related to consumer interests and safety.
Clinical Trial Application in Europe in 4 months?
Originally it was by end of September. Wonder if this "ruling" by FDA is causing RCPI to rethink its strategy for which treatment to pursue first as explanation for this delay. Now, general inflammation treatment may be best target if you consider that neutraceutical is off the market...?
And maybe, a European strategy for neutraceutical.
BTW, if ever there was a question of FDA being in big pharma back pocket, it is now answered.
I seriously doubt that it is "over". Not when people are looking at jail time. Would expect appeals, etc. that will likely keep this in the news...at least until the press can catch a glimpse of former governor and his wife in handcuffs and/or orange jumpsuits.
I suppose the "good news" is that JW came across with some credibility...and more importantly, that the people coming after governor politically got what they wanted. Maybe that allows RCPI/JW to fall into the background more than be the case otherwise.
BTW, I don't think referencing Anatabloc "miracle articles" from almost 3 years ago does anybody on the long side good at this point in the game. Not to be overly critical, because I believe your intent is good, but your continuing refrain of "big pharma lining up" and all that repeatedly weakens the Long argument. And BTW, I am Long and holding.
Yep. Specifically, in this exerpt from the AP article, wonder who the FDA's "outside experts" are...and who their interests/funding may tie back to? And by the way, the FDA seems more than willing to discount the findings of another government agency, the U.S Veterans Affairs. Seems strangely reminiscent of Anatabine study with Dept of Defense for TBI...
So the testosterone treatment "cat" is already "out of the bag". How exactly is Anatabloc any different, other than having significantly no reported links to unhealthy side effects?
<<The agency will ask its panel of outside experts this month whether the prescribing information on testosterone drugs should be revised to focus on a narrower group of patients.
The panelists will also be asked to weigh in on two recent studies that showed higher rates of cardiovascular problems in men using testosterone. A U.S. Veterans Affairs study published in November 2013 showed a 30 percent increase in stroke, heart attack and death among older men taking testosterone. In January, another federally funded study of 45,000 men with an existing heart condition suggested testosterone therapy could double the risk of heart attacks in men 65 and older.
But in its review, the FDA notes that two other studies have associated testosterone with longevity. According to the agency review, the available studies "do not provide convincing evidence that testosterone replacement therapy is associated with adverse cardiovascular events."
According to the review documents, FDA will ask its experts whether drugmakers should be required to conduct long-term follow-up studies to assess heart risks with testosterone drugs.>>
Well, nothing compared to those nasty side effects of taking Anatabloc...like a few people per hundred who may have reported a temporary upset stomach!
FDA: Little evidence to support testosterone drugs
Associated Press
By MATTHEW PERRONE 5 hours ago
WASHINGTON (AP) — The Food and Drug Administration says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by studies suggesting the hormone carries serious risks.
The agency posted its review online Wednesday ahead of a public meeting to discuss the benefits and risks of treatments that raise levels of the male hormone. Regulators agreed to convene the September 17 meeting after two federally funded studies found links between testosterone therapy and heart problems in men.
The scrutiny comes amid an industry marketing blitz for new pills, patches and formulations that has transformed testosterone a multibillion-dollar market. Advertisements for prescription gels like Fortesta and Androgel promise aging men relief from "Low-T," a condition they link to low libido, fatigue and weight gain.
But FDA reviewers state that "the need to replace testosterone in these older men remains debatable." While testosterone levels naturally decline after age 40, it's unclear whether those lower levels actually lead to the signs commonly associated with aging, including decreased energy and loss of muscle.
The FDA first approved testosterone injections in the 1950s for men who had been diagnosed with hypogonadism, a form of abnormally low testosterone caused by injury or medical illness.
But the recent advertising push is focused on otherwise healthy men who simply have lower-than-normal levels of testosterone.
The FDA memo calls testosterone use in these patients "controversial" and notes that "there are no reliable data on the benefit in such a population."
The agency will ask its panel of outside experts this month whether the prescribing information on testosterone drugs should be revised to focus on a narrower group of patients.
The panelists will also be asked to weigh in on two recent studies that showed higher rates of cardiovascular problems in men using testosterone. A U.S. Veterans Affairs study published in November 2013 showed a 30 percent increase in stroke, heart attack and death among older men taking testosterone. In January, another federally funded study of 45,000 men with an existing heart condition suggested testosterone therapy could double the risk of heart attacks in men 65 and older.
But in its review, the FDA notes that two other studies have associated testosterone with longevity. According to the agency review, the available studies "do not provide convincing evidence that testosterone replacement therapy is associated with adverse cardiovascular events."
According to the review documents, FDA will ask its experts whether drugmakers should be required to conduct long-term follow-up studies to assess heart risks with testosterone drugs.
Roughly 2.3 million U.S. patients received a prescription for testosterone last year, up 77 percent from 2010, according to FDA figures. The agency notes that more than 20 percent of patients who received a prescription did not have any record that their testosterone levels were measured.
Consumer advocacy group Public Citizen said the FDA's review downplays the evidence of heart risks shown across multiple studies. In February the group petitioned the FDA to add a boxed warning — the most serious type — to all testosterone drugs about potential heart risks. Although the FDA rejected that proposal, the group's Dr. Sidney Wolfe says he still expects the recent studies about heart risks to be added to testosterone's label.
"There will be a warning and once it happens the prescribing will drop way down, and that will be to the betterment of the public health in this country," said Wolfe, of Public Citizen's health group.
Wolfe noted that prescriptions for Androgel, the best-selling testosterone drug from Abbott Laboratories, have already fallen 23 percent since July 2013.
In a separate memo, 12 manufacturers of testosterone drugs acknowledged that there are no long-term studies of testosterone therapy, making it difficult to gauge their benefits and risks. Still the companies pledged to educate doctors and patients about the drugs "so that they can make informed treatment decisions."
The group includes Abbvie, Eli Lilly & Co., Endo Pharmaceuticals and Upshur-Smith Laboratories.
http://news.yahoo.com/fda-little-evidence-support-testosterone-163231024.html
NDIN - from FDA Website...
<<What happens after I submit a premarket notification for a new dietary ingredient to FDA?
Once you submit a premarket notification for a new dietary ingredient, we will acknowledge its receipt in writing within 75 days after we receive it. We will also notify you of the date it was received, which is the filing date for the premarket notification. For 75 days after the filing date, you cannot market (that is, introduce or deliver for introduction into interstate commerce) the new dietary ingredient or the dietary supplement that contains the new dietary ingredient.
We may contact you again if:
you did not provide all of the information required in the regulations (see 21 CFR §190.6),
we have questions about the information contained in the notification.>>
Now from RCPI August 11 Clinical Update...
<<With regard to the nutritional supplement business, the company filed a New Dietary Ingredient Notification (NDIN) in June 2014 as a measure to address certain provisions in the December 2013 FDA warning letter. Although the company does not believe that an NDIN is a prerequisite to the lawful marketing of the nutritional supplement, the NDIN was voluntarily submitted to provide the FDA with preclinical and clinical data concerning the supplement. In addition, the company is also voluntarily suspending its sale of CigRx® and Anatabloc® until such time as the company can complete its review of the FDA's response to the company's pending NDIN, which has not yet been received, as well as a review of how the nutritional supplement business may affect the company's drug development program. However, the company does anticipate these actions will bring the FDA warning letter matter to a close.>>
I'm guessing that some people were speculating that Anatabloc would be back on the market in 75 days (prospective mid Sep if they filed the NDIN at end of June) based on FDA "75 day rule". But it is hard to tell from RCPI statement whether objections or questions have actually been raised by FDA on the NDIN. It seems to me that RCPI is really telling the FDA to tell us the complete story..aka what is it that you want...and if you prefer that we not have both a neutraceutical AND a new drug, we will opt for having just the new drug. But tell us what you really want to say!!! Comments?
That's what I don't get. Note the publication was from May, 2014. I would imagine that scientific, research community is small enough, especially for potential treatment for AD, that Antabine would be "known" among the science/research community. Is attending a Conference for bio-startups really required to make such "discoveries" relevant? (not knocking it, just trying to rationalize why RCPI has been so long in "needs to be discovered" mode).
Maybe it's the FDA negative pub, and/or the Virginia trial that is causing "big pharma" interest to be muted...and just waiting for better timing?
Agree. I liked these exerpts, for example:
<<We have summarized on Figure 12 a possible mechanism of action for anatabine that highlights its potential therapeutical application in AD. Further mechanistic work will be required to precisely identify the mode of action of anatabine responsible for the prevention of tau phosphorylation and determine whether it is mainly mediated via a reduction of microgliosis/neuroinflammation, an inhibition of the kinases responsible for tau phosphorylation or a combination of both.
Our data provide in vivo evidence that a chronic oral treatment with anatabine reduces pathological tau hyperphosphorylation and the formation of pathological tau conformers/oligomers leading to a reduction of tau-related functional deficits in Tg Tau P301S mice. These data support further exploration of anatabine as a possible disease modifying agent for tau-associated neurodegenerative conditions and, in particular AD, since we have shown that anatabine also displays Aß lowering properties [22].>>
And cooperation with/from other scientists:
<<Acknowledgements
We are grateful to Dr. Peter Davies (Albert Einstein College of Medecine, Bronx, NY, USA) for the gift of the DA9, PHF-1, CP13, RZ3 and MC1 antibodies and to Dr. Lester Binder (Feinberg School of Medicine, Northwestern University, Chicago, IL, USA) for providing the TOC1 antibody. AER is the recipient of an NIA grant: RO1 AG-19795. We thank Mr. Thomas Guengant for his help during the behavioral testing.>>
Almost could care less...it's not black or white to me...mostly grey. I wouldn't vote for the guy, but wouldn't throw him in jail either based on what I've seen.
The more important question to me is, "is it better for RCPI for him to be found guilty or innocent?". Would like to see some discussion more on that topic...
If this were "industry" as opposed to "government", I would suggest that RCPI is doing a good job of requesting the FDA as to "what exactly do you want us to do?" with regards to supplement and/or new drug applications. Of course, in "industry" you would expect some clarifying response to any/all questions posed...but, of course, this IS "government"...so is there any real accountability?
So when do we find something out? RCPI update from 3 weeks back suggests that FDA will provide a response to NDIN...when?...and is the data that RCPI provided the same as it has to provide for the "objections and/or missing information" that FDA requested for IND? Still lots of questions...but seems that soon RCPI should be advising on specifics. What obligations does FDA have timeline wise for the NDIN?
From previous Rock Creek update:
"In addition, the company is also voluntarily suspending its sale of CigRx® and Anatabloc® until such time as the company can complete its review of the FDA's response to the company's pending NDIN, which has not yet been received, as well as a review of how the nutritional supplement business may affect the company's drug development program."
Response from FDA to my inquiry:
The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC) has prepared a response for case number xxxxx.
Response:
Thank you for taking the time to contact the U.S. Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN). I am able to provide you with information available at www.fda.gov that will direct you to the resources, guidance and regulations that will assist you in determining how to apply them to your unique product, circumstance, question or concern.
You may find it beneficial to review all of the information provided about dietary supplements.
For information related to Anatabloc, you will have to contact the manufacturer directly.
Dietary supplements are not FDA approved, as FDA does not approve or test dietary supplements or their ingredients for safety or effectiveness before they are marketed nor does the agency conduct testing at the requests of consumers. However, the agency has the authority take dietary supplements off the market if they are found to be unsafe, adulterated, or if the claims on the products are false and misleading.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), requires manufacturers to ensure that their products are safe and properly labeled. Properly labeled includes labeling that is truthful and not misleading, which provides ingredient and nutritional information.
To learn more about FDA please visit: Center for Food Safety and Applied Nutrition (CFSAN), Contact FDA, Submit Questions and Comments, Print Publications, Is It Really FDA Approved?, What does FDA Do? and What doesn’t FDA regulate? How do I contact the agencies that do.
Thank you for contacting FDA’s FCIC.
**Please do not reply to this email box. If you would like to submit a follow-up question or need clarification to this inquiry, please click here http://cfsan.force.com/Inquirypage and reference this inquiry’s case number.
Interesting article regarding Eli Lilly pursuit of "autoimmune" drug market. Think there is not some interest in seeing RCPI progress stopped?
http://www.ibj.com/eli-lilly-making-renewed-push-in-biotech-field-where-it-once-pioneered/PARAMS/article/49069
For those that scoff at "mouse study results", found this exerpt from the artcle especially interesting.
""Roughly a year after Lilly halted its autoimmune research effort, researchers in Greece demonstrated for the first time that biotech proteins slowed the progression of rheumatoid arthritis in mice.
That breakthrough led to the first successful human trial of a biotech autoimmune drug, the results of which were announced in 1994 by Pennsylvania-based biotech firm Centocor. When Centocor’s drug proved effective in 19 of 25 patients, it knew it had something that worked.
That drug, launched in 1998 as Remicade, became the first of the new wave of autoimmune drugs.
“That was the big tipping point, the big ‘Aha!’ moment,” Bumol said of the work that led to Remicade.""
Send note to FDA requesting status. Can't hurt...I did so today via their Web site and was issued a case number.
Although RCPI product pull was voluntary, they "pulled it" due to no clarification or approval from FDA.
They should at least be made to feel that there are people who care.