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MOST THOROUGH 10K TO DATE MARKET LIKES IT
look at the pps
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Matthias Löhr - list of publications
http://publicationslist.org/maloehr
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Matthias Löhr has worked as a translational scientist and Principal Investigator in clinical studies in GI oncology for more than 15 years. As member of the dievini team, he manages the clinical and scientific due diligence tasks associated with investment opportunities and is also involved in the evaluation of clinical studies.
After studying medicine in Germany, the United States and Switzerland, and receiving his MD both in Germany and in the United States, he completed his MD thesis and residency in pathology. This was followed by a postdoctoral fellowship at the Scripps Clinic & Research Foundation in La Jolla, California. He completed his residency in internal medicine and gastroenterology in Erlangen and Rostock, where he received his PhD and subsequently became assistant Professor. In 2000, he was appointed Professor of Molecular Gastroenterology at the University of Heidelberg and head of a division at the German Cancer Research Center (DKFZ). In 2007, he was appointed full professor of gastroenterology and hepatology at Karolinska Institutet in Stockholm, Sweden.
Professor Matthias Löhr, ...
www.tvm-capital.com, 26 May 2009 [cached]
Professor Matthias Löhr, principal investigator of the phase II clinical trial of EndoTAG™-1 for the treatment of inoperable pancreatic carcinoma, will present the results from this trial, which were published in October 2008. Matthias Löhr is professor of gastroenterology and hepatology at Karolinska Institutet, Stockholm, and Head of Molecular Gastroenterology at the German Cancer Research Center (DKFZ), Heidelberg.
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This is who Nuvilex has on their team for Late Phase 2b (mini phase 3)
same as before...along with Dr. Brian Salmons and Prof. Walter H. Günzburg, Ph.D.
Nuvilex Adds World Renowned Oncologist and Gastroenterologist to Play Major Role in Late Phase Clinical Trial
SILVER SPRING, Md., May 1, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that world renowned oncologist and gastroenterologist Professor Dr. Matthias Lohr of the famed Karolinska Institute in Stockholm, Sweden, has agreed to play a major role in Nuvilex's Phase 2b clinical trial in pancreatic cancer to be conducted in Australia, as well as other clinical studies and trials in which Nuvilex will be involved. Dr. Lohr served as Principal Investigator for the previous Phase 1/2 clinical trials that employed Nuvilex's pancreatic cancer treatment.
"Dr. Lohr's reputation as a leading oncologist, as well as his previous experience and belief in Nuvilex's Cell-in a-Box(R)/ifosfamide combination as a treatment for patients with advanced pancreatic cancer, make his input into our clinical trial invaluable," said Kenneth L. Waggoner, CEO and President of Nuvilex. "Because he was Principal Investigator in the two previous clinical trials with the Cell-in-a-Box(R)/ifosfamide combination in patients with pancreatic cancer, Nuvilex now has one of the world's top experts on the clinical use of this combination who will play a major role in this most important phase of its development as a treatment for one of the deadliest forms of cancer."
Dr. Lohr will fulfill a pivotal role in assisting the Nuvilex team in designing and conducting Nuvilex's Phase 2b clinical trial in advanced pancreatic cancer. In this two-armed clinical trial, Nuvilex's pancreatic cancer treatment (a combination of the proprietary Cell in-a-Box(R) live-cell encapsulation technology and the well-known cancer drug ifosfamide), which has already proven effective in Phase 1/2 clinical trials, will be compared "head-to-head" with the "gold standard" of care for pancreatic cancer -- Abraxane(R) plus gemcitabine.
As Principal Investigator for the two previously successful early phase clinical trials with the Cell-in-a-Box(R)/ifosfamide combination, Dr. Lohr worked closely with Clinical Network Services, the same Clinical Research Organization (CRO) in Australia recently retained by Nuvilex to manage its future Phase 2b clinical trial. In the early clinical trials, improvements in both median survival and one-year survival rate were seen with the Cell-in-a-Box(R)/ifosfamide combination as compared to historical data for Gemzar(R) (gemcitabine), the best available treatment for the disease at the time those clinical trials were conducted. In addition, the results of those clinical trials were achieved with no meaningful treatment-related side effects as compared to the serious side effects reported with Gemzar(R)-treated patients.
In commenting on his involvement in the Phase 2b trial, Dr. Lohr stated, "It is exciting to see that Nuvilex has mastered some of the challenges that the Cell-in-a-Box(R) technology had remaining when we conducted the first clinical trials. It is, of course, with great pleasure that I see our original concept brought to life again. I am very much looking forward to the upcoming clinical trial."
Some of the areas of the Phase 2b trial in which Dr. Lohr will have a significant role include supporting Nuvilex in collecting information for the design of the clinical trial, writing scientific reports and other documents needed for Ethics Committee approvals for the trial, assessing protocols and procedures to be carried out during the clinical trial, providing advice to clinical personnel conducting the trial and consulting with and providing advice to Nuvilex on a host of issues related to the clinical trial. In addition, Dr. Lohr will be consulting for Nuvilex in connection with additional clinical trials Nuvilex is planning that are associated with pancreatic cancer-related symptoms and other abdominal cancers.
Dr. Lohr currently serves as Professor of Gastroenterology and Hepatology at the Karolinska Institute and as Senior Consultant, Gastrocentrum, Karolinska University Hospital. He received the Dr. med. (MD equivalent) degree from the University of Hamburg (Germany) in 1986 and the Dr. med. habil. (PhD equivalent) degree from the University of Rostock (Germany) in 1996. His postdoctoral work during the late 1980s included time as Resident in Pathology at the University of Hamburg and as Postdoctoral Research Fellow at the Scripps Clinic and Research Foundation in La Jolla, California. Dr. Lohr became Assistant Professor in Medicine at the University of Rostock in 1996, served as Professor of Molecular Gastroenterology, University of Heidelberg from 2000-2007, as Deputy Chairman of the Department of Medicine at the same institution from 2001-2007 and as Head of the Molecular Gastroenterology Unit at the German Cancer Research Center from 2002-2009. In addition, Dr. Lohr has held Visiting Professor positions at the European Institute of Oncology in Milan (since 2003) and on the Medical Faculty at the University of Belgrade (since 2005).
Dr. Lohr has received numerous honors and awards including those from the European Pancreatic Club, the Juvenile Diabetes Foundation International and the American Gastroenterology Association. He also received an award for translational research in pancreatic carcinoma from the Hirshberg Foundation, the Innovations award of Stiftung Familie Klee (Frankfurt), the prestigious Bengt Ihre Medal from the Swedish Society of Medicine and the Presidential lecture and award from the German Gastrointestinal Society. He has served in various capacities with numerous gastroenterology/oncology organizations throughout Europe and as consultant to biotech and pharmaceutical companies. Dr. Lohr has authored more than 120 papers in peer-reviewed scientific journals.
whatever happens to resolve whatever issues with Ryan whether he stays or goes...CiaB moves forward and that is the important factor...
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It's in the Nuvilex 10K
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I for one have already read Nuvilex's 10K but thanks for keeping everyone informed...
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Nuvlilex Volume...
keep in mind not short interest....last 2 days...
Date Symbol Name Short Volume Long Volume Total Volume Short%
2014-08-01 NVLX Nuvilex Inc 325816 974249 1300065 25
2014-07-31 NVLX Nuvilex Inc 285498 1005086 1290584 22
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The language in the Nuvilex 10K is common to all stocks...they always disclose all the risks...most stocks do it...all least the ones that are honest and upfront...that was a very thorough 10K and I think the pps response today shows everyone how the long investors interpreted the report...
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It just keeps getting better and better here at Nuvilex...
IMHO
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Nuvilex will apply for extentions....
problem solved...
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License is ACTIVE..MEDICAL MARIJUANA SCIENCES INC.
Business License Exp: 2/28/2015
Business Entity Information
Status: Active File Date: 2/11/2013
Type: Domestic Corporation Entity Number: E0069582013-8
Qualifying State: NV List of Officers Due: 2/28/2015
Managed By: Expiration Date:
NV Business ID: NV20131084867 Business License Exp: 2/28/2015
Additional Information
Central Index Key:
Registered Agent Information
Name: MICHAEL R. BALABON, ESQ Address 1: 5765 S RAINBOW BLVD STE 109
Address 2: City: LAS VEGAS
State: NV Zip Code: 89118
Phone: Fax:
Mailing Address 1: Mailing Address 2:
Mailing City: Mailing State: NV
Mailing Zip Code:
Agent Type: Commercial Registered Agent - Corporation
Jurisdiction: NEVADA Status: Active
http://nvsos.gov/SOSEntitySearch/CorpDetails.aspx?lx8nvq=3uUzz1oOmE7Y0bwxqJAPTg%253d%253d&nt7=0
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when have you seen insider sells in Nuvilex...
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“mini” Phase 3 trial straight from the horses mouth....
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FUNDED THROUGH 2015....
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TURNAROUND YEAR for Nuvilex...I am looking forward to the future of this little bio...
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The 10K is THOROUGH....
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older article but good for new investors....
Can I Retire on a Biotech Stock?
Nearly everyone dreams of striking it rich in the stock market. That’s why people get into it, right? Well, it doesn’t happen every day, but it does happen more frequently than one might think for patient investors that ride market undulations with confidence in their investments, rather than panic. Even those that rode-out the market nosedive during the Great Recession have seen Wall Street rebound to record levels, including a 170% return from the S&P 500.
Looking at different industries and sectors, the biotechnology arena seems to deliver some of the most lucrative gains for small companies growing from “penny stocks” – generally defined as stocks under $5 per share – to firms with robust valuations, often times in the billions of dollars. The real beauty of biotech is that stocks can appreciate multi-fold in relatively short periods of time. The reason is simple; efficacious drugs and technologies command premiums like nothing else the markets have to offer. Moreover, the ideology of drug development levels the playing field as pharmas big and small all have to start at Point A and follow the same rules of the Food and Drug Administration.
To prove the power of potential biotech returns, take a look at just a couple companies that have delivered enormous returns to investors without even bringing a product to market, including Pharmasset, Inc. (formerly VRUS) and Pharmacyclics, Inc. (PCYC).
Pharmasset was the buzz of Wall Street about six years ago as it was developing a new oral drug to treat Hepatitis C as an alternative to the injectable interferon, the most common treatment for the disease today. As the drug, called PSI-7977, moved through early-stage and then mid-stage clinical trials, shares of Pharmasset soared from under $4 per share in mid-2007 to approximately $160 each before the Princeton, New Jersey-based company did a 2-for-1 forward split, giving shareholders one additional share for every share held, while cutting the share price in half. Shares rose again after the split, including Gilead Sciences, Inc.’s (GILD) buyout price of $137 per share in a deal worth $11 billion. At the time, PSI-7977 was still in Phase II trials and Pharmasset, which had no FDA-approved drugs, posted a $22.6 million loss in the previous quarter. That’s how valuable a novel drug can be to the industry. Apropos, investors who put $10,000 into Pharmasset around $4 and held until the Gilead acquisition recognized gains of about 6,750 percent, meaning the investment turned into roughly $685,000 in just over four years.
Pharmacyclics, a clinical-stage company developing drugs for cancer and autoimmune diseases, is still on the hot list of biotech players even though it has already produced tremendous returns in the past three years. The company was struggling with successfully maneuvering a drug down the regulatory pathway in the late 2000’s, but started finding success with its lead drug candidate ibrutinib as a new oral agent for white blood cell malignancies, such as leukemia and myeloma. Ibrutinib, a covalent inhibitor of Bruton’s tyrosine kinase (BTK), garnered the attention of Wall Street and Johnson & Johnson (JNJ) for its potential to treat a broad spectrum of lymphomas by silencing the B-cell receptor pathway that is a key to tumor cell survival. In 2011, JNJ dished-out nearly $1 billion to partner with PCYC on ibrutinib. Pharmacyclics submitted a New Drug Application to the FDA for ibrutinib and was originally expecting an answer in the first quarter of 2014. The decision came sooner than expected as on November 13, the FDA granted ibrutinib an accelerated approval for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Since bottoming in early 2009 at 57 cents, shares of Pharmacyclics have stormed ahead to as high as $143.34 last month. For those counting, that’s a stunning return of nearly 25,000 percent in less than four years.
While those are some of the extreme cases and no one should be so brash to ever predict returns like the aforementioned companies have delivered, there are a handful of juniors on the upswing with disruptive technologies that carry with them strong potential for exponential growth in coming years. Of particular note is Nuvilex, Inc. (NVLX), a small biotech focused on development and commercialization of a cellulose-based live-cell encapsulation technology that could serve to bridge many areas of great unmet medical need.
Nuvilex has acquired worldwide exclusive rights to develop the technology, also known as Cell-in-a-Box™, for all types of cancer from SG Austria Pte. Ltd. Recently, Nuvilex finalized a deal with SG Austria’s subsidiary, Austrianova Singapore Pte. Ltd., for the rights to develop treatments using the Cell-in-a-Box technology for insulin-dependent diabetes patients. It is this true platform technology that is capturing investors’ attention because it can serve as a stand-alone therapeutic or in an adjunctive capacity to improve results from current standards of care for deadly – and costly – diseases.
For decades, scientists have been trying to harness the power of cell encapsulation to improve efficacy of drug therapy, but with limited success. The technology licensed by Nuvilex has overcome some of the limiting factors of the cell encapsulation processes used by other biotechs by employing cellulose (rather than other materials not native to the body) to create a “cocoon” approximately the size of a pinhead that can host about 10,000 cells, depending on the size of the cells. Using the proprietary cellulose formulation improves the technology on several fronts, including resiliency to external forces, ease of implantation, extremely slow degradation time and permeability features of cell walls to let waste and beneficial substances out and only essential nutrients to enter.
Research has demonstrated that the Cell-in-a-Box™ live-cell encapsulation technology used by Nuvilex has a strong safety profile while substantially increasing the longevity of the protection of the encapsulated live cells while in the body. Even after more than two years in the body, no immune or inflammatory response is caused by the capsules or by the cells within in the capsules and no damage is done to surrounding tissues.
The robustness of the cellulose-based capsules allows for freezing of the encapsulated cells within them for extended periods of time (years) and then subsequent successfully thawing the cells while retaining their viability. When needed, the encapsulated cells can be thawed for use, making the technology scalable and one that results in a true “off the shelf” product that can be shipped globally for use upon demand. This property allows the live-cell encapsulation technology used by Nuvilex to stand alone above the types of live-cell encapsulation technology used by other companies
Nuvilex’s use of the Cell-in-a-Box™ technology could span a wide spectrum of indications, but the company is first targeting pancreatic cancer, a leading cause of death worldwide with the annual death rate in the U.S. nearly paralleling the diagnosis rate in 2013. This is a prime indication for Nuvilex to focus its efforts on because there are very few approved therapies for pancreatic cancer, with most carrying severe side effects. This creates an opportunity for the company to pursue accelerated regulatory pathways offered by the FDA, such as a “Breakthrough Therapy” designation or a “Fast-Track” review that can hasten drug development.
Approved 16 years ago, Eli Lilly’s (LLY) Gemzar (gemcitabine) is the only single-agent therapy to receive FDA approval for treating pancreatic cancer. Other therapies are cocktails of drugs and usually include gemcitabine, except for Folfirinox, a four-drug combo used to treat the deadly disease.
In a small-scale Phase 1/2 trial, Nuvilex evaluated 14 patients with advanced, inoperable pancreatic cancer treated with the combination of the widely-used anticancer prodrug ifosfamide plus cells capable of converting the ifosfamide into its cancer-killing form that had been encapsulated using the cellulose-based live-cell technology. Ifosfamide is a widely used anti-cancer prodrug that, when administered without encapsulation, depends upon the liver to convert it to an active state as a cancer killer. Because of this activation by the liver, the cancer-killing form of the ifosfamide can enter the general blood circulation, which, in turn, can cause toxicity to organs in the body other than the pancreatic tumor. The trial was structured to test the hypothesis that, because the encapsulated cells can activate ifosfamide, by implanting them near the tumor site, the patients might be treated with much lower doses of ifosfamide than are typically used with this drug while yielding an excellent therapeutic benefit with limited side effects from the drug.
Upon completion of the trial, when the data are compared to historical data (results from Gemzar’s pivotal Phase 3 trial that were used to obtain FDA approval and that are part of the prescribing information for the drug) for the efficacy of Gemzar, the researchers discovered that patients receiving the encapsulation/ifosfamide therapy had a median survival of 11 months, compared to only 5.7 months for gemcitabine. The one-year survival rate was doubled from 18% for Gemzar alone to 36% for encapsulation/ifosfamide-treated patients. Tumor growth was stabilized in all 14 patients, including a reduction in tumor volumes of between 25 and 50 percent in four patients. Importantly, where there were severe side effects in patients treated with Gemzar, there were no severe side effects in patients treated with the live-cell encapsulation/ifosfamide combination, likely because the dosing level of ifosfamide was greatly reduced compared to what is usually used when patients are treated with this anti-cancer drug.
Nuvilex is in the process of preparing for the initiation of a randomized, large-scale, late-phase clinical trial designed to compare the effects of its treatment head-to-head with gemcitabine in patients with advanced, inoperable pancreatic cancer. As examples of these preparations, the ifosfamide-activating cells are currently being cloned to ultimately obtain the numbers of cells required for the clinical trial and possible CROs (Contract Research Organizations), who will assist in many of the preparations for and conduct of the clinical trial, are being evaluated. If investors follow the typical procedure with biotech investing and building positions in companies as trials commence, Nuvilex will be firmly on the radar of Wall Street as that milestone approaches.
Showing the effectiveness of ifosfamide in pancreatic cancer succinctly dovetails with other corporate initiatives to develop a new treatment for breast cancer. Of the 10 most-commonly-used treatments for breast cancer in recent years, nine use the anti-cancer prodrug cyclophosphamide, which happens to be a “sister” drug of ifosfamide. The same enzyme system in the liver that converts ifosfamide into its active state converts cyclophosphamide as well.
An early/mid-stage veterinary clinical trial was conducted using living cyclophosphamide-activating cells encapsulated using the Cell-in-a-Box™ technology to treat dogs with mammary tumors (a good model test system for breast cancer in humans). Here, the encapsulated cells were implanted into the tumors of some of the dogs and then all of the animals were treated with cyclophosphamide. The control arm of the study consisted of dogs treated with cyclophosphamide alone. The results showed significant reductions in tumor volumes in the dogs whose tumors were implanted with the encapsulated cells and then treated with cyclophosphamide compared to the control arm. Even more amazing, one animal, which had two tumors, had one tumor treated with the encapsulated cells while the other tumor was not. Cyclophosphamide therapy followed per protocol, with the encapsulated-cell-treated tumor shrinking by 70%, versus only 14% for the non-encapsulated-cell-treated tumor.
Following its successful capital raise at a premium to today’s price, Nuvilex secured the rights to use the cellulose-based live-cell encapsulation technology for the development of a new treatment for insulin-dependent diabetes patients. Statistics released in November by the International Diabetes Federation (IDF) show that diabetes has grown to pandemic proportions with a record 382 million patients living with the disease in 2013, up from 371 million in 2012. By 2035, the IDF estimates that diabetes cases will have soared to 592 million at its current growth trajectory, creating a dire need for new therapeutics and another opportunity for Nuvilex to develop its novel technology.
Groundbreaking research conducted in the early 2000s and termed the “Edmonton Protocol” has shown promise in transplanting pancreatic islet cells (cells that produce insulin) derived from human cadavers into diabetes patients to support a dysfunctional pancreas that is unable to properly produce insulin. The treatment comes with heavy costs however, as constant administration of potent and expensive immunosuppressive drugs is required to prevent rejection of the transplanted islet cells by the recipients’ immune systems; without them, the patients would be open to a myriad of opportunistic infections (viral, bacterial, and fungal). Furthermore, the supply of islet insulin-producing cells from donor cadavers is limited. Islet cells from pigs have proven a viable and effective alternative, but the degradation, over time, of capsules prepared with other than the cellulose-based material employed in the Cell-in-a-Box™ capsules used by Nuvilex, particularly capsules made using alginate (a seaweed derivative commonly used to encapsulate living cells), again triggers an attack by the body’s immune system on the encapsulated islet cells and limits the longevity of such non-cellulose-based capsules, and the cells within them, in the body.
In vivo lab research has shown the potency of the cellulose-based live cell encapsulation technology licensed by Nuvilex to overcome this degradation obstacle. The Cell-in-a-Box™ capsules were well tolerated by the host and remained intact for extended periods of time. Furthermore, the cells within the capsules maintained their capability to produce insulin throughout this period.
In preclinical studies, diabetic animals were implanted with insulin-producing cells encapsulated using the cellulose-based technology. This “proof of principle” research showed that, shortly after implantation of the encapsulated insulin-producing cells, blood glucose levels became normal and stayed normal for extended periods of time. The capsules protected the cells within them from immune system attack making the use of immunosuppressive drugs unnecessary. In one six-month study, when diabetic animals were implanted with encapsulated insulin-producing cells, the blood glucose levels in the animals became normalized and remained that way for the duration of the study. At the end of the study, the capsules were found to be intact and the cells were still functioning. In other words, the insulin-producing cells were still capable of producing insulin in response to elevated levels of glucose in their surroundings.
With the technology validated in clinical and laboratory research, Nuvilex has taken a page out of blue chip companies’ playbooks by hiring Kenneth L. Waggoner, Esq. to serve as CEO and President. Dr. Robert F. Ryan will move from those positions to Chief Scientific Officer, freeing him from distractions of day-to-day operations to directly focus on late-stage clinical development of the cellulose-based live-cell encapsulation technology. In addition to his previous position as VP and General Counsel for Chevron’s Global Downstream (CVX), Waggoner was a partner in the venerable law firm of Brobeck, Phleger and Harrison, named one of the top two law firms in the world for providing services to the biotechnology industry. In that role, Waggoner worked with leading pharmas such as Amgen (AMGN), Biogen Idec (BIIB), Chiron and many more. Waggoner should have a palpable impact on Nuvilex by delivering inroads to potential partners and providing leadership as a legal biotech expert.
It takes a discerning eye to pick a biotechnology company that has the potential for exponential growth in a relatively short period of time, but they are out there. To maximize the opportunity, a company must have a novel technology that addresses large areas of unmet medical need, which opens the door to lucrative partnerships and capitalizes on FDA initiatives for expedited development and/or extended periods of exclusivity for new therapies. Nuvilex has made moves in the past year that are fundamentally accretive as it prepares for a pivotal trial that can put it in an envious position with a true platform technology that can reward stakeholders, while providing a better quality of life for millions of people worldwide who suffer from serious, and even deadly, diseases. With every stock comes risk, but due diligence on Nuvilex at these levels is a no-brainer. With a likely pre-IND meeting with the FDA within the next 6 months, these price levels may never be seen again.
http://www.baystreet.ca/articles/stockstowatch.aspx?id=687
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WOW thanks...I know I read that before but appreciate you reminding me about how Nuvilex has helped out a company like Austrianova to bring to fruition their vision to help people with Pancreatic Cancer...good find...
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I don't believe that Nuvilex is staying in this range until the trials have results next year...when the TD2 study begins I believe you are going to see the stock begin it's trek up again through this short study...
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I don't really see anyone DUMPING Nuvilex...what... a penny down today after we moved up for several days...where is the dumping...
if you can show me a chart with massive dumping I would appreciate it...
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evan though Nuvilex is this tiny pps...this is probably one of the most NON speculative bio's I have acquired in a long time...not having revenue is a non issue with a micro cap bio...Nuvilex is debt free and is concerned about how they raise money for their trials and expenditures watching out for their shareholders...they get their pay with stock...they work relentlessly...sell...but not me...I own and have owned bio's...and I know when I have a winner...
but good luck to you too...
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OK...now it has dawned on me...Hoff saw the blood flow back into the pancreas so he knew the tumor was shrinking or not growing....so if you can slow down tumor growth... Ascites will also diminish...that is why he wanted to work with CiaB and is excited about it ...
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This is a TOTALLY DIFFERENT RESEARCH
The first task of the research team, led by Dr. Richard Hyslop, a professor of chemistry and biochemistry at UNC, is to identify cells that are capable of activating the cannabis.
GREELEY – The University of Northern Colorado is one of the first schools in the state to begin investigating the cancer-fighting properties of marijuana, using a new partnership with biotechnology company Nuvilex.
Silver Springs, Md.-based Nuvilex (OTCQB: NVLX) launched the research project with UNC in May. Its goal is to determine whether the company’s patented technology can be used along with medical cannabis to kill tumors and extend the lives of patients with advanced brain and pancreatic cancer.
The idea is to have patients take inactive cannabinoids, which are the active chemical constituent of marijuana. Once the inactive substance enters the body, it attaches to a special “encapsulated” cell that has been injected near the tumor site. When the inactive cannabinoids reach the site, they are activated by the cell. The test will be to determine how effective these substances, when coupled with this targeted cell-injection technology, are in fighting cancer and minimizing its side effects.
The technology, dubbed Cell-in-a-Box, is a live-cell encapsulation mechanism that allows a certain cell to be stored in a capsule and delivered into the human body, said Ken Waggoner, chief executive of Nuvilex.
The first task of the research team, led by Dr. Richard Hyslop, a professor of chemistry and biochemistry at UNC, is to identify cells that are capable of activating the cannabis.
“The type of cell that we are going to incorporate will have a particular type of activity that is capable of converting a component of cannabis to an active anti-cancer drug,” he said.
Cannabinoids are made up of several different compounds which have different characteristics, said physician Dr. Mark Rabe, a member of the Medical Marijuana Scientific Advisory Board at Nuvilex. With legalization has come a wave of new research examining the cancer-fighting properties of these different cannabinoid compounds.
How effective are cannabinoids in fighting cancer?
According to the National Cancer Institute at the National Institutes of Health, laboratory and animal studies have shown that cannabinoids have tumor-fighting capabilities, which can kill cancer cells. However, no clinical trials have been conducted in the United States.
“Cannabis and cannabinoids may have benefits in treating the symptoms of cancer or the side effects of cancer therapies, including nausea and vomiting, anxiety and loss of appetite,” according to the NIH.
Despite the lack of human clinical trials, Hyslop said he has confidence in marijuana’s ability to fight cancer.
An expert in drug metabolism, “I’ve been working with anti-cancer drugs since the mid-70s,” Hyslop said.
Hyslop’s work this summer is to begin screening a preliminary set of cells to determine which are the best candidates to use in the treatment protocol.
“We have some information that the type of activity that we need is located in several types of cells, and that’s what we’re screening,” he said.
If cannabinoids really can reduce or eliminate tumors, the research will bring another benefit – helping patients avoid potential side effects by taking active medical cannabis.
As an active chemical, cannabinoids may create drug-like effects throughout the body, Hyslop said. Thus, if patients want to use cannabinoids to attack tumors, they have to use dangerously large doses, which can create side effects.
According to the American Cancer Society, “Marijuana overdoses do not cause death, but may cause mental impairment and distressing emotional states, such as paranoia, hallucinations and disconnection from reality. Overdoses can also cause fast or disturbed heart rhythm, sleepiness, clumsiness, dry mouth, dizziness and low blood pressure.”
However, inactive cannabinoids don’t have any druglike effects. Therefore, the technology may minimize side effects, Hyslop said.
Nuvilex declined to disclose the ongoing cost for the research.
“The initial research could be completed as soon as September or October. It also may run into next year,” Hyslop said, “Nuvilex will eventually put it into clinical trials, which may take years.”
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Nuvilex, Inc. (NVLX) will begin preclinical studies in early August with its Contract Research Organization (CRO) Translational Drug Development (TD2) to study the first of 4 symptoms associated with pancreatic cancer and other abdominal cancers. In what is essentially the biggest step in Nuvilex’s history to date, the company will enter the clinic under its own brand for the first time ever, and it will do so with the highly respected oncology CRO, TD2 and its Chief Development Officer, Dr. Daniel Von Hoff. In the studies, Nuvilex and TD2 will determine what effect the company’s pancreatic cancer treatment will have on these symptoms.
This study is the key thing that is going to put Nuvilex front and center...the exposure from having Dr.Von Hoff world renowned cancer doctor and TD2 the U.S. premier CRO conducting a study under the Nuvilex name for the first time is big....short lived study and then results...
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thank you so much for the info...we had already seen that but just to verify the fact that businesses do get paid some kind of compensation for their work is good to know...Nuvilex has paid for promotion that has been taking them into the light...that is how I found this stock and did my DD and I can't be happier...but thanks for your DD.....
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you are spot on about Nuvilex's Cell-in-a-Box...and the naysayers have their reason that we know and the new investors to Nuvilex need to just do some DD to see the potential here...to see why we are all so excited to get in on the ground floor of a tiny bio at this pps that is going to be incorporated into all kinds of cancer...like I said this is not a drug going for approval....the drug Nuvilex is using was approved decades ago...but any pharma could use CiaB with their own drug...
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I agree...what people seem to forget is that this is not trials for a new drug...this is technology to deliver a drug that has been approved a long time ago...and the fact that the Phase I/II trials already beat both standard of care makes Nuvilex not a lottery ticket at all..
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who cares...every one of my small bio's use stock promoters...and they are all up on fundamentals...using a stock promoter means nothing but getting your name out there and getting the company noticed and we all know that it has worked for Nuvilex hasn't it now....this is a really old subject that really means nothing...
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because it is not a PR from Nuvilex's public relations...go to Nuvilex's web and see what they have posted....it's not rocket science...
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( NVLX ) Nuvilex Nears Crucial Quality of Life Study in Malignant Ascites Associated with Pancreatic and Other Abdominal Cancers
In what is essentially the biggest step in Nuvilex's history to date, the company will enter the clinic under its own brand for the first time ever, and it will do so with the highly respected oncology CRO, TD2 and its Chief Development Officer, Dr. Daniel Von Hoff. In the studies, Nuvilex and TD2 will determine what effect the company's pancreatic cancer treatment will have on these symptoms.
the only thing this little mice study needs to prove is slowing the accumulation of ascites fluid in cancer patients ....
this is what will get Nuvilex noticed...
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one thing to keep in mind...this small mice study that TD2 with Hoff is doing is the key to validity for Nuvilex and will get us noticed before our trials even start in 1st Q next year...Hoff..world renowned cancer doctor...strong ties to FDA and the best CRO in U.S.....our journey begins with this study in a couple of weeks...
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Dr. Daniel Von Hoff, Chief Development Officer for TD2.....
In my mind we had clarification yesterday too...lol..to think Hoff is the chief development officer and would not be involved???
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The Wall Street Journal ( NVLX ) Nuvilex Nears Crucial Quality of Life Study in Malignant Ascites Associated with Pancreatic and Other Abdominal Cancers
New York, NY / ACCESSWIRE / July 23, 2014 / Nuvilex, Inc. (OTCQB: NVLX) will begin preclinical studies in early August with its Contract Research Organization (CRO) Translational Drug Development (TD2) to study the first of 4 symptoms associated with pancreatic cancer and other abdominal cancers. In what is essentially the biggest step in Nuvilex's history to date, the company will enter the clinic under its own brand for the first time ever, and it will do so with the highly respected oncology CRO, TD2 and its Chief Development Officer, Dr. Daniel Von Hoff. In the studies, Nuvilex and TD2 will determine what effect the company's pancreatic cancer treatment will have on these symptoms.
Nuvilex's first preclinical study will test the success of the Cell-in-a-Box(R) /ifosfamide combination in slowing the accumulation of ascites fluid in cancer patients -- specifically malignant ascites. This is likely the initial study because in general, the prognosis for patients with malignant ascites is poor. According to the National Cancer Institute, the mean survival time is less than 4 months depending on the type of malignancy.
Malignant ascites is the abnormal accumulation of abdominal fluid due to the direct effects of cancer, and it appears most often in patients with pancreatic, breast, colon, ovarian, uterine and gastrointestinal tract (stomach and intestines) cancers. The fluid itself can contain cancerous cells, which, in turn, can "seed" at various places in the abdomen and form new tumors, so the fluid most continuously be drained from the patient.
Cancer patients that develop ascites deal with significant symptoms including pain, and endure poor quality of life. Nuvilex expects that its treatment can improve the quality of life for patients with pancreatic cancer and other abdominal cancers by slowing down this abnormal accumulation of malignant ascites.
So, now the question we're left with is; can slowing the accumulation of malignant ascites, potentially increase the mean survival time in those patients, and, in turn, can slowing the ascites improve the quality of life and potentially increase the survival rate for patients with advanced, inoperable pancreatic cancer.
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I post once in a while about chart stats ...and I have never been interested the the short position on Nuvilex...nor do I harp about pr's or smmg...so those comments should be directed at someone else or not directed at all...and I own quite a bit of Nuvilex and plan on holding for a long time like I have my other profitable bio's...
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I am just going to wait and see the results from the pre-clinical trial...I am done with this silly conversation...
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why don't you give Nuvilex a call or email them and ask who contacted who...
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Dr. Von Hoff called Nuvilex on their work with pancreatic cancer ...and then asked to be involved...so you really think that he is not going to be overseeing the study...
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Today's pullback is nothing more than momentum traders selling after buying in the low .20's...we are a couple weeks from pre-clinical trials with Dr.Von Hoff Nuvilex will go back up...
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I would appreciate it Alydyr if you would not refer to all of us on this mb as uneducated...I am very educated in Nuvilex...I own quite a few bio's and one of them that I bought as a so called penny stock is sitting over $8.60 at this moment...so I would say that was an educated buy just like Nuvilex will turn out to be...
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You fail to understand that I have no problem with Nuvilex paying compensation to anyone employed at Nuvilex or paying compensation for financing or paying compensation to media to get the name Nuvilex noticed....and you still did not answer my question...because I have no insider knowledge like you just insinuated...
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