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well I have to say selling is not smart right here just like it never has been...you buy and hold and add and get rich on a Frost stock...been there done it...
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6 green days up all started the day after Frost purchased...I own Frost stocks...everyone knows to follow the money with Frost...
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they were indirct per sec...for his trust...I don't see why it really matters...direct or indirect...still a buy and look what it did for the stock....
http://insidertrading.org/form4.php?id=4945581
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It was not a could of....It is easy enough to check....http://openinsider.com/search?q=cocp
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If you know Frost I would bet it was an open market buy also...he bought 111,200 shs on the 11th @ .29 when the high was .29 and the low was .27....
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Senate Bill 1262 was to REGULATE mmj....and it didn't pass...so that leaves all the cities and counties to regulate it on their own...they wanted this bill before 2016 elections for legalizing mj so they could get REGULATIONS in place....THAT IS ALL...did you read it....
Exactly....Nuvilex is coming into it's own...and we all know it...
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The Pancreatic Cancer Research Team (PCRT) includes 62 investigators from 34 institutions in the US and Europe.....
here is the location and the names...https://maps.google.com/maps/ms?ie=UTF8&oe=UTF8&msa=0&msid=110842871695848533083.00046592f130fb2cd0d08&dg=feature
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I would say that everything is answered on this topic concerning the role that Dr. Von Hoff will play in reference to the TD2 study starting next week and the trials after that...we already know that Hoff called Nuvilex ...not the other way around...
thanks for your DD wendy...
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I guess that settles that question about Dr. Von Hoff wanting to be involved with Nuvilex and Cell-in-a-Box...I was about to post it also...
thanks wendy
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To get approval all we really have to do is have at least the same results as phase 1/2 with reduced ascites and reduced pain in the TD2 clinicals with better results than the 2 standards and QUALITY OF LIFE ...which the other standards do not have...they have horrible side effects...
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Nuvilex's Phase 1/2 Trials ALREADY BEAT the ONLY 2 other standards out there...
I don't think we have one thing to worry about...
and on top of that we have new studies now with Hoff and TD2 starting next week...
and access to the PCRT ...
everything going for this company...
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KEEPS GETTING BETTER FOR THIS NUVILEX
all the trial data now published and out there from not only the phase I/II trial but also the 2nd phase 2...they know the path to take now with the larger late phase 2b with is the lower dose and more rounds...so that puts both of those to rest...
TD2 study to start next week...
all going well and coming to fruition...
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NOTE: from the publication...
Pharmaceutics 2014, 6 458
2.6. Quality of Life
Both trials included an assessment of the quality of life of patients using the core questionnaire for
cancer patients, QLQ-C30, and a German quality of life scale for pancreas patients [42], which were
completed by the patient. This was done independently; thus, the assessment of the quality of life data
did not interfere with the routine documentation of the adverse events that were reported by the
patient. Quality of life data were available from the baseline evaluation for all 14 patients and
for the analysis of change from eight patients in the first trial, and the analysis was performed
strictly according to the European Organization for Research and Treatment of Cancer (EORTC)
recommendations [43]. In the first trial, evidence was obtained that there was a general increase in
quality of life, including no requirement for increased pain medication. In the second trial, data from
the disease-specific module of the questionnaire revealed that pain during the night decreased, but
patients felt themselves to be less attractive and lost interest in sex. All other scales and items remained
fairly stable during the observation period; no further improvements in quality of life data were
observed, besides reduced pain during the night.
Well a lot of us have put an absurd amount of money in Nuvilex so we betting that we are right...
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PR...Aug. 14, 2014, 9:01 a.m. EDT
Nuvilex Announces Publication of Combined Results of the Initial Phase 1/2 Clinical Trial and a Second Phase 2 Clinical Trial of the Cell-in-a-Box(R) Plus Ifosfamide Combination in Patients With Advanced, Inoperable Pancreatic Cancer
SILVER SPRING, Md., Aug 14, 2014 (GLOBE NEWSWIRE via COMTEX) --
Nuvilex, Inc. (otcqb:NVLX), a clinical-stage, international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that its partner, Austrianova, has reported the results from the second Phase 2 clinical trial combining the Cell-in-a-Box® cellulose-based live cell encapsulation technology plus low doses of the anticancer prodrug ifosfamide in patients with advanced, inoperable cancer has been published in the scientific journal Pharmaceutics. The title of the publication is "Encapsulated Cells Expressing a Chemotherapeutic Activating Enzyme Allow the Targeting of Subtoxic Chemotherapy and Are Safe and Efficacious: Data from Two Clinical Trials in Pancreatic Cancer." The entire report can be viewed by clicking http://www.mdpi.com/1999-4923/6/3/447 and then clicking on "Full-Text PDF" on the left side of the page.
Nuvilex's CEO and President, Kenneth L. Waggoner, commented, "It is very interesting to see the results of a second Phase 2 clinical trial of our pancreatic cancer treatment in patients with advanced, inoperable pancreatic cancer compared and contrasted to the results of the initial Phase 1/2 clinical trials, with the results from both summarized together in this single publication. We believe the results from the second Phase 2 clinical trial show that the efficacious nature of Nuvilex's pancreatic cancer treatment seen in the Phase 1/2 trial was once again evident in the Phase 2 clinical trial. However, discrepancies between the two trials are also reported. For example, in the second Phase 2 clinical trial, when the dose of ifosfamide was increased over that used in the Phase 1/2 clinical trial, the antitumor effectiveness of the treatment appeared to be slightly reduced, but the side effect profile of the treatment was increased in severity. Also, we believe that the overall utility of Nuvilex's pancreatic cancer treatment was illustrated by the fact that it could be readily employed in multiple treatment centers. Interestingly, noted European gastroenterologist and oncologist Dr. Matthias Löhr was Principal Investigator for both clinical trials. Dr. Löhr is assisting Nuvilex in the development and oversight of our upcoming Phase 2b clinical trial in Australia."
In total, 27 patients with advanced, inoperable pancreatic cancer have been treated with the Cell-in-a-Box®/ifosfamide combination - 14 in the Phase ½ clinical trial and 13 in the second Phase 2 clinical trial. Both trials were uncontrolled (no comparator arms), open-label studies. In each of the clinical trials, a single implantation of Cell-in-Box® capsules (each capsule contained approximately 10,000 cells capable of converting the anticancer prodrug ifosfamide into its "cancer-killing" form by virtue of their over-expression of an isoform [CYP2B1] of human cytochrome P450) was used and two courses of treatment with ifosfamide were administered. In both clinical trials, there were no deleterious effects, such as inflammation or pancreatitis, that could be attributed to the Cell-in-a-Box® capsules being implanted in the patients.
The median survival of patients in the Phase 1/2 clinical trial was about 40 weeks versus the 33 weeks seen in the Phase 2 clinical trial. The percentage of patients who survived one year was somewhat lower in the Phase 2 clinical trial (23%) than in the Phase ½ clinical trial (38%). There were several other differences between the trials. First, whereas the Phase 1/2 clinical trial was done at a single study center (in Rostock, Germany), the Phase 2 clinical trial was conducted at four centers in two European countries (in Rostock, Berlin and Munich in Germany, and in Berne, Switzerland). Second, the dose (1 g/m2) of ifosfamide used in the Phase 1/2 clinical trial was one-third of the "normal" dose of ifosfamide, whereas the dose used in the Phase 2 clinical trial was twice (2 g/m2) that dose. Third, differences were seen in the severity of adverse events (side effects) in the two clinical trials. In the Phase 1/2 clinical trial, no adverse events were seen that could be attributed to the treatment, but in the Phase 2 clinical trial, severe side effects were observed that the investigators believed were caused by the higher dose of ifosfamide used in the latter trial. According to a quality-of-life (QOL) questionnaire, although a reduction in the severity of the pain associated with the disease was noted in both studies, other deleterious effects on QOL were reported by patients in the Phase 2 clinical trial that were not reported by patients in the Phase 1/2 clinical trial. In light of these results, we believe that 1 g/m2 rather than 2 mg/m2 is the appropriate dose of ifosfamide to use as part of Nuvilex's treatment for advanced, inoperable pancreatic cancer.
Mr. Waggoner concluded, "With the publication of this article in Pharmaceutics, the history to date of the development of Nuvilex's pancreatic cancer treatment has been completed. The 'rest of the story' is now being written, beginning with the preclinical studies by Translational Drug Development (TD2) set to commence in the U.S. during the week of August 18, 2014. These initial preclinical studies will examine the effects of our cancer treatment on the rate of accumulation of malignant ascites fluid. A subsequent study to be conducted by TD2 will concern the effects of our treatment on the severe pain associated with pancreatic cancer. Nuvilex's two-prong approach to the treatment of advanced, inoperable pancreatic cancer will be rounded out with our Phase 2b clinical trial to be conducted in Australia under the aegis of our Clinical Research Organization in that country, Clinical Network Services."
http://www.marketwatch.com/story/nuvilex-announces-publication-of-combined-results-of-the-initial-phase-12-clinical-trial-and-a-second-phase-2-clinical-trial-of-the-cell-in-a-boxr-plus-ifosfamide-combination-in-patients-with-advanced-2014-08-14
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Cell-in-a-Box technology was successful......Austrianova was just not successful taking it all the way to market...
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NEW PUBLICATION
Encapsulated Cells Expressing a Chemotherapeutic Activating
Enzyme Allow the Targeting of Subtoxic Chemotherapy and
Are Safe and Efficacious: Data from Two Clinical Trials in
Pancreatic Cancer
Received: 24 March 2014; in revised form: 2 July 2014 / Accepted: 30 July 2014 /
Published: 11 August 2014
download the PDF
so any of you that were wondering where the publication for the second phase II is....here it is....
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NOTE: the last line....We look forward to working together with Nuvilex, with the help of the Thailand Center of Excellence for Life Sciences (TCELS), to bring this technology into further trials so it becomes mainstream clinical practice as quickly as possible."
And this from the TCELS web page....NOTE:...the line...
and private sector partners including Austrianova Thailand Ltd.
Do we have a new partner?
TCELS successfully flew its flag at the 2014 BIO International Convention
Establishing collaborations with US giant firms and government agencies.
The Thailand Centre of Excellence for Life Sciences (TCELS) successfully flew its flag at the 2014 BIO International Convention established collaborations with US giant firms and government agencies.
The 2014 BIO International Convention, held from 23-26 June in San Diego, California, drew 20,000 participants including researchers, scientists, investors and businessmen from both the public and private sectors. TCELS led a team of Thai delegates from allied agencies including the Thailand Board of Investment (BOI), Biodiversity Based Economy Development Office (BEDO), National Nanotechnology Centre (NANOTEC) under National Science and Technology Development Agency (NSTDA), National Science Technology and Innovation Policy Office (STI), Naresuan University, Prince of Songkla University, King Mongkut University of Technology Thonburi and private sector partners including Austrianova Thailand Ltd., Siam Bioscience Co., Ltd, Photo Bio Care Co., Ltd, etc. Works and innovation by Thai researchers were also presented at the Thai Pavilion.
TCELS presented projects under its support including a whitening product made from natural latex extracted by Prince of Songkla University and Naresuan University, and pre-clinical and clinical research developments that meet international standards.
CEO of TCELS, Dr. Nares Damrongchai, said that during this three-day event, more than 800 visitors showed their interest and sought details about Bio-Nanotechnology investment, standard clinical research and development, as well as Thai life-science products.
Dr. Nares said that Thailand has achieved great success at this event as it could establish collaborations with giant firms and government agencies big countries like USA, India, Czech Republic, Spain etc. TCELS’ team also went for a site visit to Scripps Research Institute. It will have collaboration on human resource development with them. Most importantly, TCELS is dealing with a high potential company in drug development for infectious diseases. It seeks for Thai venture capitalists to join the investment for such drug development.
CEO of TCELS also said that after the BIO International Convention, he had a chance to attend the international conference of stem cell in Canada. The conference focused on the global laboratory advancements of cell and gene research for treatment and therapy of many diseases such as Alzheimer, Parkinson, cardiovascular, and cancer including regenerative tissues like corner tissues (like cornea) According to the latest advancements, now it has been proved and accepted that some diseases can be treated by cell and gene therapy, for example, some blood diseases. There were also discussions about social and legal issues including the ownership between the tissue owners and the researchers, which is still an ongoing argument in many countries.
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Updated on 14 August 2014
Austrianova has developed a technology for encapsulation of living mammalian, Cell-in-a-Box
Read more at: http://www.biospectrumasia.com/biospectrum/news/218537/austrianovas-encapsulated-cell-treat-pancreatic-cancer?WT.rss_f=Biotech&WT.rss_a=Austrianova%27s+encapsulated+cell+to+treat+pancreatic+cancer#.U-yM1PmfK6w
Singapore: Singapore-based Austrianova's encapsulated cell technology has demonstrated to treat pancreatic cancer in a phase 2 study, according to a paper published in Biotech Journal Pharmaceutics. Austrianova has developed a technology for encapsulation of living mammalian (Cell-in-a-Box) that protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The technology has been proven safe and efficacious in clinical trials carried out in Europe and allows companies to develop any kind of cells as a one-for-all living pharmaceutical. The results from a new previously unreported phase 2 multicentre clinical trial were presented and were compared with data from the first clinical trial previously published in The Lancet and Cancer Therapy. In both trials encapsulated cells were used to allow lower doses of chemotherapy to be used for effective treatment of pancreatic cancer while minimizing the usual side effects. The newly published data from the phase 2 multicentre trial confirmed the results obtained in the previous trial and also confirmed the dose of chemotherapy administered in that trial. The trial also demonstrated that the procedure could be performed in four independent clinical centres located in two different countries. The survival data from these trials compares favourably with recently developed treatments for pancreatic cancer like abraxane and FOLFIRINOX, showing similar efficacy but with less toxicity. Austrianova partner, Nuvilex will aim to provide additional clinical evidence in their upcoming clinical trials. Mr Brian Salmons, CEO, Austrianova stated "This publication summarizes the clinical experience that has been obtained using encapsulated cells in combination with low dose chemotherapy for the treatment of pancreatic cancer in a total of 27 patients and forms the basis for future trials. We are pleased that the data has been published in the rigorously peer-reviewed, international journal Pharmaceutics". Mr Walter H Gunzburg, chairman and CTO, Austrianova said "Pancreatic cancer is a devastating disease. This data strongly supports the use of encapsulated cells as an effective tool in the oncologists arsenal, while at the same time providing a low toxicity treatment option for patients. We look forward to working together with Nuvilex, with the help of the Thailand Center of Excellence for Life Sciences (TCELS), to bring this technology into further trials so it becomes mainstream clinical practice as quickly as possible."
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Opko is a stock that you buy and pack away and don't even have to look at or worry about...I bought this stock at about low 3's and don't even bother with it...I know what a Frost Company can do ...I don't post here much because I just sit back and let Frost do his thing...and in the end ...well you all know the end...
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Lots of good info for Nuvilex investors...thanks for your DD...I too agree that everything is coming to fruition for the patient shareholders...
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Nuvilex long volume to short volume yesterday....
80% BUYS 20% sells
Short Volume Long Volume Total Volume Short%
1139775 4436566 5576341 20
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Nuvilex Provides Update on Status of Preclinical Studies at Translational Drug Development
SILVER SPRING, Md., Aug 13, 2014 (GLOBE NEWSWIRE via COMTEX) --
Nuvilex, Inc. (otcqb:NVLX), a clinical-stage, international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it is providing shareholders with an update on the status of Nuvilex's preclinical studies to be conducted by Translational Drug Development (TD2) in Scottsdale, Arizona.
The CEO and President of Nuvilex, Kenneth L. Waggoner, said, "In an effort to keep our shareholders informed on the very important preclinical studies to determine if Nuvilex's unique treatment of cancer can slow the accumulation of fluid in the abdomen, known as "malignant ascites," that is characteristic of the growth of many abdominal tumors, including pancreatic cancer, we wanted to announce that the encapsulated cells that will be used in the preclinical studies have arrived in the U.S. These are the encapsulated calls capable of converting the anticancer prodrug ifosfamide into its cancer-killing form using the Cell-in-a-Box® cellulose-based live cell encapsulation technology. With the arrival of the encapsulated cells, the preclinical studies are now slated to begin at TD2 the week of August 18, 2014."
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Nuvilex
August 6th 2014: Austrianova Thailand Presents at ThaiTECT
Dr. Brian Salmons and Prof. Walter Gunzburg were invited by Thailand Center for Excellency in Life Sciences (TCELS) to share their journey from discovery to development at their annual ThaiTECT conference. It was a great opportunity for the conference attendees to gain insight into the reality of transitioning from basic research to industry. Walter and Brian gave helpful advice particularly about the importance of have open dialog with regulatory agencies and being persistent to deal with the ups and downs along the way.
Great Find...Nuvilex has been hit with this like a lot of stocks on the OTC....and some deserve it and some like Nuvilex don't...it all works out in the end...you just find a stock by whatever means ..even paid promotions ...do your relentless DD...and buy...and hold...and know that you have done everything to validate your convictions and the rest is noise..Nuvilex is ready to come to fruition...and soon...study starts any time now...give or take...common with bio's...always have patience..it is science...
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Alydyr....can you please go back and look at the other Nuvilex posts and re-read Otsy's post....he said nothing like the accusations you are making on this mb...please re-read everything because us shareholders do not understand what you are insinuating....it would be much appreciated to all the long investors here because we would not want to miss any important information...and if you could get back with us with any concrete information that you have gotten from the company or from Waggoner that would really settle this issue...
much appreciated
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Alydyr...since Otsy did not say anything about Nuvilex being involved in ANY investigation can you please tell the shareholders where you are getting YOUR information from...do you have insider information since you seem so adamant about this...
I think your NVLX investigative approach is wonderful...I have and am following you with anticipation for what information you will come up with to inform the shareholders so as we are not left in the dark...could you please keep us updated...
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SU2C is doing great work on pancreatic cancer...and it gets a lot of exposure because of all the movie people involved...Dr. Von Hoff working with the teams and also with the PCRT...if anyone can further the cause for a cure he can...we are very lucky to have him involved with Nuvilex and he will be instrumental in getting FDA approval...he always does...
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SU2C...Von Hoff....Researchers step up hunt for new pancreatic-cancer treatments....http://seattletimes.com/html/nationworld/2024064922_pancreaticcancerxml.html
and now Nuvilex joins the fight...
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NUVILEX...Dr.Hoff has a record of getting drugs approved so he must know what the right trial design is...I imagine it just might be the study TD2 is commencing shortly....
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Nuvilex has one of the best lawyers CEO for protecting against this sort of accusations....so I sent the info to Waggoner to see what we can find out...nothing here...
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Nuvilex's delivery Cell-in-a-Box is going to be a game changer ...
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I also was going to research this but felt it was a waste of my time so I sent a copy of it to Mr. Waggoner at Nuvilex so if he wanted to he could respond to the accusation...Being a Lawyer I imagine he knows how to handle this type of stuff...but he is really busy getting ready for the study that is starting any day now...
Nuvilex
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NUVILEX READY TO POP WITH ANY NEWS.....
news of the study with TD2 should be out any day now...
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the best investments are having an eye for a stock that no one wants or knows about and realizing it's potential like Nuvilex...it is called a hidden gem...have you heard of them....bigger question...have you ever invested in one and been there to reap the explosion that happens when they hit...no worries here...
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WAGGONER IS A WISE CEO GOT US HERE
Nuvilex would not be at this point without him...
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it is right in the Nuvilex 10K...If you do not know how to pull up an sec report than say so and we will tell you how ...personally I think everyone should read the company reports in full themselves for the stocks they own...go to sec.gov and pull up Nuvlilex and it is there...
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Seriously...who doesn't know that it was a phase 1/2....
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Nuvilex
MARKET'S REACTION NEUTRAL TO NUVILEX 10K
I think that says it all....
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