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Malignant ascites: To date, none of the different options has been subjected to evidence-based clinical trials and there are no accepted guidelines for the management of MA.
Do you guys realize that Nuvilex with Hoff's TD2 results could be the first to accomplish a treatment for ascites if the results show a significant reduction in ascites or REMISSION...Nuvilex could be the new GUIDELINE...
http://www.bioportfolio.com/resources/pmarticle/307026/Malignant-ascites-pathophysiology-and-treatment.html
The therapies in this article...."However, NO IMPROVEMENTS IN OVERALL SURVIVAL was observed in any of the clinical trials reported."....we could be the GUIDELINE if we show reduced ascites and improvement in overall survival...
http://www.bioportfolio.com/resources/pmarticle/976526/Malignant-ascites-in-ovarian-cancer-and-the-role-of-targeted-therapeutics.html
bull
Breakthrough diabetes research to be commercialised
03 Nov 2014
Professor Ann Simpson, picture by Joanne Saad
In summary:
US company Nuvilex has obtained exclusive worldwide rights to use human insulin producing cells developed by UTS's Professor Ann Simpson and her colleagues
The cells could eliminate the need for injections for Type 1 diabetics, a milestone in 20 years' research to develop the capacity of liver cells to take over the function of the pancreas
Australian research that has produced a line of insulin producing cells that could eliminate the need for injections for Type 1 diabetics will be commercialised by US company Nuvilex and its subsidiaries Nuvilex Australia and Nuvilex Europe.
The clinical-stage biotechnology company has obtained exclusive worldwide rights to use human insulin producing cells, termed "Melligen" cells, developed by UTS's Professor Ann Simpson and her colleagues.
In Type 1 or juvenile-onset diabetes the islet cells have been destroyed by an autoimmune disease.
Professor Simpson has been working over the past 20 years to develop the capacity of liver cells to take over the function of the pancreatic "islet" cells that normally produce insulin in the body and this agreement is a significant milestone for her work.
Professor Simpson began exploring the possibility activating liver cells to take up the role of the pancreas early in her research because of their similar makeup. "When a foetus develops, the liver and the pancreas form from the same endodermal origin," she said.
"I am pleased that after many years of diabetes research at UTS, Nuvilex will now be developing this technology for commercialisation to a global market," Professor Simpson said. "My team and I are excited by the prospect of working with Nuvilex to eliminate daily injections for insulin-dependent diabetic patients."
Nuvilex will undertake further study of Melligen cells with the goal of encapsulating them using the company's novel and proprietary Cell-in-a-Box® cellulose-based live cell technology. Animal testing will be undertaken to prove the encapsulated cells are capable of producing insulin "on demand" in diabetic animals.
Ultimately encapsulated Melligen cells will be placed into patients with Type 1 diabetes where it is hoped they will function as a form of "bio-artificial pancreas". In laboratory studies, Melligen cells have been shown to respond directly to the amount of glucose in their surroundings.
"This is a disease that affects millions of individuals around the world," said Nuvilex's CEO and President, Kenneth L. Waggoner." Some of the complications diabetics suffer from are eye disease, foot and leg problems, kidney disease and cardiovascular disease. These complications can be dangerous and even life-threatening.
"If we are successful, those afflicted with Type 1 diabetes will be freed from depending on daily insulin injections or the use of insulin pumps as well as the constant need to monitor their blood glucose levels and modify their diets."
The announcement of the Nuvilex agreement has coincided with the awarding of a National Health and Medical Research Council (NHMRC) grant to Professor Simpson for related work. Over the past 20 years she has received more than $7 million to advance research aimed at reversing Type 1 diabetes by using the liver as a surrogate system to produce insulin.
http://newsroom.uts.edu.au/news/2014/11/breakthrough-diabetes-research-be-commercialised?utm_source=twitter&utm_medium=utsnewsroom&utm_campaign=03-11-14%20diabetes%20research
Once the EMA receives the ODD application and validates it (makes sure everything is on it and complete)...
Direct from the EMA
"The evaluation process takes a maximum of 90 days from validation."
just like the FDA...which is <90 days...
Nuvilex announced they had submitted for ODD to the EMA...on Sept. 2, 2014
Nuvilex announced they had submitted for ODD to the FDA...on Oct. 13, 2014
so that puts the timeline for EMA in December and FDA in January ...
and we could get an answer anytime between...
bull
DIRECT FROM THE FDA...
What happens after submission?
You will be sent a letter acknowledging receipt of the application.
Reviewed by reviewer ? designation Team Leader ?OOPD director.
Expect <90 days to decision.
A negative decision can always be readdressed.
Roughly 60-70% of applications result in
granting orphan drug designation status.
EXPECT LESS THAN 90 DAYS TO DECISION
bull
NOW is the time to accumulate NVLX...and it only takes 30 to 90 days for ODD from the FDA...
And also DO NOT UNDERESTIMATE DR. VON HOFF...with his connections to the FDA...
And the news pending is Dr. Von Hoff's TD2 Results...DO NOT UNDERESTIMATE THESE RESULTS...they could very easily change the game for Nuvilex...
When the results come out and if there is no ascites or we get major tumor shrinkage or REMISSION...all longs are going to be very well rewarded for their patience...
And with his connections to other Pharmas and Bigger Bios...you can bet he very well could play a role with some kind of partnership or buyout for CiaB for cancers etc...
bull
This NVLX is a buy and hold type of security...and anyone that does that will be rewarded immensely for their patience...and I think some of that reward will be coming to the long term patient investors sooner than later...
TD2 Results
bull
Cell_in_a_Box treated mice are living longer than expected or we would of heard something by now...the control mice do not live that long especially with an aggressive cancer like ovarian cancer...
The longer they live the better it is for Nuvilex...that would mean major shrinkage of tumors or even REMISSION...
BAD news travels fast in biotechs...they get it out of the way and start over...GOOD news takes a while...
And can everyone imagine if the mice that were given the ovarian cancer drug and CiaB with ifosfamide combination are doing even better than the ones treated with Ciab with ifosfamide...I can...
And when the results surface...if that is the case it not only validates Nuvilex's CiaB but also validates the treatment of a new combo therapy...
So I for one am very looking forward to the upcoming TD2 Results from Dr. Von Hoff...
bull
I can answer that with one thing...200dma...
go Nuvilex
bull
Video: Dr. Hyslop Discussing Cell in a Box
Click Here to View Video of Dr. Hyslop in the Lab Discussing Cell in Box & Cannabis
Nuvilex, Inc. Engaged in "Cutting Edge" Cannabis Preclinical Studies Using Model Compounds With Cell-in-a-Box
NEW YORK, NY--(Marketwired - October 29, 2014) - Nuvilex, Inc. (NVLX) isn't letting the upcoming mid-term elections or the views in Washington, D.C., on medical marijuana slow down its research. The company is currently engaged in preclinical studies at the University of Northern Colorado (UNC) targeting Cannabis-based cancer treatments using Nuvilex's Cell-in-a-Box® cellulose-based live cell encapsulation technology.
While waiting for a Schedule 1 license from the DEA in order to conduct research using marijuana, Dr. Richard M. Hyslop, Professor of Chemistry and Biochemistry at UNC, along with his colleague Dr. Corina Brown are conducting these preclinical studies using model compounds that are similar chemically to the components they are looking for in Cannabis.
Dr. Hyslop said in an interview with the Biz West Newspaper in Northern Colorado, that the idea is to use the model compounds to screen live cells in an effort to find those cells that can eventually be encapsulated. "The type of cell that we're going to incorporate is going to have a particular type of activity that is capable of converting a component of Cannabis to an active anti-cancer drug. What the research involves is identifying the type of cell that is capable of doing that."
The goal behind this research is to eventually create a treatment for "solid" tumors using constituents (cannabinoids) of the Cannabis plant and the company's live-cell encapsulation technology, Cell-in-a-Box. Initially, Nuvilex will target solid tumors of the brain and pancreas.
Dr. Hyslop has been involved in cancer research for more than 35 years and is leading a team of scientists from UNC in what Nuvilex's CEO calls "cutting edge" research on behalf of the company. Dr. Hyslop, who is a member of the Scientific Advisory Board of Nuvilex's subsidiary, Medical Marijuana Sciences, is the latest in the biotechnology arena to be impressed by Nuvilex's Cell-in-a-Box and the role it can play in targeted therapies.
The Cell-in-a-Box technology offers a way to encapsulate live cells capable of converting anticancer prodrugs (those that require metabolic conversion into their cancer-killing forms in order to be effective) in protective, pin-head-sized cocoons.
Nuvilex is using the technology for its treatment for advanced, inoperable pancreatic cancer which combines Cell-in-a-Box and the well-known anticancer prodrug ifosfamide. The company is preparing for late-phase clinical trials using its treatment in early 2015, but it is also using the same treatment in what the company hopes will be groundbreaking preclinical studies to treat the symptoms associated with abdominal cancers, namely slowing the accumulation of malignant ascites fluid common with these cancers, and treating the unbearable pain associated with abdominal cancers.
Drs. Hyslop and Brown will develop cancer treatments that combine the Cell-in-a-Box technology with cannabinoid prodrugs instead of ifosfamide. Their efforts to understand the chemical and biochemical processes involved in the interaction of substances derived from a sustainable plant source, such as Cannabis, with sustainable live cell encapsulation (Cell-in-a-Box) provides the opportunity to develop what Nuvilex is calling a "green" approach to treating cancers like pancreatic, brain, breast, and prostate cancer that affect hundreds of thousands of individuals worldwide each year.
For thousands of years, Cannabis has provided a sustainable source of fiber, food, energy and medicine. The Cannabis plant's cannabinoid constituents, with the most recognized of these being tetrahdyrocannabinol and cannabidiol, have been documented to possess broad anti-inflammatory, antioxidant, analgesic, nerve-protecting and anticancer properties as well as other therapeutic applications.
Watch Dr. Hyslop's interview with Biz West discussing Cell-in-a-Box® and preclinical studies at UNC:
Nuvilex, Inc. Engaged in "Cutting Edge" Cannabis Preclinical Studies Using Model Compounds With Cell-in-a-Box
NEW YORK, NY--(Marketwired - October 29, 2014) - Nuvilex, Inc. (NVLX) isn't letting the upcoming mid-term elections or the views in Washington, D.C., on medical marijuana slow down its research. The company is currently engaged in preclinical studies at the University of Northern Colorado (UNC) targeting Cannabis-based cancer treatments using Nuvilex's Cell-in-a-Box® cellulose-based live cell encapsulation technology.
While waiting for a Schedule 1 license from the DEA in order to conduct research using marijuana, Dr. Richard M. Hyslop, Professor of Chemistry and Biochemistry at UNC, along with his colleague Dr. Corina Brown are conducting these preclinical studies using model compounds that are similar chemically to the components they are looking for in Cannabis.
Dr. Hyslop said in an interview with the Biz West Newspaper in Northern Colorado, that the idea is to use the model compounds to screen live cells in an effort to find those cells that can eventually be encapsulated. "The type of cell that we're going to incorporate is going to have a particular type of activity that is capable of converting a component of Cannabis to an active anti-cancer drug. What the research involves is identifying the type of cell that is capable of doing that."
The goal behind this research is to eventually create a treatment for "solid" tumors using constituents (cannabinoids) of the Cannabis plant and the company's live-cell encapsulation technology, Cell-in-a-Box. Initially, Nuvilex will target solid tumors of the brain and pancreas.
Dr. Hyslop has been involved in cancer research for more than 35 years and is leading a team of scientists from UNC in what Nuvilex's CEO calls "cutting edge" research on behalf of the company. Dr. Hyslop, who is a member of the Scientific Advisory Board of Nuvilex's subsidiary, Medical Marijuana Sciences, is the latest in the biotechnology arena to be impressed by Nuvilex's Cell-in-a-Box and the role it can play in targeted therapies.
The Cell-in-a-Box technology offers a way to encapsulate live cells capable of converting anticancer prodrugs (those that require metabolic conversion into their cancer-killing forms in order to be effective) in protective, pin-head-sized cocoons.
Nuvilex is using the technology for its treatment for advanced, inoperable pancreatic cancer which combines Cell-in-a-Box and the well-known anticancer prodrug ifosfamide. The company is preparing for late-phase clinical trials using its treatment in early 2015, but it is also using the same treatment in what the company hopes will be groundbreaking preclinical studies to treat the symptoms associated with abdominal cancers, namely slowing the accumulation of malignant ascites fluid common with these cancers, and treating the unbearable pain associated with abdominal cancers.
Drs. Hyslop and Brown will develop cancer treatments that combine the Cell-in-a-Box technology with cannabinoid prodrugs instead of ifosfamide. Their efforts to understand the chemical and biochemical processes involved in the interaction of substances derived from a sustainable plant source, such as Cannabis, with sustainable live cell encapsulation (Cell-in-a-Box) provides the opportunity to develop what Nuvilex is calling a "green" approach to treating cancers like pancreatic, brain, breast, and prostate cancer that affect hundreds of thousands of individuals worldwide each year.
For thousands of years, Cannabis has provided a sustainable source of fiber, food, energy and medicine. The Cannabis plant's cannabinoid constituents, with the most recognized of these being tetrahdyrocannabinol and cannabidiol, have been documented to possess broad anti-inflammatory, antioxidant, analgesic, nerve-protecting and anticancer properties as well as other therapeutic applications.
Watch Dr. Hyslop's interview with Biz West discussing Cell-in-a-Box® and preclinical studies at UNC:
Nuvilex, Inc. Engaged in "Cutting Edge" Cannabis Preclinical Studies Using Model Compounds With Cell-in-a-Box
NEW YORK, NY--(Marketwired - October 29, 2014) - Nuvilex, Inc. (NVLX) isn't letting the upcoming mid-term elections or the views in Washington, D.C., on medical marijuana slow down its research. The company is currently engaged in preclinical studies at the University of Northern Colorado (UNC) targeting Cannabis-based cancer treatments using Nuvilex's Cell-in-a-Box® cellulose-based live cell encapsulation technology.
While waiting for a Schedule 1 license from the DEA in order to conduct research using marijuana, Dr. Richard M. Hyslop, Professor of Chemistry and Biochemistry at UNC, along with his colleague Dr. Corina Brown are conducting these preclinical studies using model compounds that are similar chemically to the components they are looking for in Cannabis.
Dr. Hyslop said in an interview with the Biz West Newspaper in Northern Colorado, that the idea is to use the model compounds to screen live cells in an effort to find those cells that can eventually be encapsulated. "The type of cell that we're going to incorporate is going to have a particular type of activity that is capable of converting a component of Cannabis to an active anti-cancer drug. What the research involves is identifying the type of cell that is capable of doing that."
The goal behind this research is to eventually create a treatment for "solid" tumors using constituents (cannabinoids) of the Cannabis plant and the company's live-cell encapsulation technology, Cell-in-a-Box. Initially, Nuvilex will target solid tumors of the brain and pancreas.
Dr. Hyslop has been involved in cancer research for more than 35 years and is leading a team of scientists from UNC in what Nuvilex's CEO calls "cutting edge" research on behalf of the company. Dr. Hyslop, who is a member of the Scientific Advisory Board of Nuvilex's subsidiary, Medical Marijuana Sciences, is the latest in the biotechnology arena to be impressed by Nuvilex's Cell-in-a-Box and the role it can play in targeted therapies.
The Cell-in-a-Box technology offers a way to encapsulate live cells capable of converting anticancer prodrugs (those that require metabolic conversion into their cancer-killing forms in order to be effective) in protective, pin-head-sized cocoons.
Nuvilex is using the technology for its treatment for advanced, inoperable pancreatic cancer which combines Cell-in-a-Box and the well-known anticancer prodrug ifosfamide. The company is preparing for late-phase clinical trials using its treatment in early 2015, but it is also using the same treatment in what the company hopes will be groundbreaking preclinical studies to treat the symptoms associated with abdominal cancers, namely slowing the accumulation of malignant ascites fluid common with these cancers, and treating the unbearable pain associated with abdominal cancers.
Drs. Hyslop and Brown will develop cancer treatments that combine the Cell-in-a-Box technology with cannabinoid prodrugs instead of ifosfamide. Their efforts to understand the chemical and biochemical processes involved in the interaction of substances derived from a sustainable plant source, such as Cannabis, with sustainable live cell encapsulation (Cell-in-a-Box) provides the opportunity to develop what Nuvilex is calling a "green" approach to treating cancers like pancreatic, brain, breast, and prostate cancer that affect hundreds of thousands of individuals worldwide each year.
For thousands of years, Cannabis has provided a sustainable source of fiber, food, energy and medicine. The Cannabis plant's cannabinoid constituents, with the most recognized of these being tetrahdyrocannabinol and cannabidiol, have been documented to possess broad anti-inflammatory, antioxidant, analgesic, nerve-protecting and anticancer properties as well as other therapeutic applications.
Watch Dr. Hyslop's interview with Biz West discussing Cell-in-a-Box® and preclinical studies at UNC:
Nuvilex, Inc. Engaged in "Cutting Edge" Cannabis Preclinical Studies Using Model Compounds With Cell-in-a-Box
NEW YORK, NY--(Marketwired - October 29, 2014) - Nuvilex, Inc. (NVLX) isn't letting the upcoming mid-term elections or the views in Washington, D.C., on medical marijuana slow down its research. The company is currently engaged in preclinical studies at the University of Northern Colorado (UNC) targeting Cannabis-based cancer treatments using Nuvilex's Cell-in-a-Box® cellulose-based live cell encapsulation technology.
While waiting for a Schedule 1 license from the DEA in order to conduct research using marijuana, Dr. Richard M. Hyslop, Professor of Chemistry and Biochemistry at UNC, along with his colleague Dr. Corina Brown are conducting these preclinical studies using model compounds that are similar chemically to the components they are looking for in Cannabis.
Dr. Hyslop said in an interview with the Biz West Newspaper in Northern Colorado, that the idea is to use the model compounds to screen live cells in an effort to find those cells that can eventually be encapsulated. "The type of cell that we're going to incorporate is going to have a particular type of activity that is capable of converting a component of Cannabis to an active anti-cancer drug. What the research involves is identifying the type of cell that is capable of doing that."
The goal behind this research is to eventually create a treatment for "solid" tumors using constituents (cannabinoids) of the Cannabis plant and the company's live-cell encapsulation technology, Cell-in-a-Box. Initially, Nuvilex will target solid tumors of the brain and pancreas.
Dr. Hyslop has been involved in cancer research for more than 35 years and is leading a team of scientists from UNC in what Nuvilex's CEO calls "cutting edge" research on behalf of the company. Dr. Hyslop, who is a member of the Scientific Advisory Board of Nuvilex's subsidiary, Medical Marijuana Sciences, is the latest in the biotechnology arena to be impressed by Nuvilex's Cell-in-a-Box and the role it can play in targeted therapies.
The Cell-in-a-Box technology offers a way to encapsulate live cells capable of converting anticancer prodrugs (those that require metabolic conversion into their cancer-killing forms in order to be effective) in protective, pin-head-sized cocoons.
Nuvilex is using the technology for its treatment for advanced, inoperable pancreatic cancer which combines Cell-in-a-Box and the well-known anticancer prodrug ifosfamide. The company is preparing for late-phase clinical trials using its treatment in early 2015, but it is also using the same treatment in what the company hopes will be groundbreaking preclinical studies to treat the symptoms associated with abdominal cancers, namely slowing the accumulation of malignant ascites fluid common with these cancers, and treating the unbearable pain associated with abdominal cancers.
Drs. Hyslop and Brown will develop cancer treatments that combine the Cell-in-a-Box technology with cannabinoid prodrugs instead of ifosfamide. Their efforts to understand the chemical and biochemical processes involved in the interaction of substances derived from a sustainable plant source, such as Cannabis, with sustainable live cell encapsulation (Cell-in-a-Box) provides the opportunity to develop what Nuvilex is calling a "green" approach to treating cancers like pancreatic, brain, breast, and prostate cancer that affect hundreds of thousands of individuals worldwide each year.
For thousands of years, Cannabis has provided a sustainable source of fiber, food, energy and medicine. The Cannabis plant's cannabinoid constituents, with the most recognized of these being tetrahdyrocannabinol and cannabidiol, have been documented to possess broad anti-inflammatory, antioxidant, analgesic, nerve-protecting and anticancer properties as well as other therapeutic applications.
Watch Dr. Hyslop's interview with Biz West discussing Cell-in-a-Box® and preclinical studies at UNC:
Nuvilex, Inc. Engaged in "Cutting Edge" Cannabis Preclinical Studies Using Model Compounds With Cell-in-a-Box
NEW YORK, NY--(Marketwired - October 29, 2014) - Nuvilex, Inc. (NVLX) isn't letting the upcoming mid-term elections or the views in Washington, D.C., on medical marijuana slow down its research. The company is currently engaged in preclinical studies at the University of Northern Colorado (UNC) targeting Cannabis-based cancer treatments using Nuvilex's Cell-in-a-Box® cellulose-based live cell encapsulation technology.
While waiting for a Schedule 1 license from the DEA in order to conduct research using marijuana, Dr. Richard M. Hyslop, Professor of Chemistry and Biochemistry at UNC, along with his colleague Dr. Corina Brown are conducting these preclinical studies using model compounds that are similar chemically to the components they are looking for in Cannabis.
Dr. Hyslop said in an interview with the Biz West Newspaper in Northern Colorado, that the idea is to use the model compounds to screen live cells in an effort to find those cells that can eventually be encapsulated. "The type of cell that we're going to incorporate is going to have a particular type of activity that is capable of converting a component of Cannabis to an active anti-cancer drug. What the research involves is identifying the type of cell that is capable of doing that."
The goal behind this research is to eventually create a treatment for "solid" tumors using constituents (cannabinoids) of the Cannabis plant and the company's live-cell encapsulation technology, Cell-in-a-Box. Initially, Nuvilex will target solid tumors of the brain and pancreas.
Dr. Hyslop has been involved in cancer research for more than 35 years and is leading a team of scientists from UNC in what Nuvilex's CEO calls "cutting edge" research on behalf of the company. Dr. Hyslop, who is a member of the Scientific Advisory Board of Nuvilex's subsidiary, Medical Marijuana Sciences, is the latest in the biotechnology arena to be impressed by Nuvilex's Cell-in-a-Box and the role it can play in targeted therapies.
The Cell-in-a-Box technology offers a way to encapsulate live cells capable of converting anticancer prodrugs (those that require metabolic conversion into their cancer-killing forms in order to be effective) in protective, pin-head-sized cocoons.
Nuvilex is using the technology for its treatment for advanced, inoperable pancreatic cancer which combines Cell-in-a-Box and the well-known anticancer prodrug ifosfamide. The company is preparing for late-phase clinical trials using its treatment in early 2015, but it is also using the same treatment in what the company hopes will be groundbreaking preclinical studies to treat the symptoms associated with abdominal cancers, namely slowing the accumulation of malignant ascites fluid common with these cancers, and treating the unbearable pain associated with abdominal cancers.
Drs. Hyslop and Brown will develop cancer treatments that combine the Cell-in-a-Box technology with cannabinoid prodrugs instead of ifosfamide. Their efforts to understand the chemical and biochemical processes involved in the interaction of substances derived from a sustainable plant source, such as Cannabis, with sustainable live cell encapsulation (Cell-in-a-Box) provides the opportunity to develop what Nuvilex is calling a "green" approach to treating cancers like pancreatic, brain, breast, and prostate cancer that affect hundreds of thousands of individuals worldwide each year.
For thousands of years, Cannabis has provided a sustainable source of fiber, food, energy and medicine. The Cannabis plant's cannabinoid constituents, with the most recognized of these being tetrahdyrocannabinol and cannabidiol, have been documented to possess broad anti-inflammatory, antioxidant, analgesic, nerve-protecting and anticancer properties as well as other therapeutic applications.
Watch Dr. Hyslop's interview with Biz West discussing Cell-in-a-Box® and preclinical studies at UNC:
Right now we are trading right under the 200dma...so this is expected...I would use this opportunity to buy or add to my position in Nuvilex before we close over the 200dma...because once that happens we are moving up...and with PR's that are expected to surface soon...that could happen...
good luck
bull
Great find rudy...I have been saying this for a while...that they already know these cells will work...because they had worked with them before...and that they just had to go through the tests again for the studies to begin...thanks for posting this...
bull
November is Pancreatic Cancer Awareness Month...there would be no better time for Dr. Von Hoff to announce the results of the TD2 study on ascites...or maybe no ascites and remission...
Go Nuvilex
bull
If closing down 0.0088 on Friday for Nuvilex is Tanked...I wish when any of my stocks tank if would be 0.0088...and using that reference...any stock that closed down on Friday TANKED...
bull
Purchase and Sale of Assets and Stock
a.
Subject to the terms and conditions of this Addendum, and on the terms and subject to the conditions set forth in this Addendum, Nuvilex shall purchase, take and receive from SG Austria, and SG Austria shall sell, convey, assign, transfer and deliver to Nuvilex, all of SG Austria’s right, title and interest in and to all of the tangible and intangible property of BBB and all BBB stock, (the “Purchased Assets”), free and clear of any and all liens claims and encumbrances, except as otherwise specifically provided herein. A list of the Purchased Assets is attached hereto as “Exhibit D” on page 135 and incorporated herein.
b.
The Purchased Assets shall include without limitation, all of SG Austria’s right, title and interest in the assets and stock of the BBB, as follows:
i.
the Licenses;
ii.
the 22P1G cells and all vials of frozen stocks stored at any facility, including but not limited to ViruSure, University of Vienna, ASPL, etc.
iii.
all books and records of BBB, including, without limitation, all files, invoices, forms, accounts, correspondence, accounting records, and other books and records relating to the operation of BBB which are held by Hoop;
iv.
all copyrights, marks (which includes trademarks, service marks, collective marks, and/or certification marks, if any, and all the goodwill appurtenant to and associated therewith), software, licenses, trade secrets (technical and non technical), data and documentation (including electronic media), and other confidential information,
intellectual property rights and similar intangible property rights,
whether or not subject to legally enforceable restrictions or protections against unauthorized third party usage, and rights therein and the goodwill associated therewith belonging to BBB;
v.
all shares of BBB stock;
vi.
all rights, benefits and interests of SG Austria in, to and under all written contracts, licenses, leases, commitments, undertakings and other agreements or arrangements (the “Assumed Contracts”) held or owned by BBB.
This NVLX is a buy and hold type of security...and I still don't see any dumping...very nice here...today at only 0.0283 % down it's collapsing?... that's more like a head bow...
so Friday when the WHEELS CAME OFF... the price was .2389...now this week it hit .27... hmm... what kind of wheels are we talking about...
I definitely would think hard about being on the sidelines...
Von Hoff's TD2 Results will be coming out...and I would not underestimate what the results will be...I for one would not want to be paying retail after the results...
And we have Orphan Drug Status coming on top of that...
All before the end of the year...
bull
Oh and for those who may not be educated on how Nuvilex's treatment will be judged... in reference to the low number of patients in the trial... realize it was a phase I/II which doesn't require a lot...
And realize that we're dealing with a drug (ifosfamide) that has already been approved by the FDA... so we don't need a huge study because we're not dealing with side effects... it's a proof of concept type thing... which Cell in a Box... is passing...
They don't need hundreds of patients to prove the cells do in fact work inside the capsules if they work on 26 people then it's proof the concept works...
If Ifosfamide is already approved so the need to do a long... many patient trials for toxicity purposes (which is usually the reason trials are longer and have more patients) isn't there...
If NVLX was trying to get a new drug approved yes... the number of patients would matter because we'd have to present the FDA with an extensive toxicity study... but already approved drugs nope don't need it...
And they've already proven no side effects in P I/II which is all they needed to do along with proving that the Cell in a Box wouldn't migrate or mutate... proven!!!
The EMA will give Nuvilex Orphan Drug Status and so will the FDA...Both will be soon...I will personally reply to this post with the news so everyone here can see the approval...
Good Luck
bull
We've had very strong news the last 3 Mondays... so you are correct... What strong news is next?
EDUCATED investors are BUYING NVLX...I don't see any dumping...I see BUYING...EDUCATED investors have been buying and adding to their position since the stock bottomed at .165...this is typically how it works when EDUCATED SMART investors see value in a stock...with their buying they run it up before the DR. Von Hoff TD2 RESULTS surface...that way they buy their position with wholesale prices not retail prices like the uneducated investor...
Good Luck to you too...
Long term investors don't need luck...we have knowledge...
bull
Well it will never ever see .10 again so good luck with that... Yes that's right I said never ever and I will say it again!... NVLX will never ever revisit the .10 pps!... Also for all of those who are sitting on the sidelines choosing not to jump in... no biggie!... They will all pay retail for NVLX while those of us with our eye on the definite future here at NVLX will pay wholesale. Good luck!
Today we are one day closer to what could be and should be the biggest news in Nuvilex's history to date... pre-clinical results... Today we are again moving into the green... Today some are enjoying profit because they realize NVLX is going to continue to get better and better and those folks who came off of the sidelines and realize they won't be getting cheaper shares are in the green with each tick up... So far today that's 10 ticks up times how many shares they chose to purchase?... IF you're on the sidelines still... do you really think the anticipation that is growing for what could be landmark pre-clinical results is going to make the stock go down and not more and more up?... It's time to join the anticipation and enjoy each tick up before the big explosion of ticks up... when results hit the newswire...
840,600 shares bought in the last 30 minutes today...more than what traded all day...I would say someone saw the incredible value in Nuvilex and took a large position today...
bull
Nuvilex...see those of you who got off the sidelines first got the better price ahead of huge results news...those still sitting... your price is getting more and more expensive and while the early birds are seeing profit with each tick up... you wait!
So what those sitting on the sidelines have to decide on... do you wait and miss a potential landmark PR?...Or do you get in now because we could see a headline that states...Nuvilex has doubled life expectancy...tripled... shrunk the tumor... never saw the accumulation of Ascites... we'll only know once!...Where will you be on that day?...
While it may not have been anticipated that Cell in a Box would be performing so well that the trials are still ongoing...there is no delay... there is only success and the longer we hear nothing...the more success we're having at TD2 under the leadership and guidance of world renowned oncologist, Dr. Daniel Von Hoff...
I didn't even hear Nuvilex give a general guideline on the TD2 Results...they know better than that...Von Hoff will say when the study is over...if those treated mice are still alive then that means remission...
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Nuvilex is very good at what they do...putting out the information needed for their investors in a very rigid PR...putting out the facts...SMMG is very good at what they do...taking that rigid talk and putting it into layman's terms so the average investor can absorb that information...telling the story of Nuvilex...there is a place in this super huge large internet for BOTH...
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Nuvilex, Inc. Moves Closer to "Bio-Artificial Pancreas" Diabetes Treatment With License for Insulin-Producing Cells
NEW YORK, NY--(Marketwired - October 21, 2014) - Nuvilex, Inc. (NVLX) has carefully mapped out its plan to develop a diabetes treatment using the Cell-in-a-Box®platform technology. It started in November 2013 when the company acquired the exclusive worldwide rights to use the cellulose-based live-cell encapsulation technology for the development of treatments for diabetes. This acquisition gave Nuvilex a proven delivery system with which it could firmly plant its flag in the race for a diabetes treatment.
Now, almost one year later, Nuvilex has quite possibly made a game-changing leap forward in that race by securing a line of "live cells" that could potentially be encapsulated in the Cell-in-a-Box technology.
Last week the company announced that it has secured the worldwide rights to use human insulin-producing cells (Melligen cells), developed by professor Ann Simpson and her colleagues at the University of Technology in Sydney, Australia (UTS), for the development of a treatment for insulin-dependent (Type 1 or juvenile-onset) diabetes.
In these two agreements, Nuvilex has the necessary ingredients, a delivery system and human insulin-producing cells, to develop a treatment that can compete commercially in the almost $500 billion global diabetes healthcare market. Currently there is a mad dash to develop such a treatment that can address what is becoming a real epidemic with close to 400 million people worldwide living with diabetes. According to the International Diabetes Federation, that number is expected to balloon to 552 million by 2030.
Type 1 diabetes is an autoimmune disease in which a person's pancreas stops producing insulin, which is a hormone that enables people to get energy from the foods they eat. It occurs when the body's immune system attacks and destroys the insulin-producing cells in the pancreas, called beta cells. Currently treating the disease requires a lifetime of daily injections of insulin to control blood glucose levels.
When Dru-Ann Sgarlato of Fredericksburg, Virginia, and the mother of a 12 year old Type 1 diabetic, read that Nuvilex had secured the worldwide rights to use these human insulin-producing cells, she said, "Amazing! It's sometimes frustrating that they can do all of this but we still don't have a cure. Hell, if my son Devin could have 2 years before having to inject these cells again it would be so worth it. I'd cry and fall to my knees."
The 2 years that Dru-Ann is referring to relates to one of many advantages Nuvilex's delivery system has over the competition. Cell-in-a-Box is a cellulose-based encapsulation technology that has proven through two Phase I/II advanced pancreatic cancer clinical trials that it does not break down even after long periods of time (greater than 2 years) after being implanted inside the body.
Another key advantage that Cell-in-a-Box holds over competing cell encapsulation technologies, which is especially relevant to a diabetes treatment, is that the capsules do not elicit a response from the body's immune system which would destroy the capsules and the insulin-producing cells inside them.
Dru-Ann Sgarlato is a typical parent of a diabetic child who spends every single day dealing with injections and pumps and constantly monitoring blood glucose levels to keep her son safe. "We check Devin's blood sugar approximately 15 times a day and all through the night, every night. At year's end, Devin's fingers have been poked no less than 5,400 times."
The Melligen cells will have to endure preclinical and clinical testing, but essentially they would replace the insulin-secreting beta cells that have been destroyed by the autoimmune process in Type 1 diabetics.
Professor Ann Simpson and her team developed the Melligen cells which were originally derived from a human liver cancer cell line. Before Nuvilex can use the cells in the development of its treatment, the company will first have to prove that they do not form tumors (tumorigenic) when implanted into animals. If studies successfully prove the Melligen cells are not tumorigenic, Nuvilex plans to have them encapsulated using the Cell-in-a-Box technology as part of its planned treatment for diabetes.
It is believed that animal testing of the encapsulated Melligen cells will prove that they are capable of producing insulin "on demand" in diabetic animals. As blood glucose levels rise in animals implanted with Melligen cells, these cells will produce increasing amounts of insulin in response. When blood glucose levels fall, less insulin will be produced by the Melligen cells.
Nuvilex's decision to acquire the worldwide rights to use Cell-in-a-Box to develop a diabetes treatment was based, almost exclusively, on the results of a "proof-of-principle" study, much like the Melligen cells will endure, where islet cells (from pigs) that produce insulin were transplanted into diabetic rats. The rats had much higher than normal levels of glucose in their bloodstream and had a difficult time controlling their glucose levels, just as humans with diabetes do.
In those diabetic rats that received Cell-in-a-Box with the encapsulated islet cells, their blood glucose levels normalized and remained stable for the duration of a 6 month study, indicating the encapsulated cells produced insulin in response to their higher than normal blood glucose levels.
According to the company, the cellulose-based Cell-in-a-Box technology seems to have prevented the encapsulated cells inside from being attacked by the diabetic rats' immune systems, even in the absence of immunosuppressive drugs.
So, in this "proof-of-principle" study, the encapsulated cells appear to have acted as a type of "artificial" or replacement pancreas. Now, the company hopes to duplicate that success, this time with human insulin-producing cells. Ultimately, Nuvilex's plan is to encapsulate Melligen cells using the Cell-in-a-Box technology and then placing them into patients with Type 1 diabetes where, hopefully, they will serve long term as a form of "bio-artificial pancreas."
I would say this statement from Waggoner in the latest Nuvilex PR says we have started Diabetes.
"In addition to our work in the cancer arena, we are now involved in the development of a novel treatment for diabetes."
Nuvilex Contracts With University of Veterinary Medicine in Vienna to Conduct Preclinical Studies on the Use of Cell-in-a Box(R) to Develop Diabetes Treatment
DIABETES STUDIES HAVE BEGUN...
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I have been saying that...given that Dr. Günzburg worked with these cells already...and came to the same results as Ann Simpson about producing insulin...you don't think either of them tested for tumorigenic...
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PR OUT...Nuvilex Contracts With University of Veterinary Medicine in Vienna to Conduct Preclinical Studies on the Use of Cell-in-a Box(R) to Develop Diabetes Treatment
SILVER SPRING, Md., Oct. 20, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company developing cell and gene therapy solutions for the treatment of diseases, announced today that it has entered into a Collaborative Research Agreement (CRA) with the University of Veterinary Medicine in Vienna, Austria (University). The CRA calls for the University to perform "in vitro" and animal studies that use the Cell-in-a-Box(R) cellulose-based live cell encapsulation technology to develop a new treatment for insulin-dependent diabetes. Nuvilex has been granted worldwide, royalty-free, rights to use the results of the research conducted by the University for all commercial purposes.
Nuvilex's CEO and President, Kenneth L. Waggoner, said of the agreement, "The signing of the Collaborative Research Agreement with the University represents a significant development for Nuvilex. There are several individuals at the University who are exceedingly familiar with the Cell-in-a-Box(R) technology. Most notably is Prof. Dr. Walter H. Gunzburg, who is a co-developer of the technology and Nuvilex's Chief Scientific Officer. Dr. Gunzburg has also played a major role in the development of our pancreatic cancer treatment that is based on the Cell-in-a-Box(R) technology. We consider our new relationship with the University to be a "major salvo" as we join the battle to find a better treatment option for the many millions of people around the world who suffer from insulin-dependent diabetes. In addition, having the University 'on board' lays the foundation for the establishment of a Diabetes Consortium that we hope will, in the relatively near future, come to include institutions and individuals throughout Europe as well as other countries as we strive to develop a 'bio-artificial' pancreas."
Among the initial studies to be performed by the University will be the testing of an insulin-producing cell line developed by the University of Technology, Sydney, to determine whether that cell line has the potential to form tumors when implanted into animals; i.e. whether those cells are "tumorigenic." If this cell line proves to be non-tumorigenic, then cells from this cell line will be encapsulated using the Cell-in-a-Box(R) technology.
Additional animal studies will be carried out at the University to determine if these encapsulated cells can act as a form of "bio-artificial pancreas" in animal model systems. Dr. Gunzburg and his associates have already worked with these insulin-producing cells in an in vitro setting and have confirmed that they can produce insulin in direct response to the levels of glucose (sugar) to which they are exposed.
Waggoner added, "The establishment of this relationship with the University of Veterinary Medicine Vienna marks an important stage in the development of Nuvilex as a multi-dimensional biotech company. In addition to our work in the cancer arena, we are now involved in the development of a novel treatment for diabetes. This is an area of medicine that affects over 380 million individuals worldwide and where improvements in treatment are constantly needed. We believe that the true platform nature of the Cell-in-a-Box(R) encapsulation technology will prove to be a major asset and will ultimately set Nuvilex apart from other competitors in this field."
It's Time to Revisit Nuvilex, Inc. and its Cell-in-a-Box® Live-Cell Encapsulation Technology for Cancer & Diabetes Treatments
Nuvilex, Inc. (OTCQB: NVLX) just might be the biggest steal in the market right now... period! If you're looking for a pure "diamond in the rough" to invest in, a true blockbuster opportunity in the making... Nuvilex, Inc. is the biotechnology for you.
We introduced NVLX to our subscribers back when it was less than .05/share in February 2013. It moved soon after into the teens where it traded in a channel from .10 to .17 for quite some time before heading to its high of .62 on news of funding... and it got there quickly once that news hit!!
If funding news was the impetus behind new highs at Nuvilex in early 2014, then you're in for the potential ride of your life with the news that current shareholders are eagerly anticipating. The significance to all of our subscribers who have yet to jump on board is that today's share price offers an excellent entry point ahead of what should be the company's biggest news ever.
After hitting .62 in Q1 2014, the stock price dwindled back down below .20 after the company went through a long lull in telling its story while it pieced together a number of big contracts and got its ducks in a row for what Nuvilex is now on the precipice of accomplishing. They are back to telling their story and releasing one big news item after another, and the price has moved from .168 to .25 where it hit Friday before settling at .2389 at the Close.
Anyone who invests in biotech stocks knows that hitting a number of key milestones equates to a number of big price movements upwards! Nuvilex has quite a few big milestones that it will be announcing soon... and for our subscribers, you can get in before the milestone announcements start unfolding.
Here is a quick look ahead at what we think will move Nuvilex's price back up to new highs and beyond in the very near future:
The company entered into pre-clinical studies with world renowned oncologist, Dr. Daniel Von Hoff at Translational Drug Development or TD2 which is quite possibly the premiere oncology CRO in the country if not the world. These pre-clinical studies to study the symptoms associated with abdominal cancers like pancreatic cancer, liver cancer, ovarian cancer, etc, are still in progress, and the longer they go on, the better Nuvilex's technology is apparently working.
This is truly a case of no news is good... make that great news!
In the study, 4 groups of mice were injected with ovarian cancer which is a very aggressive cancer. The study is to determine if Nuvilex's Cell in a Box technology can slow the onset and accumulation of ascites, a fluid that builds up in the abdominal cavity of those patients with an abdominal cancer. The fluid is often seeded with cancer cells and can create more tumors in the patient as the fluid builds up throughout the abdominal cavity.
The mice in Group 1 were the control group, the 2nd group was given a current drug on the market used to treat this symptom, the 3rd group was given Nuvilex's treatment which combines the Cell in a Box technology with the anticancer prodrug ifosfamide, and finally the 4th group was given Nuvilex's treatment plus the already marketed drug on the market.
Current shareholders are waiting on the results from this pre-clinical study. If the results are as good as many expect them to be, then Dr. Daniel Von Hoff could go to the FDA and request a short (3 to 6 months) Phase I/II human clinical trial and then request an accelerated approval for Nuvilex's treatment to improve the quality of life for those patients with abdominal cancers.
One week ago, Nuvilex applied to the FDA for the Orphan Drug Designation for its pancreatic cancer treatment.
The company has also applied to the EMA (European Medicines Agency), the equivalent to the FDA in Europe for the same Orphan Drug Designation. Nuvilex expects to learn this year (2014) if it will be awarded the designation from the EMA, which should create quite a stir for this small biotech.
Nuvilex has announced that it expects to begin its Phase 2b or "mini Phase 3" in the first quarter of 2015. The start of these trials will, of course, be preceded by a number of big announcements related to the start of those late phase trials.
Late last week... Nuvilex announced that it has secured the worldwide license for an insulin-producing cell line that will be tested to determine if the cell line can be encapsulated in Cell in a Box and serve as the company's diabetes treatment.
With what seems like an entire biotechnology sector engaged in a race to develop a diabetes treatment, Nuvilex may have just taken the lead. There are two sides forming in the race: Those companies, universities and organizations who are trying to develop a delivery system for a treatment, and those who are trying to develop a cell line or treatment to deliver to the hundreds of millions around the world who suffer with the disease.
Nuvilex may now have both if this recently obtained cell line proves successful!!! We expect pre-clinical and clinical trials to be announced which could capture the attention of the national media given Nuvilex may have just catapulted itself into the lead among many company's trying to develop a treatment.
It is becoming more and more clear to us that Nuvilex could very well be a buy-out candidate sooner rather than later... and if the company receives blockbuster results (which we fully expect) from its pre-clinical studies that could come at any time now... and when (not if) the company receives the Orphan Drug Designation from the FDA and EMA, we expect the talk of a buy-out to heat up.
Cancer and Diabetes breakthroughs... priced at .20-something/share... Don't wait too long to put Nuvilex back on your radar or to build a position. We feel Nuvilex is going to be that biotech which comes along every once in a while and the market takes a chance on it as a "diamond in the rough" and then cashes in on it — big!
Stock Market Media Group was not compensated for the research, writing, production, and release of this Newsletter on NVLX.
http://us4.campaign-archive2.com/?u=39c1baafca0ca88a1e89940ba&id=1b670726c1
By how fast substantial PR's are surfacing now...and looking at the chart...I say we hit .26 in a couple days...depending on what news Nuvilex gives us this week it could be higher...I knew it was never going to .10...
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