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A topical compound might be a quicker and less expensive route to approval. The burden of proof necessary to appease the FDA might not be as great, either.
I think that's a good basic summary. Perhaps the use of a topical anatabine for psoriasis side steps the potential food effect issue. One thing to note in the psoriasis graphs: anatabine helps psoriatic symptoms, but does not cure or reverse them. This is not surprising to me, as anatabine is nothing more than a compound in certain common foods. I wouldn't be surprised if other foods, like those known to contribute to inflammation, would counter the efficacy of anatabine. Of course, it would be helpful to know how much anatabine is present in foods that contain it, as compared to the amount in the pills or topical solution.
Even if certain foods dampen the effect of anatabine, however, it would be critical to also analyze foods effect on those same markers without anatabine. In other words, anatabine could help by not raising the levels of inflammatory proteins which would have otherwise been elevated without a-bine.
In addition, it looks like they have chosen their initial therapeutic target: Psoriasis. Starting on page 15 (of the 8K), there is new data on a mouse model of Psoriasis. Page 24 shows that Psoriasis and Osteoarthritis will be their initial targeted indications, followed by UC/Crohn's, Thyroiditis, and finally Alzheimer's/Multiple Sclerosis.
Per the June 11th 8K (released this morning):
Rock Creek Pharmaceuticals Announces Clinical Update
SARASOTA, Fla., June 10, 2015 – Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company focused on chronic inflammatory
disease and neurologic disorders, announced today an update on its clinical and regulatory drug development activities.
Phase I Trial Update
The United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) approved in January 2015 a Clinical Trial Application (CTA) to
commence a Phase I study of the Company's lead compound,Anatabine Citrate. The trial consists of three parts, with Part Two being optional. The objectives
of Parts One and Two are to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of various modified and immediate release formulations of
anatabine citrate in healthy adult subjects, and to identify an optimal formulation for multiple day dosing in Part Three. Exploratory pharmacodynamic (PD)
outcome measures are also being assessed.
As previously announced, the Company completed recruitment and commenced human dosing for the study by March 1, 2015. As of June 1, 2015, Part One
of the Phase I study is complete, and the Company announces that there were no reports of serious adverse events (AEs) or AEs leading to study withdrawal.
Further, there were no safety concerns raised by the Company’s UK contract research organization or its UK based trial medical monitor.
The Company now expects to conduct an abbreviated Part Two of the study primarily to evaluate the effects of food on PK parameters. Dosing in Part Two is
expected to commence and be completed within the third quarter 2015.
Subsequently, the Company expects to conduct Part Three of the study comprised of a double-blind, placebo-controlled, seven-day multiple dose study of
the optimal formulation in healthy subjects and is targeting study completion and generating preliminary results in the third quarter 2015. It is anticipated
that follow up data management and analysis will be completed during the fourth quarter 2015. As per the trial design, outcome measures will focus primarily
on overall safety and tolerability with secondary measures focusing on standard PK parameters and also PD assessment, specifically measuring the impact of
the drug on inflammatory processes
New Zealand Study
As previously announced, the Company completed its New Zealand study of the Company’s nutritional supplement variant of Anatabine Citrate. In
December 2014, the Company received a New Zealand Ministry of Health Ethics Committee approval to conduct a single-site, single dose, open-label human
study, entitled “Determination of the Blood Pharmacodynamic Effects following a Single Dose of Oral Anatabine Citrate in Normal, Healthy
Volunteers.” The primary outcome measure of the study was a pharmacodynamic assessment of whether a single dose of orally administered anatabine citrate
can acutely attenuate expression and/or production of pro-inflammatory mediators in human white blood cells, thus creating an anti-inflammatory effect.
Follow up analysis is complete and the Company is expecting to provide a formal report in the third quarter.
So...what hasn't happened, and in the face of a seemingly insurmountable financial hurdle currently (which continues to reach new peaks, by the way) is a massive fact of better and brighter days? Massive fact?!? What does that mean???
Hard to overstate the significance of this.
Are you trying to point out a competitor has the jump on RCPI?
Is that a real question?
“We need this,” said David Shurtleff, deputy director of the NIH Center for Complementary and Integrative Health, explaining why his agency is helping to get the drug approved.
http://www.washingtonpost.com/business/economy/pill-promises-a-safer-cheaper-way-than-chantix-to-quit-smoking/2015/05/15/8ce5590c-f830-11e4-9030-b4732caefe81_story.html
By Todd C. Frankel May 15
Rick Stewart didn’t know about the laburnum trees growing in Bulgaria — and their potential to produce a drug for quitting smoking — back when he was the chief executive of the pharmaceutical company Amarin.
He was too deep inside the drug industry, a place often criticized for its short-sighted focus on profits. He had to fail first. Only then could he spot the opportunity in those yellow-flowering trees.
Now, with the help of the National Institutes of Health, Stewart is trying to introduce the laburnum-derived drug to the U.S. market. The pill works by interrupting tobacco cravings, much like Pfizer’s top-selling Chantix, but possibly without that drug’s high-profile side effects and at a much lower price. A recent run of positive studies have buoyed the pill’s prospects. Today, researchers are excited about what could be the first new treatment for smoking cessation to emerge in years.
“We need this,” said David Shurtleff, deputy director of the NIH Center for Complementary and Integrative Health, explaining why his agency is helping to get the drug approved.
But laburnum’s promise is not new. It was just overlooked — for decades — highlighting holes in how drugs are traditionally developed.
In 2007, Stewart had staked his job as the head of Amarin on a different drug. Miraxion was for treating Huntington’s Disease, and early on it showed signs of improving symptoms of the neurological disorder. But then the drug failed two late-stage trials. Investors in Amarin, a $240 million company based in New Jersey, were stunned. The company’s stock fell 80 percent. Stewart was out of a job.
“The CEO always falls on his sword,” Stewart, 56, says now.
But Miraxion did appear to help patients with Huntington’s — it just took longer than the six months allotted during the clinical trials. Yet the damage was done. This led Stewart and Anthony Clarke, who also lost his job after running the trials for Amarin, to wonder what other misunderstood drugs were out there. They went on a hunt.
“These drugs are uncared for or unwanted. They need tender loving care,” Stewart says. “And pharma, for whatever reason, can’t be bothered with them.”
They set up a tiny company outside London named Ricanto — a mash-up of their first names. They describe the firm’s focus as pharmaceutical asset optimization. They believed innovation was not limited to new drugs. Sometimes it’s just about rediscovering old ones.
Ricanto found a compounded drug used by a few European doctors for a rare autoimmune disorder and introduced it to a larger market. It then helped identify a treatment for severe childhood epilepsy and sold the drug rights to San Diego-based Zogenix in a $130 million deal.
In 2009, Stewart learned of the laburnum trees.
A co-worker told him about a company in Bulgaria named Sopharma that made a stop-smoking drug called Tabex. The pills contained cytisine, a natural compound found in the tree’s seeds. The drug was farmed from massive laburnum orchards in Bulgaria. Cytisine targeted brain receptors to block nicotine cravings. Its power had been recognized since at least the 1940s, when Russian soldiers in World War II, short on tobacco, reportedly turned to smoking the tree’s leaves. Some soldiers found they no longer needed cigarettes.
Sopharma began making the Tabex-branded cytisine pills in 1964, but they were available only in Central and Eastern Europe.
Stewart had never heard of the drug. But he was intrigued. He was also wary. Nearly 1 billion people smoke worldwide, according to the World Health Organization. Tobacco is blamed for 5 million deaths a year. A cheap, effective drug to help smokers quit would be huge. He wondered how others could have missed this opportunity.
There are only three treatment options for U.S. smokers looking to quit.
Chantix is the newest, debuting on the market in 2006. At the time, it was the first prescription drug approved for smoking cessation by the U.S. Food and Drug Administration in nearly a decade, since GlaxoSmithKline’s antidepressant Zyban. Aside from those two drugs, there also are the nicotine-replacement gums, lozenges and patches. But that’s it. The promise of treatments such as nicotine vaccines or other drugs had flamed out. Nothing new has come down the pike.
In 2008, Chantix (sold as Champix overseas) posted $846 million in worldwide sales. But that blockbuster number dropped 17 percent the next year when the FDA slapped a “black box” warning on Chantix and Zyban because of the risk of suicidal behaviors and other mental-health problems. Facing a wave of damaging publicity, Pfizer went on to settle 2,900 lawsuits for nearly $300 million. Chantix’s reputation is still suffering. Last year, it recorded $647 million in sales.
The risk of severe side effects alarmed Stewart.
Cytisine and Chantix work in similar ways. In fact, Pfizer chemists closely studied the plant product as they developed their synthetic drug. But Pfizer supercharged its derivative to increase efficacy. Stewart noted that Tabex had amassed a database of 5 million users in Eastern Europe without signs of Chantix-like side effects.
“Why aren’t we seeing the suicidality?” he recalls thinking.
One study suggested it was because cytisine is less potent. And many researchers today believe the worst side effects attributed to Chantix — such as suicidal thoughts — are unrelated to the drug. (A Pfizer study to be released later this year is expected by many to support this notion.) But stark differences between the two drugs are found in other severe reactions, including abnormal dreams, insomnia and nausea. These are rare for cytisine, but seen in up to 30 percent of Chantix users.
Stewart struck a deal with Sopharma. He wanted to get the drug approved in Western Europe and the United States. Instead of calling it Tabex, the pill would be named Extab.
But Stewart still faced a daunting problem with cytisine.
“There’s no money in it,” said Dr. Taylor Hays, director of the Nicotine Dependence Center at the Mayor Clinic in Rochester, Minn., who would love to see cytisine get a shot here. “And that’s what usually motivates people to try bringing it to market. The money is going to drive it.”
“It’s just frustrating to think that there’s something that could be helping people and we’re not using it,” said Dr. Nancy Rigotti, director of the Tobacco Treatment Unit at Massachusetts General Hospital.
A natural product like cytisine cannot be patented. That makes its market position harder to defend. And getting a drug approved requires millions of dollars. Drug companies say the cost of developing and getting approval for a new drug is $1 billion. This might explain why some companies have seen blockbuster profits with treatments for rare diseases, such as Genzyme’s drug for Goucher disease, which costs $300,000 a year.
“They’re fixated on patent protection and new drugs,” Stewart said.
Stewart is banking on two things to turn a profit with Extab. One is the limited cytisine supply. A competitor would need to plant vast orchards of laburnum trees — hundreds of thousands of them — and wait four years before the drug-containing seeds could be harvested.
The other thing is that Extab is new to the U.S. market. No one has ever tried to get it approved. So the drug would have five years of U.S. market exclusivity as a novel drug under the 1984 Hatch-Waxman Act. That’s less than the typical 20-year window for patented medicines. But it’s something.
“It’s a really old, novel drug,” Stewart says.
Still, he needed help getting the drug through the U.S. regulatory maze. He needed to get lucky. And he did.
British medical authorities offered to pay for and run a clinical trial of cytisine. In 2011, the findings were published in the New England Journal of Medicine, showing cytisine was 3.4 times more likely than placebo to help people quit smoking and stay that way for one year, on par with Chantix.
Then a review by University of Sheffield researchers compared cytisine with Chantix and concluded that while more investigation was needed, “Cytisine is estimated to be both more clinically effective and cost-effective than (Chantix).”
But the real turning point came in December, when another study was published in the New England Journal of Medicine. Researchers with New Zealand’s National Institute for Health Innovation found cytisine was superior to the nicotine-replacement gum or patch.
The drug now had two large-scale clinical trials under its belt.
But more work lies ahead.
“I’m either absolutely mad or I guess I really believe in it,” Stewart says.
European regulators and the FDA are considering what more they need, Stewart says.
In preparation, a lab in California recently started early-stage safety tests on Extab. The NIH is picking up the tab. The NIH’s Shurtleff said the agency wants to support promising drugs that don’t have a clear path to the marketplace, especially natural products.
“That’s where we come in and provide that capital,” he says.
It could take three to five more years for the FDA’s blessing. Stewart said he hopes to find a partner to help his small firm with the U.S. market. He also brushes off any suggestion that Extab would go head-to-head with Chantix, which is made by one of the world’s biggest drug firms. It’s a strategic move on his part.
“They’ll crush us,” he says.
Stewart estimated that Extab could see $400 million in annual sales worldwide five years after launch. Pfizer will notice that.
Currently, the cytisine supply comes from 100,000 laburnum trees planted in fields ringed by protective fences in Bulgaria. Stewart knows that will not be enough if all goes to plan — if the FDA approves, if Extab takes off. He will need to ramp up production.
He has plans to plant 300,000 more of those yellow-flowering trees, including some in the United States, orchards so large they would be impossible to miss.
Todd C. Frankel is a reporter covering people and policy. You can follow him on Twitter: @tcfrankel.
I hear what you are saying, but the stock is only trading at .09c pre-split --not exactly a screaming endorsement.
It's not hard to believe in the least.
For RCPI and its investors, there are more immediate concerns (from the March 23rd 8K):
On March 23, 2015, Rock Creek Pharmaceuticals, Inc. (the "Company") received a letter from the Listing Qualifications Department of The Nasdaq Stock Market, LLC ("Nasdaq"), notifying the Company that, for the last 30 consecutive business days, the Company has failed to comply with Nasdaq Listing Rule 5550(b)(2), which requires the Company to maintain a minimum "Market Value of Listed Securities" of $35 million for continued listing on the Nasdaq Capital Market. The letter also noted that the Company did not meet the alternative requirements under Listing Rules 5550(b)(1) or 5550(b)(3).
Dr. Oz: His tidbit on GMO's:
Dr. Mehmet Oz April 23, 2015
http://time.com/3831926/dr-oz-criticism-answers/?xid=newsletter-brief
Other times the topics are controversial, but are still worthwhile, like our campaign supporting GMO labeling. And this brings me back to a motive for the letter. These doctors criticized my “baseless and relentless opposition to the genetic engineering of food crops,” which is another false accusation. Whether you support genetically engineered crops or not, the freedom to make an informed choice should belong to consumers. The bill in Congress this month proposing to block states from independently requiring labeling offers a coup to pro-GMO groups.
As a scientist, I am not that concerned about GMOs themselves, but I am worried about why they were created. Highly toxic herbicides would kill crops unless they were genetically modified, but with the genetic upgrade, these plants can be doused with much higher doses, with potential complications to the environment. The WHO believes that glyphosate is “probably a human carcinogen.” Perhaps we are all showing “disdain for science and evidence-based medicine,” but I would argue that unleashing these products creates a real-time experiment on the human species. Sure, we will eventually know if these pesticides are a problem, but at the expense of the pain and suffering and disease in real people. I owe my kids more. And so do you.
Rather than reiterate another poster's unsubstantiated claim with more of the same, please enlighten us with examples confirming your belief?
Synthesized? MS? You are splitting hairs here. I cannot take your argument seriously. Sorry...
More detailed article on the study:
http://www.cbsnews.com/news/dietary-supplements-linked-to-increased-cancer-risk/
Dietary supplements linked to increased cancer risk
Consumers are always looking for ways to minimize their cancer risk, which is one reason why many turn to over-the-counter vitamin and mineral supplements. But new research finds that while companies promote dietary supplements for their cancer-prevention benefit, some may end up doing more harm than good.
Dr. Tim Byers, director for cancer prevention and control at the University of Colorado Cancer Center, conducted a meta-analysis of two decades worth of research -- 12 trials that involved more than 300,000 people -- and found a number of supplements actually made a person much more likely to develop certain types of cancer.
Byers began his investigation on the association between supplements and cancer risk 20 years ago. He and many other researchers observed that people who ate more fruits and vegetables cut their risk for cancer. Byers and his colleagues wondered if taking supplements that provide the same vitamins and minerals as fruits and vegetables could offer similar protection.
But his findings suggested just the opposite -- rather than warding off cancer, taking lots of supplements may raise a person's risk.
"There's enough evidence along these lines that we should really consider better regulation of these nutritional supplements," Byers told CBS News. "I think it's time to step back and say there's probably a safety issue."
Byers presented his research Monday at the annual meeting of the American Association for Cancer Research, in Philadelphia.
Through his analysis, Byers found that people who took high doses beta carotene supplements had an increased risk for lung cancer. Selenium supplements were associated with skin cancer. Men who took vitamin E had an elevated risk for prostate cancer. Folic acid, a B vitamin, taken in excess could lead to an increased risk for colon cancer.
Byers says it's still unclear why supplements could have this adverse effect, but he and other researchers hope to learn more about the association.
Other studies Byers reviewed indicated that many other supplements had no apparent impact on cancer risk -- neither increasing nor decreasing it. Recent research has shown that for the most part, vitamin supplements have little impact on a person's long-term health. Some research has even gone as far as to say that they are a waste of money.
An analysis of 24 studies and two trials published in the Annals of Internal Medicine in 2013 looked at the role of vitamin supplements for the prevention of chronic diseases. That study involved more than 350,000 people and it found little evidence that vitamin and mineral supplementation impacted the risk for a number of chronic health conditions, including cancer.
Byers says consumers should be cautious about using supplements. However, this doesn't mean you have to avoid them altogether. "I think when people take supplements they shouldn't take them at levels higher than what you can get in your diet," he said. Byers and other experts urge people to incorporate more fruits and vegetables into their diet, rather than relying on supplements.
A person who has a known deficiency of a certain vitamin or mineral -- either due to diet or health condition that prevents proper absorption -- can take a supplement, preferably a multivitamin that provides levels in line with recommended daily allowances. But in every case, Byers cautions consumers to acknowledge that there may be "harm in excess."
Excessive use of dietary supplements linked to increase cancer risk
http://www.sciencedaily.com/releases/2015/04/150420182403.htm
April 20, 2015
University of Colorado Cancer Center
While dietary supplements may be advertised to promote health, new research shows a link between consumption of over-the-counter supplements and increased cancer risk, if the supplements are taken in excess of the recommended dietary amount.
"We are not sure why this is happening at the molecular level but evidence shows that people who take more dietary supplements than needed tend to have a higher risk of developing cancer," explains Byers, associate director for cancer prevention and control at the CU Cancer Center.
The line of research started 20 years ago with the observation that people who ate more fruits and vegetables tended to have less cancer. Researchers including Byers wanted to see if taking extra vitamins and minerals would reduce cancer risk even further.
"When we first tested dietary supplements in animal models we found that the results were promising," says Byers. "Eventually we were able to move on to the human populations. We studied thousands of patients for ten years who were taking dietary supplements and placebos."
The results were not what they expected.
"We found that the supplements were actually not beneficial for their health. In fact, some people actually got more cancer while on the vitamins," explains Byers.
One trial exploring the effects of beta-keratin supplements showed that taking more than the recommended dosage increased the risk for developing both lung cancer and heart disease by 20 percent. Folic acid, which was thought to help reduce the number of polyps in a colon, actually increased the number in another trial.
"This is not to say that people need to be afraid of taking vitamins and minerals," says Byers. "If taken at the correct dosage, multivitamins can be good for you. But there is no substitute for good, nutritional food."
Byers says that people can get the daily recommended doses of vitamins and minerals in their diets by eating healthy meal and that many adults who take vitamin supplements may not need them.
"At the end of the day we have discovered that taking extra vitamins and minerals do more harm than good," says Byers.
How about it? How was the author being deceptive, and what do you suggest his agenda is?
I dealt with the MS thing, so let's deal with the 'synthesized' anatabine thing. How on Earth is the author attempting to mislead, and what is his goal, by not specifically describing anatabine citrate as a synthesized compound by Rock Creek? Good luck with your 'research'.
That was just two of the points I noticed that told me the guy who wrote the story was just not doing the kind of research a true professional journalist would have done
SAYS the guy who picks apart and criticizes everyone else.
I remember pointing out the oddity of the source, and suggesting it was strategically released to bring attention to the compound
As I recall, when the Euro trial direction was first publicized, there was an article from a Euro MS organization highlighting MS. I remember pointing out the oddity of the source, and suggesting it was strategically released to bring attention to the compound. I don't recall anyone else on this board questioning the connection. Why now? MS has been regularly mentioned on this board as a legitimate indication for anatabine citrate, which makes pointing out this minute aspect of the article as an 'error', ridiculous.
My remark was here: #msg-110570662
The story was linked here (by Leifsmith): #msg-110555211
And here is the article (posted in February):
http://www.ms-uk.org/emergingtherapies
Could anatabine citrate be a used as a multiple sclerosis therapy?
(03/02/15)
Drug development company Rock Creek Pharmaceuticals has announced a new clinical trial application with the Medicines Healthcare Products Regulatory Agency (MHRA) has been approved. The company is set to proceed with a Phase I study of Anatabine Citrate, a chemical that is found naturally in aubergine, potatoes, green tomatoes and other members of the Solanaceae family of plants, as well as in tobacco and tobacco smoke. The chemical is known for its anti-inflammatory properties unique from other anti-inflammatory drugs on the market, and may benefit patients with multiple sclerosis (MS).
The Phase I study will evaluate Anatabine’s pharmacokinetic profile in the form of modified release formulation prototypes, and its safety and tolerability profiles in healthy volunteers. The first two parts will involve an open-label, non-controlled, single-dose study on 14 healthy participants, using six formula variations, with each administered dose spaced 7-14 days apart. The variations will be distinct in dose and duration of therapeutic action. This will allow the company to determine which formulation is most ideal, based on safety. The third and last part of the Phase I study will be a double-blind, placebo-controlled, seven-day multiple dose study of the identified optimal formulation in healthy subjects.
“We are delighted to have been granted regulatory approval to begin our Phase I studies in the UK. This is the first clinical phase for our lead drug and will focus on safety and tolerability of six different formulations, five of which have modified release profiles and are of different doses. We look forward to generating our first human clinical data under this CTA,” said Rock Creek Pharmaceuticals CEO Dr Michael Mullan.
Rock Creek’s UK-based partner, Quotient Clinical, is set to begin enrollment of healthy subjects this month. While the company expects the study to stretch well into August, they expect to have a significant amount of research findings by mid-2015. Rock Creek also announced Quotient Clinical will be utilizing its RapidFACT® (Rapid Formulation development And Clinical Testing) service to hasten the development of these novel, oral, modified release formulations that have been co-developed between the two companies.
Source: Multiple Sclerosis News Today © BioNews-tx.com 2015 (03/02/15)
Any comments on the purported safety issues the McDonnell resignation letter indicated? How about the additional studies (the FDA requested) which should have concluded by 4th Quarter 2014?
Don't focus on me. Just provide us with relevant examples of the author's screw ups. I've already shared a few times my example (his last sentence made no sense).
I'm guessing that the "safety issue" is a general term, not specific:
The NDA process requires a company to prove the safety and efficacy of a new drug product to the FDA’s satisfaction.
We are currently complying with the FDA’s comments by undertaking additional preclinical studies which address those concerns. We expect to complete those additional studies during the fourth quarter of 2014.
Edit: McDonnell used the term "safety issues" in his resignation letter. Is there prior public documentation to suggest that safety was a/the purpose of the hold? I haven't been able to find any:
From the Sept. 30, 2014 10-Q (http://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=9891585&type=HTML&symbol=RCPI&companyName=Rock+Creek+Pharmaceuticals+Inc&formType=10-Q&dateFiled=2014-11-10&cik=0000776008):
On August 25, 2014, the Company received a response to the NDIN from the FDA. The letter indicated that the FDA considers anatabine, a principal ingredient in these products, to be a drug, because anatabine was intended to provide anti-inflammatory support, and was previously authorized for investigation as a new drug. Based on the FDA position, the Company permanently exited the dietary supplement business for anatabine in the United States (“U.S.”). However, the Company will continue to seek opportunities to license the product for overseas markets. All of the Company’s revenues, cost of goods sold, marketing and sales, inventory and manufacturing machinery related to the dietary supplement business were accounted for as discontinued operations effective September 2014, since the Company exited the U.S. market. The FDA notified the Company in a close out letter dated October 21, 2014 that the FDA has completed it’s evaluation of the Company’s corrective actions in response to the warning letter issued on December 24, 2013. In this notification the FDA stated based on it’s evaluation, the Company has addressed the putative violations in the warning letter
Regulatory Hurdles; IND or European Equivalent Process
The drug development business is highly regulated, and requires the filing of an IND application (or the European equivalent) and a Clinical Trial application (“CTA”) related to any new pharmaceutical products we intend to introduce. We filed an IND application in June 2014, however, the FDA has issued a clinical hold on the application. We are currently complying with the FDA’s comments by undertaking additional preclinical studies which address those concerns. We expect to complete those additional studies during the fourth quarter of 2014.
and those who are still short will loose from this point forward
He noted that the FDA last August issued a clinical hold order, which directed the company not to proceed with a proposed trial in the U.S. “until safety issues raised by the FDA are resolved,” the filing states.
Article frankly was fine with exception of final sentence...
I'm bewildered as to why you are continuing to obsess over this. Most of what you are suggesting Jenkins do was already written in the article. In fact, the article revolves around the fact that they (Rock Creek) have commenced and continue to stay the course with the Euro clinical trials of Anatabine Citrate. I'm glad Jenkins didn't say they were "excited" about the main compound, or reiterate the facts in the article (continuing to pursue blah blah blah). It would have been cliché and boilerplate, respectively.
Poorly written? Perhaps. Poorly researched? Not at all. The article is a fact based, real-time account of the happenings at Rock Creek.
More obvious than this being a "short agenda", is your denial of the true catalysts for the destruction of the company (regulatory conflict/prior and existing mgmt), and your conspiratorial paranoia of a looming evil: the shorts. While they exist, they are the effect, not the cause.
The FDA is gonna love this. I have to wonder, though, why Faux News is the only outlet to pick-up the story:
http://www.foxnews.com/health/2015/04/16/dietary-supplement-may-prevent-and-treat-prostate-cancer-study-says/
Dietary supplement may prevent and treat prostate cancer, study says
Published April 16, 2015
Researchers at the University of Miami have found that an over-the-counter supplement is effective in both preventing and treating prostate cancer.
The supplement, 4-methylumbelliferone (4-MU), is a non-toxic oral agent used as a dietary supplement in Europe and Asia for improving liver health. Treating mice with the supplement appeared to inhibit prostate cancer from further developing starting as soon as eight weeks after the rodents were diagnosed.
“The results were simply amazing,” principal investigator Vinata B. Lokeshwar, a professor of urology and director of the pilot and translational studies component of the Miami Clinical and Translational Science Institute, said in a news release.
The team also found that 4-MU halted the metastatic spread of prostate cancer.
According to the National Cancer Institute, prostate cancer is the most common nonskin cancer and second leading cause of cancer-related death in men in the U.S. In 2014, there were an estimated 233,000 new cases and about 30,000 deaths. Projections for 2015 are similar.
For their study, researchers used a mice model of prostate cancer, treating mice at distinct stages of the disease and stopping treatment at 28 weeks.
When treatment started at eight or 12 weeks, it completely inhibited prostate cancer development and growth. At 22 weeks, researchers found that small cancers had stopped growing and in some cases even regressed.
“Also, to our amazement, while 60 percent of the animals in the control group experienced metastasis to distant organs, none of the treatment group developed metastasis. 4-MU did all of this without causing toxicity to the host,” Travis Yates, former graduate student of the school’s Sheila and David Fuente graduate program in cancer biology, and current postdoctoral fellow at the University of Pennsylvania, said in the news release.
Researchers noted that the earlier the treatment started, the better the protection provided by the 4-MU.
According to researchers’ histological studies, 4-MU halted growth of new blood vessels, thus cutting off nutrient supply to prostate tumors and reversing their ability to metastasize.
The National Cancer Institute funded the study.
I agree with your assessment, particularly regarding the author's last sentence. It doesn't even make sense, as it is inconsistent with his own fact based reporting throughout the piece. I feel that Rock Creek was being baited, and wisely didn't take a bite.
Nice write up in the WSJ...not:
http://www.wsj.com/articles/BL-270B-1795
TRGT-The hits keep coming at 'em. Still have over $100m in cash though. The two companies should talk: Mullan/RCPI really needs capital, and TRGT needs a drug...badly:
http://finance.yahoo.com/news/targacept-announces-negative-top-line-123000914.html
Targacept Announces Negative Top-Line Results from Exploratory Study of TC-6499 in Diabetic Gastroparesis
WINSTON-SALEM, NC--(BUSINESS WIRE)--
Targacept, Inc. (TRGT) today announced top-line results from a Phase 1/2 exploratory study of TC-6499 as a treatment for diabetic gastroparesis, a chronic disorder that slows or stops the passage of food from the stomach to the small intestine. In the trial, TC-6499 did not meet the primary endpoint of the study, change in gastric emptying half-time (BT_t1/2), as measured by a carbon (13C) labeled gastric emptying breath test, relative to placebo.
“The results we saw do not support the prior signal we had seen suggesting that TC-6499 might increase gastric motility in this patient population,” said Dr. Stephen A. Hill, Targacept’s President and Chief Executive Officer. “While TC-6499 did demonstrate a positive safety and tolerability profile in this study, these results do not warrant further development of TC-6499 in this therapeutic area.”
About the Study
The Phase 1/2 exploratory study was a double-blind, placebo-controlled, randomized, four-way crossover study conducted at seven sites in the United States. A total of 21 subjects with diabetic gastroparesis completed the study and received one of four treatments (2mg, 5mg and 10mg of TC-6499 and placebo) in a randomized, crossover manner on each of four treatment visits, with each dosing period separated by approximately seven days. The primary endpoint of the study was change in gastric emptying half-time (BT_t1/2), as measured by a carbon (13C) labeled gastric emptying breath test, for each active treatment relative to placebo. The study also assessed the safety, tolerability and pharmacokinetics of TC-6499.
Targacept has historically focused on developing NNR Therapeutics™ to treat patients suffering from serious nervous system and gastrointestinal/genitourinary diseases and disorders. Targacept is dedicated to building health and restoring independence for patients. For more information, please visit www.targacept.com.
It was a typo: The last 3 letters are scrambled and the 't' was omitted :)
Dementia 'halted in mice brains'
http://www.bbc.com/news/health-32315763
Tweaking the brain's immune system with a drug has prevented mice developing dementia, a study shows.
The team at Duke University, in the US, showed immune cells which start attacking nutrients in the brain may be a trigger for the disease.
They say their findings could open up new avenues of research for a field that has not developed a single drug to slow the progression of the disease.
Experts said the findings offered new hope of a treatment.
The researchers indentified microglia - normally the first line of defence against infection in the brain - as major players in the development of dementia.
They found some microglia changed to become exceptionally adept at breaking down a component of protein, an amino acid called arginine, in the early stages of the disease.
As arginine levels plummeted, the immune cells appeared to dampened the immune system in the brain.
Stopping dementia
In mouse experiments, a chemical was used to block the enzymes that break down arginine.
They showed fewer of the characteristics of dementia such as damaged proteins collecting in the brain and the animals performed better in memory tests.
One of the researchers, Dr Matthew Kan, said: "All of this suggests to us that if you can block this local process of amino acid deprivation, then you can protect the mouse, at least from Alzheimer's disease.
"We see this study opening the doors to thinking about Alzheimer's in a completely different way, to break the stalemate of ideas in Alzheimer's disease."
However, the findings do not suggest that arginine supplements could combat dementia as the boosted levels would still be broken down.
'Hope'
Dr James Pickett, from the Alzheimer's Society said the study was "offering hope that these findings could lead to new treatments for dementia".
He added: "This study in animals joins some of the dots in our incomplete understanding of the processes that cause Alzheimer's disease, in particular around the role played by the immune system."
Dr Laura Phipps, from Alzheimer's Research UK, said the study was "interesting" and shed "more light on the mechanisms of immune system involvement in Alzheimer's".
But she cautioned clinical trials in people were still needed and that "the findings do not suggest that supplementation of the amino acid could mirror the benefits seen in these mice".
Motherfrackers!?!?!
http://www.washingtonpost.com/news/to-your-health/wp/2015/04/09/rise-of-deadly-radon-gas-in-pennsylvania-buildings-linked-to-fracking-industry/
Writing in the journal Environmental Health Perspective, researchers analyzed levels of radon — a colorless, odorless gas that is radioactive and has been linked to lung cancer — in 860,000 buildings from 1989 to 2013. They found that those in the same areas of the state as the fracking operations generally showed higher readings of radon. About 42 percent of the readings were higher than what is considered safe by federal standards. Moreover, the researchers discovered that radon levels spiked overall in 2004, at about the same time fracking activity began to pick up.