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Has_MedaSorb_found_the_Holy_Grail_which_has_eluded_medicine_for_decades? -
Written by M.E.Garza
Friday, 05 February 2010 05:00
http://biomedreports.com/articles/most-popular/27800-has-medasorb-found-the-holy-grail-to-treat-severe-infections.html
Anna Nicole Smith clearly didn't think she needed medical attention for systemic sepsis syndrome, a lethal blood infection when she passed away at the Seminole Hard Rock Hotel and Casino resort in Hollywood, Florida.
Even as I write this report, legendary singer Etta James remains hospitalized in a Southern California as she recovers from sepsis, an infection, her manager said was caused by a urinary tract infection.
And as we read headlines that toxic cleaners are believed to be an underlying factor in Jett Travolta’s (son of actor John Travolta) untimely death at the age of 16, his father and mother held a fundraiser just last night in Ocala Florida for a detoxification project for local firefighters, policemen and emergency workers who have been exposed to toxins.
Actress Britney Murphy's main cause of death was pneumonia but iron deficiency anaemia and 'multiple drug intoxication' were cited as contributing factors by the Los Angeles County coroner's office and although the medical report issued to the media didn't name sepsis directly, it was a likely contributor, according to doctors familiar with the report.
According to experts, severe sepsis is a life-threatening condition which can affect anyone, and most often develops in patients with pneumonia, trauma, surgery, burns or cancer. Over 18 million cases of severe sepsis occur each year – that’s equivalent to the entire population of Denmark, Finland, Ireland and Norway added together. In the U.S., it kills more people than either heart attacks, strokes or any single type of cancer.
The number of severe sepsis cases is grows at a rate of 1.5% per year, due mainly to the growing use of invasive procedures and increasing numbers of elderly and high-risk individuals such as cancer and HIV patients. Older people are at increased risk of sepsis as they are more prone to infections due to ageing, co-morbidities, use of invasive surgical techniques and other problems.
Yes, Sepsis is a major challenge in medicine and according to various publications, massive resources have been invested in developing and evaluating potential therapies, and considerable effort has been undertaken to understand the systemic inflammation and multiple-system organ failure characteristics of severe sepsis.
Three years ago, I nearly died when my blood became infected after a severe bout with diverticulitis. I suddenly fell very ill and ended up in the hospital for nearly three weeks as doctors fought, first to calm the severe infection that threatened to shut down my kidneys before carting me off to surgery.
The demands made on hospital staff by patients like me, with these types of infections, place a significant burden on healthcare resources and one medical publication says it accounts for 40% of total ICU expenditure.
When I showed some of those same doctors who had treated me images and descriptions of Medasorb Technologies’ (MSBT.OB) flagship Cytosorb therapeutic device, they just about all asked the same thing:
“Is this real?”
“We could really use something like this,” said others.
These days, the first-line treatment doctors rely on to try to eliminate the underlying infections with antibiotics. Indeed, I remember having six or eight different antibiotic drips going into a main line and my blood was being tested every few hours in an effort to monitor how my body was responding.
Depending on the patient’s clinical status, additional therapies are initiated, including drug therapy and supportive care, such as mechanical ventilation and kidney dialysis.
There has been considerable excitement recently amongst critical care clinicians who care for patients like me. For the first time there are trials showing positive results involving new therapeutic interventions like Medasorb’s. I spoke to Phillip Chan, MD, PhD, the CEO of Chief Executive Officer of the company. Dr. Chan is a Board-certified internal medicine physician with a strong background in clinical medicine and research, having completed his residency at Harvard Medical School at the Beth Israel Deaconess Medical Center. Dr. Chan received his MD/PhD from Yale University School of Medicine and his BS in cell and molecular biology from Cornell.
BioMedReports: Can you tell us about your company?
DR.CHAN: Sure, well Medasorb Technologies Corporation is a publically traded clinical trial stage therapeutic device company working to save lives through blood purification, that’s essentially what we do. At Medasorb we’ve developed a highly bio-compatible, porous, polymer bead purification technology that can remove things as small as drugs and toxins from blood and physiologic fluids. Right now we are currently conducting a 100 patient, randomize controlled clinical trial in Europe with our flagship product CytoSorb to treat patients with severe sepsis which is often called “overwhelming infection”.
CytoSorb is a highly efficient cytokine filter designed to treat severe sepsis by reducing potentially deadly cytokine-storm which is a well known major cause of organ failure and mortality with this disease. We’re currently driving to complete our European sepsis trial and with a hopeful positive outcome, plan to obtain C Mark approval for CytoSorb in the EU and begin commercializing it this year in fact.
We plan to take the data from this trial and present it to the FDA who has already approved an IDE application and investigational device exemption application that they approved in 2007 to run a limited sepsis study and look to them to now begin a pivotal study in the US in either late 2010 or currently 2011 to allow commercialization in the United States as well.
We recently announced preliminary positive proof of concept in humans, using Cytosorb to treat severe sepsis patients in the setting of lung injury in a 22 patient randomized control pilot study. We reported a summary of clinical data from all 13 patients that had fully monitored, completed data sets – this is 7 treated, 6 control patients – that demonstrated improvements with Cytosorb treatment in key clinical endpoints. So we think the therapy has been safe. There have been no serious device related adverse events in more than 500 human treatments, more than 150 of which have actually been in patients with sepsis.
So, the underlying technology is protected by a broad intellectual property portfolio of now 27 issued patents, with multiple applications pending that range from composition of matter to clinical application patents. A key part of our know-how is related to polymer production, which we conduct at our manufacturing facility in New Jersey under strict, well documented, reproducible processes that meet FDA clinical trial standards.
BioMedReports: You just said something interesting that I wasn’t aware of – you said that the Cytosorb technology can also clear a person from drug substances?
Dr. Chan: Our polymer platform technology is a highly porous polymer bead. We can change the size and the pore distribution of those pores to enable the removal of different things of different sizes. So the Cytosorb resin is actually specifically designed to remove a bin of substances in the specific weight range we call the cytokine ‘sweet spot’, typically 10 to 50 Kilodaltons (molecular weight) which is where most of the cytokines reside, and that’s exactly where Cytosorb targets. We have the ability to change those pores and pore size and pore distribution to be able to remove things that we want. We actually have a number of different resins that can remove different things from blood and physiologic fluids.
[For instance] imaging a sponge, the sponge looks very porous. We can make those pores very large or very small, and they trap things that are either very large or very small respectively.
BioMedReports: What is the market potential for this product. Can you tell us a little about that?
Dr. Chan: Severe sepsis is often called overwhelming infection and is one of the leading causes of death in the world. It afflicts people of all ages, particularly the very old and the very young, and it also afflicts all walks of life and all ethnicities. Unfortunately, all of us on the phone and elsewhere know someone who has developed a severe infection. It could be something as catastrophic as a ruptured appendix, or something more common as pneumonia, maybe a bad urinary tract infection or even influenza where the infection has gotten out of hand and sent that person to the intensive care unit on life support, with failing critical organs like the hearts, lungs, and kidneys. So this is severe sepsis and it afflicts more than a million people in the United States, roughly 1.5 million people in Europe, and an estimated 18 million people worldwide every single year. Despite the best medical care here in the United States, one in every three patients die of this disease, and in fact, more people die of severe sepsis in the United States than either heart attacks or strokes or any single form of cancer, so it’s a major unmet medical need.
Without better treatments for severe sepsis and its more deadly cousin septic shock, which has a mortality rate of about 50% or more, the numbers are only expected to grow with trends like an aging population and an increase in antibiotic resistant bacteria, the increased use of implantable devices like artificial hips and knees, diseases like diabetes and cancer, all put people at high risk of infection and sepsis, and all of these are driving the incidents of sepsis higher. So right now, Cygress? From Eli Lilly (NYSE: LLY) is the only product approved in the United States or Europe to treat to treat severe sepsis. It is a good drug, but it has had limited adoption by clinicians because of concerns about cost, efficacy, timing of use as well as potentially deadly side effects – well, I should say potentially ‘dangerous’ side effects. So this really leaves a wide open market for other sepsis treatments and we estimate that the total addressable market for Cytosorb in the US and the EU to be collectively about $6 to $8 billion dollars. We also believe that China and India represent extremely large follow up markets for us.
BioMedReports: You know it’s interesting, we spoke to doctors about your technology to get their feel for it and the reaction we heard most was “Wow, is this real? And if it is, we could really use something like this.” Do you get the same type of reaction out there?
Dr. Chan: We do. We talked to a number of thought leaders in this space. As clinicians should react, they were cautiously optimistic. They wanted, obviously, to see data, but they felt that this was really an approach worth pursuing and an approach that could actually really work. And so hopefully with some of the data that we’ve shown from our pilot study, we’re getting to that point.
BioMedReports:What is the potential impact that Medasorb can have in that market we just talked about?
Dr. Chan: I think that to understand how our science and technology works, it’s important to understand the path physiology of severe sepsis. Severe sepsis is really caused by two problems. One, is the infection, which can often be treated by antibiotics or other types of agents and can be addressed effectively. However, the other facet of sepsis is really the body’s immuno response to the infection. Normally the body produces things called cytokines that help stimulate and regulate the immune system, and they’re normally helpful. But in severe infection and in many people, the body’s immune system goes haywire and produces massive amounts of these cytokines to point where they’re no longer helpful but in fact, they are actually toxic to the body and can directly kill cells and damage organs leading to organ failure and in many cases, death.
So for instance, certain cytokines can cause blood vessels in the lungs to become leaky, allowing inflammatory fluid, cells and other cytokines to fill up the lungs and the person drowns in essentially his or her own fluids. Cytokine storm can also lead to hemodynamic collapse, where the heart can no longer get blood and oxygen to critical organs, leading again, to organ injury. Cytokine storm can also shut down the kidneys, which is another major risk factor for death from severe sepsis. So the role of cytokine storm in sepsis is widely accepted by clinicians and researchers, and has been very well researched, and I always point to the fact that if you do a pub-med search on cytokines and sepsis you’ll literally bring up 10,000 articles.
To drive the point home, there was a Phase I study done by another company in 2006 that was reported by the New England Journal of Medicine. What they had developed was a monoclonal antibody that was designed to stimulate the immune system to treat cancer. When they actually injected this antibody into six healthy young male volunteers, who did not have infection or cancer – they were healthy, they all developed cytokine storm and then all developed the hallmarks of severe sepsis including acute lung injury, renal failure, clotting disorders, and in fact, two of the patients, two of the volunteers who had the worse cytokine storm actually developed severe septic shock and acute respiratory distress syndrome.
This is just an example of how it is not the infection, but rather the cytokine storm that causes multi-organ failure and sepsis. The reduction of cytokine storm has been the Holy Grail for the industry for the past 2 to 3 decades, and unfortunately most of the approaches that have been tried have only been capable of removing one cytokine or one inflammatory mediator at a time. The problem is that different cytokines have overlapping functions and there’s so much redundancy in the immune response that if you remove one cytokine, even if it’s an important one, twenty others will take its place. So what is really necessary is a broad spectrum approach to try and remove cytokines across the board, and reduce them to a level where they are no longer toxic, but not reduce them so much that they can no longer help the body fight infection. And that technology has not been available until just recently, and with Cytosorb, we are one of the leaders in that field.
Cytosorb is a very effective cytokine filter that can broadly remove cytokines from blood. The treatment is very simple. You use a standard dialysis machine found in most hospitals by leading vendors like Baxter, B. Braun and others, to essentially pump blood out of the body through our cartridge. The blood goes directly through our cartridge and contacts the resin. Cytokines are absorbed and removed from blood and that purified blood is then put back into the body. We treat for 6 hours a day for 7 days each day with a new device. We have the ability to treat an entire person’s blood volume 20 to 30 times over the course of a 6 hour treatment. So the goal is really to reduce cytokine storm, prevent and limit organ damage and allow the body time to heal and recover.
We believe that our device is extremely effective at removing cytokines from blood. We know this from our invitro studies that we’ve done where we can remove 50 to 70% of certain cytokines in the first hour of treatment, and over the course of four hours actually remove 90 to 95% of certain cytokines.
In our bench top circulation system that simulates treatment. Our polymer resin is highly hemo-compatible. It meets what is called the ISO-10993 standard for 30 day medical device implantables. That includes things like bio-compatibility, hemo-compatibility, cyto-toxicity, geno-toxicity, acute sensitivity and other factors. Our device also has massive capacity unlike a standard hemo-dialyzer that has very limited capacity to bind cytokines because of very limited surface area. A single one of our cartridges has 7 football fields worth of surface area in which to bind cytokines. That is really important and a major differentiator between our technology and others based on that capacity because you need massive capacity to impact cytokine storm.
Our technology is also what we call a ‘razor blade in other people’s razor’ model, because it is compatible with standard hemo-dialysis equipment. It also contains no cells, no antibodies, nothing that can degrade over time, so it has excellent shelf life stability. We currently have 3 year shelf life stability at room temperature. It really does have a number of significant advantages over other technologies, most of which don’t work.
BioMedReports: Let’s talk about the trials in Europe. Has it been easier to accrue patients there then if you had done the trials in the US for example?
Dr. Chan: We continue to make good progress. We’re working with a stellar group of experienced and motivated investigators, many who are thought leaders in critical care in Germany. That’s very important. Germany, as you know, is the largest medical device market in the EU and the 3rd largest in the world, so it makes a great first market for us. There have been a number of issues related particularly to distance, language as well as time differences that pose a number of different challenges, but we’ve learned to adapt.
BioMedReports: Tell us about any additional goals for the company for 2010?
Dr. Chan: I think that is the major goal and that is the event that will drive the greatest shareholder value for the company, the successful completion of our trial as well as getting C mark approval. We have a number of other initiatives under way that I can’t talk about right now but we hope those will also bear fruit for the company and represent a potential upside for investors.
BioMedReports: What are the challenges you see for the company in 2010?
Dr. Chan: One of the major challenges for us is that we have a lot going on at the company with a lot of moving parts. There are a lot of things we need to accomplish this year including completing trials, strategic partnership discussions, a C Mark approval, beginning commercialization, regulatory discussions with the FDA, other things along those lines. I would say that we do have a very strong management team and we are working diligently to execute on our vision. We’re in the midst of preparing our C Mark application to try and speed approval if we complete our trial successfully.
BioMedReports: Have you discussed any strategic partnerships to go to market or to do the trials for example?
Dr. Chan: If our technology works as we hope, it really has the potential to be a blockbuster product that can impact the top and bottom lines of most potential strategic partners. We have a very active business development program under way at the company that’s been going on now for more than a year.
Cytostorb is an extensively patented product. It has a highly profitable business model. It’s in a market that has little competition and literally has a world of opportunity in front of it. We believe it’s a technology that is attractive to potential investors and hopefully with positive data from our trial we can make something happen there, but we aren’t dependent on a strategic partnership. Whether we partner with a larger company or take the product to market directly, we’re prepared to do either.
MedaSorb at Biotech Showcase 2010 (Audio_& Slideshow-Presentation)
http://webcastingplayer.corporate-ir.net/player/PlayerHost.aspx?EventId=2674413&StreamId=1420772&TIK=&override=reg
XL Capital Ltd to Present at Credit Suisse Financial Services Forum on February 11, 2010
04.02.2010 18:14
http://www.finanznachrichten.de/nachrichten-2010-02/16067582-xl-capital-ltd-to-present-at-credit-suisse-financial-services-forum-on-february-11-2010-008.htm
HAMILTON, Bermuda, Feb. 4 /PRNewswire-FirstCall/ -- XL Capital Ltd ("XL" or the "Company") today announced that Chief Executive Officer Michael S. McGavick is scheduled to present at the Credit Suisse Financial Services Forum 2010 at the Mandarin Oriental Hotel in Miami, Florida on Thursday, February 11, 2010 at 3:30 p.m. EST.
A live webcast of Mr. McGavick's presentation will be available via http://www.xlcapital.com/. A replay of the presentation will be available via http://www.xlcapital.com/ following the live webcast and will be archived there for approximately 30 days following the presentation date.
XL Capital Ltd, through its subsidiaries, is a global insurance and reinsurance company providing property, casualty and specialty products to industrial, commercial and professional firms, insurance companies and other enterprises on a worldwide basis. More information about XL Capital Ltd is available at http://www.xlcapital.com/.
XL Capital Ltd
CONTACT: David Radulski, Investor Relations, +1-441-294-7460, or Carol
Parker Trott, Media Relations, +1-441-294-7290, both of XL Capital Ltd
Web site: http://www.xlcapital.com/
© 2010 PR Newswire
http://biomedreports.com/articles/subscriber-only-content/27655-watchlist-alert-for-thursday.html
Written by BioMedReports.Com
Thursday, 04 February 2010 06:44
...
...BioMedReports will be issusing a special report on MSBT, including an interview with Dr. Chan within the next 24-48 hours.
... BioMedReports will be issusing a special report on MSBT, including an interview with Dr. Chan within the next 24-48 hours.
has the potential to be a blockbuster product
http://www.tradingmarkets.com/news/stock-alert/msbt_medasorb-s-blockbuster-product-could-be-commercialized-this-year-753686.html
Dr. Chan noted, "If our technology works the way we hope it does, then it has the potential to be a blockbuster product. That can impact the top and bottom lines of most strategic partners. We believe we have a product that has little competition, a big market with unmet needs, technology attractive to strategic partners, and a solid, profitable business model."
If MedaSorb meets its goals, it will not only be attractive to strategic partners, but to prospective shareholders as well.
NewCardio's Chief Medical Officer, Dr. Ihor Gussak, to Present at Prestigious Cardiac Electrophysiology Conference in Tokyo
Date : 02/04/2010 @ 8:00AM
Source : PR Newswire
Stock : (NWCI)
http://ih.advfn.com/p.php?pid=nmona&article=41396179&symbol=NWCI
NewCardio's Chief Medical Officer, Dr. Ihor Gussak, to Present at Prestigious Cardiac Electrophysiology Conference in Tokyo
Dr. Gussak to Provide Special Lecture at the Japanese Idiopathic Ventricular Fibrillation (J-IVFS) Annual Meeting on February 8, 2010
SAN JOSE, Calif., Feb. 4 /PRNewswire-FirstCall/ --
NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, announced today that its Chief Medical Officer, Ihor Gussak MD, PhD, FACC, world-recognized expert in electrocardiology and cardiac safety, will provide a special lecture at the prestigious Japanese Idiopathic Ventricular Fibrillation (J-IVFS) Annual Meeting at the Sankei Plaza convention center in Tokyo, Japan on February 8, 2010. Dr. Gussak's presentation, Early Ventricular Repolarization: ECG Phenomena and Arrhythmogenic Potentials" will be Chaired by Prof. Kaoru Sugi (Toho University Ohashi Medical Center)
The 45-minute presentation will show how a three-dimensional (3D) ECG analysis, made possible by NewCardio's technology, provides additional information on subtle or non-conclusive changes, which clinicians can use to assess risk of sudden cardiac arrest more appropriately and effectively. NewCardio's platform technology, which applies advanced 3D techniques and modern computer software, can help clinicians to identify patients at risk of fatal arrhythmias by providing clinicians a deeper look and additional information compared to traditional techniques
"NewCardio remains committed to deploying state-of-the-art science and technology to enable more accurate diagnosis and risk stratification of serious cardiac conditions and to advance the prevention and treatment of life-threatening conditions, including electrical diseases of the heart," commented Dr. Gussak. "I am excited to share our latest developments and discuss the far-reaching potential of our platform technology at the J-IVFS."
The J-IVFS is one of the most prestigious Cardiac Electrophysiology events in the world, covering areas of particular focus in Japan where idiopathic sudden cardiac arrest is endemic and very problematic. Distinguished attendees at the event include Dr. Masakazu Hiraoka (Ministry of Health, Labor and Welfare, Labor Health Appeal Committee), Professor Kazutaka Aonuma (University of Tsukuba), Naohiko Aihara (National Cardiovascular Center), Dr. Masahiko Takagi (Osaka City University Graduate School of Medicine), Dr. Yukio Sekiguchi (University of Tsukuba), Dr.Yasuhiro Yokyama (National Disaster Medical Center), Professor Hirotsugu Atarashi (Nihon Medical University Tama Nagayama Hospital) and Dr. Akihiko Nogami (Yokohama Rosai Hospital), and Dr. Sami Viskin (Israel)
Dr. Gussak is a Fellow of the American College of Cardiology, and serves on the Clinical Cardiology Council of the American Heart Association. He is a member of the American Academy of Pharmaceutical Physicians, the International Cardiac Electrophysiology Society, the International Society for Holter and Noninvasive Electrocardiology, the Drug Information Association, and the International Scientific Committee on Arrhythmogenic Right Ventricular Dysplasia-Cardiomyopathy. He has published several textbooks and numerous peer-reviewed articles on these and other subjects in clinical cardiology
NewCardio's innovative 3D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12-lead electrocardiogram (ECG). NewCardio's lead product is QTinno(TM), a software suite that provides an automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. The Company believes that its QTinno(TM), software-based, analytical technology is the industry's first solution for the reliable automated analysis of ECGs used to determine cardiac toxicity during drug development
About NewCardio, Inc
NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). NewCardio's three-dimensional ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit http://www.newcardio.com/
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2008 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements
To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0
Investor Contact: Hayden IR Jeff Stanlis, Partner (602) 476-1821
DATASOURCE: NewCardio, Inc
CONTACT: Investors, Jeff Stanlis, Partner at Hayden IR, +1-602-476-1821,
, for NewCardio, Inc
Web Site: http://www.newcardio.com/
...very huge news - AGAIN!!!
"This is a very exciting time for Keryx, as we have transitioned into a late-stage development company with two drugs in Phase 3 pursuing three indications under SPAs.
http://ih.advfn.com/p.php?pid=nmona&cb=1265214686&article=41377888&symbol=N%5EKERX
...yes and NO
(was during LIVE-chat)
Biomed-Chat (without LINK / make your own DD)
Feb 3 2010, 4:00 PM BioMedReports:
Another one to keep an eye on- and we haven't started to cover them yet (stock tip, hint, hint) is Medasorb.
Feb 3 2010, 4:00 PM BioMedReports:
MSBT.
Feb 3 2010, 4:01 PM BioMedReports:
These guys are on the verge of entering a $6 billion dollar market that has no other competitors.
Feb 3 2010, 4:02 PM BioMedReports:
A full report is coming soon and you're going to start to see them make headlines because their technology is very close to getting EU approval and going commercial.
Feb 3 2010, 4:02 PM BioMedReports:
NOW is the time to get in to some of these. at tje ground floor- with CONFIDENCE!
DLTA (up +90% this week...) LINK back
Outstanding: 13,557,107
Float: 10,792,999
http://ih.advfn.com/p.php?pid=squote&symbol=DLTA
EMCORE Enters Into an Agreement to Sell a Majority Interest in Its Fiber Optics Business Resulting in the Completion of Its Restructuring
Date : 02/03/2010 @ 9:44AM
Source : MarketWire
Stock : EMCORE (EMKR)
http://ih.advfn.com/p.php?pid=nmona&cb=1265211506&article=41379588&symbol=N^EMKR
Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of KRX-0401 (Perifosine)
Date : 02/03/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=41377888&symbol=KERX
Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of KRX-0401 (Perifosine)
Date : 02/03/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=41377888&symbol=KERX
Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of KRX-0401 (Perifosine) in
Phase 3 X-PECT Trial (Xeloda(R) + Perifosine Evaluation in Colorectal cancer Treatment) to be led by Dr. Johanna Bendell, Director, GI Oncology Research, Sarah Cannon Research Institute
NEW YORK, Feb. 3 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer. The SPA provides agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission
PHASE 3 TRIAL DESIGN:
The Phase 3 X-PECT (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) trial will be a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine (capecitabine is a chemotherapy marketed by Roche as Xeloda®) vs. placebo + capecitabine in approximately 430 patients with refractory metastatic colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin®), irinotecan, bevacizumab (Avastin®) and, if K-Ras wild-type (WT), failed therapy with prior cetuximab (Erbitux®) or panitumumab (Vectibix®). For oxaliplatin-based therapy, failure of therapy will also include patients who discontinued due to toxicity. The primary endpoint is overall survival (OS), with secondary endpoints including overall response rate (ORR: complete responses + partial responses), progression-free survival (PFS) and safety. The median OS for the X-PECT study's targeted patient population, that has failed prior therapies as described above, is approximately 5 months. The X-PECT study will be powered at 90% to detect a statistically significant difference in OS, with an assumed median OS for the control arm of 5-6 months and 7-8 months for the perifosine arm. Approximately 360 events of death will trigger the un-blinding of the study
Approximately 40 to 50 U.S. sites will participate in the study. The study is expected to begin in 2Q 2010, and enrollment is expected to take approximately 12 months, with study completion expected in 2H 2011. Dr. Johanna Bendell, Director of GI Oncology Research for the Sarah Cannon Research Institute, Nashville, Tennessee, will lead the Phase 3 investigational team that includes Dr. Cathy Eng, Associate Medical Director for the Colorectal Center at MD Anderson Cancer Center in Houston, Texas
Dr. Johanna Bendell, commented, "More active agents are needed to improve survival for patients with metastatic colorectal cancer. We are very excited about this Phase 3 trial, which is based on the encouraging randomized Phase 2 data that demonstrated an improvement in overall survival and time to progression using perifosine plus capecitabine over placebo plus capecitabine in patients with metastatic colorectal cancer. As such, we are moving forward with the randomized Phase 3 X-PECT trial, and we hope to continue to see these improvements in patient outcomes."
Dr. Cathy Eng, added, "The updated Phase 2 data presented at the 2010 Gastrointestinal Cancers Symposium in Orlando, Florida, demonstrated promising activity and outcomes for heavily pretreated metastatic colorectal cancer patients treated with the combination of perifosine plus capecitabine and provided heightened awareness of the potential therapeutic role of an oral PI3K/Akt pathway inhibitor. The Phase 3 X-PECT trial will provide a greatly needed opportunity for our patients that would normally have very limited treatment options."
Ron Bentsur, Chief Executive Officer of Keryx, stated, "This SPA represents another important milestone for the company, and we wish to thank the FDA for their guidance and support in this process. We also wish to thank the Phase 2 investigators and the experts that helped us obtain this SPA. We are very encouraged by the colon Phase 2 data that was recently announced, which showed a statistically significant survival advantage in a refractory metastatic patient population." Mr. Bentsur continued, "This is a very exciting time for Keryx, as we have transitioned into a late-stage development company with two drugs in Phase 3 pursuing three indications under SPAs. We eagerly await the commencement of the X-PECT study within a few months."
Perifosine is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track Designation granted
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the United States. It is estimated that over 146,000 people were diagnosed with some form of colorectal cancer with over 49,000 patients dying from colorectal cancer in 2009. Surgery is often the main treatment for early stage colorectal cancer. When colorectal cancer metastasizes (spreads to other parts of the body such as the liver) chemotherapy is commonly used. Treatment of patients with recurrent or advanced colorectal cancer depends on the location of the disease. Chemotherapy regimens (i.e. FOLFOX or FOLFIRI either with or without bevacizumab) have been shown to increase survival rates in patients with metastatic/advanced colorectal cancer. Currently, there are seven approved drugs for patients with metastatic colorectal cancer: 5-fluorouracil (5-FU), capecitabine (Xeloda(R)), irinotecan (Camptosar(R)), oxaliplatin (Eloxatin(R)), bevacizumab (Avastin(R)), cetuximab (Erbitux(R)), and panitumumab (Vectibix(R)). Depending on the stage of the cancer, two or more of these types of treatment may be combined at the same time or used after one another. For example, FOLFOX combines 5-FU, leucovorin and oxaliplatin and FOLFIRI combines 5-FU, leucovorin and irinotecan. Bevacizumab, a VEGF monoclonal antibody, is commonly administered with chemotherapy. Typically, patients who fail 5-FU, oxaliplatin, irinotecan, and bevacizumab-containing therapies, and who have wild-type KRAS status receive EGFR monoclonal antibody therapy with either cetuximab or panitumumab. Once patients progress on these agents, there are no further standard treatment options
About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application
Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gui dances/ucm080571.pdf
About Keryx Biopharmaceuticals, Inc
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, a key signaling cascade that has been shown to induce cell growth and cell transformation. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK pathway, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), in multiple myeloma, with a Phase 3 trial in refractory metastatic colorectal cancer, under SPA, pending commencement, and in Phase 2 clinical development for several other tumor types. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is pending commencement under an SPA agreement with the FDA. Keryx is headquartered in New York City
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401; the risk that the data (both safety and efficacy) from the Phase 3 study will not coincide with the data analyses from the Phase 2 previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com/. The information found on our website and the FDA website is not incorporated by reference into this press release and is included for reference purposes only
KERYX CONTACT: Lauren Fischer Director of Investor Relations Keryx Biopharmaceuticals Tel: 212 531 5962 E-mail:
DATASOURCE: Keryx Biopharmaceuticals, Inc
CONTACT: Lauren Fischer, Director of Investor Relations, Keryx
Biopharmaceuticals, +1-212-531-5962,
Web Site: http://www.keryx.com/
DLTA ! (Link back...)
ProLogis Declares Dividends on Common Shares
Date : 02/01/2010 @ 5:15PM
Source : PR Newswire
Stock : (PLD)
http://ih.advfn.com/p.php?pid=nmona&article=41348621&symbol=PLD
DENVER, Feb. 1 /PRNewswire-FirstCall/ --
ProLogis (NYSE:PLD), a leading global provider of distribution facilities, announced today that its Board set the annualized dividend level for 2010 at $0.60 per common share, or $0.15 per quarter. In addition, the Board declared ProLogis' first quarter dividend of $0.15 per common share, payable on February 26, 2010, to shareholders of record on February 12, 2010
About ProLogis
ProLogis is a leading global provider of distribution facilities, with more than 475 million square feet of industrial space owned and managed (44 million square meters) in markets across North America, Europe and Asia. The company leases its industrial facilities to more than 4,500 customers, including manufacturers, retailers, transportation companies, third-party logistics providers and other enterprises with large-scale distribution needs. For additional information about the company, go to http://www.prologis.com/.
DATASOURCE: ProLogis
CONTACT: Robbin Lee of ProLogis, +1-303-567-5690,
Web Site: http://www.prologis.com/
Delta Oil & Gas (DLTA) -
Delta Oil & Gas, Inc. Completes Drilling of 4 Wells at its Oklahoma Prospect
Date : 02/01/2010 @ 9:00AM
Source : Business Wire
Stock : Delta Oil and Gas, Inc. (DLTA)
http://ih.advfn.com/p.php?pid=nmona&cb=1265131338&article=41339407&symbol=NB^DLTA
NexMed Granted Request for Continued Listing on NASDAQ
Date : 02/01/2010 @ 2:34PM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1265053376&article=41346243&symbol=N^NEXM
NexMed Granted Request for Continued Listing on NASDAQ
Date : 02/01/2010 @ 2:34PM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1265053376&article=41346243&symbol=N^NEXM
Stocks climb as manufacturing, spending increase
Jumps in manufacturing activity and consumer spending lift stock prices
Monday February 1, 2010, 12:31 pm
http://finance.yahoo.com/news/Stocks-climb-as-manufacturing-apf-105375914.html?x=0&sec=topStories&pos=main&asset=&ccode=
06:58AM - ProLogis upgraded by UBS
http://finance.yahoo.com/q/ud?s=PLD
http://www.marketwatch.com/story/ubs-upgrades-some-reits-after-sell-off-2010-02-01?siteid=yhoof2
www.advantageofstemcellresearch.com
Two New Innovations in Stem Cell Research
Filed under: Uncategorized
01 Feb 2010
http://www.advantageofstemcellresearch.com/two-new-innovations-in-stem-cell-research.html
Stem cell research has been riddled with controversy since its inception.
It is because of this controversy that stem cell research hasn’t received as much support, under past administrations, as it should have.
Most of the controversy over stem cell research stem from the idea that a fetus has to be destroyed in order for the stem cells to be harvested.
This might not be the case anymore with the discovery of two unique methods of collecting stem cells.
The first of these methods entails extracting the stem cells from the placenta of a fetus.
By doing this not only are researchers able to collect stem cells, they do no harm whatsoever to the fetus.
The second of these innovations in stem cell research is the potential use of skin cells to emulate stem cells.
Scientists have devised a way to manipulate the genes within a skin cell in order for it to behave exactly like a stem cell.
If this method of creating stem cells can be perfected, it opens up a completely different avenue for stem cell research to progress.
No longer will there be any real controversy over the subject of stem cell research, as the necessity for embryonic stem cells can be eliminated.
Under the Obama administration, all restrictions over federal funding of stem cell research has been repealed.
With the increase funding going towards stem cell research, new advances and potential benefits are sure to be found.
... time will tell!
Date : 01/13/2010 @ 3:00PM
Source : Edgar (US Regulatory)
Stock : - (SCLL)
http://ih.advfn.com/p.php?pid=nmona&cb=1263413430&article=41095210&symbol=NO^SCLL
Stem Cell Innovations, Inc., (SCLL.PK) wishes to update its shareholders on various aspects of the company over the past year.
Our human embryonic germ cell technology has matured substantially. This work was significantly more difficult than originally anticipated but has resulted in a series of interesting and useful observations that will fill in several missing pieces in human stem cell biology. These observations are currently being finalized and assembled into a form suitable for publication in scientific journals. We anticipate the publication of several such scientific papers over the coming year and these advances will enable us to pursue the application of our technology to drug discovery, liver disease and cancer. It is important to note that this technology is completely separate from standard human embryonic stem cells and comprises a unique and valuable intellectual property.
As a result of the shareholder vote that was held in August, the number of authorized shares was expanded to 20 billion. There are currently 2,844,387,312 shares issued and outstanding. The financing by Margie Chassman that was announced in conjunction with the vote has been completed. These funds, along with income from ongoing and new contract research, should enable the Company to put a program in place over the next six to nine months that will enable us to become listed again on the Bulletin Board and become current with our filings. It is important to the Company to be as transparent as possible within the confines of this difficult financial environment and we are working diligently to achieve this.
Delta Oil & Gas, Inc. Completes Drilling of 4 Wells at its Oklahoma Prospect
Date : 02/01/2010 @ 9:00AM
Source : Business Wire
Stock : Delta Oil and Gas, Inc. (DLTA)
http://ih.advfn.com/p.php?pid=nmona&article=41339407&symbol=DLTA
Delta Oil and Gas, Inc. (OTC:BB – DLTA) is pleased to report that the company has successfully drilled four of four wells at its Oklahoma Prospect and has completed the first well. All four wells have been successful in finding hydrocarbons. Initial flow test results of the wells confirm that this represents a significant new discovery
The initial well was perforated in one of the lower zones on January 22, 2010. Since perforation, the well has flowed at rates of 400 to 550 barrels of fluid per day with an oil cut ranging from 50 to 70%. It is believed that the water is primarily the result of the drilling and completion process, and that most if not all of it will disappear shortly. The natural gas production rates are estimated to be between 200 and 300 mcf per day. A gathering line is being laid and the well should be producing, and subsequently selling, both gas and oil very shortly
The 2nd, 3rd and 4th wells have now all been drilled and all flowed oil at good pressures and volume in drill stem tests taken from the most significant zones. Electric logs indicate that the drilling of all wells may have intersected up to nine separate pay zones. The initial indications are that on the fourth well, two significant pay zones were intersected which total approximately 34 feet of hydrocarbon pay. In addition, there may be several other smaller pay zones
Because of the success of this drilling program, there may be the potential for one or more offset wells in which Delta would participate. Delta owns a 5% working interest in the wells covered by this drilling program and has fully paid the costs associated with this program
About Delta Oil and Gas Delta Oil is an exploration company focused on developing North American oil and natural gas reserves. Delta Oil’s current focus is on the exploration of its land portfolio comprised of working interests in acreage in King City, California; Southern Saskatchewan, Canada; and South Central, Oklahoma. As a result of its acquisition of a controlling interest in The Stallion Group, a Nevada corporation, it expanded its property interests to include acreage in the North Sacramento Valley, California
On behalf of the Board of Directors, DOUGLAS N. BOLEN, President Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Delta Oil’s intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company's actual results could differ materially from those in any such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended December 31, 2008 and the quarterly reports on Form 10-Q filed subsequently. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Delta Oil & Gas, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release
Historical Prices -
http://ih.advfn.com/p.php?pid=historical&cb=1264966963&symbol=DVAR
Date Adj Close
2010/01/29__242,103__0.10
2010/01/28___16,200__0.070
2010/01/27____4,000__0.070
2010/01/26___14,000__0.074
2010/01/25___39,000__0.074
2010/01/22__123,315__0.074
2010/01/21___31,000__0.052
2010/01/20___81,785__0.040
2010/01/19___15,000__0.016
2010/01/18
Dovarri - Investor Relations
DVAR (Dovarri, Inc.)
www.dovarri.com
Phone - 713.273.6880
Fax - 713.273.6882
Toll Free - 1.888.DOVARRI (1.888.368.2774)
Dovarri Management:
Geary Broadnax - President and CEO
Larry Baty - Chief Financial Officer
Investor Relations:
713.273.6880
Mailing Address:
Dovarri, Inc.
5718 Westheimer Suite 1440
Houston, TX 77057
Officer/Director Disclosure (Transaction Date: 12.08, 2009)
http://www.pinksheets.com/otciq/ajax/showFinancialReportById.pdf?id=27020
Annual Report (Year Ended September 30, 2009)
http://www.pinksheets.com/otciq/ajax/showFinancialReportById.pdf?id=26045
Common Stock ($.001 par value)
150,000,000 shares authorized
112,126,351 issued and outstanding
15,869,130 Float (shares)
# as of Jun 30, 2009
WaMu Shareholders get an Equity Committee: Video
..."deadline" 03.03, 2010
World Stem Cells & Regenerative Medicine Congress 2010
http://www.terrapinn.com/2010/stemcells/
Stem Cell Innovations, Inc.-Deals & Alliances Report
Published Date: January 2010
Published By: Life Science Analytics (LSA)
Page Count: 34
http://www.mindbranch.com/Stem-Cell-Innovations-R762-40935/
...interesting post @ yahoo:
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_N/threadview?m=tm&bn=12527&tid=54708&mid=54708&tof=5&frt=2
1) Vitaros, first ED cream for men for faster achievement of erection with no adverse reations since it is topical not systemic!! (no blurreed vsion, no head aches, no muscle aches, no toxicity when combines with Nitrates, other cardiac drugs, no slow metabolism problems for the elderly and those mixing with alcohol!!!. no toxicity issues!!
2) latest on Warner Chilcot info, awaiting the possible $2.5 Milion when they file their Vitaros NDA!!! (BIG NEWS COMING!!)
3) latest on partner discussions for NM00060 for 'mild oncymyosis) mild toe nail infection with NEXM's nail polish lacquer!! makes lots of sense to me as a great product!!
4) Latest on Health Canada near approval of Vitaros for the Canadian markets!! and latest on partner discussions!!!
5) new topical pain cream with NAIDS for joint and muscle pain!! just apply it topically! with rapid onset of action.!! (wow!!)
6) Update on possibility of a potentiated Taxol now used of IV and NEXM will i ntroduce their preckinical studies for an oral Taxol and other possible oral combos with NEXACT!!! (WOW!!!).. sure to stir up alot of atttention if this bioavialbility is potentiated and even more effective and much easier to administer. (funds will be buying, imo)!!
All you bashers better pray for your souls and moonies!! if I am right. I say Bio-Quant can achieve it with NexACT!! imo.
7) other topical, potential drug candidates.
8) Bio-Quant's CRO business and their positive revenue flow is sure to attract fund investment!!!