Nuvilex has a TRIPLE BOTTOM...the first of the triple bottom the low was 0.21 so let's just wait and see where it goes before making predictions..

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Nuvilex Submits Application for Orphan Drug Designation to the European Medicines Agency for Its Cell-in-a-Box

and the EMEA is already familiar with CiaB so it probably won't take very long this time...

Nuvilex Begins Preclinical Studies With Translational Drug Development

and are probably half way done ....

these are the only 2 things that matter right now...not old news being repeated...

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WOW GREAT INFO...here is some more...
CANCER RESEARCH AND BIOSTATISTICS PROGRAMS

The Statistical Center for SWOG, largest of the cooperative groups supported by the National Cancer Institute, is co-located at CRAB. At any one time 100 trials may be active with hundreds more in followup. The results of these trials are central to setting the standard of care for patients in the US and abroad.

CRAB is also the statistical center for the Myeloma Institute of Research and Therapy, a particularly innovative and productive group specializing in the treatment of myeloma.

Our Clinical Trial Services division is built on the decades of experience of our leadership and staff. We offer clinical trials services to research consortia, foundations and pharmaceutical companies. These services tend to focus on under-researched and under-funded cancers such as pancreatic and lung cancer.

CRAB also serves as the statistical center for the SU2C Pancreatic Cancer Dream Team and collaborates closely on the Pancreatic Cancer Research and Therapy clincial trials.

In addition to our own Clinical Trial Consortium for Lung Cancer, CRAB scientists have partnered with the International Association for the Study of Lung Cancer to update and improve the lung cancer staging criteria used world wide.
RECENT SUCCESSES AND CURRENT CHALLENGES

Our leadership in clinical research has helped improve treatment of many cancer types. CRAB assisted in the identification of 70 genes that can predict the prognosis for myeloma patients, guiding better treatment options. In fact, some myeloma patients are living 4 times longer than just 10 years thanks in part to our collaborations with myeloma centers across the country.

As a partner of the International Association for the Study of Lung Cancer, lung cancer staging was developed based on more than 100,000 cases of lung cancer gather from around the world and analyzed by CRAB scientists.

In service to the Stand Up to Cancer Pancreatic Dream Team and Pancreatic Cancer Research Team, CRAB actively participates in the effort to better understand the science behind one of the deadliest cancers.

There is an urgent need to improve surival rates for lung cancer patients. 160,000 people in the United States alone died of lung cancer in 2012. That is why CRAB formed the Clincial Trial Consortium for Lung Cancer (CTC), a collaboration among top-tier lung cancer researchers to better understand lung cancer and identify more effective treatment options. Fighting lung cancer one clinical trial at a time, CRAB uses advancements in the fields of laboratory testing and drug development to find treatments that are safe and effective while considering survival and quality of life. Funding is needed to support this important research.

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Since we are looking at the charts there is more of a chance of a reversal in Nuvilex since we have a triple bottom...they have not been able to sell it under .213 twice before...so it is a perfect time to buy right in front of the TD2 study results that we could get as early as next month...

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Any thoughts from long investors when the results of the Nuvilex TD2 study should come in...with the life expectancy being fairly short with the control mice with malignant tumors...I am like others who think the study would be over in October sometime...

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I agree and do not see why this is questioned anyway when Dr. Von Hoff is Physician in Chief at tgen and TD2 is wholly owned by tgen...so it is not hard to figure out that Hoff has a major role in Nuvilex's pain and ascites studies especially since it was Hoff's idea in the first place...

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Could you elaborate on that and provide us with some kind of a link or something that specifically connects the Von Hoff TD2 study to the pps of the stock going down...I don't get the connection...

TIA
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Anyone know if Von Hoff is out of the country...is there anyone that close to the world renowned pancreatic cancer doctor in the globe that can get in touch with him and see...I personally do not know and it is not important to me ...he is overseeing many trials...it does not mean that he has to stand over anyone with a magnifying glass...that is the beauty of hiring the best people...I guess we will hear from Nuvilex and Von Hoff when the TD2 Study results come out shortly...

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BUYING NUVILEX AT THIS LEVEL...then you are in the bigger majority...last 3 days....83% buying to selling....82% buying to selling....80% buying to selling...

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We all know what the larger picture for Nuvilex is and where this is going with CiaB for cancer...ALL abdominal cancers...Nuvilex's CiaB with different drugs and different cancers...hmmm don't we have a new drug and new cancer cells (ovarian cancer cells) being used now in the study being conducted by Von Hoff and TD2 ...

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Everything is right here at Nuvilex...and 4th Q is going to bring about HUGE CHANGES...

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Nuvilex/TD2 Von Hoff Study for pain and ascites...interesting...pain is #4 for Spending by Therapeutic Area in 2017 for Developed Markets and pain is #1 for Pharmerging Markets


Table I: Spending by Therapeutic Area in 2017, Developed Markets
Top 20 Classes = 71% of total; others represent 29%

Therapeutic Area Sales in 2017 (constant exchange rates, US dollars)

Oncology $74–84 Billion
Diabetes $34–39 Billion
Anti-TNFs $32–37 Billion
Pain $31–36 Billion
Asthma/Chronic Obstructive Pulmonary Disorder $31–36 Billion
Other Central Nervous System Drugs $26–31 Billion
Hypertension $23–26 Billion
Immunostimulants $22–25 Billion
HIV Antivirals $22–25 Billion
Dermatology $22–25 Billion
Antibiotics $18-21 Billion
Cholesterol $16–19 Billion
Anti-Epileptics $15–18 Billion
Immunosuppressants $15–18 Billion
Antipsychoitics $13–16 Billion
Antiulcerants $12–14 Billion
Antidepressants $10–12 Billion
Antivirals, excluding HIV $8–10 Billion
ADHD (Attention Deficit Hyperactivity Disorder) $7–9 Billion
Interferons $6–8 Billion

Table II: Spending by Therapeutic Area in 2017, Pharmerging Markets
Top 20 Classes = 45% of total; others represent 55%

Therapeutic Area Sales in 2017 (Constant exchange rates, US dollars)

Pain $22–25 Billion
Other Central Nervous System Drugs $20–23 Billion
Antibiotics $18–21 Billion
Oncology $17–20 Billion
Hypertension $14–17 Billion
Diabetes $10–12 Billion
Dermatology $10–12 Billion
Antiulcerants $9–11 Billion
Cholesterol $6–8 Billion
Asthma/Chronic Obstructive Pulmonary Disease $3–5 Billion
Anti-Epileptics $3–5 Billion
Antivirals, excluding HIV $3–5 Billion
Immunosuppressants $3–5 Billion
Allergy $3–5 Billion
Antidepressants $3–5 Billion
Antiplatelets $3–5 Billion
Antipsychotics $2–3 Billion
Heparins $1–2 Billion
Erectile dysfunction $1–2 Billion
Immunostimulants $1–2 Billion

http://connect.dcat.org/blogs/patricia-van-arnum/2014/04/25/the-small-molecule-and-large-molecule-divide-in-the-global-oncology-market#.VAyYa_mfK6w

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Nuvilex's TD2 is being done for all abdominal cancers...at first I thought it was just for pancreatic cancer until the verbiage changed in the PR's...they are not working toward approval for symptoms just for pancreatic cancer...when they go for approval it will be for all abdominal cancers...

VERBIAGE CHANGES...

Nuvilex Begins Preclinical Studies With Translational Drug Development to Determine if Nuvilex's Unique Cancer Treatment Can Slow Accumulation of Malignant Ascites Fluid...
" announced today that studies are underway at Translational Drug Development's (TD2) facilities in Scottsdale, Arizona, to determine if Nuvilex's unique cancer treatment can slow the accumulation of fluid, known as "malignant ascites," in the abdomen that is characteristic of the growth of many abdominal tumors."

Nuvilex Provides Update on Status of Preclinical Studies at Translational Drug Development...
"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"

Nuvilex Aims for Market Exclusivity with Orphan Drug Status While Eyeing Larger Cancer Market for Cell-in-a-Box Technology
"Nuvilex, Inc. (otcqb:NVLX) has used the last two weeks to further solidify its position as a biotechnology firm, and to further its treatment for advanced pancreatic cancer, as well as, other abdominal cancers"

Nuvilex Eyes FDA Accelerated Approval Process by Improving Quality of Life in Pancreatic Cancer Patients...
"These are two commonly occurring symptoms associated with advanced pancreatic cancer as well as other abdominal cancers"
" Nuvilex and TD2 may very well be on the path to proving that the combination of Cell-in-a-Box/ifosfamide can benefit those suffering from pancreatic cancer and all other abdominal cancers where the growth of tumors is causing intense pain and where ascites is prevalent. "
"In another major announcement two weeks ago, Nuvilex stated that it and Translational Drug Development (TD2) officially began the first of 4 different pre-clinical studies that will determine what effect the company's pancreatic cancer treatment will have on symptoms associated with abdominal cancers."...
"These are just a few of the abdominal cancers, and as should be obvious by the 5.4 million new cases they represent annually, Nuvilex is potentially developing a treatment that could compete in what is a huge and virtually untapped symptoms market."

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Not only does Nuvilex have world renowned doctors for the Ocean Eleven's Team but they have a CEO that has done more for Nuvilex in 9 months than the last 9 years...and Crabtree's connection is Von Hoff...they knew each other before the study and that could be another factor in Hoff wanting to be involved with CiaB...

and as far as the compensation... when I look at the minuscule salaries that these guys are working for to bring CiaB to market...with personal sacrifice to their families...Waggoner makes a salary of 50,000 for a lawyer with his credentials...for a Ceo of a Biotechnology comapany...and Crabtree makes a salary of 59,830 with a Ph.D and his credentials...I have no problem with giving those shares...those shares do not relate to a monthly compensation added to their salary for them and their families...because anyone can see they are not selling them...that is readily easy information to see...any time an insider sells stock you can find that...and Gruden is an employee and served as Chief Financial Officer and Chairman of the Board and makes a salary of only 34,000 for doing both...and was also compensation for the last 3 years not 1 year and at one time worked for no salary...so she maybe did not know how to steer the ship but that does not matter any more because we have Waggoner to do that...and the compensation they got came with requirements from all of these guys...

and anyone who has been in the stock for a long time is finally going to see some results from the hard work these guys have been doing for Nuvilex...and as soon as the 4 Q this year...not too long to wait is it...especially for the ones that have been in Nuvilex for years...Nuvilex the company is about to explode and the stock will follow the fundamentals and this is only the beginning...this company started with the purchase agreement to buy CiaB for Cancers and CiaB for Diabetes...and that was just a short time ago...and look at the progress made since Dec...remember 4th Q...

I would say good luck but we don't need it...we have what we need...
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I am glad to see that my post on the Chardan Capital Deal with Nuvilex helped out so there is no misunderstanding anymore....

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How smart of Waggoner to place the subsidiary in Ireland where the taxes are lower and in a country that is very friendly to corporations to bring in big business to Ireland...coincidentally this is not the first connection to Ireland...Austrianova had one...

Irish millionaire funds development of Austrianova
11.07.2007
Vienna – Gerard Ryan, Irish millionaire and pharmacist, has funded a large part of Austrianova’s recent financing round, which totalled a35 million. Austrianova is developing a cell encapsulation technology, which could be used as a new method of drug delivery to treat various forms of cancer or metabolic diseases. Thomas Fischer, CFO of Austrianova, said to EuroBiotechNews: “We are delighted by this large amount of financing donated by a real pharma expert”. Until 2001, Ryan owned a number of pharmacies, which he sold to German Celesio AG for an undisclosed amount. Today, the Irish native is one of the main owners of the CRO Firecrest Clinical, based in Limerick.
The fundraising will enable Austria­nova to complete Phase III trials for NovaCaps against pancreatic cancer and puts the company into a better negotiating position concerning a potential pharma deal. NovaCaps for pancreatic cancer has received orphan drug designation from the EMEA. Austrianova is currently commissioning a GMP manufacturing facility for Novacaps in anti­cipation of obtaining marketing authorisation for the product in 2009/2010.

Nice to see the serious players in Singapore give CiaB recognition... SingTel...massive communications company and its parent company Temasek Holdings...300 billion dollar investment company owned by the government of Singapore...

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Austrianova Declared the Winner of the 2014 Best Innovation Award

September 3rd 2014: Austrianova Declared the Winner of the 2014 Best Innovation Award

Singapore, September3rd2014

Austrianova announced today that they are the recipients of the Emerging Enterprises 2014 Best Innovation award. The award was presented at a gala dinner and awards ceremony held at the Ritz Carlton hotel in Singapore and was organised and hosted by the main sponsor, OCBC bank, with the Innovation award being sponsored by SingTel. Dr. John Dangerfield, the COO of Austrianova,and Wee Jin Tan, Project Manager, attended the gala dinner and award ceremony and they accepted the award on behalf of the Austrianova team.

Brian Salmons, CEO of Austrianova, stated “This prestigious award now in its seventh year recognises Austrianova’s innovative Cell-in-a-Box® and Bac-in-a-Box® cell encapsulation technologies. It is particularly pleasing that we were chosen from over 900 emerging enterprises in Singapore from all kinds of different fields, not only biotech or biomedical companies”.

go Nuvilex/Austrianova
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Since we are already using Bristol-Myers Squibb's Ifosfamide it would make perfect sense that we would be using Bristol-Myers Squibb's Paraplatin Injection for the Von Hoff TD2 study...since that is the original drug not the generic for ovarian cancer... and since we have a relationship there already...


go Nuvilex
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Just in case some did not read this abstract or catch the meaning of it...in the abstract the mice that were treated with ifosfamide+Capcell and treated day 2-6 did the best and treatment with Capcell™ and repeated administrations of ifosfamide on days 2–6 resulted in complete tumor remission (Tumor volume: 0 mm3, P<0.05) in all animals

now what does that mean for the Von Hoff TD2 study being conducted as I write...

both the pain and ascites is associated with the tumor ...not the treatment per Dr. Crabtree...

so complete tumor remission...what do you think that is going to do to the symptoms...

I guess there is still some misunderstanding about what is going on in Nuvilex...the Orphan Drug Designation for EU that we just applied for... is for the Late Phase 2b trial that is being conducted which when completed Nuvilex will apply for approval in the EU...Australia...and the U.S. not the preclinical that Dr.Von Hoff and TD2 are conducting right now...

I hope this clears things up ...
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This could be the drug they are using....the most common drug used for ovarian cancer is Carboplatin alone and Carboplatin with paclitaxel (Taxol)...and Carboplatin is the generic name for Paraplatin...and guess who makes Paraplatin...Bristol-Myers Squibb's Paraplatin Injection...


Nuvilex TD2 study
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good DD and the TD2 study is for ascites....Doctors often diagnose peritoneal cancer in advanced stages. Supportive care can help relieve symptoms of peritoneal cancer such as pain, weight loss, or fluid buildup.

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THIS IS WHY HOFF KNOWS TD2 STUDY WILL WORK...PLEASE READ....
I remembered something I had read before and forgot about because I had read it before Von Hoff came about...and I went looking for it because of something esusun said this morning...and I asked esusan wasn't it a Lohr study and she told me yep....this is what esusan said..."recent DD (by me) showed Ciab/ ifosfamide worked well for Ascites associated with colon cancer , this study was also done with mice . do your DD , i expect von Hoff studies to re-confirm this"

so here it is in plain sight and why Hoff knows CiaB is going to work with TD2 study...
NOTE: the part that says " Early i.p. treatment with ifosfamide and CYP2B1 cells resulted in a complete response."
NOTE: Treatment with Capcell™ and repeated administrations of ifosfamide on days 2–6 resulted in complete tumor remission

http://www.nature.com/cgt/journal/v13/n1/full/7700849a.html

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Nuvilex with Orphan Drug Status ... Once a
compound has been granted orphan designation, the odds for approval are high (82%) compared to traditional drugs (35%)... and orphan designation for the drug in the orphan indication is maintained regardless of follow-on indications...also one model for development is based on lead development of a compound with a relatively quick-to-market orphan indication, followed by consideration of expansion to other indications....

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There might be a misunderstanding on the CHARDAN CAPITAL Deal...with it being an "At the Market" banking agreement...which was laid out very clearly in the PR...under which Nuvilex may seek to raise up to a total of $50,000,000 depending upon market conditions and at the discretion of Nuvilex...In the banking agreement, Chardan Capital Markets will act as the exclusive placement agent for Nuvilex...meaning they will be the agent for any offering if or when Nuvilex wants needs to ...The funds will be used for: (i) late-phase clinical trials in pancreatic cancer with Clinical Network Services (CNS) in Australia; (ii) preclinical studies and clinical trials with Translational Drug Development (TD2) to address the symptoms of pancreatic cancer to be conducted in the U.S.; and (iii) further testing and research for diabetes in Europe.

now keep in mind that they don't ever have to do an offering depending on what happens in the future for Nuvilex and we all know that they have things in the works...

I hope this clears things up ...
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Nuvilex coming to fruition...EU application done...then Australia...then the U.S.

go Nuvilex
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Nuvilex Applies for Orphan Drug Status

Nuvilex Submits Application for Orphan Drug Designation to the European Medicines Agency for Its Cell-in-a-Box(R) Treatment for Pancreatic Cancer

SILVER SPRING, Md., Sep 02, 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 has submitted an application to the European Medicines Agency (EMA) for an Orphan Drug Designation for its Cell-in-a-Box® treatment for pancreatic cancer. Nuvilex's pancreatic cancer treatment consists of the combination of Cell-in-a-Box® with low doses of the anticancer drug ifosfamide. The Cell-in-a-Box® portion of the treatment consists of live cells capable of converting ifosfamide into its cancer-killing form that have been enclosed in protective pin-head sized spherical capsules that are composed of bio-inert cellulose.

This first submission of Nuvilex's pancreatic cancer treatment is being made in Europe because, in the mid-2000s, an application for the Orphan Drug Designation for the encapsulated live cell (Cell-in-a-Box®) component of the pancreatic cancer treatment was approved in principle in Europe by the precursor to the EMA - the EMEA. The sponsor of this application is Nuvilex's newest subsidiary, Nuvilex Europe Limited, which was recently formed to develop and commercialize treatments for cancer and diabetes throughout the European market.

Kenneth L. Waggoner, Nuvilex's CEO and President, commented, "The submission of this application for the Orphan Drug Designation represents a major step in the development process for Nuvilex's pancreatic cancer treatment. If the Orphan Drug Designation is granted, Nuvilex could receive special assistance in its treatment's development process, exemptions or reductions in regulatory fees from the EMA and a very significant period of marketing exclusivity of 10 years for its treatment of pancreatic cancer.

"Since the cellulose-based encapsulation of live, ifosfamide-activating cells for their use in treating pancreatic cancer has been previously approved in principle for the Orphan Drug Designation in Europe, we are encouraged that this will be the case once again, particularly given that additional data have been submitted to support the new application and the fact that the Cell-in-a-Box® technology has matured significantly since the previous application. Europe is just the first of several markets in which Nuvilex plans to submit similar applications for the Orphan Drug Designation. The United States and Australia are two such markets."

The Orphan Drug Designation is given to drugs or treatments for "rare," life-threatening diseases. In Europe, a rare disease is defined as one that occurs in less than 5 of every 10,000 people. According to incidence estimates, the prevalence of pancreatic cancer in the European Union is less than 1.5 cases per 10,000 people, a figure significantly below that required for Nuvilex's pancreatic cancer treatment to qualify for the Orphan Drug Designation.

The fact that 82,000 deaths from pancreatic cancer are predicted in the European Union in 2014, that it is incurable in more than 95% of patients and that median survival is much less than one year all testify to the life-threatening nature of the disease. Importantly, as noted above, the Orphan Drug Designation in Europe for a drug or treatment carries with it an extension of 10 years of marketing exclusivity after marketing approval is granted by the EMA.

Mr. Waggoner added, "Special thanks for the preparation of this application must be given to Ms. Natalie Thomas of Clinical Network Services, the Clinical Research Organization contracted by Nuvilex to carry out our Phase 2b trial in pancreatic cancer, to Dr. Prof. Walter H. Günzburg and Dr. Brian Salmons of Austrianova who were co-developers of the Cell-in-a-Box® technology and who jointly contributed to the application and to Dr. Matthias Löhr, the Principal Investigator for the two completed clinical trials, who was also a significant contributor to the application and who will oversee all aspects of the future development of Nuvilex's pancreatic cancer treatment."

Nuvilex investors need to realize the importance of the Von Hoff TD2 study...unlike the 2b study being readied for the first part of next year that when completed Nuvilex plans on filing for approval for Cell_in_a_Box for Pancreatic Cancer...Nuvilex's TD2 study being a preclinical mouse study it would be easy to think that the results of this study is not going to benefit Nuvilex in the near future...that any value will not be seen for years... nothing could be more untrue...

In the last PR "The current standard of care requires that malignant ascites fluid be removed from the abdomen of cancer patients " if you have never seen anyone with ascites google (pics of ascites)...the unbearable pain these poor patients must go through is hard to look at especially the ones of the babies...the process of removing the ascites fluid must be very painful too...you can also see pics of that...they do not remove it with a needle...they cut the patient open and suck out the fluid...as Von Hoff has said the pain usually kills these patients before the cancer does...the study even if it only slows the onset of ascites means these patients will have this process does less often...

We also learned several things from the last PR that was a surprise to all of us...that the mice would be injected with human ovarian cancer cells because(i) they reproduce rapidly and form tumors; and (ii) the resultant tumors are proficient at producing malignant ascites fluid...

And we learned that there would be 4 groups in the study...

One group of mice will be treated with Nuvilex's pancreatic cancer treatment consisting of the combination of Cell-in-a-Box(R) encapsulated live cells and the cancer prodrug ifosfamide (the encapsulated cells express an enzyme, CYP2B1, which converts ifosfamide into its cancer-killing form)...

A second group of mice will be treated with a drug normally used to treat ovarian cancer...

A third group will be administered that drug along with Nuvilex's Cell-in-a-Box(R) encapsulated live cells and ifosfamide combination...

The remaining mice will serve as the "control" group for comparison purposes...

so not only do we get to see what our original therapy can do for ascites...but we also get to see what CiaB can do with combo drugs...

why is this important...first to see CiaB with a different cancer drug...and to see how the cancer community responds to that...

so there is no doubt in my mind that other bio companies have a close eye on this study especially with Von Hoff at the helm of it...I can think of one in particular that has a lot to lose if our trials take us to approval but I can also see that our CiaB could not only benefit that company but others...with other drugs and other diseases...

We are being watched and this little preclinical study is the one with the magnifying glass on top of it...

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Just to remind Nuvilex shareholders... we should never think that the company is sitting stagnant and not doing what they set out to do...with all the work being done in the background...behind the scenes...that we know nothing about YET...here is an older article that outlines where the company was going with Diabetes that was written in March 18, 2013...http://www.stockmarketmediagroup.com/nuvilex-inc-diabetes-studies-could-eliminate-need-for-daily-insulin-requirements/

Now we can fast forward to the 10K that just came out and compare the 10K and Waggoner's words... to the article...

Diabetes Studies

Diabetes is a major problem throughout the world. Approximately 382 million cases have been diagnosed world-wide. It is estimated that this number will rise to 592 million by 2035. Approximately 175 million have diabetes and do not know it. Diabetes caused 5.1 million deaths in 2013; every six seconds a person dies from the complications caused by diabetes. Treatments for diabetes and its complications caused at least $580 billion in health care expenditure in 2013. In 2013, more than 21 million live births were affected by diabetes during pregnancy.

Diabetes is caused by insufficient availability of, or resistance to, the hormone insulin. Insulin is produced by the islet cells of the pancreas. Its function is to assist in the transport of glucose (sugar) in the blood to the inside of most types of cells in the body where it is used as a source of energy for those cells. In Type 1 diabetes, which usually begins at a young age, the islet cells of the pancreas have been destroyed, usually by an autoimmune reaction. Type 1 diabetics require daily insulin administration through injection or through the use of an insulin pump. Type 2 diabetes, which is more prevalent than Type 1, can be controlled by diet and exercise in its early stages. As time goes by, it may be necessary to use antidiabetic drugs to control the diabetes. However, over time these too may lose their effectiveness. Thus, even Type 2 diabetics may eventually need insulin administration.

Dr. Günzburg and Dr. Salmons are also fulfilling a major role in the development of the Company’s treatment for diabetes that is based on the Cell-in-a-Box® technology. Dr. Günzburg and Dr. Salmons have introduced the Company to the participants and potential participants in the Company’s diabetes program in an attempt to develop a medical breakthrough in how diabetes will be treated in the future throughout the world. Researchers at a major university in Australia have developed insulin-producing cells from a human hepatocellular carcinoma cell line. These cells have been exhaustively tested in vitro and found to be capable of producing insulin in direct correlation to the amount of glucose in their surroundings. Negotiations are underway between Nuvilex and that university for an exclusive, worldwide license to use these insulin-producing cells in combination with the Cell-in-a-Box® technology in developing a product for the treatment of insulin-dependent diabetes. No assurance can be made that such a license will be entered into, however. Further, the license is contingent on the insulin-producing cells passing a tumorigenicity test that will be conducted by the University of Veterinary Medicine Vienna (“UVMV”) where Dr. Günzburg is a professor in the Department of Virology. He will coordinate all of the work for the Company being done by UVMV. This test will show whether or not these particular cells have the capacity to form tumors because they were developed from a liver cancer cell line. If they do not, then preclinical animal studies will first be done with these cells. If the studies are successful, they will lead to clinical trials. In the event that the cells are tumorigenic, then it will be necessary to develop another insulin-producing cell line for encapsulation.

Since Dr. Günzburg and Dr. Salmons have previously worked with these insulin-producing cells and have them in frozen storage at Austrianova Singapore, the Australian university was approached to obtain permission for these stored cells to be used for the tumorigenicity testing. Written authorization from the Australian university has been obtained for the use of these insulin-producing cells for this testing. Since the tumorigenicity of the cells will be determined at the UVMV, the terms and conditions of a Collaborative Research Agreement (“CRA”) between the Company and the UVMV has been agreed to between the parties. The CRA is in the final stages of drafting. Once finalized and signed, the tumorigenicity studies will commence. However, no assurance can be made that the CRA will be finalized between the parties.

3

In the majority of diabetes animal models used by others, the diabetic condition is induced by employing drugs to destroy the normal insulin-producing capability of the pancreas in those animals. The University of Munich (“UOM”) in Germany operates a €5-million animal farm that houses animals for research purposes. Scientists at the UOM have developed unique transgenic mouse and pig models of diabetes. Through the use of gene transfer technologies, mice and pigs that are diabetic at birth have been developed. These model systems more closely mimic Type 1 diabetes in humans than any other model systems available world-wide. Through introductions by Dr. Günzburg and Dr. Salmons, the investigators at UOM have agreed to join the Nuvilex team in its efforts to develop a treatment for diabetes based on the Cell-in-a-Box® technology. The Company plans to enter into a research agreement with the UOM in the near term. However, no assurance can be made that such an agreement will be entered into between the Company and the UOM.

The Company is in the process of developing a diabetes consortium consisting of major universities, renowned scientists and physicians and CNS (“Diabetes Consortium”). Executive officers of Nuvilex and the institutions identified above have already explored the possibility of joining the Diabetes Consortium. These institutions will be part of the Diabetes Consortium, as will Dr. Gunzburg and Dr. Salmons through their consulting company, Vin-de-Bona Trading Co. Pte Ltd (“Vin-de-Bona”). The consensus among individuals that could be involved is that the formation of the Diabetes Consortium would be beneficial to all parties and may be a way of optimizing the development of the Company’s treatment for diabetes given the free flow of ideas and communication that would occur within such a consortium. Dr. Löhr has a great deal of interest and expertise in treating diabetes. Because of this, he will be assisting the Company in the development of a treatment for diabetes that will employ the Cell-in-a-Box® cellulose-based live cell encapsulation technology. If and when the Diabetes Consortium finally reaches fruition, Dr. Löhr is also expected to play a prominent role in it.

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Thanks for the great post on Nuvilex and Diabetes...I have been talking for a long time about the Diabetes being the game changer...and I think it is about to fall into place soon for Nuvilex to put everything they have into Diabetes Research...appreciate the post...

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Nuvilex having a CEO that is a lawyer and also our in house counsel...you are right...could it be any better...

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Nuvilex's CEO sure does have high credentials...
Thanks for posting ...

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Nuvilex is one awesome stock that I want to own...I guess it depends on what stocks you invest in...I invest in mainly bio's and last summer was one of the best for all my bio's...so out goes the sell in may for me...not so this summer because of the fed who should not weigh in on a sector they know nothing about...and the hit in march...but also the year before my bio's kicked it...so I really couldn't care about what month is good or bad...I know what I want to own...and it is Nuvilex...so I guess some will learn what Nuvilex is all about in the short coming months...

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Yesterday was the bottom in Nuvilex...and today was the buy signal...with the inverted head and shoulders...I added yesterday like I said at the bottom...and next week it will go up...

good luck

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NUVILEX FORMING INVERTED HEAD AND SHOULDERS...should be a good week after the holiday...

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Waggoner..."The second half of 2014 should prove to be a very dynamic time for Nuvilex. We will be working diligently on the steps required for CNS to conduct our Phase 2b clinical trial in advanced pancreatic cancer in Australia and pursuing Orphan Drug status for our pancreatic cancer treatment in the U.S., the EU and Australia. We anticipate preparing for preclinical studies utilizing our Cell-in-a-Box® technology for diabetes. We will be working with TD2 on the preclinical studies in the U.S. related to symptoms experienced by patients suffering from advanced pancreatic cancer and making preparations for the subsequent clinical trials that will be conducted by TD2 in the U.S."

we have to be getting close to receiving Orphan Drug Designation...they said it is in the works...I hope we hear soon...

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wow all those great PR's in one place to be able to read them...thanks for the compilation...nice to read them again and confirm why I own Nuvilex...and now with the TD2 study underway and trials coming up first of next year... I'm excited...and excited to hear our next steps in Diabetes...and the results of Von Hoff study

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I want to hear about Nuvilex + Diabetes...we should be hearing something soon...they have been meeting on it...I want to know about the cell line we are going to acquire for our trials...

Meetings have been held between Nuvilex's principal officers and scientists and principals from some of the major universities in Europe concerning the use of the Cell-in-a-Box® technology in developing a treatment for insulin-dependent diabetes. Scientists at one of these institutions have developed unique transgenic animal models for insulin-dependent diabetes. Nuvilex has initiated negotiations for their use in its studies of this disease. In addition, scientists at an Australian university have developed a human cell line that secretes increasing amounts of insulin in response to increasing levels of glucose in their surroundings. If the results of preclinical tests on these cells are positive, Nuvilex will finalize negotiations to acquire this cell line for use with the Cell-in-a-Box® technology as a first step in developing its treatment for diabetes.

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Looks like a weight has been lifted off of Nuvilex stock so we should see the stock rise back up and maybe next week hear some news...I would like to hear something on Diabetes with the testing of the human live cells...

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Nuvilex is getting ready to fly...When did October become a bad month for stocks...it was sell in may and go away...put out there by all the big boys so they could go on summer vacation...but that does not even work any more because my bio's kicked butt last year in the summer...the only reason bio's have been hit this year is because in March they got hit by wall street wanting the sell in may so they could spend the summer in Martha's Vineyard ...and in July they got hit by Yellen newly appointed so called expert to the FED that all of a sudden is an expert on biotech...there is nothing wrong with Nuvilex or the way it is trading...I own and have owned bio's... quite a few bio's...

so if you could give me some kind of proof in the way of some links about October being a terrible month for stocks I would appreciate you sharing your knowledge...

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