Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
This will help you guys with the timeline to the Trials...patience...things don't just happen over night...they have a lot to get done...every thing they accomplish is one step further to the Phase trials....
Nuvilex, Inc. COO Discusses Upcoming Phase III Pancreatic Cancer Trials
Dr. Gerald Crabtree Addresses Study Sites, Seeking Fast Track & Orphan Drug Status and More
Written by ? Stock Market Media Group Staff — May 13, 2013
Nuvilex, Inc. (OTCQB: NVLX) COO Dr. Gerald Crabtree is no stranger to late stage clinical trials or dealing with blockbuster therapies for cancer patients. It’s likely that is exactly why he’s the COO at the small Silver Spring, Maryland, biotech. The road that Nuvilex is currently on – preparing for a large scale Phase III clinical trial to treat advanced, inoperable pancreatic cancer using its cell encapsulation technology or “Cell-in-a-Box” combined with the cancer killing drug, ifosfamide – Dr. Crabtree is no stranger to traveling.
With a great deal of excitement surrounding this company’s technology and the amazing results it’s shown in clinical trials against advanced pancreatic cancer and in pre-clinical studies in diabetes and against mammary tumors, there are many new investors taking a look at the company. Some are new to biotechs and some are new to the Phase III clinical trials process, so as you can imagine, this is generating plenty of questions surrounding what Nuvilex must endure to begin those trials.
Stock Market Media Group, a research and content development investor relations firm, spoke extensively about the company’s upcoming trials with the COO who has had a large role in several Phase III trials including a role with the team at Bristol-Myers Squibb (NYSE: BMY) that developed the blockbuster cancer drug, Taxol. In our discussion this week Dr. Crabtree addressed some of the items that must be dealt with before a late-stage clinical trial can begin, and where Nuvilex is in that process.
It’s Time for Nuvilex, Inc. to Go Head to Head with Eli Lilly
After completing two successful independent Phase II clinical trials where the second trial confirmed the data found in the first, the company has been in a position to move forward with a large scale, Phase III trial that will allow Nuvilex to go head to head with the best current single agent treatment for late stage, inoperable pancreatic cancer which for now is Eli Lilly’s (NYSE: LLY) Gemzar. Initially, a development plan had been formulated that was centered on a late-phase clinical trial that would be conducted in the EU, Australia, Thailand and Singapore. Dr. Crabtree says this was because the Phase II trials were done in the EU, and because Singapore is the location of Austrianova Singapore, the owners and developers of the cell encapsulation technology, but now he says that plan has expanded to include the United States.
“More recently, we have come to believe that studies should also be conducted in the US as well. This change will make this a truly global trial with studies in several countries being conducted in unison. This type of strategy is used by many companies that develop not only cancer drugs, but drugs for other indications too. In this way, if the Phase III trials are successful, marketing approval could be obtained almost simultaneously throughout a large part of the world.”
Dr. Crabtree walked us through some of the major steps that are necessary to initiate and conduct the Phase III trials. He says some of the steps we’ll talk about are already in progress and others are still to be initiated, particularly for the US-based studies, and the steps are in no order of priority, but does say most of the initiatives we’ll discuss that are left undone will occur more or less concurrently.
Nuvilex Starts by Building a Bank
One obvious area that will need to be addressed in a large scale trial that uses encapsulated cells in its technology is a large bank of cells to draw from during the study. The COO agrees and says:
“The requisite number of drug-activating cells needs to be available for the encapsulation process to ensure that sufficient cells are available to conduct the trial. With this in mind, in conjunction with ViruSure GmbH, a company in Austria that specializes in the amplification of pathogen-free cells, the Master Cell Bank of cells containing high levels of the enzyme CYP2B1 which activates the drug ifosfamide that we’ll be using as the cancer drug in our study is currently being expanded. Obtaining the requisite number of cells for the Phase III trial will be one of the rate-limiting factors for trial initiation.”
An additional area that shouldn’t be a big mystery is the company securing the sites where the patients will be treated during the trial. The COO says this isn’t as easy as just selecting from a list of hospitals. Additionally, not only does the company have to identify study sites, but Dr. Crabtree says responsible oncologists at those sites must be identified.
“Already, these things are in progress for the EU, Australia, Thailand, and Singapore studies, and they still need to complete this task for the US trials.”
A Familiar Face Could Return as the Company’s PI
Dr. Crabtree turned to a few areas that may be a bit more “inside baseball” and therefore unknown to many of the investors in biotech stocks. The first is identifying a Principal Investigator (PI), and Dr. Crabtree says there may be more than one for Nuvilex’s Phase III trial.
“In our case, given the planned wide geographic distribution of the study sites for the trial, more than one PI will probably be necessary. The PI is responsible for monitoring the overall conduct of the trials in their particular area. In our case, the PIs need to be experienced (in clinical trials) individuals with an excellent background in oncology, and in particular, the treatment of pancreatic cancer. The noted gastroenterologist/oncologist, Dr. Matthius Löhr has expressed interest in serving as a PI for the EU, Australia, Singapore and Thailand studies. Dr. Löhr is the individual who served as PI for the two Phase II trials, so he is the ideal person for the PI role because he’s familiar with the cell encapsulation technology and with the use of the cell encapsulation/ifosfamide treatment in patients with advanced pancreatic cancer.”
Dr. Löhr is currently located at the famed Karolinska Institute in Sweden. Nuvilex’s COO says a PI for the US studies remains to be identified.
Another issue that must be dealt with is the necessity of “finding” suitable facilities in which the necessary encapsulation process can be done in a large enough scale to satisfy the needs of the Phase III trial.
Dr. Crabtree stated “Facilities must be identified in which the encapsulation can be done according to GMP (Good Manufacturing Practices) standards; this is an absolute requirement for drug regulatory authorities such as the FDA, before they will grant marketing approval for any treatment or drug for any indication. Currently, efforts are underway to do so, and possible sites are being examined in the Far East; these are already GMP compliant.”
Where Would a Trial be Without a Cook Book
Nuvilex will have to develop a protocol for conducting the Phase III trial which Dr. Crabtree calls a form of “cook book” for the study.
“The protocol describes things like the type of study – in our case a two-armed, randomized study comparing our treatment vs. the best available single drug treatment (currently Gemzar), patient inclusion/exclusion criteria, the “mechanics” of carrying out the trial, end points for the trial; e.g. the type of study, median survival time, one-year survival rate, to name a few of those things. The development of the protocol will involve at least members of the Company, the PI(s), regulatory authorities, and possibly other participating investigators. We have not begun this process at this time, but some of the required information can be “gleaned” from the previous Phase II studies and this information will be part of the Phase III clinical trials protocol.”
One key initiative that can make life simpler for the company during preparations for the trial is that a Contract Research Organization (CRO) must be engaged.
“The CRO will be responsible for coordinating all aspects of the conduct of the trial. For example, the CRO can assist in the identification of study sites and investigators therein, coordinate delivery of encapsulated cells and drugs to study sites, constantly monitor the daily conduct of the study, etc. The chosen CRO will be one that has international experience in conducting Phase III clinical trials in oncology. This is an important facet of the conduct of our pivotal Phase III trial. In addition, the chosen CRO should be one that has expertise in interacting with drug regulatory authorities. We are in the process of acquiring “dossiers” for possible candidate CROs.”
“Cell-in-a-Box” on the Fast Track
Dr. Crabtree says a vital item on the list is that meetings with drug regulatory authorities must be held and he says the CRO can assist in these. It will be in these meetings where the general conduct of the study, assistance in finalizing the study protocol, etc. will be discussed. In addition, the COO says some key long term designations can be hashed out in these meetings that can benefit the company in the end.
“Importantly, “orphan drug” status for the treatment will be sought from the various regulatory authorities. The orphan drug designation is given to drugs/treatments for “rare” diseases. In the US for example, the orphan drug designation can be given to a drug/treatment for diseases that are diagnosed in less than 200,000 people each year. Since about 45,000 new cases of pancreatic cancer occur each year, our treatment should qualify for orphan drug status. In the EU, the orphan drug designation is reserved for treatments for disease that occur in less than 5 out of every 10,000 people.
The granting of orphan drug status would give us 7 years of marketing exclusivity for our treatment in the US and 10 years in the EU.”
In addition, Dr. Crabtree says the company will apply to “Fast Track” the company’s treatment. According to the FDA, Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases.
Determining whether a disease is serious is a matter of judgment, but generally it’s based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious diseases. Nuvilex’s COO feels his company’s treatment fits the definition:
“Because the survival of patients with advanced pancreatic cancer is so very short, in spite of the most aggressive treatment, we will seek “Fast Track” status from the various regulatory authorities because our treatment will, if successful, fill an unmet medical need. If this is granted, the time taken for the entire drug approval process by regulatory authorities will be significantly shortened. In the past, the EMEA (FDA’s equivalent in the EU) has found the orphan drug designation for the treatment to be acceptable in principle.”
The FDA says that most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a new drug application is reduced.
Finally “Investigator” meetings need to be held, and Dr. Crabtree says this is where all participating investigators will meet to discuss all aspects of the trial.
“Representatives from the chosen CRO will probably participate in these meetings. Usually these meetings are “chaired” by PIs, but this is not always the case. Given the proposed geographic distribution of the study sites/investigators, several such meetings will be necessary. At these meetings, the protocol will be discussed in detail; potential “problems” will be discussed and resolved, etc. The holding of such investigator meetings will occur near the date of the trial initiation.”
Dr. Crabtree reminds us that these initiatives are in no particular order and that those items that are not completed yet can be done concurrently and the list can come together quickly as the different pieces fall into place.
http://www.stockmarketmediagroup.com/nuvilex-inc-coo-discusses-upcoming-phase-iii-pancreatic-cancer-trials/
bull
Nuvilex is one awesome stock.... and company....takes days to weed out the weak hands and minutes to put them into strong long hands....I wish I had more time and I would write some mini novels about Nuvilex
bull
Now aren't you glad you did not cave and sell your Nuvilex shares...if you were smart you added to them today....
bull
Medical Marijuana Sciences is a subsidiary of Nuvilex....that will be using Cell-in-a-Box technology with cannabidiol (CBD)...has nothing to do with the Pancreatic Cancer...Diabetes...Breast Cancer with Cell-in-a-box.....
baffles me what the h some of you are talking about sometimes....
do some DD so you know what you own.....
bull
what are you screaming about...the stock is going sideways consolidating nicely....stocks go up and down....some buy in low and some buy in high....happens every day...you can not always time a bottom or top...go chart the stock and calm down...
bull
the buy @ .45 for 150,000 shares was not on the ask or the bid...
we both agree it is going up....have you seen all the buying today here in the 4's.....all good
bull
and my guess would be the low is 0.0455...and the low will rise from there...the stock is following the trend lines in the apex of the triangle...that is the reason for the tight trading...it is bouncing off the trend lines....
bull
I'll take that bet....no way will this stock be only $1.00 in 3 to 5 years....after finishing Phase Trials...and going to market...that nuts...nuvilex will hit a dollar before they even start...
bull
It has bottomed here 2 times before....this is the triple bottom at .305 to .310...and regardless that some people think charts don't work with small stocks like Nuvilex....I say bull...they work with every stock...all the day traders and swing traders trade by charts...where do you think they get their buy and sell alerts from....
the drop from the highs had nothing to do with the company and everything to do with traders...and every time they drop it they cover their short position...and to each their own but I just get tired of listening to the bull...
Date Symbol Short Volume Long Volume Total Volume Short%
2014-03-18 NVLX 2030134 6751954 8782088 23
2014-03-17 NVLX 1376968 3483426 4860394 28
2014-03-14 NVLX 2013943 4161911 6175854 33
2014-03-13 NVLX 2374997 5349672 7724669 31
2014-03-12 NVLX 3535863 5281627 8817490 40
bull
I always chart my stocks...chart the stock...it always bottoms right here....I am buying and so are other longs I know.....and so are shorts...so don't be swayed by some of the comments on here...use your own good judgement...
bull
Same as last time...no big deal
if it keeps you up at night maybe you are too heavily invested in one stock....with that said....I am heavily invested in Nuvilex among others and it doesn't keep me up at all because I know what I have because I did my DD and I am not selling one single share....stocks like this make millionaires.....
today is just a repeat of previous behavior and we all know why...the stock also did exactly what it did last time and hit it's support...which is the same as last time..so I guess there is at least one person that didn't get their shs today..
bull
what did you buy xtrm for.....a day trade or a swing trade...because nothing else...you sure are not a long that thinks the company has something....go find another stock that moves quick enough for you....XTRM is consolidating just fine....
bull
esq10...it was disclosed to the investors that read the 8K....not everything is in a press release ....companies expect their investors to read all the sec documents...that is what they are for...to inform the stockholders...that is why I always say do your DD...
from the 8K
As consideration for its commitment to purchase shares of Common Stock pursuant to the Purchase Agreement, the Company has agreed to issue to Lincoln Park 5,062,500 shares of Common Stock upon execution of the Purchase Agreement, and 5,062,500 shares of Common Stock which will only be issued to Lincoln Park pro rata to the extent it makes additional purchases against the $25,000,000 total, or in the event the registration statement filed pursuant to the Registration Rights Agreement is not declared effective within 270 days from the date of the Purchase Agreement.
bull
Keep it in Perspective Longs.....over .38 was a breakout of triangle....AGAIN to the upside...now it's over .37...company has stronger support now of investors....stock has more support....LESS MOMO'S this attack than last...they are the ones dumping on the lying alpo hits.....not long investors...
bull
stock is trading right inside the triangle at the apex...it has very little room to roam... 0.045 to 0.054 anything above that it breaks out of the apex.....
bull
we have read the 10 Q....there is nothing new in there...nothing we did not already know ....we don't take your word for anything...we read for ourselves...and you are not talking anyone out of anything here...why do you think the stock did not drop like a rock like you wish it to....we know what we are holding with Nuvilex...
bull
Technical....if we trade right here....the stock could break out by Wednesday.....
bull
or not 2b.....that is the question....Whether 'tis nobler in the mind to suffer The slings and arrows of outrageous fortune.....
damn straight it is.....
they will do a 2b followed by Phase III because they will do what is necessary to be successful in the end result...would you want it any other way....do you want corners cut....or do you want the end result for Cell-in-a-Box to go to market....and we all make a crapload of money....
bull
in a year from now I will be sitting on profits from almost 400,000 shares bought at .20..and the way I am adding to my position probably more than that.....
how many shares are you trading weekly....
just make sure you come back in a year when NVLX is up and tell us what you made...
because that is the difference ...us longs will still be long and short sellers never show their face again...
bull
if you look at trading this morning....that tells what the investors think of nuvilex.....
I have made a ton of money on Nuvilex already..and I am long and holding....
bull
The CEO and President of Nuvilex, Kenneth L. Waggoner, stated, "Because of the collaboration of Drs. Günzburg and Salmons for more than a decade, the Cell-in-a-Box(R) live-cell encapsulation technology has now matured to the point that it will soon see its fulfilment as a platform for the development of treatments for cancer and diabetes. The exposure that Dr. Günzburg's presentation at the BioPharma Asia Convention gave the technology as a whole, and our pancreatic cancer treatment in particular, can only serve to generate interest as we move to advance the technology for the treatment of patients with this devastating disease."
did you guys catch that....
has now matured to the point that it will soon see its fulfilment
bull
and I could copy and paste the disclosure on funding from any one of my bio stocks 10Q's and you would think you were reading the 10Q form Nuvilex......it means nothing.....they have 27M at their fingertips for the taking.....
bull
for those of you that do not chart ...when a stock trades in a pattern like this....a triangle...as it moves through the triangle toward the apex (the point) the spread gets tighter and the volume gets lower...it's almost to the apex...sell now and maybe kick yourself next week...it is going to move up...it is consolidating...
bull
this is a typical textbook pullback from a breakout of a triangle...nothing more nothing less....who cares about the shorts...if you are long you take the pullbacks to add to your position or if you are looking for an entry you take the pullbacks to start a position...too many people putting too much spin on what is or is not happening....who cares....
remember why you bought the stock in the first place...and good grief have some patience....or if you are a trader go find a pump and dump that everyone talks about so much...you should get a lot of action there....
nuvilex is an investment...when some understand that like we do...they will make a lot of money off of the little under the radar Hidden Gem called Nuvilex...
GL
bull
Chart it....we are going to be breaking out of a pattern... we have a triangle and are trading near the apex...we have been trading in the middle of it but at mid 5's will be at the top of trend line in a few trading days....but it could consolidate here until next week...mid week... unless bigger buying comes in and takes it out to the upside...then we take off...
bull
14 cannabis stocks to watch in 2014
Nuvilex
Nuvilex (NVLX) was a big winner in 2013, with shares gaining 258 percent. Nuvilex is a biotech company with research focused on "live-cell encapsulation," a process to protect healthy cells from disease. The company hopes to use its research primarily to fight breast cancer, pancreatic cancer and diabetes. Although its market cap is just $78 million, the company does file with the SEC.
http://money.msn.com/investing/14-cannabis-stocks-to-watch-in-2014-1
bull
chart definitely has a pattern here that looks like we should be breaking out of in the next few trading days...but this consolidation is a good thing....shs going into stronger hands...
bull
chart the stock...it is consolidating .......nothing more nothing less...it definitely is not being dumped...everyone's choice what stock they own or don't own...
bull
Mariam.... good don't sell them....keep true to what u knew when u decided to buy Nuvilex....
you won't be sorry
bull
nice while it lasted...all 30 seconds....lol
bull
chart looks good....it is just hitting resistance and a fib level...to put it in respective.....
it took the shorts 4 DAYS to take nvlx down to the low from where we closed yesterday.....it took longs 15 minutes yesterday to erase those 4 days....don't tell me this stock is not strong
bull
the difference in us is that I am not a trader....I find under the radar stocks....that I buy and accumulate until I have a very large position and then I sit on them....I do very well with this strategy...that is why I don't care if this stock takes off like a rocket because of all the momo's jumping on it and then dumping it like they do...I am just fine adding to my position down here before it makes it's moves up...that is the beauty of recognizing a stock under the radar...you get it dirt cheap...and make a ton of money on them....
GL to you
bull
then don't buy or sell...this stock has been under the radar since I have owned it and it still is....why do you think it has not moved with other mj stocks...
bull
what do you expect for a nickel stock....get your position...hold and forget it for right now....
bull
don't worry about it right now and just add and hold ...they are getting things together here...and buying anywhere in here....you are going to look back and laugh that you got shs so cheap and were worried about it...they are getting financial reporting moving and the land.....
Alternative Reporting Standard
Deregistered a/o Jan 06, 2014
give them time...
bull
this stock is way under the radar...I have been buying since .01...give it time...
bull
I read some of the posts here today....and maybe you should not listen to everything...I called the low @ 0.311 and outtrader called a buy signal at 0.312 ...and I called when it got over .34 and said it would take off over .341 ....outtrader and I were calming new and young investors...
bull
20140590: Phillip Frost, M.D.; Opko Health Inc.
DATE: March 4, 2014
TRANSACTION NUMBER: 20140590
ACQUIRING PARTY: Phillip Frost, M.D.
ACQUIRED PARTY: Opko Health Inc.
GRANTING STATUS: Granted
that is why he has been buying relentlessly every single day to gain 51% of his own company like us longs have been saying....
bull
Mariam.....Nuvelex is a great stock...you will do fine.... just be careful who u listen to....especially with the amount of money u invested...stick to the longs and u can't go wrong...see u in yazoo land....
bull
us longs are still here...we are busy buying..adding to our positions...and just a heads up...read the posts.. the shorts are buying too... so you will be blessed with their wisdom on how great this company is in the coming weeks lol...
until this stock has a higher pps...expect more of the same...
holding strong
bull