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Here is the study...
http://www.nature.com/cgt/journal/v13/n1/full/7700849a.html
What you said... :). Great post...
Completely different forum. He is talking trial design in this interview. He is not addressing anything that has to do with a specific drug, trial or company. Great read, however, to provide insight as to why TD2 is being so detailed in the preclinicals.
"Medelis: So the complete phase Ib sounds like a win-win-win since there is benefit to patients, investigators, and sponsors?
Dr. Von Hoff: Approaching the phase Ib as not just a toxicity trial but also a therapeutic opportunity is actually a quadruple win. CMOs benefit on the business side; they get better data faster, helping to drive fundraising and corporate development. Investigators have an opportunity to make an impact, delivering better care and the chance for a better outcome. And sponsors get answers faster and with less bureaucratic hassle since trial management is streamlined.
Last but not least, the complete phase Ib is an important opportunity to truly help patients. And in the end, that’s the most valuable win of all."
http://www.medelis.com/clinical-cancer-research-abstracts/complete-phase-ib-trial-design/
Yes, Promised Land, I totally agree. Very good news for shareholders... Good to see you. Hope all is well...
Dr Von Hoff is CDO of TD2, and TD2 has spoken.
I can't answer your question about when results will be shared but knowing this has already shown tumor remission is good enough for me. I can wait for new study results whenever they are released.
That assertion is absurd. Dr Von Hoff called that "Lawyer" wanting to do studies with CiaB technology. Have you seen the video? The CEO of TD2 shared the story himself as to how they got involved with this company.
And in the end, there will be a lot of other doctors and patients who will want this technology as well, no matter how long it took to get to market.
Have you watched the video, patent concerns were laid to rest IMO.
See circa 24 minutes into the video.
There may be a very good reason preclinical results are not being shared. The fact that the data was already there from 10 years ago, Dr Von Hoff wanted to do studies with this same but now improved technology based on this data and TD2 is moving forward into human trials, speaks volumes.
From the article referenced...
"The bottom line is, while this morning's commentary from Stock Market Media Group may have referenced data that was ten years old, it's still quite relevant, and encouraging."
Therefore, today's PR was very significant for shareholders who have been awaiting current preclinical results. With improved technology, Dr Von Hoff and his team designing the trials, we can expect that they are seeing similar, if not improved results from those conducted 10 years ago...
I think Dr Von Hoff also believed the 10 year old data to be relevant and that is why he contacted us...
$PMCB amongst those companies in the forefront of treatment for diabetes as mentioned in this recent Bioworld Insght article.
"Pharmacyte Biotech Inc. (formerly Nuvilex Inc.), of Silver Spring, Md., is taking a different cell therapy approach with its Cell-in-a-Box technology, originally developed by its partner, Austrianova Singapore Pte Ltd., of Singapore. Using a multi- step process, the live cells are suspended in a medium that contains a polymer and sodium cellulose sulfate. The suspension is passed through a droplet-forming machine and the resulting droplets fall into a solution containing another polymer. The interaction between the two polymers causes a membrane, or “shell,” to form around each droplet.
The live cell encapsulation technology serves as a platform to treat multiple diseases. In type 1 and insulin-dependent type 2 diabetes, the Cell-in-a-Box technology is used to encapsulate a human cell line that’s been genetically modified to produce insulin on demand and secrete it in proportion to glucose levels in the body. The company has global rights to the insulin- producing, or Melligen, cells developed at the University of Technology Sydney (Australia). Although the program is still in preclinical development, “we think we have a shot at curing diabetes,” said Kenneth Waggoner, the company’s CEO, president and general counsel. “We certainly know we can reverse the diabetic condition for those with type 1.”
http://www.pharmacytebiotech.com/wp-content/uploads/2015/06/BWIS06012015.pdf
I bet this is the data that got Dr Von Hoff's attention. Now we have a much improved Cell in a Box(R) technology in similar preclinical trials only this time TD2 used an ovarian cancer as opposed to colon cancer. Additionally, Dr Von Hoff has personally assisted in architecting the studies in preparation for human trials.
This is very good news. I had never seen this data before but can only guess that the current trials must be at least as good but more likely, even better with all of the improvents to the technology.
My confidence is even greater knowing that Dr Von Hoff will be leading the march to the FDA and TD2 will be conducting human trials. The video is worth watching again while keeping these historic results in mind...
"Complete Tumor Remission"
http://www.pharmacytebiotech.com/media/
http://finance.yahoo.com/news/pharmacyte-biotechs-cancer-treatment-shows-133000454.html
At about 18 minutes in, Dr Gunzburg hints at how good the animal studies have been thus far for malignant ascites. Also, I now have a better understanding of TD2s objective in speeding up the approval process so these additional studies may seem to lengthen the overall process but the reality is that the foundation for fast tracking is being set which in the end is a win/win for all...
Go $PMCB. :)
And the CEO of TD2, Stephen Gately confirmed what our CEO, Ken Waggoner, told us a year ago, Dr Von Hoff contacted us because he saw data about what Cell in a Box technology could do...
See circa 17 minutes...
http://www.pharmacytebiotech.com/media/
http://www.td2inc.com/about/leadership
Hey guys, we had nice volume today. I think folks have had an opportunity to watch the video now... I expect more and more volume added through this week, at minimum. Hopefully, that will help get us there....
You must have watched the video... :)
I thought the volume may pick up this week while at the ASCO conference and now we have a new corporate video to share... Will be very interesting to see what the rest of the week brings...
http://www.pharmacytebiotech.com/media/
Yeah, I saw that a few weeks ago. A small, placeholder, investment just like Fisher Asset Management. It is significant, IMO, that these Institutional Investors have us on their watch lists.
http://finance.yahoo.com/q/mh?s=PMCB+Major+Holders
No worries Pete. I knew you would do it. Hope you had a chance to watch it...
New corporate video. Answered questions regarding patent concerns and I heard a nugget on info regarding preclinical trial results. Also, we now know why Dr Von Hoff called us and wanted to work with Cell in a Box(R) technology. Rich with info. A must for all investors to view...
http://www.pharmacytebiotech.com/media/
That would be Pete. He does a great job. I guess we now need a link to our new corporate video in the intro...
Very good point because time is definitely money, especially here. That is why you have to be a believer. Not a waste of time or money when it all washes out, IMO...
Holding for the long term, most definitely...
And it looks like some folks are taking advantage and loading up.
GLTA
I agree, you have to have real commitment to the technology because we are battling agains big odds here. I am with you. I am also in for the long haul here. In the grand scheme of things, nothing has changed except that Dr Von Hoff and his team want more information to prepare for human trials.
Have a good weekend!
I know we wanted to hear the results JDT but we also know what a patient advocate that Dr Von Hoff is. He would not only not waste time but he would also want to ensure the foundation is solid to move forward with human trials. I believe that we are in new territory using a delivery system such as Cell in a Box technology. If Dr Von Hoff can go to the FDA with all the i's dotted and t's crossed, that will bode well for any future approval requests.
The good news is that this additional study is not expected to push the planned start of human trials And should position us very well with the FDA for approvals and the optimal success in human trials.
Let's not forget that Dr Von Hoff has lots of experience with the FDA and getting approvals...
Thanks for the analysis, Pete...
Thanks Mick...
Can someone provide a chart analysis? I haven't looked at one and don't read charts but just the way we have been trading recently, I am thinking we have some accumulation in the works. Also, what's up with all the dma crossings? :)
It's a diversion tactic. If someone can discourage folks from looking at the science which is the future of the company and its future profits, they may be able to get folks to sell or reconsider their investment. Part of DD is being able to read through these deceitful tactics. I always look to other sources before making my choices. It always boils down to a personal choice and personal responsibility.
I will have all of my shares in tact when we do hear from Dr Von Hoff and all of my personal DD tells me that he will be sharing the miracle of Cell in a Box(R) technology. He was pretty excited to be working with CiaB over a year ago...
"The Nuvilex team presents us with a new tool to employ against the symptoms and invasive properties of this very challenging cancer," said Daniel D. Von Hoff, M.D., Chief Development Officer of TD2. "Our Pancreatic Cancer Research Team (PCRT) colleagues are enthusiastic to begin clinical trials with this approach."
Those clinical trials had positive results and lead to extented trials which will result in 2 different human trials for 2 different treatments to start in 3q & 4q of this year. A very significant outcome which some folks would rather other investors to disregard.
http://www.pharmacytebiotech.com/pharmacyte-biotech-on-track-to-commence-clinical-trials/
http://www.td2inc.com/news/nuvilex-selects-translational-drug-development-td2-to-advanc
Q & A with our CEO on our Cell in a Box(R) technology and clinical trials.
http://www.pharmacytebiotech.com/qa-with-pharmacyte-ceo-kenneth-l-waggoner-on-pmcbs-new-direction/
Dr Crabtree in a radio interview sharing Cell in a Box's (R) advances in the treatment of diabetes. If you are interested in understanding the potential of this product, listening to this will be very educational.
http://www.pharmacytebiotech.com/new-advances-in-diabetes-treatment-insulin-producing-cells-that-could-replace-injections/
Not big news but good news for sure. They will have many opportunities to meet with big Pharma and investors with whom to share Cell in a Box technology. I will be closely watching the volume over the next couple of weeks. We may gain some new investors...
Just checked the website, looks like the abstracts were do in March. I don't know if our results were ready by then. Chances are we are not conference presenters but will more likely have smaller meetings with interested parties... Still, could they have results ready to discuss at these meetings? If they do, I am sure we will hear about them as well...
http://am.asco.org/abstracts
Very well written and informative article...
http://www.smallcapnetwork.com/Investors-This-Is-the-Next-Generation-of-Drug-Delivery/s/article/view/p/mid/7/id/1831/
It would be nice if our abstract for our recent studies was ready for presentation for this conference.
Hey, Promised Land. It's nice to hear they are looking and with our new mutual connection, you never know... A relationship with them could be a possibility...
I totally agree Pete.
There's lots of news I'd love to hear and tomorrow is as good a day as any for an update. I sure hope so. I don't think a buy out just yet but I do see that on the horizon... Like the article mentioned M&As are the happening thing for today's biotech's.... I see the value in CiaB technology and I am sure there are big pharmas who do as well...
Interesting article...
http://www.forbes.com/sites/genemarcial/2015/05/25/is-pfizer-on-the-brink-of-a-new-mega-deal/
Prior to joining Alchemia, Mr. Liquard spent seven years with Pfizer in New York where he held various commercial roles of increasing scope and responsibility, including most recently as Senior Director, Portfolio Development Leader, Emerging Markets for the Established Products portfolio. Mr. Liquard also spent three years as a key member of the company's EP US Brands P&L Leadership Team. In this role, he engineered the group's 505(b)(2) investment strategy, culminating in the $700M acquisition of NextWave Pharmaceuticals. He also led the NextWave pre- and post- acquisition integration efforts. In addition, Mr. Liquard worked as a Director within the New Product Planning and Portfolio & Decision Analysis groups at Pfizer. There he was responsible for formulating investment decisions on business development opportunities and internal development programs across multiple therapeutic area -
http://globenewswire.com/news-release/2015/04/14/724305/10128777/en/PharmaCyte-Biotech-Appoints-Former-Pfizer-and-Alchemia-Executive-to-Board-of-Directors.html#sthash.1xP2vnji.dpuf
I was just commenting to friends on the unusually low volume when that happened... Interesting and now we are back on track for over a million being traded today.