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AND DON'T BE SHOCKED WHEN THE BIG MONEY DOES JUMP INTO PHARMACYTE
there is no way to answer that...on any stock...I have seen even the best analysts get it wrong on stocks they cover...there are too many scenarios...PharmaCyte could be bought out after Hoff's results...even before the human trial...the whole company could be bought out...or just the CiaB for all Cancers...what Hoff is working on...and we could retain the CiaB for Diabetes and Cannabis...I will say it won't be a penny stock...which will be a blessing in itself if for no other reason then getting rid of the penny traders...
bull
NO... I am not worried...I know what I have invested in...and the pps of PharmaCyte right now does not matter to me... being on the OTC this stock is being played...especially by the traders...there is proof of that in the posts you read...
and look at all the successful bios and the pps they started at...take Celgene for instance...it was under a dollar...and how many splits have they done now because it is like a runaway train...and their Abraxane that Dr. Von Hoff got to market for them was acquired by Celgene...the reason they bought Abraxis...for that one drug...
now PharmaCyte HAS HOFF WORKING ON Cell-in-a-Box...take the best educated guess and all the DD and what do you think is going to happen?
bull
I agree...with this extended study to cover everything needed for the human trial...and is successful like the first study...which I fully expect it will be...a phase I or phase I/II successful human trial should be all they need for fast track approval... with there being no other treatment that reduces or eliminates ascites...except for the painful manual way...and the fact that CiaB does this in combination with the standard treatment for these cancers...BIG....
PharmaCyte Biotech's Expanded Follow-up Study on Malignant Ascites Fluid Accumulation in Final Stages of Preparation
SILVER SPRING, Md., Jan. 26, 2015 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live cell encapsulation technology, Cell-in-a-Box(R), today reported that preparations for an expanded, follow-up study of the effectiveness of its pancreatic cancer treatment (a combination of low doses of the cancer prodrug ifosfamide and Cell-in-a- Box(R) capsules containing live cells capable of converting ifosfamide into its cancer-killing form) on the accumulation of malignant ascites fluid are in their final stages. This preclinical study will be conducted by Translational Drug Development (TD2) in the United States. Pancreatic cancer expert Dr. Daniel D. Von Hoff is the Chief Development Officer of TD2 and a principal architect of the study. It is expected that the study will begin in approximately two weeks.
This expanded study is designed to build upon the successful results of the pilot study that was completed by TD2 late last year. In that study, mice bearing an aggressive human ovarian cancer (ES-2), which produces significant amounts of malignant ascites fluid, were divided into 4 groups with 10 mice in each group. The mice in Group 1 served as a control group. Group 2 was made up of mice treated with PharmaCyte Biotech's pancreatic cancer treatment. Group 3 was treated with cisplatin, a chemotherapy drug often used to treat ovarian cancer. Group 4 was treated with a combination of PharmaCyte Biotech's pancreatic cancer treatment and cisplatin.
The new expanded study will use the same ES-2 ovarian cancer model, but in this study, the mice will be divided into 13 different treatment groups with 10 mice in each group. This study is designed to better define the parameters that will be needed to design a future Phase 1 clinical trial in humans that suffer from malignant ascites fluid accumulation as a result of their abdominal cancers, such as pancreatic, liver, ovarian, uterine and colon.
Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech, said, "We are looking forward to this expanded preclinical study of the effectiveness of our pancreatic cancer treatment in reducing the rate of malignant ascites fluid accumulation in the abdomen. If successful, it could quickly lead to a clinical trial in patients with abdominal tumors who suffer from this very serious cancer-associated malady. The accumulation of ascites fluid is problematic for patients with an abdominal cancer because it's very painful and can cause breathing problems. Once it gets to a certain stage, it must be removed on a regular basis. This procedure in itself is very uncomfortable for patients and costly. Hopefully, our pancreatic cancer treatment will slow the accumulation of this malignant ascites fluid and thus reduce the number of withdrawals of the fluid that are needed over a given period of time. To our knowledge, there is no other treatment on the market that can accomplish this - particularly in the case of advanced cancers."
http://finance.yahoo.com/news/pharmacyte-biotechs-expanded-study-malignant-140000166.html
Nuvilex Announces Name Change to PharmaCyte Biotech
Company's Shares Will Trade Under New Ticker Symbol PHCB
SILVER SPRING, Md., Jan. 7, 2015 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX) today announced that the Company has changed its name to PharmaCyte Biotech, Inc. Shares in PharmaCyte Biotech will trade under the new ticker symbol "PHCB" on the OTCQB electronic platform. The new symbol is expected to become effective at the open of the market on January 8, 2014. The name change is part of the Company's transformation process to operate solely as a pure biotechnology firm leveraging its Cell-in-a-Box(R) technology, a proprietary cell encapsulation platform being utilized to develop "targeted" treatments for solid cancerous tumors and insulin dependent diabetes.
"Over the past year, we've implemented an aggressive strategy to facilitate the advancement of the treatments we are developing for cancer and diabetes, with our Cell-in-a-Box(R) technology at the core of these treatments. Our new name reflects the tremendous progress we've accomplished in terms of clinical development and signifies the structural completion of our transition to becoming a fully dedicated biotechnology company," said Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech.
Some of the highlights in 2014 that have marked this transition include:
Receiving "orphan drug" designation from the U.S. Food and Drug Administration (FDA) for the Company's pancreatic cancer treatment, with applications filed with the EMA and the TGA for the same status in Europe and Australia.
Development of a clinical protocol for a planned Phase 2b clinical trial with the goal of initiating the clinical trial in 2015.
A preclinical study being completed evaluating the effectiveness of the Company's pancreatic cancer treatment on the accumulation of malignant ascites fluid often associated with the growth of abdominal cancers with positive results that have led to a follow-up study about to be launched.
The establishment of a world-wide Diabetes Consortium with a number of research agreements now in place with major universities and institutions that will permit the development of a break-through treatment for insulin dependent diabetes that combines Cell-in-a-Box(R) with insulin-producing cells.
Progression at the University of Northern Colorado in the pursuit of treatments for brain and other forms of difficult to treat cancers that will combine cannabinoid or cannabinoid-like compounds with the Cell-in-a-Box(R) technology.
"With exciting developments on the horizon for 2015, our work to develop treatments for both cancer and diabetes will move forward under our new name because it speaks to what we actually do here at PharmaCyte Biotech," concluded Mr. Waggoner.
new ticker symbol "PHCB" is expected to become effective at the open of the market on January 8, 2014
they know things before others...I would venture to say something big is up...they want pps dropped fast...like last time...I would be loading up...
so just to get a balanced opinion ...could you share some of the other DD you have done on Nuvilex on CiaB and what they have accomplished in a very short period of time for the newbies here...I am not new but thought you might have a different prospective on the good of nuvilex also so they could get a very well rounded picture....
thanks in advance...
Nuvilex to Attend 2015 Gastrointestinal Cancers Symposium in San Francisco, January 15-17, 2015
SILVER SPRING, Md., Jan. 6, 2015 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX) today announced that its Chief Executive Officer (CEO), Kenneth L Waggoner, JD, and its Chief Operating Officer, Gerald W. Crabtree, Ph.D., will be attending the 2015 Gastrointestinal Cancers Symposium, "Bridging Cancer Biology to Clinical GI Oncology," to be held in the Moscone West Convention Center in San Francisco, California, January 15-17, 2015.
Nuvilex's CEO, Kenneth L. Waggoner, stated, "Our attendance at this pivotal Symposium, which is dedicated to recent advances in the treatment of cancers of the GI tract, is essential because a substantial portion of the Symposium will be dedicated to the treatment of pancreatic cancer and because a significant component of Nuvilex's portfolio is devoted to the development of treatments for this deadly disease and the symptoms associated with it. The treatments Nuvilex will employ to attack pancreatic cancer are based on the use of the proprietary Cell-in-a-Box(R) cellulose-based live cell encapsulation technology in combination with low doses of the anticancer prodrug ifosfamide that has been deemed effective in two previous clinical trials. Our targeted chemotherapy platform has now shown encouraging results in early preclinical studies in the U.S. performed by Translational Drug Development (TD2) that are concerned with the development of malignant ascites fluid in animals with an abdominal cancer."
The Gastrointestinal Cancers Symposium is an annual event held in January in San Francisco and is co-sponsored by the American Gastroenterological Association, the American Society of Clinical Oncology, the American Society of Radiation Oncology, the American Society for Radiation Oncology and the Society of Surgical Oncology. This Symposium is expected to attract over 3,000 participants from around the world who are experts in the treatment of cancers of the pancreas, small bowel, colon, rectum, hepatobiliary tract, esophagus and stomach. At this event, many of the latest developments in the prevention, screening, diagnosis, multidisciplinary treatment and translational research of GI cancers will be presented.
"upon initial review the results appear to be exceedingly positive and have now led to the design of a follow-up study"...
there is says it all...
bull
Nuvilex got Orphan Drug Designation from the FDA...simple as that...
Date Designated: 12-17-2014
Orphan Designation Status: Designated
If a journalist made a statement like that he'd be in court right now for lying.... The company not showing up on a report doesn't mean they were approved or not approved.... You make it sound that if you're not on a report you were denied... which is NOT the case....
bull
EMA has NOT denied ODD for Nuvilex...expect a YES...and I expect you to come back and have this conversation when they put out the PR on it...
bull
Nuvilex either presented their case yesterday or today at the COMP meeting...which will then give their recommendation for approval for ODD...we should hear soon...
bull
This was such a smart move wendy on Nuvilex's part...to distinguish itself from the pot companies out there...Nuvilex never was a pot stock...we all know it is a biotech...but unfortunately a lot of new investors do not do all their DD before weighing to buy a stock...they see one phrase and move on...to their disadvantage...
bull
I agree with you rudy...Nuvilex's comp meeting is either today or tomorrow with the EMA...we could hear an answer as early as tomorrow...expect a yes...
bull
Nuvilex does not have to be the one to develop products to be bought out...check out many other developmental stage bio's to find that out...
bull
Look at it this way...all this substantial news being released on all the hard work that Nuvilex and all these worldwide renowned doctors and researchers are doing to bring CiaB to the people who desperately need it...
are the concrete blocks under Nuvilex that supports the endpoint...
the stock pps will take care of itself in due time...I think sooner than later...Nuvilex and CiaB Technology will not get buried much longer...I think the big turning point for nuvilex will be when the results of Hoff's study are revealed...and we get the exposure we all know nuvilex deserves...
bull
Nuvilex Announces the Formation of a Diabetes Consortium for the Development of Its Treatment for Insulin-Dependent Diabetes
SILVER SPRING, Md., Nov. 24, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today that it has formed a "Diabetes Consortium" that will be tasked with the development of Nuvilex's treatment for insulin-dependent diabetes.
The composition of the Diabetes Consortium has evolved over many months. In addition to key personnel from Nuvilex, it consists of principals from Austrianova - Prof. Dr. Walter H. Gunzburg, the Chief Technical Officer of Austrianova and Nuvilex's Chief Scientific Officer, Dr. Brian Salmons, the CEO of Austrianova (Drs. Gunzburg and Salmons co-developed the Cell-in-a-Box(R) technology) and Prof. Ann Simpson of the University of Technology Sydney (UTS) who, along with her professional colleagues at UTS, developed the insulin-producing cells known as Melligen cells. The plan is for these cells to be used as part of Nuvilex's diabetes treatment.
The Diabetes Consortium will also include scientists from the University of Veterinary Medicine Vienna (UVMV) where many of the preclinical studies will be done to develop Nuvilex's diabetes treatment. This research will be led by Prof. Dr. Walter H. Gunzburg, who is a member of the faculty at the UVMV. Other members of the Diabetes Consortium are renowned researchers Prof. Eckhard Wolf and Prof. Rudiger Wanke from the Ludwig-Maximillians University of Munich (UOM) who have developed unique animal models for insulin-dependent diabetes, as well as the former Chief Scientist of Austrianova, Dr. Eva Maria Brandtner, who conducted much of the early research on encapsulated Melligen cells and is now at the VIVIT Research Institute in Austria.
Noted European gastroenterologist and oncologist Dr. Matthias Lohr, who is experienced in the treatment of diabetes and who also serves as the Chairman of Nuvilex's Scientific Advisory Board, will play a major role in overseeing the research to be done within the Diabetes Consortium.
Kenneth L. Waggoner, the CEO and President of Nuvilex, commented, "We believe that, within the Diabetes Consortium, we have assembled a world-class group of scientists who have a keen and laser-focused interest in developing a treatment for insulin-dependent diabetes. The establishment of the Diabetes Consortium will allow for the free flow of critically important scientific information between all parties in the Diabetes Consortium as well as the collaboration between major research institutions from around the globe. This should serve to optimize the overall development time as we strive to create an entirely new treatment for insulin-dependent diabetes - a debilitating and dangerous disease that affects so many around the world."
Pivotal for the treatment will be the encapsulation of live insulin-producing Melligen cells using the proprietary, cellulose-based live cell encapsulation technology known as Cell-in-a-Box(R). These cells and the models at both the UVMV and the UOM will be used for the preclinical studies needed in preparation for clinical trials of Nuvilex's diabetes treatment.
Nuvilex's Chief Scientific Officer, Prof. Dr. Walter H. Gunzburg, said, "The formation of this Diabetes Consortium by Nuvilex is very timely and vitally important. Its existence should greatly facilitate our overall efforts as Nuvilex works to develop a unique treatment for insulin-dependent diabetes based on the Cell-in-a-Box(R) live cell encapsulation technology. In doing so, we believe that we will be able to develop a true "bio-artificial pancreas" that is both long-lived and effective in treating this devastating disease."
Nuvilex Executives in Southeast Asia to Further Advance Cell-in-a-Box Technology(R)
http://finance.yahoo.com/news/nuvilex-executives-southeast-asia-further-143627372.html
Nuvilex’s Chief Executive Officer, Kenneth L. Waggoner, and Chief Operating Officer, Gerald W. Crabtree, Ph.D., are in Singapore to finalize the Diabetes Consortium that will develop a treatment for insulin dependent diabetes...
to negotiate an additional worldwide, exclusive license to use Cell-in-a-Box® live cell encapsulation with cannabinoids to treat diseases and related symptoms...
to tour the new facilities of Austrianova in Singapore. Mr. Waggoner and Dr. Crabtree will also be attending the grand opening of the cGMP (current Good Manufacturing Practices) facility in Thailand where the cells required for Nuvilex’s preclinical and clinical trials will be encapsulated using the Cell-in-a-Box® technology
Mr. Waggoner and Dr. Crabtree also met with some of Austrianova’s key shareholders to further develop the close relationship between the two companies and to emphasize and establish additional common goals shared by both entities.
Discussions are scheduled to finalize a number of new and existing projects, both at the scientific and commercial level. They will involve participation of academic colleagues from around the globe.
IMO they are definitely not only accomplishing everything they set out to do but at a pace so much faster than I imagined...and combined with ODD 2015 is going to be a great year for Nuvilex...
bull
Nuvilex Executives in Southeast Asia To Further Advance Cell-in-a-Box Technology
SILVER SPRING, MD - November 21, 2014 - InvestorsHub NewsWire - Nuvilex, Inc. (OTCQB: NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today Nuvilex’s Chief Executive Officer, Kenneth L. Waggoner, and Chief Operating Officer, Gerald W. Crabtree, Ph.D., are in Singapore to finalize the Diabetes Consortium that will develop a treatment for insulin dependent diabetes, to negotiate an additional worldwide, exclusive license to use Cell-in-a-Box® live cell encapsulation with cannabinoids to treat diseases and related symptoms and to tour the new facilities of Austrianova in Singapore. Mr. Waggoner and Dr. Crabtree will also be attending the grand opening of the cGMP (current Good Manufacturing Practices) facility in Thailand where the cells required for Nuvilex’s preclinical and clinical trials will be encapsulated using the Cell-in-a-Box® technology.
Mr. Waggoner and Dr. Crabtree visited Austrianova’s headquarters at Biopolis, Singapore today. As well as viewing Austrianova’s current lab and office space in Centros, they viewed the new, larger facility in Synapse, part of the newly built Phase 3 of Biopolis, where Austrianova will take up residence on December 1, 2014. The new state-of-the-art laboratory and office space has been custom built for Austrianova.
Biopolis, which just celebrated its 11th anniversary, has established a reputation as a world-class biomedical research hub and has established Singapore as a center of scientific excellence. As such, Biopolis plays a pivotal role in bringing together major research institutes to create a center of excellence in the biomedical sciences and serves as a focal point to attract and groom top scientific talent to do world-class research in Singapore. As part of the Singapore visit, Mr. Waggoner and Dr. Crabtree also met with some of Austrianova’s key shareholders to further develop the close relationship between the two companies and to emphasize and establish additional common goals shared by both entities.
Discussions are scheduled to finalize a number of new and existing projects, both at the scientific and commercial level. They will involve participation of academic colleagues from around the globe.
Dr. Brian Salmons, CEO of Austrianova said, “This multipurpose meeting has been extremely important in setting the course for the next year, as well as aligning the aims and goals of all parties involved. It has been a pleasure to host Mr. Waggoner and Dr. Crabtree in Southeast Asia and to welcome them to our facilities in Singapore and Thailand”. Mr. Waggoner stated, “This has been a very rewarding trip, and we look forward in the coming days to bring to fruition the plans we have discussed during our visit.”
Dec. 9th or 10th is the COMP meeting Nuvilex will have with the EMA for Orphan Drug Designation...expect a PR after that and expect a big old YES...
come back to the MB after that announcement and we should all have quite a nice conversation about it...
bull
Like you said..."You can find information of the CEO selling his insider shares "...and there is no such information on any insider selling their shares of Nuvilex...
bull
It is the first step necessary to move on to human trials...which they said would take place the 1st Q of 2015...so to answer your question...no it isn't a far step away from human trials...
and the Phase I/II human trial for pain and ascites will be small and short...
if Hoff shows results from that trial like he apparently got from the mice study...with great results in ascites and pain and produces a significant survival advantage ( Quality of Life )...
then he could take it directly to the FDA for approval just based on that...
these studies could be short lived before we see approval for CiaB...
bull
Nuvilex is looking GREAT...
Long investors know what they own...this was a preliminary report that does not show the whole story...it gives us a pretty good idea of what is coming though...the results will be announced somewhere big first medically...not in a PR...I for one can not wait to see the full results...
Cell in a Box/ifosfamide plus Cisplatin is now a proven combination therapy and could replace the gold standard for ovarian cancer...so I think we can all see where this is headed...
after a short Phase I/II Hoff could be walking this straight to the FDA for approval...and no that isn't far fetched...
and the answer from the EMA will be given at the Dec. 9th-
10th meeting...and I WOULD expect a YES...and the FDA to follow...and then Australia...
bull
Nuvilex's treatment will be combined with Cisplatin and become the new Gold Standard for Ovarian Cancer
As someone just pointed out to me... clearly you can see from the results that Nuvilex is headed to the FDA for a combination therapy of Cell in a Box/ifosfamide plus Cisplatin much like Celgene did with Abraxane plus gemcitabine....
I couldn't agree more...
bull
Nuvilex Announces Preliminary Data from Preclinical Study on Effects of Pancreatic Cancer Treatment on Ascites Fluid Formation
SILVER SPRING, MD - November 19, 2014 - InvestorsHub NewsWire - Nuvilex, Inc. (OTCQB: NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today that promising preliminary data has been released from the preclinical animal study on the effects of Nuvilex’s pancreatic cancer treatment on the accumulation of ascites fluid in tumor-bearing animals. This study, performed by Nuvilex contractor, Translational Drug Development (TD2), employed immunosuppressed mice implanted with disseminated human ovarian cancer cells into the peritoneal cavity.
Preliminary data analysis suggests that treatment with Nuvilex’s live-cell encapsulation technology, Cell-in-a-Box® plus ifosfamide, produces a significant survival advantage as compared to non-treated control animals. Nuvilex’s treatment appears to be at least as good as cisplatin, the current standard of care for ovarian cancer. However, when the encapsulated cells plus ifosfamide were used in conjunction with cisplatin, the survival rate was greatly enhanced. The final data analysis will be released in the future.
“The data itself is not only exciting from an ascites point of view, but also provides further evidence that encapsulated cells plus ifosfamide are effective at treating yet another type of malignant tumor. This provides the rationale for additional clinical trials of this novel therapy,” said Prof. Dr. Walter H. Günzburg, the Chief Scientific Officer of Nuvilex.
Nuvilex CEO and President, Kenneth L. Waggoner, stated, “We couldn’t be more elated with the information we’re receiving from TD-2 as Nuvilex’s preclinical studies progress. Based on the preliminary data we’ve received, Nuvilex’s treatment appears to be performing admirably alone and remarkably as a combination treatment. This data justifies our decision last year to purchase the exclusive global rights to further develop Cell-in-a-Box® cancer treatments.”
I actually did no such thing as say there WOULD BE a big push for pancreatic cancer month by nvlx...I said it would be a good month for Nuvilex to give the results of the TD2 study in the month of November...and the month is not over yet...
bull
Here is the info for you as to what the Orphan Drug Application is for...
... 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(R)) 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.
http://finance.yahoo.com/news/nuvilex-submits-application-orphan-drug-130000183.html
bull
Because when we applied for ODD with the EMA it is easy to find out by the date of the PR...when we applied and when the deadline for application was and when the COMP meeting is...all listed with the EMA...
DD is golden...28 August 2014.......12 September 2014.......9-10 December 2014
expect an answer at our meeting on the 9th or 10th...expect a yes
so check back with the mb after the PR comes out ...we should all have quite a nice conversation about it...
bull
And to LuCo ...we are going for ODD for Pancreatic Cancer for the 2b based on the trials they have completed...the same technology that the EMEA approved last time... not on an ongoing study that has no results yet...how would they do that?
and we will be getting approval with the EMA...and how do I know that...common sense...
bull
Reason why I think CiaB WILL GET orphan status...Nuvilex did not apply for Orphan Drug Designation on CiaB for Ascites...
expect a yes answer at the 9-10 December 2014 meeting...for EMA
bull
efood...COMP meeting 9-10 December 2014...for Nuvilex for ODD...they will get approval...and the FDA collaborating with other agencies around the world now...they will get that too...
bull
EMA Orphan Drug Designation...this would be ours...so expect a meeting then...deadline 28 August 2014...Start of procedure 12 September 2014...COMP meeting 9-10 December 2014...expect a yes also...
coming to fruition...hats off to the long investors who know how to find an under the radar hidden gem like Nuvilex...and not only be smart enough but patient enough to get in on the bottom floor...this is still the basement...
bull
To assume that true longs have not made any money in NVLX is wrong...I am in the green and I know plenty of longs that are way in the green...the first of this year the stock was around .10 cents...for smart investors that alone is more than a 100% gain...and for the smart investors that bought the first of 2013 when the stock was at .03 cents...well they are the ones way in the green...combine this with how many shares a lot of us individually own...I say we are sitting pretty nice...and this is only the beginning...getting in on the ground floor...
good luck with your trading
bull
Nuvilex is preparing for a Late Stage Phase 2b Trial in the first Q of next year...not a phase III...
they will then go to the EMA...FDA...and the TGA and ask for approval based on the results of the smaller 2b...
and the Phase I/II already proved to be better than the first line of treatment that Celgene has...
the shareholder value in the near term will come from the TD2 Hoff study on ascites for which we are awaiting results...
bull
Nuvilex Applies in Australia for the Orphan Drug Designation for Pancreatic Cancer Treatment
SILVER SPRING, Md., Nov. 7, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), a clinical-stage biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has submitted, through its subsidiary Nuvilex Australia, an application to the Therapeutic Goods Administration (TGA) in Australia to obtain the Orphan Drug Designation for its pancreatic cancer treatment. This submission follows similar applications to the United States Food and Drug Administration and the European Medicines Agency in the European Union (EU). Like those in the U.S. (7 years) and the EU (10 years), granting of the Orphan Drug Designation carries with it a significant period of marketing exclusivity. In Australia this period is 5 years.
Nuvilex's CEO and President, Kenneth L. Waggoner, commented, "The application for the Orphan Drug Designation in Australia is the third such application made to the drug regulatory authorities in major areas of the world. In order for the Orphan Drug Designation to be granted to a particular drug or treatment, the target disease must be considered life-threatening and 'rare.' Pancreatic cancer, no matter where it occurs in the world, is undoubtedly life-threatening and, in our opinion, its prevalence in Australia classifies it as a rare disease. It is expected that this application to the TGA will be reviewed relatively quickly, and we may have a decision on it before the end of the year."
Nuvilex's pancreatic cancer treatment consists of implanting living cells that have been encapsulated in pin-head sized, cellulose-based, protective "cocoons" through the use of the proprietary Cell-in-a-Box(R) technology, followed by the administration of low doses of the anticancer prodrug ifosfamide. Ifosfamide is a drug that must be converted into its "cancer-killing" form for it to be effective. The cells that are encapsulated are efficient and effective at carrying out this conversion. By placing these encapsulated ifosfamide-activating cells in proximity to the pancreatic cancer, the anticancer effects of the drug are optimized. In addition, as shown in early-phase clinical trials, because low doses of the anticancer drug are used the side effects from it are greatly reduced in severity and the treatment is well tolerated by the patients undergoing this novel treatment.
Mr. Waggoner continued, "As with the applications for the Orphan Drug Designation in the U.S. and the EU, we are extremely grateful to our colleagues at Clinical Network Services (CNS) for their assistance in the preparation of this Australian submission. In particular, the services of Dr. Natalie Thomas in the preparation and submission of this application were invaluable. CNS, one of Australia's leading Contract Research Organizations, has been contracted by Nuvilex to conduct its Phase 2b pancreatic cancer clinical trial in that country."
Could you please supply us with several mice studies that prove your time table for Nuvilex's TD2 Hoff study...
ones that compare to our study as close as you can get...
with mice that have no immune system...that will be injected with aggressive human ovarian cancer cells which were chosen for these studies because they reproduce rapidly and form tumors...
and the resultant tumors are proficient at producing malignant ascites fluid...
I ask this because I have read a lot of mice studies and the range of time it takes for cancer studies can be as few as 10 days before euthanasia...depending on what the study endpoints are...
thanks in advance
bull