Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[NukeJohn]

Anatabloc and Alzheimer's Disease....


Star has a product (Anatabloc) available off the shelf today that reduces beta amyloid and can help people with Alzheimer's. We have already seen the test results on mice (where they regained their cognitive ability), and now formal tests are underway in a peer reviewed, IRB approved, clinical trial at the Roskamp Institute. The IRB approved the test in April and patients have been enrolled for the 3 month long test. The Star Scientific President (Paul Perito) was quoted in the PR as saying he wanted this study done as soon as possible, so the results can't be that far off. If you read this post carefully (including the links), then you will have a clue what the results will show.

First, look at this article in The New York Times yesterday....

http://www.nytimes.com/2012/07/12/health/research/rare-gene-mutation-is-found-to-stave-off-alzheimers.html?hp

excerpts....

A study of a rare gene mutation that protects people against Alzheimer’s disease provides the strongest evidence yet that excessive levels of a normal brain substance, beta amyloid, are a driving force in the disease — bolstering hopes that anti-amyloid drugs already under development might alter the disease’s course or even prevent it......

Dr. Richard Mohs, leader of neuroscience early clinical development at Eli Lilly, said the company was “very encouraged by these study results.” They show, he said, that despite an initial failure, the strategy of focusing on drugs to reduce beta amyloid levels is “a logical path for the development of effective therapies that may slow disease progression.”


well....guess what? Anatabloc reduces those beta amyloid levels and it is a safe nutraceutical available off the shelf at GNC. An IRB approved clinical trial (with 120 human patients) is now underway at the Roskamp Insitutute, but we already know the results from the comments made by Dr. Mullan's after he conducted inititial testing. Read this report by a fellow retail investor who attended the Roskamp presentation in June 2011. Dr. Mullan even said he would give Anatabloc (RCP-006) to his own mother if she had Alzheimer's. First, here is the press release from Star Scientific when the journal article on Beta Amyloid was published. It revealed the reduction of beta amyloid in mice and showed that the mice with Anatabloc regained their cognitive ability (and mice with Alzhiemer's could solve the maze after receiving Anatabloc).

http://www.prnewswire.com/news-releases/star-scientific-reports-first-peer-reviewed-article-on-anatabine-and-alzheimers-disease-by-roskamp-institute-131069033.html

excerpts.....

GLEN ALLEN, Va., Oct. 4, 2011 /PRNewswire/ -- Star Scientific, Inc. (Nasdaq: CIGX) reports today the publication of the first peer-reviewed article on the in-vitro and in-vivo activity of anatabine in Alzheimer's Disease. The article is authored by scientists at the Roskamp Institute and is electronically published in the European Journal of Pharmacology (2011 Sept 19). It states that anatabine lowers Alzheimer's A-beta production in-vitro and in-vivo.

In the article the authors describe the accumulation of an abnormal substance, called A-beta, the substance that leads to amyloid formation and damage to brain tissue. They studied the formation of A-beta and showed how anatabine lowers levels of two forms of A-beta (1-40 and 1-42) in a dose-dependent manner, possibly by preventing or reducing formation from the precursor protein. After showing the activity in the test tube, the researchers went on to show that when anatabine is given to mice vulnerable to accumulation of amyloid, treatment with anatabine lowers brain levels of both A-beta (1-40) and A-beta (1-42), postulated to be due to effects on NFKB activation. Michael Mullan, MD, Ph.D., Roskamp Institute co-director and one of the article's authors, commented, "This paper demonstrates anatabine's potential as an anti-inflammatory agent and shows it may have broad applications including for disorders like Alzheimer's Disease."

Anatabine citrate is one of the active ingredients in Anatabloc™, a dietary supplement developed by Star Scientific's subsidiary, Rock Creek Pharmaceuticals. Anatabloc™, which entered the market on August 30, is designed to provide anti-inflammatory support (www.anatabloc.com). Curtis Wright, MD, MPH, Senior Vice President of Rock Creek Pharmaceuticals, expressed his opinion of the Roskamp findings. "While we were aware that Roskamp was conducting studies of the effects of dietary supplementation with anatabine in Alzheimer's Disease, it is gratifying that external peer review validated the work they have done. The research confirms that this natural plant compound shows an interesting regulatory effect on brain immune responses. It is one thing to believe your own results; it is quite another to have them accepted by your peers in the scientific community." Anatabine for the Roskamp research was provided through Rock Creek Pharmaceuticals.

Ongoing human clinical studies of anatabine citrate, and the commercial product Anatabloc™, are examining the potential role of nutritional supplementation in regulating low-level inflammation controlled by the NF?B system.

Source: PR Newswire (s.tt/1bKeR)



Now, think about the implications of this April 2012 Press Release when this IRB approved study is finished and it shows that Anatabloc successfully slows the progression of Alzheimers (and may even reverse some of the damage) in humans. Also, you may note they announce enrollment started in April 2012 and they said it would be a three month study (how long can it take to find 120 patients with Alzheimer's to start the study?)

excerpts...(Bold is mine)

This study developed out of Roskamp's earlier research work published in the European Journal of Pharmacology (Paris D et al. Anatabine lowers Alzheimer's AB production in vitro and in vivo, Eur J Pharmacol. 2011 Nov 30;670(2-3):384-91) and multiple reports of use of the supplement in users with Alzheimer's disease. Both Rock Creek's and Roskamp's medical teams agreed that enough preliminary data was now available to initiate the study.

The study, entitled "A Three Month, Single-Site or Multi-Site, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability and Potential Effects of the Dietary Supplement Anatabine in Subjects with Alzheimer's Disease" is a six-visit, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the safety, tolerability, and potential effects of anatabine dietary supplementation in subjects with mild to moderate Alzheimer's disease (AD). Secondary aims are to evaluate the effects of this specially formulated version of Anatabloc® (patent pending) on amyloid beta (AB), global outcome, and functional measures of AD. Although the Roskamp Institute will be the primary study site, it is anticipated other sites may be added as needed to fulfill enrollment goals. The study will enroll subjects at least 65 years of age with a diagnosis of mild to moderate Alzheimer's disease, and it is expected that a minimum of 120 subjects will complete the trial.

Dr. Ryan Lanier, Chief Clinical Scientist for Rock Creek Pharmaceuticals, who coordinated the development of the study protocol, commented, "The Roskamp Institute has done its usual thorough job in working with Rock Creek to design a study that will begin to bring definitive answers to whether supplements of this class are tolerable and have demonstrable effects in supporting the medical treatment of individuals with this terrible condition. In answering calls from physicians looking for ways to support their patients suffering from Alzheimer's, it has been intensely frustrating to tell them that we are preparing for such a study, but have to complete the preliminary work to support a study in this population. Doing good science takes time and patience, but I am very glad we have the data needed to get started. The work done by Roskamp to date has been of world-class quality and I am confident that the same quality will continue in its role as the primary site for the Alzheimer's study. We will do everything we can to support the Roskamp Institute in that effort."

Rock Creek Pharmaceuticals and the Roskamp Institute have worked collaboratively on research relating to the company's anatabine compound for a number of years, occasioned by the Institute's interest in the effect of the compound on immune system support. Inflammation and the proper or aberrant functioning of the immune system is a critical factor in a number of neurological disorders studied by the Institute, and helping the immune system regain its natural balance through nutrition is one path toward supporting current medical treatments for such conditions.

Paul L. Perito, Rock Creek's Chairman and CEO stated, "I have waited a long time for this pivotal event, with considerable anticipation. We strongly believe that our nutritional products will be of value to physicians in providing optimal care for their patients, and I'm going to make sure that we do everything we can to get this study done as fast as possible."



The two key things that I think are important are

1. Anatabloc is a nutraceutical that has been taken for >3 years by several hundred thousand patients (as both CIGRX and Anatabloc). Since it is a nutraceutical found in everyday foods (Green tomatoes, peppers, cucumbers, etc.) it is safe and has had no reported side effects or drug interactions.

2. Anatabloc is available now....it does not have to go through years of FDA approved clinical trial testing.

The world is about to learn about this.....and families of people with AD will be frequenting the local GNC stores.


JMHO,

NJ