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Taking RCPI private?
Could it be someone in the know is buying majority shares to take the company private after the bankruptcy, buy the patents cheap, and take the Psoriasis product to market? Maybe one of the lenders who might find it cheaper this way than to loan them money for shares, ie Hudson Bay. I have seen nothing of where they stand with the Psoriasis interim results. One would think by now they should have a handle on it otherwise they would have stopped. Mullan still has his other company to survive on, hopefully with a product from this or from Roskamp.????
Mystery: What does inflammation have to do with Alzheimer's disease?, Life Science, Cari Nierenberg, Live Science Contributor | September 26, 2016
Excerpts:
"The release of too much protein by microglia can cause trouble at the synapses, or connections, between nerve cells, Selkoe said.Scientists wonder whether drugs aimed at controlling inflammation in the brain could also help control memory problems, he said."
Article at:
http://www.livescience.com/56253-biggest-mysteries-of-alzheimers-disease.html
Lundbeck says Alzheimer's drug fails in late-stage study, HEALTH NEWS | Thu Sep 22, 2016, Ankur Banerjee
Excerpts:
"Danish drugmaker H Lundbeck A/S's highly anticipated experimental Alzheimer's drug failed in a late-stage study, underscoring the challenges faced by drugmakers to tackle the debilitating memory-robbing disease.
The Copenhagen-based company said on Thursday both doses of the drug, idalopirdine, showed a "weak efficacy profile" and failed to reduce cognitive decline measured on a scale called ADAS-cog in the study named Starshine.
Idalopirdine, which is being developed with Japan's Otsuka Pharmaceutical Co Ltd, is being tested in patients with mild to moderate Alzheimer's disease."
"Long-awaited late-stage results from Eli Lilly and Co's experimental drug solanezumab, which is being tested in patients with mild Alzheimer's, is expected to be announced in the fourth quarter."
Article at:
http://www.reuters.com/article/us-h-lundbeck-study-idUSKCN11S2B6?feedType=nl&feedName=healthNews&utm_source=Sailthru&utm_medium=email&utm_campaign=US%20Health%20Report%202016-09-23&utm_term=US%20Health%20Report
Psoriasis may carry clogged-arteries risk similar to that with diabetes, August 31, 2016, Kathryn Doyle
Excerpts:
"People with psoriasis may be at increased risk of calcium buildup in the arteries – an indicator of heart disease risk – comparable to that of people with diabetes, according to a new study.
Comparing people in their 50s with psoriasis, diabetes or neither disease, researchers found that moderate to severe calcium buildup, or atherosclerosis, was about five times as common in people with diabetes or psoriasis as it was in the others."
"Psoriasis, characterized by itchy red and silvery patches on the skin, is an autoimmune disease that affects about 2 percent of North Americans and Europeans. Diabetes is much more common, affecting about 9 percent of the U.S. population, according to the Centers for Disease Control and Prevention (CDC).
People with diabetes are twice as likely to have heart disease or a stroke as people without diabetes, and to experience these at an earlier age, according to CDC.
One risk factor common to both psoriasis and diabetes and thought to play a role in elevated heart disease risk is chronic inflammation, which is known to promote arterial buildup."
"“The precise mechanism explaining the association of psoriasis and cardiovascular diseases is not known but it is thought that chronic inflammation, common to both disorders, is the primary culprit,” Gelfand, who was not involved in the study, told Reuters Health by email."
Article at:
http://kfgo.com/news/articles/2016/aug/31/psoriasis-may-carry-clogged-arteries-risk-similar-to-that-with-diabetes/
Struggling Sarasota biopharma considering bankruptcy
Aug 30, 2016, 7:17am EDT Updated Aug 30, 2016, 7:30am EDT in Tampa Bay Business Journal
Excerpts:
"Rock Creek Pharmaceuticals Inc. is considering options — including bankruptcy — after two debtholders said the company was in default."
"In October 2015, it raised $20 million in a private placement of senior secured convertible notes.
On Aug. 24, one of the note holders, Hudson Bay Master Fund Ltd., sent Rock Creek an event of default redemption notice, withdrawing $6.7 million from its account and claiming it is still owed nearly $7 million, Rock Creek disclosed in a SEC filing late on Aug. 29.
Separately, Tenor Capital Management sent Rock Creek an event of default notice on behalf of Alto Opportunity Master Fund, also a note holder, the filing said. Tenor has withdrawn $3.5 million from its account and demanded the balance remaining of $3.8 million be paid in cash no later than Aug. 31.
Rock Creek was in discussion with the note holders when they issued the notices, and has neither agreed nor denied their allegations, the filing said.
“The company is actively exploring all options for treatment of its debt and funding its operating needs, including, but not limited to, initiation of proceedings under laws related to bankruptcy or insolvency,” the filing said."
Article at:
http://www.bizjournals.com/tampabay/news/2016/08/30/struggling-sarasota-biopharma-considering.html
Yes, very interesting article---maybe you should forward to RCPI?
High court overturns former Virginia governor's conviction, Tobacco Industry News Today, SAM HANANE, Jun. 27, 2016
Excerpt:
"A unanimous Supreme Court on Monday threw out the bribery conviction of former Virginia Gov. Bob McDonnell in a ruling that could make it tougher to prosecute elected officials accused of corruption."
Article at:
http://tobacco.einnews.com/article/334120930/x1LMEu3XCng-L5Q9
Posted by: "Allan J. Kvasnicka", CIGX_VIPGROUP
From>Edmund Stephen
To: > See Below
Sent: Wednesday, June 22, 2016 3:16 PM
Posted by: "Allan J. Kvasnicka"
Subject: A matter of importance
This is the final version of what I sent FINRA and The SEC and FL Senators and Congressman
June 22, 2016
FINRA
Richard G. Ketchum, Chairman and CEO Thomas Gira, Executive VP, Market Regulation Susan F. Axelrod, Executive VP Regulatory Operations
CC:
Securities and Exchange Commission Mary Jo White Chairman Andrew Ceresney, Director of the Division of Enforcement Stephen Luparello, Director of the Division of Trading and Markets
Senator Bill Nelson, US Senate Senator Marco Rubio, US Senate Congressman Alan Grayson US Congress
Dear Sirs and Madame;
I am writing you about a serious matter that affects millions of investors and one that has been a well-known grievance that has gone unaddressed for too many years. It is the ability of a sinister group of mostly institutional investors with high-speed computers, elaborate algorithms and superior capital to by-pass rules about shorting, delivering stock and in many cases collusion to destroy new companies who require access to our capital markets to fund their research and growth. This is especially true in the biotech area where research and lengthy regulatory procedures are particularly costly. These hedge funds (and others) can decide the winners and losers by shorting the companies’ stocks to levels that make funding impossible, irrespective of the merits of the science or business. If this were done in a legal way, one might say that the strong should survive, but, as I mentioned, these predators are able to operate around the rules affecting shorting, delivering stock and even collusion. Unfortunately, regulators do little to enforce existing rules, and the result is that some companies end up with millions of shares being traded that are unauthorized, unissued and sold illegally. This means that the perpetrators are literally creating counterfeit shares. This may not come as a surprise to anyone who follows these things closely. The real surprise is that our regulators, whose primary responsibility is to protect the public and to insure orderly markets, seem to be disinclined to do anything about it.
Earlier this month, I wrote the “whistleblower” department of FINRA (my letter follows) about a stock I own that has been a victim of this criminal activity. I was asked for specifics, even though the stock’s trading volume had gone from 88,000 shares a day to over 32,000,000 shares a day in a month and a half (a 36,000% increase and more shares daily than the company had outstanding) and the price was down 98%. The “details” he seeks are embedded in the trading desks and back offices of the firms making markets in the stocks and the institutions “trading” the stock, where I have no access but the regulators, should they decide to enforce the rules, do. I know that they will find that there are many millions of “naked short” shares that have been outstanding for years. I don’t know if anything will come of my complaint, and I know that I shouldn’t expect any follow-up, that’s the untransparent world in which these matters are handled. But there is a far bigger issue involved here, and that’s why I am writing a broader audience. Do we really want to allow winners and losers to be decided in a rigged market? How many biotech companies with wonderful life-saving or life-improving ideas have been destroyed by a handful of greedy (and politically connected) hedge funds able to operate outside the rules? This isn’t just bad business, it has absolutely life-altering consequences, and it is happening every day!
You. the people I have addressed above can make a difference. It is within your power to finally put an end to this illegal activity. Are you willing to address this issue that hurts so many millions of the investors you are empowered to protect? If you are unaware that it is happening, a quick check of “street-savvy” contacts will confirm its wide-spread existence.
I have included in this letter my Congressman and the two senators from Florida for several reasons. First, you are my representatives. Second, the company at issue is headquartered in Florida, and thirdly, you have many constituents in Florida who are retired, invest in the markets and have been victimized by these crimes. I should also add, that as seniors, we are most affected when promising new medicines can never make it past this criminal activity. I will be sending copies of this letter to other members of Congress who have oversight responsibilities.
Sincerely,
Edmund A. Stephan, Jr. Kissimmee,FL 863
My Letter written to FINRA on June 7, 2016
. Dear Sir or Madame:
I am writing about what I see as collusive and manipulative activity in the trading of the common stock of Rock creek Pharmaceuticals (RCPI) over the past three months. This manipulation has occurred while the stock declined 98% and saw its daily volume increase as follows:
March 1.9 Million shares 88.000 shares a day
April 4.4 million shares 212,000 shares a day
May 150 million shares 7,000,000 shares a day
June (first 4 days) 128 million shares 32,000,000 shares a day
In just over two months, the daily volume has gone from 88,000 shares a day to 32,000,000 shares a day up 363 times or a 36,000% increase. During this period, the stock has declined from $.50 to $.011.
The company has fewer than 30 million shares outstanding, so that, on some days it is trading more than the entire number of outstanding shares, and many times its “float.” On Thursday of last week, it traded almost two times the number of outstanding shares. During the period in question, reported institutional liquidations have been minimal and no one has reported a new 5% position. Clearly we can attribute the volume increases to institutions’ manipulative “painting the tape.” This has been predatory and I believe collusive activity and is deserving of a full regulatory investigation. I would suggest a trading halt to balance everyone’s books AND to require sellers to abide by mandatory delivery rules which seem to have been utterly ignored in this situation.
Among the most aggressive sellers (shorters?) have been Maxim Group (MAXM), Knight Capital Group NITE) and Cantor Fitzgerald (CANT).
Biotech companies by their very nature need regular access to capital markets to finance their research and their expensive and lengthy regulatory process. If we allow a small group of predatory institutions with fancy algorithms and high-speed computer access working in total disregard of shorting, delivery and illegal-pool regulations to select winners and losers at the expense of the public and start-up companies, then something is wrong with the system and its requirement to maintain “orderly markets.” I do hope that you will exercise your regulatory authority and look into this matter.
Sincerely,
Edmund A. Stephan, Jr.
Disclosure: I am retired from the securities industry. I am a shareholder of RCPI
SEC Form DEFA14A filed on July 8, 2016
The following document for Rock Creek Pharmaceuticals (OTCQB:RCPI) was filed with the U.S. Securities and Exchange Commission.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 7, 2016
ROCK CREEK PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
000-15324
(Commission File Number)
52-1402131
(IRS Employer Identification No.)
2040 Whitfield Avenue, Suite 300
Sarasota, Florida 34243
(Address of principal executive offices, including zip code)
844-727-0727
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
x Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
ITEM 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT.
On July 7, 2016, Rock Creek Pharmaceuticals, Inc. (the “Company”) entered into an Interim Note Agreement with Hudson Bay Master Fund Ltd. (“Hudson Bay”), a holder of a Senior Secured Convertible Notes in the original principal amount of $13 million issued by the Company in a private placement on October 15, 2015 (the “Hudson Bay Note”). On July 7, 2016, the Company also entered into an Interim Note Agreement with Alto Opportunity Master Fund, SPC (“Alto”), which acquired from the Company a Senior Secured Convertible Note in the original principal amount of $7.0 million also on October 15, 2015 (the “Alto Note”, and together with the Hudson Note, the “Notes”).
Under the Hudson Bay Interim Note Agreement, Hudson Bay agreed that, during the period through August 12, 2016, or such sooner date on which the Company holds its 2016 annual stockholder meeting (the “Interim Period”), Hudson Bay will refrain from selling shares of the Company’s common stock at a price less than $.02 per share (subject to adjustment for stock splits, reverse stock splits, and the like) on which the aggregate composite daily dollar trading volume of the Company’s common stock fails to be at least $225,000, and Hudson Bay will refrain from selling on any trading day an amount of Company common stock equal to more than 30% of the aggregate composite daily trading volume of the Company’s common stock. Under the Alto Interim Note Agreement, Alto agreed that, during the Interim Period, Alto will refrain from selling shares of the Company’s common stock at a price less than $.02 per share (subject to adjustment for stock splits, reverse stock splits, and the like) on which the aggregate composite daily dollar trading volume of the Company’s common stock fails to be at least $225,000, and Alto will refrain from selling on any trading day an amount of Company common stock equal to more than 20% of the aggregate composite daily trading volume of the Company’s common stock.
Under both Interim Note Agreements, the Company has agreed that it will call its annual stockholder meeting for a date no later than August 12, 2016 and will propose and recommend to its stockholders at the meeting a reverse stock split with a range of values of up to a reverse split of one-for-200 shares, with the final value to be determined by the Board of Directors of the Company after the vote.
In connection with the Hudson Bay Interim Note Agreement, the Company issued 8,515,000 shares of common stock to Hudson Bay as conversion shares toward the payment of the Company’s July amortization payment under the Hudson Bay Note. In connection with the Alto Interim Note Agreement, the Company issued 8,315,000 shares of common stock to Alto as conversion shares toward the payment of the Company’s July amortization payment under the Alto Note. After giving effect to the issuance of these conversion shares to Hudson Bay and Alto, as of July 7, 2016, the Company had approximately 170,444,758 shares of common stock outstanding, and the remaining outstanding principal balance of the Notes was approximately $15.1 million in the aggregate.
Under the Hudson Bay Interim Note Agreement, Hudson Bay agreed to consent to the release to the Company of an aggregate of $300,000 from the deposit control account that secures the repayment of the Hudson Bay Note on July 25, 2016 subject to compliance with various equity conditions. Under the Alto Interim Note Agreement, Alto agreed to consent to the release to the Company of an aggregate of $200,000 from the deposit control account that secures the repayment of the Alto Note on July 25, 2016 subject to compliance with various equity conditions. As of July 7, 2016, an aggregate of approximately $10.88 million remains in the Company’s deposit control accounts before giving effect to the anticipated July 25 release.
The foregoing does not purport to be a complete description of the Interim Note Agreements and is qualified in its entirety by reference to the full text of the Interim Note Agreements, a form of which is attached as Exhibit 10.1 to this Form 8-K and is incorporated by reference herein.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS
10.1 Form of Interim Note Agreement, dated July 7, 2016.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ROCK CREEK PHARMACEUTICALS, INC.
By: /s/ Michael J. Mullan
Michael J. Mullan
Chairman of the Board and Chief Executive Officer
Date: July 8, 2016
Scientists believe this common household object could cause Alzheimer's and Parkinson's
16:40, 3 JUL 2016 UPDATED 16:40, 3 JUL 2016
BY IMOGEN ROBINSON
Excerpts:
"Researchers believe copper pipes cause proteins in the brain to misfold, leading to brain damage"
Article at:
http://www.mirror.co.uk/science/scientists-believe-common-household-object-8340028
Part of RCPI history: Supreme Court Vacates Ex-Virginia Governor’s Graft Conviction, New York Times, ADAM LIPTAKJUNE 27, 2016
Article at:
http://www.nytimes.com/2016/06/28/us/politics/supreme-court-bob-mcdonnell-virginia.html?emc=edit_na_20160627&nlid=65292337&ref=cta&_r=0
Rock Creek Pharmaceuticals to Present at the 2016 BIO International Convention and the LD Micro Invitational Conference, News Release Issued: Jun 1, 2016 (8:30am EDT)
"SARASOTA, Fla., June 1, 2016 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (OTCQB: RCPI), a clinical-stage drug development company focused on the application of its lead compound to treat acute and chronic inflammatory conditions, announced today that Michael Mullan, MBBS, Ph.D., Chairman and CEO of Rock Creek Pharmaceuticals, will be presenting the Company's ongoing drug development initiatives, as well as updates to the Company's corporate and regulatory strategy at two upcoming industry and investor conferences."
"Dr. Mullan will first present at the 2016 BIO International Convention on Monday, June 6, 2016 at 3:30PM Pacific Time, in Room 2, at the Moscone Center in San Francisco, California. A live audio/slide webcast will be available on the Company's website and at the following link:
https://www.veracast.com/webcasts/bio/internationalconvention2016/06131287174.cfm
Dr. Mullan will also present at the 6th Annual LD Micro Invitational investor conference on June 9, 2016 at 10AM Pacific Time at the Luxe Sunset Bel Air Hotel in Los Angeles, California. The LD Micro Invitational will feature 195 companies in the small/micro-cap space.
Both conferences will provide a venue to meet with investors, partnering prospects and biotechnology industry participants."
Judge Napolitano Says Fed Investigation Targeting Virginia Gov. McAuliffe Is Connected to Clinton in The Blaze, May. 24, 2016, Dave Urbanski
Excerpts:
"In the wake of reports that Virginia Democratic Gov. Terry McAuliffe is under federal investigation regarding possible illegal campaign contributions, Judge Andrew Napolitano told Fox News that the investigation has ties to Democratic presidential candidate Hillary Clinton.
Democratic gubernatorial candidate, Terry McAuliffe, gestures during an interview in Richmond, Va., Tuesday, Oct. 15, 2013. McAuliffe faces Republican Ken Cuccinelli in the November election. (AP Photo/Steve Helber)
Virginia Gov. Terry McAuliffe (AP Photo/Steve Helber)
Napolitano on Tuesday noted to Fox News that the team investigating McAuliffe also is investigating public corruption allegations against Clinton, specifically whether she made decisions while secretary of state to benefit her husband, former President Bill Clinton, as well as the Clinton Foundation.
“It is in that connection that Terry McAuliffe’s name came up, because he was the nominal head of the foundation during that period,” Napolitano told Fox News."
Article at:
http://www.theblaze.com/stories/2016/05/24/judge-napolitano-says-fed-investigation-targeting-virginia-gov-mcauliffe-is-connected-to-clinton-heres-how/
Rock Creek Pharmaceuticals Inc (OTCMKTS:RCPI) Finally Bounces
Excerpts:
"To say Rock Creek Pharmaceuticals Inc (OTCMKTS:RCPI) has been a horrible investment is an understatement. Bad management combined with toxic financings destroyed a company that many had thought had such great promise. Now after hitting 52 week lows and putting in a double bottom on the charts, investors are asking if this bounce is for real and will it last?
Rock Creek Pharmaceuticals Inc is an emerging drug development company focused on the discovery, development and commercialization of new drugs, formulations and compounds that provide therapies for chronic and acute inflammatory diseases. Its compound is a small molecule, cholinergic agonist that exhibits anti-inflammatory pharmacological characteristics, distinct from other anti-inflammatory drugs available such as biologics, steroids and non-steroidal anti-inflammatories. The Company’s lead compound has been investigated extensively in pre-clinical (in vitro and in vivo) studies resulting in several peer reviewed and published scientific journal articles, covering models of multiple sclerosis, Alzheimer’s disease, and autoimmune thyroiditis. All these studies demonstrated the anti-inflammatory effects of the Company’s compound. In addition, the Company’s compilation of human exposure safety and tolerability data, has provided important insights for ongoing clinical and regulatory pharmaceutical development.
In the first quarter, RCPI recorded a net loss of $2.7 million for the three months ended March 31, 2016, compared to a net loss of $338 thousand for the same period in 2015. The net loss for the three months ended March 31, 2015 included a one-time receipt of $3.5 million of insurance proceeds. General and administrative expenses were $1.2 million for the three months ended March 31, 2016, a 63% decrease of $2.1 million, from $3.3 million for the same period in 2015. CEO Dr Michael Mullan said:
“As reflected in today’s filing, apart from advancement of the Company’s clinical program, the Company’s past legal challenges are also beginning to ameliorate. We are pleased that we have recently resolved the consumer class action lawsuit and we have made favorable progress on other legal matters, the details of which are included in today’s filing. The Company continues to move forward with our focus on psoriasis and dermatological skin diseases, as a means to attaining proof of concept for our compound. Our drug has a novel anti-inflammatory mechanism of action, and contingent upon continued access to sufficient capital, we expect to test its therapeutic potential in our Phase IB Psoriasis study in Q4 of 2016.”
One of the problems facing the company is that its Phase IB Psoriasis study is still a long ways off. The company needs to deliver some news in the meantime and we think the answer lies in its IP portfolio. The Company’s IP portfolio currently includes a composition of matter patent for anatabine citrate, a patent for large scale anatabine synthesis, and numerous US and foreign patents pending for “use” of anatabine and salts thereof, and its isomers and derivatives for inflammatory conditions. Those conditions include, but are not limited to, such diseases as psoriasis, thyroiditis, arthritis, Alzheimer’s disease, and multiple sclerosis, as well as a recently published “patent pending” application for use of anatabine in various conditions of inflammatory lung disease. We see great value in its IP and makes RCPI certainly worth more than $.02 per share. RCPI recently said:
Rock Creek Pharmaceuticals had retained a major, national intellectual property advisory and investment bank (IP Advisor) to value and monitor the growth of the Company’s IP. Since that disclosure, the Company has achieved a number of milestones, further developed the Company’s clinical assets, and defined and embarked upon a commercial development pathway in dermatology, all of which has reinforced and enhanced the Company’s IP positions. Given the current market capitalization of the Company, together with the Company’s belief that its assets and technology are undervalued in the market place, management has decided to re-engage the IP Advisor to recalculate and update the valuation analysis of the Company’s intellectual property. This may position the Company for potential alternative capital sourcing strategies."
Article at:
http://www.insiderfinancial.com/rock-creek-pharmaceuticals-inc-otcmktsrcpi-finally-bounces/115607/
The Zombie Apocalypse, Part 2, Tech Digest, PATRICK COX MAY 23, 2016
Patrick Cox talks about Alzheimers and the Zika virus. Interesting that he says: "AD is a particularly difficult disease to treat because it has many causes, all related to aging. It may be, in fact, that the only true cure for Alzheimer’s is to be found in anti-aging therapeutics."
Read at:
http://www.mauldineconomics.com/tech/tech-digest/the-zombie-apocalypse-part-2
Rock Creek Pharmaceuticals, Buy, Maxim Group, May 17, 2016
Email from Ted Jenkins PR link:
https://groups.yahoo.com/neo/groups/CIGX_VIPGROUP/attachments/1122024198;_ylc=X3oDMTJyb3RuOGtlBF9TAzk3MzU5NzE0BGdycElkAzc0Nzk0NTAwBGdycHNwSWQDMTcwNTAwMTc3OQRzZWMDYXR0YWNobWVudARzbGsDdmlld09uV2ViBHN0aW1lAzE0NjM0OTA0OTg-
Tech Digest---More Evidence Vitamin NR Extends Life Spans, BY PATRICK COX MAY 16, 2016
Extending life span using a vitamin NR may help keep seniors healthy.
See at:
http://www.mauldineconomics.com/tech/tech-digest/more-evidence-vitamin-nr-extends-life-spans
PDF New Rock Creek Presentation at:
http://investors.rockcreekpharmaceuticals.com/presentations-and-webinars?item=25
Rock Creek Pharmaceuticals Provides Clinical Update and Announces 2016 First Quarter Results
May 16, 2016
Excerpts:
"Rock Creek Pharmaceuticals, Inc., (OTCQB: RCPI), a clinical-stage drug development company focused on the application of its lead compound to treat acute and chronic inflammatory conditions, today filed its 2016 first quarter report on Form 10-Q with the Securities and Exchange Commission and provided clinical commentary and review on the Company's operations for its first quarter.
Rock Creek Pharmaceuticals
Topical Drug Product Development
The Company has developed a range of anatabine cream and ointment topical formulations to move forward in pre-clinical and clinical development. Preclinical testing to date has shown the ointment demonstrates good stability and performance in skin delivery and permeation testing. The ointment formulations will therefore be advanced into clinical development.
Pre-Clinical Models of Psoriasis
The Company has initiated a second pre-clinical study of psoriasis using the imiquimod (IMQ)-induced psoriasis mouse model. This model recapitulates many features of the pathology of human psoriasis such as erythema, scaling, keratinocyte proliferation, skin thickening and activation of IL23, IL17 and IL22 cytokines. Although data are still being evaluated, the Company's initial findings show reduction in the proliferation of skin cells (keratinocytes) which characterize human psoriatic plaques. The Company's recent Investor Presentation, filed on May 16, 2016, on Form 8-K, contains a brief discussion of the IMQ model, highlighting epidermal staining of representative skin sections. The pictorial representation is self-evident, showing anatabine's ability to reduce keratinocyte proliferation induced by IMQ. The Company is encouraged by anatabine's potential efficacy in dermatological disease, and is currently quantifying and evaluating the psoriasis model data for submission for peer review publication. Further, these data will be helpful in designing the Company's Phase IB human proof of concept study and may potentially enhance the Company's intellectual property position.
The May 16 Investor Presentation also highlights the results of the TPA-irritant psoriasis mouse model, where the proliferation of keratinocytes was also significantly reduced. Complementary results show significant reductions in activation of STAT3 and NF-kB, two critical regulators of inflammation (see below).
Clinical Activities
The Company's upcoming Phase IB psoriasis study is being designed to achieve several goals: First, although the Company has conducted successful oral Phase I systemic safety studies, it is required that the Company's new anatabine topical formulations are also formally evaluated for human safety. A primary goal of this study will therefore be the evaluation of safety and tolerability of different doses of the topical formulations. Second, the Phase IB is being designed to evaluate human clinical efficacy of anatabine citrate on psoriasis. The standard evaluation of efficacy is visual inspection and scoring of the psoriatic plaques by experts. These observations will be supplemented in our study with ultrasonography and pathological evaluation of skin biopsies. These will allow assessment of the impact of our drug on the depth of the psoriatic lesion and the degree of infiltration of inflammatory cells, among other parameters. Finally, the Company will be collecting biomarker data from the skin biopsies. In particular, we will measure the activity of NFK-B and STAT3, which have been previously identified as critical regulators of inflammation. A great deal of scientific and clinical work performed by the Company and others suggests that the Company's drug will suppress inflammation by inhibiting the activation of these regulators of gene activity. Verification of the relationship between reduced activation of these transcription factors and reduced psoriatic pathology will be regarded as further evidence of anatabine's mechanism of action. Further, if the overall results are positive, this study will provide the proof of concept that the mechanism of action of our compound can potentially be therapeutic, not only in dermatological disorders, but in other inflammation driven human diseases as well.
To support its clinical plan, the Company has undertaken a dermal toxicity program, which will allow the safe dosing of psoriasis patients in the dermal clinical studies. By careful species selection, this dermal toxicity testing program will confirm the range of anatabine citrate concentrations for dosing in the Phase IB study, but will also support multiple clinical study protocols for a follow on Phase IIa/II psoriasis trial in 2017.
Atopic Dermatitis Pre-Clinical Model
In addition to its work in psoriasis, the Company has expanded its dermatological focus to determine whether anatabine has applicability in atopic dermatitis (AD) or "eczema". Recent forecasts suggests that this market, within a number of major countries, will grow to in excess of $5B by the early part of the next decade, growing at a compound annual growth rate of close to 4%. Accordingly, the Company has been evaluating anatabine's attributes in a chronic mouse model of TMA-induced contact hypersensitivity, a pre-clinical model for AD, known simply as the TMA model. This well-studied model of chemical sensitization shows many of the features of AD, including swelling, inflammatory cell infiltration and inflammatory marker/cytokine increase. Initial observations and early results show that swelling associated with AT in this model is decreased with treatment by both anatabine citrate cream and anatabine citrate ointment. Importantly, the proliferation of the epidermal keratinocytes produced by TMA is also opposed by the anatabine derived topical therapeutics. Further detailed analyses are ongoing, however, pictorial representations of anatabine's effect through skin section epidermal staining, and graphical data measurements of reduced ear thickness in affected mice, are also included in the recent Investor Presentation. More detail on the Company's plans for atopic dermatitis will be conveyed later in the year.
Executive Commentary
Michael Mullan (MBBS, PhD), Chairman and Chief Executive Officer of Rock Creek Pharmaceuticals, commented, "As reflected in today's filing, apart from advancement of the Company's clinical program, the Company's past legal challenges are also beginning to ameliorate. We are pleased that we have recently resolved the consumer class action lawsuit and we have made favorable progress on other legal matters, the details of which are included in today's filing."
Dr Mullan added, "The Company continues to move forward with our focus on psoriasis and dermatological skin diseases, as a means to attaining proof of concept for our compound. Our drug has a novel anti-inflammatory mechanism of action, and contingent upon continued access to sufficient capital, we expect to test its therapeutic potential in our Phase IB Psoriasis study in Q4 of 2016."
Press Release at:
http://investors.rockcreekpharmaceuticals.com/2016-05-16-Rock-Creek-Pharmaceuticals-Provides-Clinical-Update-and-Announces-2016-First-Quarter-Results
The Quest for Immortality-Radical Life Extension vs. Anti-Aging, PATRICK COX MAY 9, 2016
Patrick Cox has published his latest Tech Digest newsletter. In it he discusses the recent gene therapy research on life extension by Dr William Andrews and Elizabeth Parrish. Cox has recorded a video where he discusses with Andrews/Parrish the research.
See at:
http://www.mauldineconomics.com/tech/tech-digest/radical-life-extension-vs.-anti-aging
My comments: In the past, there were discussions that Anatabine Citrate via it's anti-inflammatory action slowed the shortening of Telemorese in addition/or part of reducing chronic inflammation. This article/video takes a quantum jump in not slowing but lengthening Telemorese.
Watch the video of Dr Seneff. She starts at about 19.20 into the video. Could it be that she has found the major cause of autoimmune disorders and it's rise? All the articles about Alzheimers, IBD, Parkinson's, Diabetes, etc and their relationship to chronic inflammation appear to be linked to our use of GMO foods treated with Glyphosate herbicides. What do you think?
Autism Rates To Increase By 2025? Glyphosate Herbicide May Be Responsible For Future Half Of Children With Autism says Dr. Stephanie Seneff, Susan Scutti,
Medical Daily, Jan 5, 2015
My comments: Note the RCPI patent for Autism application
Excerpts:
"By 2025, half the children born in the United States will be diagnosed with autism, says Dr. Stephanie Seneff, a senior research scientist at the MIT Computer Science and Artificial Intelligence Laboratory. “Is there a toxic substance that is currently in our environment on the rise in step with increasing rates of autism that could explain this?” She asks in a 2013 presentation (video below) sponsored by Wellesley League of Women Voters. “The answer is yes, I’m quite sure that I’m right, and the answer is glyphosate.
Glyphosate, according to the Environmental Protection Agency, is a herbicide registered for use on a variety of fruit, vegetable, and field crops and widely used to control weeds. It is the active ingredient in RoundUp, a product made by Monsanto, which ranks as the number one herbicide worldwide. On the rise in China, RoundUp is a particular favorite in America, where genetically modified (GM) crops are bred to resist damage from the product — it kills the weeds, essentially, without hurting the GM plants.
According to Seneff, urine testing shows Americans have 10 times the glyphosate accumulation as Europeans. Even worse, the chemical is present in unusually high quantities in the breast milk of American mothers. Seneff refers to glyphosate as “a deceptively simple molecule” that kills by interrupting the shikimate pathway in weeds and other pest plants. Because our human cells don’t have this same pathway, scientists and researchers mistakenly assume glyphosate exposure is harmless to us. However, the flora residing in our intestines (where they help us digest food) do have a shikimate pathway, and so when glyphosate kills these beneficial bacteria, it harms our immune system. This science is explained in a paper, which Seneff wrote with co-author Anthony Samsel and appears in the online journal Entropy."
Article at:
http://www.medicaldaily.com/autism-rates-increase-2025-glyphosate-herbicide-may-be-responsible-future-half-316388
How Elizabeth Parrish Reversed Her Biological Age by 20 Years —and the Emergence of DIY Biotech, PATRICK COX MAY 2, 2016
Excerpts near bottom of article:
"Another example of an amateur scientist letting his enthusiasm for science lead to trouble is the Bob McDonnell corruption case. I’m not so interested in McDonnell’s fate as I am in the man the media has accused of corrupting him.
He’s self-taught scientist Jonnie Williams. It’s only now coming out that the notoriously generous Williams didn’t try to get the governor to promote his product, as was widely misreported. Rather, he wanted McDonnell to propose to the University of Virginia to investigate the compound.
Williams didn’t ask anyone to falsify data, and the governor didn’t pressure the university to do the research. Other major scientific institutions such as Johns Hopkins Medical and the Roskamp Institute were also seriously investigating the compound and have generated historic and unprecedented data."
"I don’t believe any of this would have happened to Williams if he had the right letters, like MD or PhD, behind his name. Because he is a self-taught scientist, the media could portray him as a snake oil salesman, despite massive evidence that the compound is a major scientific breakthrough—which is now going through clinical trials in Great Britain.
I expect Elizabeth Parrish to be treated similarly, even if her data is great. There are forces that will always resist the intrusion of upstart amateurs into biotechnology. The falling cost of biotech tools will, however, produce more and more amateur scientists like Parrish and Williams."
Read the entire article at(and subscribe):
http://www.mauldineconomics.com/tech/tech-digest/how-elizabeth-parrish-reversed-her-biological-age-by-20-years-and-the-emerg
Rock Creek Pharmaceuticals, Inc. (NASDAQ:RCPI) ABR Of 1
May 1, 2016 10:32 am·
Excerpts:
"Analysts have a buy call on Rock Creek Pharmaceuticals, Inc. (NASDAQ:RCPI) stock. As of 2016-04-30, it had an ABR of 1. The rating is fixed on a scale of 1-5. Here three stands for hold call. This analyst brokerage rating computation is based on 1 calls.
The one-year target of Rock Creek Pharmaceuticals, Inc. (NASDAQ:RCPI) stock is $4 and the median target is $4. The range varies in between $4 and $4, indicating a standard deviation of 0%.
Zacks conducts its research on the broad scale and assigns ABR to stocks on behalf of several investment sites. The rating can be stated as the mean of research calls of different brokerages on a stock. ABR can come in decimals while Rank assigned by Zacks comes only in whole numbers."
Article at:
http://theenterpriseleader.com/analyst-research/rock-creek-pharmaceuticals-inc-nasdaqrcpi-abr-of-1/97028/
Alzheimer's risk higher in people with rosacea, Medical News Today,
Catharine Paddock PhD, April 28, 2016
Excerpt:
"When they analyzed the data, the researchers found that compared with patients who did not have the skin complaint, those with rosacea had a 7 percent increased risk of dementia and a 25 percent increased risk of Alzheimer's disease, with older people at the higher risk end."
Article at:
http://www.medicalnewstoday.com/articles/309658.php
SUPREME COURT-Judges seem poised to overturn McDonnell conviction, Tobacco Industry News, April 28, 2016
Excerpt:
"WASHINGTON — The Supreme Court could make it tougher for the government to crack down on public corruption, signaling Wednesday that it may overturn former Virginia Gov. Bob McDonnell’s federal bribery conviction"
Article at:
http://tobacco.einnews.com/article/323664241/QpDXmPt20H49pVtu
"The Anti-Aging Pill, An anti-aging startup hopes to elude the U.S. Food and Drug"
My comments: Worth watching to see if they run into problems with the FDA.
Article at:
https://www.technologyreview.com/s/534636/the-anti-aging-pill/
Worth watching:
"Neurophage Pharma may be able to treat Alzheimers, Parkinsons, Huntingtons and other brain diseases (in Next Big Future)
alzheimer's, brain, disease, medicine, parkinson's disease, science, virus
Facebook Twitter linkedin google Reddit
Israeli scientist named Beka Solomon, a professor at Tel Aviv University, made a serendipitous discovery one day when she was testing a new class of agents against Alzheimer’s disease. If it pans out, it might mark the beginning of the end of Alzheimer’s, Parkinson’s, and many other neurodegenerative diseases. It’s a remarkable story, and the main character isn’t Solomon or any other scientist but a humble virus that scientists refer to as M13.
Among the many varieties of viruses, there is a kind that only infects bacteria. Known as bacteriophages, or just phages, these microbes are ancient (over three billion years old) and ubiquitous: they’re found everywhere from the ocean floor to human stomachs. The phage M13’s goal is to infect just one type of bacteria, Escherichia coli, or E. coli, which can be found in copious amounts in the intestines of mammals. Like other microorganisms, phages such as M13 have only one purpose: to pass on their genes. In order to do this, they have developed weapons to enable them to invade, take over, and even kill their bacterial hosts. Before the advent of antibiotics, in fact, doctors occasionally used phages to fight otherwise incurable bacterial infections.
Neurophage Pharmaceuticals is a company formed around using the key proteins of the M13 virus to treat disease.
M13 phage-treated mice had 80% fewer plaques than untreated ones.
They were able to show the M13 phage dissolved amyloid-beta plaques when the phage was delivered through the rodents’ nasal passages. Over the next two years, researchers at NeuroPhage discovered something totally unexpected: the M13 virus could also dissolve other amyloid aggregates—the tau tangles found in Alzheimer’s and also the amyloid plaques associated with other diseases, including alpha-synuclein (Parkinson’s), huntingtin (Huntington’s disease), and superoxide dismutase (amyotrophic lateral sclerosis). The phage even worked against the amyloids in prion diseases (a class that includes Creutzfeldt-Jakob disease). Fisher and his colleagues demonstrated this first in test tubes and then in a series of animal experiments. Astonishingly, the simple M13 virus appeared in principle to possess the properties of a “pan therapy,” a universal elixir of the kind the chemist Chris Dobson had imagined.
The M13 phage's special abilities involved a set of proteins displayed on the tip of the virus, called GP3.
NPT088 uses GP3 proteins.
NeuroPhage’s lead candidate, NPT088 is a differentiated drug candidate because it targets a variety of toxic misfolded proteins with applications in Alzheimer’s, Parkinson’s and many rare diseases.
Neurophage is a private company launched in 2008 and has raised over $50 million to date from Mérieux Développement, Shire LLC and private investors and foundations.
SOURCES - Neurophage Pharmaceuticals, PBS"
Article at:
http://nextbigfuture.com/2016/03/neurophage-pharma-may-be-able-to-treat.html
TBI Article by Dr Fiona Crawford:
'Allan J. Kvasnicka' AJKvas@sbcglobal.net [CIGX_VIPGROUP] <CIGX_VIPGROUP@yahoogroups.com> Today at 3:27 AM
To
CIGX_VIPGROUP@yahoogroups.com
Message body
Thanks to pharma_treasure on Yahoo RCPI message board ------
Latest studies: Brain disease from contact sports
New ESPN article on TBI as related to the NFL, where Dr. Fiona Crawford’s research and comments are cited.
Google
Latest studies: Brain disease from contact sports more common
"At the Roskamp Institute in Sarasota, Florida, researchers are using mice to try to show how the buildup of tau protein may occur in response to blows to the head. After a single hit or even five hits over a short period of time, the researchers did not see any persistent effects on tau in the brains of the mice.
The researchers then developed a new chronic injury model, striking the mice twice a week over a period of three months, an approach intended to mimic sports-related head trauma and referred to internally as "the NFL model." The researchers, after the mice were euthanized, studied their brains and saw persistent changes in tau, months after the injury, consistent with some of the changes that have been seen in former NFL players with CTE.
"It does change the pathology for the worse," said Dr. Fiona Crawford, president and CEO of the Roskamp Institute and director of its Traumatic Brain Injury Research Program. "What we do really has opened my eyes, and it's quite scary."
HOW DOES THE ABOVE RELATE TO RCPI AND WHAT IS ITS SIGNIFICANCE?
Dr. Fiona Crawford has a ~ $750K grant from the USDD to study GWI using Anatabine Citrate (AC). Dr. Crawford is right in the middle of TBI research, CTE research, GWI research AND AC IS RIGHT IN THE MIDDLE OF DR. CRAWFORD’S THINKING! I welcome you all to read between the lines.
Have a great weekend,
AJK
Judge tosses false claims class action vs makers of 'wonder drug' supplement Anatabloc, Scott Holland, Feb. 12, 2016, 1:51pm
Posted by: "Allan J. Kvasnicka on CIGX_VIP Group
Excerpts:
"“The Amended Complaint states, for example, that Baldwin viewed Star Scientific’s investor statements regarding Anatabloc’s ability to treat inflammation. It does not identify any specific investor statement, however, nor does it specify the content of these statements, or when or where Baldwin read them.”
Though the amended complaint contended the defendants used studies of questionable scientific value to promote Anatabloc, Pallmeyer said Baldwin and Van Norman failed to “identify scientific studies or other evidence showing that Anatabloc was ineffective at treating inflammation.”
Pallmeyer dismissed the entire amended complaint, though three counts were dismissed without prejudice, leaving Baldwin and Van Norman 21 days to file another amended complaint with respect to those claims."
Article at:
http://cookcountyrecord.com/stories/510663283-judge-tosses-false-claims-class-action-vs-makers-of-wonder-drug-supplement-anatabloc
Worth Rereading---A New Look at Brain Inflammation in Alzheimer's `in News, Dana Foundation, Jim Schnabel, January 16, 2013
Excerpts:````
"Since the late 1980s, various studies have found hints that the chronic inflammation found in Alzheimer’s hastens the disease process, and may even be a disease trigger. A history of serious head injury, which typically causes brain inflammation, is known to be a risk factor for Alzheimer’s. Systemic infection—another cause of inflammation—also appears to accelerate the disease. Several epidemiological studies have found that older people who use anti-inflammatory drugs regularly appear to have significantly lower incidences of Alzheimer’s.
The value of those epidemiological studies came into question several years ago, when more rigorous placebo-controlled clinical trials of anti-inflammatory drugs—ibuprofen, naproxen, and celecoxib, for example—failed to show signs of helping people who already have Alzheimer’s dementia or early cognitive impairment. In some cases these drugs apparently accelerated the course of the disease. Yet in a little-publicized study, published in late 2011, naproxen seemed to have a marked effect in preventing the disease: It reduced the incidence of Alzheimer’s among elderly people who started out cognitively normal and took the drug for more than two years".
"Frank Heppner, Burkhard Becher, and their laboratories in Germany and Switzerland reported in November 2012 on experiments with two closely related inflammation-promoting proteins, IL-12 and IL-23. The proteins are among those pumped out by microglia when the cells become immunologically active, and the researchers found signs that the proteins exist at elevated levels in the cerebrospinal fluid of people with Alzheimer’s. Blocking the two proteins in young “Alzheimer’s mice”—in this case a two-mutant-gene model that is normally quite resistant to amyloid-reducing therapies—prevented most of the usual buildup of amyloid plaques. Blocking these inflammatory proteins in older Alzheimer’s mice, whose brains were already plaque-ridden, reduced soluble, more toxic forms of amyloid beta, and reversed the mice’s cognitive deficits.
A therapy, ustekinumab, that simultaneously blocks IL-12 and IL-23 (by blocking a molecular subunit found in each) is already FDA-approved for treating psoriasis. Heppner, whose laboratory is at Charité teaching hospital in Berlin, would like to understand better how the IL-12/23-blocking treatment really works against the disease, and improve upon the strategy if possible. He suspects that microglial-produced IL-12 and IL-23 may stem the activity of astrocytes, helper cells that also have a role in neuroinflammation and the clearance of amyloid beta. In any case, he says, given the availability of an approved and apparently well-tolerated IL-12/23-blocking drug, “I think it’s not unfeasible to even go directly into patients [for clinical trials] right now.”
"The new inflammation hypothesis
How each of these inflammation pathways relates to the Alzheimer’s disease process is not yet clear. But in the MRP14 study, Heneka and his colleagues found that the protein doesn’t just push microglia into an activated, inflammatory state. It also somehow increases the presence and activity of a neuronal enzyme, BACE1, that helps to produce amyloid beta, and thus increases amyloid beta production. Heneka suspects that inflammation helps to start the disease process by boosting the production of amyloid beta—and then helps to sustain the process by reducing the ability of microglia to remove amyloid beta. A key point is that amyloid beta accumulation seems to be both a cause and an effect of chronic inflammation.
“Usually inflammation is there to limit the invasion of foreign bacteria or viruses or parasites, and once these are removed, then the inflammation is resolved by anti-inflammatory mechanisms,” Heneka says. “But in the [Alzheimer’s] brain, there is the constant detection of the ongoing amyloid beta deposition, which does not allow the inflammation to resolve.”
Inflammation as an actor
The idea that inflammation doesn’t just add to Alzheimer’s, but also helps to get it started, has been supported by the recent development, in Knuesel’s laboratory, of mice that seem to mimic the process. Unlike other Alzheimer’s-model mice, Knuesel’s have not been genetically engineered to produce excess amyloid beta or mutant tau. They are normal lab mice that have been injected twice—once in the womb and later in adulthood—with virus-mimicking molecules that cause chronic neuroinflammation.
Analyses of the brain changes in these mice, and comparisons to brain tissue from people with Alzheimer’s, suggest to her that inflammation may help trigger Alzheimer’s by exacerbating a common age-related problem with neurons. As they get older and their functions become less efficient, neurons lose their ability to transport and properly dispose of proteins. [See recent Dana briefing paper.] This decline is apt to show up first in neurons’ output stalks, or axons, which, being long and thin, are particularly vulnerable to a disruption of their internal transport systems. If enough proteinaceous waste builds up in an axon, it will swell—a feature often seen in Alzheimer’s brains—and may try to bubble off a waste-filled granule, which will then be consumed by nearby microglia.
Inflammation worsens this problem in several ways: First, it increases the production of amyloid-beta in inflamed regions. Second, it stresses neurons and hastens the age-related decline of their protein-transport and disposal systems. Third, it pushes microglia into a reactive, inflammatory state and thus reduces their ability to clear up axons’ expelled waste.
Eventually this proteinaceous waste builds up outside damaged axons. Much of it will consist of amyloid beta and its aggregates. Some of these aggregates will clump together in plaques, and all of them will further inflame microglia, leading into a vicious cycle of amyloid beta deposition, inflammation, and neuronal damage. Ultimately the damaged axons will degenerate, their downstream synaptic terminals will die, the rest of their neuronal bodies will die, and the neuronal networks to which they belonged will stop functioning properly. In some cases, especially familial, early-onset Alzheimer’s, excess production or aggregation of amyloid beta might be the main initiator of the process – but for ordinary late-onset Alzheimer’s, aging and inflammation might be the most common triggers."
Article at:
http://www.dana.org/News/Details.aspx?id=43258
Also see:
http://www.nhs.uk/news/2012/11November/Pages/Psoriasis-drug-could-hold-key-to-dementia-treatment.aspx
Sooooo----Does Mullan know something we don't? Why is he pushing psoriasis now? Is he connecting the dots?
Anatabine Citrate discussed by Patrick Cox in his latest newsletter:
http://www.mauldineconomics.com/tech/tech-digest/macrophages-obesity-and-the-arrival-of-winter-in-the-subtropics
Scientists May Have Just Discovered The Key To Halting Alzheimer's in HuffPost Science, Carolyn Gregoire, 01/11/2016
Excerpts:
"Curbing brain inflammation may help people treat and prevent Alzheimer's disease, according to a landmark new study."
"[b]An overactive immune system can result in chronic inflammation, which previous research has linked to Alzheimer's. These new findings makes it increasingly apparent that inflammation is not a result of Alzheimer's as much as a key driver of the disease[/u]. "
"With an aging population and no new dementia drugs in over a decade, the need to find treatments that can slow or stop disease progression is greater than ever."
""These findings are as close to evidence as we can get to show that this particular pathway is active in the development of Alzheimer's disease," Gomez-Nicola said in a statement. "The next step is to work closely with our partners in industry to find a safe and suitable drug that can be tested to see if it works in humans.""
Article at:
http://www.huffingtonpost.com/entry/brain-inflammation-alzheimers_568fff10e4b0a2b6fb6fe1c4?cps=gravity_5043_-3062563892598735393&kvcommref=mostpopular
Berberine---may be worth looking at. Another natural ingredients big Pharma doesn't want you to know about. ~Has reduced my pre-diabetic blood sugar from the 120 to 140 range to below 100 after 4 weeks dosing at 400 mg/3 x day, before meals.
Excerpt from Wikipedia:
"Diabetes, dyslipidemias and cardiovascular conditions[edit]
During the last few decades, many studies have shown berberine has various beneficial effects on the cardiovascular system and significant anti-inflammatory activities.[19] A Canadian report suggested berberine can effectively reduce intracellular superoxide levels in LPS-stimulated macrophages. Such a restoration of cellular redox by berberine is mediated by its selective inhibition of gp91phox expression and enhancement of SOD activity.[20]
Berberine exerts up-regulating activity on both the low-density-lipoprotein receptor (LDLR) and the insulin receptor (InsR). This one-drug-multiple-target characteristic might be suitable for the treatment of metabolic syndrome.[21][22]
Diabetes mellitus[edit]
Berberine has been tested and used successfully in experimental[23][24] and human diabetes mellitus.[25][26][27][28]
Berberine has been shown to lower elevated blood glucose as effectively as metformin.[29] The mechanisms of action include inhibition of aldose reductase,[30] inducing glycolysis,[31] preventing insulin resistance[32][33] through increasing insulin receptor expression[26] and acting like incretins.[34] A new study suggested berberine may overcome insulin resistance via modulating key molecules in insulin signaling pathway, leading to increased glucose uptake in insulin-resistant cells.[35]
Berberine might exert its insulinotropic effect in isolated rat islets by up-regulating the expression of hepatocyte nuclear factor 4 alpha, which probably acts solely or together with other HNFs to modulate glucokinase activity, rendering ß cells more sensitive to glucose fluctuation and to respond more effectively to glucose challenge.[36]
Berberine seems to inhibit human dipeptidyl peptidase-4 (DPP4), as well as the prodiabetic target human protein tyrosine phosphatase 1B (h-PTP 1B), which explain at least some of its antihyperglycemic activities.[37] Berberine suppresses intestinal disaccharidases with beneficial metabolic effects in diabetic states.[38]
A recent comprehensive metabolomics method, applied to 60 type 2 diabetics, suggested administration of berberine down-regulates the high level of free fatty acids which are known to be toxic to the pancreas and cause insulin resistance. These results suggest berberine might play a pivotal role in the treatment of type 2 diabetes, concluded the authors.[25]
Berberine has been shown to boost the effects of metformin and 2,4-thiazolidinedione (TZD), and can partly replace the commercial drugs, which could lead to a reduction in toxicity and side effects of the latter.[39]
Berberine inhibits FOXO1,[40] which integrates insulin signaling with mitochondrial function. Inhibition of Foxo1 can improve hepatic metabolism during insulin resistance and the metabolic syndrome.[41]"
"Cancer[edit]
Berberine has drawn extensive attention towards its antineoplastic effects.[64][65] It seems to suppress the growth of a wide variety of tumor cells, including breast cancer,[66] leukemia, melanoma,[67] epidermoid carcinoma, hepatoma, pancreatic cancer,[68] oral carcinoma, tongue carcinoma,[69] glioblastoma, prostate carcinoma and gastric carcinoma.[70][71] Animal studies have shown that berberine can suppress chemical-induced carcinogenesis, clastogenesis,[72] tumor promotion, tumor invasion,[73][74][75][76][77] prostate cancer,[78][79][80][81] neuroblastoma,[82][83] and leukemia.[49][84]
It is a radiosensitizer of tumor cells, but not of normal cells. How berberine mediates these effects is not fully understood, but its ability to inhibit angiogenesis and to modulate Mcl-1, Bcl-xL, cyclooxygenase (COX)-2, MDR, tumor necrosis factor (TNF)- and IL-6, iNOS, IL-12, intercellular adhesion molecule-1 and ELAM-1 expression, MCP-1 and CINC-1, cyclin D1,[85] activator protein (AP-1), HIF-1, PPAR-, and topoisomerase II has been shown. By using yeast mutants, berberine was found to bind and inhibit stress-induced mitogen-activated protein kinase kinase activation. Because apoptotic, carcinogenic, and inflammatory effects and various gene products (such as TNF-a, IL-6, COX-2, adhesion molecules, cyclin D1, and MDR) modulated by berberine are regulated by the transcription factor nuclear factor- B (NF- B), it is postulated this pathway plays a major role in the action of berberine.[86] Berberine suppressed NF-?B activation induced by various inflammatory agents and carcinogens. This alkaloid also suppressed constitutive NF-?B activation found in certain tumor cells. It seems to protect against side effects of radiation therapy in lung cancer.[87] However, new studies suggest that while berberine decreases cell growth, it increases the side population (stem cell) fraction of H460 lung cancer cells.[88] In lung cancer it can also act through suppression of TGF-ß1-induced epithelial-to-mesenchymal transition.[89] Berberine enhances chemosensitivity to some chemotherapeutic agents like irinotecan .[90]"
Article at:
https://en.wikipedia.org/wiki/Berberine
Another hint at Anatabine Citrate?
New Drug for Severe Form of Arthritis Shows Promise in Trial in Drugs.com, Dec. 23, 2015
Excerpts:
"A drug recently approved for the skin condition psoriasis may also help people with a debilitating form of arthritis that attacks the spine, a new clinical trial finds."
"Almost 3 million Americans have ankylosing spondylitis, according to the U.S. Centers for Disease Control and Prevention. The disease is usually diagnosed in young people, before the age of 40.
The exact cause is unknown, but spondylitis does involve abnormal immune system activity that triggers chronic inflammation in the spine. A few gene variants have been linked to an increased risk of the disease -- and it's thought that some mix of genes and environment is to blame, according to the Spondylitis Association of America."
"Zashin saw the results as encouraging for spondylitis patients who are not getting relief from current treatments. "There is an entirely new class of drugs on the horizon that might be of benefit for them," he said."
Article at:
http://www.drugs.com/news/new-severe-arthritis-shows-promise-trial-59517.html?utm_source=ddc&utm_medium=email&utm_campaign=Weekly+Drug+News+Round-Up%3A+December+23%2C+2015&utm_content=New+Drug+for+Severe+Form+of+Arthritis+Shows+Promise+in+Trial
Public Enemy No. 1: Inflammation: The Health Breakthroughs of 2015,
Men's Journal, December 15, 2015
Article at:
https://www.google.com/url?rct=j&sa=t&url=http://www.mensjournal.com/health-fitness/health/public-enemy-no-1-inflammation-the-health-breakthroughs-of-2015-20151214&ct=ga&cd=CAEYACoTOTA5NDI0NjU3NzQ3MzE3MzcwNTIaMDA5YTI5MDc0ZGYzYmNlZTpjb206ZW46VVM&usg=AFQjCNE_GZJUsH4_IEjRstVorFJ4G5BsHg
I stand corrected, thanks Leifsmith
Rock Creek Pharmaceuticals to Present at Biotech Showcase 2016
Dec 10, 2015
Excerpts:
"SARASOTA, Fla., Dec. 10, 2015 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (OTCQB: RCPI), a clinical stage, drug development company which is focused on the application of its lead compound to treat chronic inflammatory conditions, announced today that the Company will present at Biotech Showcase 2016 on Monday, January 11, 2016 at 10:00AM in the Powell Room, Third Floor, Park 55, Hilton Hotel in San Francisco, CA.
Rock Creek Pharmaceuticals
Michael Mullan, MBBS, Ph.D., Chairman and CEO of Rock Creek Pharmaceuticals, will present the Company's ongoing drug development initiatives, as well as updates to the company's corporate and regulatory strategy."
PR announcement at:
http://investors.rockcreekpharmaceuticals.com/index.php?s=43&item=215