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I am not concerned. These are the things that need to be accomplish before trials can begin...
"In the coming weeks and months, a number of major “milestone” tasks will take place that will enable PharmaCyte Biotech’s first clinical trial to commence. Many of these must be completed before a formal Investigational New Drug application (“IND”) is filed with the drug regulatory authorities.
Finalization of Trial Design: With pivotal input from PharmaCyte Biotech’s renowned team of oncologists, the design of its clinical trial will be finalized with the goal of creating the highest probability of developing positive data during the trial that could lead to marketing approval of its treatment for pancreatic cancer.
IND Team: An IND Team will be established to prepare the IND and review it before being formally submitted to the regulatory authorities. PharmaCyte Biotech’s IND Team, many of whom have already been retained, will include: (i) a Project Manager; (ii) a Medical Officer; (iii) a Statistician; (iv) a Chemistry, Manufacturing and Controls Expert; (v) a Pharmacologist; (vi) a Pharmakineticist; (vii) a Toxicologist; (viii) an Interventional Radiologist; (ix) a Radiologist; and (x) a Regulatory Affairs person.
Chemistry, Manufacturing and Controls Information: The manufacturing of investigational biological products are subject to stringent regulatory considerations. PharmaCyte Biotech will be working with Austrianova – the manufacturer of the encapsulated live cells used in PharmaCyte Biotech’s treatment for pancreatic cancer – to develop this information.
Clinical Protocol: A “protocol” will be prepared with by its Contract Research Organization with the invaluable assistance of PharmaCyte Biotech’s team of oncologists. The clinical protocol can be viewed as a “recipe” on how the clinical trial will be conducted. The protocol will include such things as: (i) the qualifications needed for particular patients to be included in the trial; (ii) how PharmaCyte Biotech’s treatment and the treatment used in the “comparator” arm of the study will be administered and the schedule and duration of these treatments; (iii) the specific “endpoints” for the trial and the types of data that will be collected to determine these endpoints; and (iv) the types of data analysis that will be employed in reaching conclusions about the overall success of the trial.
Pre-IND Meeting: This meeting will be requested by PharmaCyte Biotech and initiates communication with the drug regulatory authorities that will be responsible for approving its product to market. This communication is particularly important for a company like PharmaCyte biotech that is developing a new product or technology. The purpose of a pre-IND meeting is to discuss the information that will be used to prepare the IND, such as product characterization, final and in-process testing of the product, previous animal test data, prior clinical trial data and the proposed clinical protocol. Input from the regulatory authorities given during the pre-IND meeting will lead to “fine-tuning” the clinical trial protocol and will identify any additional items that may need to be included in the IND.
Clinical Trial Study Sites: Clinical study sites will be evaluated and enrolled to participate in the clinical trial. Each site will need to be multidisciplinary in nature, where medical oncologists, interventional radiologists, radiologists and other cancer specialists work together to offer multidisciplinary cancer treatments and who will work in concert in conducting their part of the clinical trial.
IND: An Investigational New Drug application will be submitted to the drug regulatory authorities before PharmaCyte Biotech can begin the clinical trial. The IND will include animal study data, toxicity (side effects that cause great harm) data, manufacturing information, the clinical protocol for the trial, data from any prior human clinical trials and information about the Principal Investigator who will oversee all aspects of the trial."
http://www.otcmarkets.com/stock/PMCB/news/PharmaCyte-Biotech-Discusses-Major-Milestones-Ahead-of-Phase-2b-Clinical-Trial-in-Pancreatic-Cancer?id=114463&b=y
I remember you lone wolf. What we need right now is for Austrianova to have their facility, which produces Cell in a Box, to get GMP certification. The facility is in Thailand. The most recent inspection by a third party was good so there is no reason to think Austrianova won't get it. In fact, Austrianova has had a previous cGMP facility but it was not as large as the facility in Thailand.
Biotechs take longer because there are factors involved over which the company has no control. The fact that we continue to press forward in all of our efforts with oncology and diabetes speaks to me that no one is concerned that we will get cGMP. Like Warren Buffett said, some things just take time.
"You can't produce a baby in one month by getting nine women pregnant.”
Very nice find Brian...
Yeah,been off line for a while. Very nice to see how we closed today...
Yep,that's only a matter of time as well. :)
I like the countdown but I look at it like this...
It's only a matter of months before Cell in a Box technology shares results with the world the amazing things it can do for patients with pancreatic cancer and type 1 diabetes.
Cool, thanks...
Another great post... :) I like bios too. Hurts to have to wait so long because all of them are volatile during the waiting periods. CUR isn't OTC but because it is so cheap, it attracts penny traders and whenever that happens... Oh well, I just hold on to mine until I no longer believe in the science. CUR looks to be doing some good things. Good entry for newbies, imo...
I don't hold a position but it is one on my watchlist for the science...
That is one of the best posts I have ever read. I agree totally with your sentiments. However, I don't flip. I wish I knew how to do that but I also wonder how it affects the company with the added volatility. Nonetheless, I hold for the dream and know that there will be the ups and downs to weather. :) MM for you as well...
You have to understand this from a historical perspective, and read between the lines. Our intent from the very beginning was to pick up where Austrianova left off. We were going to continue using Australia based CNS as our CRO. In fact, if you listen to the previous radio interviews, you will hear us say that we are not even going after FDA immediately. We were going to just work in the overseas arena.
Then, in January 2014, we got an email from Dr Von Hoff wanting to get involved with testing CiaB at TD2. We decided on two separate treatments, phase 1 trials, based on TD2s research, pain and malignant ascites.
Now, with TD2s continued interest and support, we are going to be conducting trials with their access to, most likely, every PC patient in the US and Europe. So now we have access to so many more patients and a new trial design that sets us up beautifully for FDA approval.
So, you can hang your hat on the fact that we realized that the new trial design and the multitude of patient access we get through TD2 caused us to go with them for our next phase or you can move forward and know that this was the right move AND it is obvious that the guidance we are getting from our new partners is more noteworthy than that inconsequential point...
Thanks mick.
Mirna Therapeutics Appoints Dr. Miguel Barbosa as Executive Vice President and Chief Scientific Officer
Mirna Therapeutics, Inc. (Nasdaq:MIRN), a clinical-stage biopharmaceutical company developing a broad pipeline of microRNA-based oncology therapeutics, announced the appointment of Dr. Miguel Barbosa, Ph.D. as Executive Vice President and Chief Scientific Officer.
Dr. Barbosa has joined the Company with 20 years of biopharmaceutical research discovery experience. For the past decade, he served in senior leadership roles at several Johnson & Johnson subsidiaries. Most recently, Dr. Barbosa was Executive in Residence, Therapeutic Innovation at Johnson & Johnson Innovation, where he led the identification and development of new R&D and business models. Prior to that, he was Vice President, Immunology Research & External Innovation, at Janssen Research & Development L.L.C., also a J&J company, where he led immunology discovery and translational research programs. Earlier in his career, he served as Vice President, Discovery Research, at J&J’s Centocor Research & Development, Inc.
“We are pleased to welcome Miguel to the role of Chief Scientific Officer,” said Paul Lammers, M.D., M.Sc., Mirna's President and Chief Executive Officer. “As a highly accomplished industry executive with a proven ability to lead top research and development programs, we are confident Miguel’s expertise and strategic vision, particularly in emerging areas of science, will prove critical as we advance our pipeline of microRNA-based oncology therapeutics.”
Dr. Barbosa received a B.S. in Genetics from the University of California, Davis, and a Ph.D. in Microbiology & Immunology from the University of California, Los Angeles, and completed his training at the National Cancer Institute.
How about a chart for today? Thanks
Yeah, halted for about an hour...
Halted for bid being at 5.70, outside price band. What was that?
Sorry for your loss. So many invested here are invested for the same reason as you, we know someone who has died from this horrible disease. In fact, Ken Waggoner's father also died of pancreatic cancer. I think we are all so blessed that Dr Von Hoff has such a commitment to those suffering from this disease. I think he really saw something in CiaB and is executing his plan to get it to patients.
Best wishes for all stakeholders especially those in need of treatment for pancreatic cancer...
Thanks Pete... Very nice...
Thanks mick...
They are a new IPO only since Oct 1. This is their business...
MIRN is a clinical-stage biopharmaceutical company developing a broad pipeline of microRNA-based oncology therapeutics. microRNAs are naturally occurring, short ribonucleic acid, or RNA, molecules, or oligonucleotides, that play a critical role in regulating key biological pathways.
Misexpression of even a single microRNA can contribute to disease development and tumor suppressor microRNAs are commonly reduced in cancer.
MIRN's scientists and others at leading academic institutions have identified numerous tumor suppressor microRNAs that play key roles in preventing normal cells from becoming cancerous and facilitating proper cancer immunosurveillance.
To enable therapeutic application of these tumor suppressor microRNAs, MIRN pioneered technologies for creating RNA molecules that function as natural microRNAs when they enter human cells.
Mirna rallies major players for $42M round, hits the gas in immuno-oncology
April 30, 2015 | By Damian Garde
Mirna Therapeutics hauled in a $41.8 million D round to get its RNA treatment into Phase II trials, assembling a big-name syndicate to back its ambitions in immuno-oncology.
Baxter Ventures ($BAX) led the Austin biotech's latest round, joined by new backers including Celgene ($CELG) and Morningside, and a group of repeat investors featuring New Enterprise Associates, Pfizer ($PFE), Sofinnova Ventures and others.
Mirna has earmarked its latest cash for MRX34, a micro-RNA treatment designed to mimic a naturally occurring tumor suppressant that helps the immune system better attack cancerous growth. The treatment is currently in an open-label Phase I trial, charting a dose-dependent effect on key oncogenes in interim results presented at this month's American Association for Cancer Research.
DATE: TUESDAY, NOVEMBER 10TH | 11AM ET / 8AM PT
The next revolution in clinical trial execution is taking shape in the rapid adoption of mHealth technologies. PPD experts discuss how current PPD-conducted studies assess the feasibility of wearable data collection devices in trials to achieve focused endpoints and improve the patient experience. Register Now!
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Now the biotech is planning to roll MRX34 into a Phase Ib study with eyes on kicking off Phase II next year. Mirna plans to nail down an ideal indication for the treatment once it has final results from the Phase I study, which is examining the drug's effect on hepatocellular carcinoma, other solid tumors and hematological malignancies. The latest fundraise will also allow Mirna to get a second, undisclosed microRNA treatment into the clinic and mount a combination therapy program, the company said.
The microRNA field has long been fraught with setbacks and safety concerns, but investors have warmed up to the prospect in recent years. And Mirna, billing itself as a leader in the space, believes the future is bright for microRNA therapies.
"This successful financing further demonstrates the enthusiasm of the investment community for the Mirna opportunity and is an important validation of the therapeutic potential of our differentiated microRNA replacement therapy approach," CEO Paul Lammers said in a statement.
Mirna's round comes nearly three years after Mirna banked $34.5 million in Series C funds, cash that helped the biotech get its top prospect into the clinic in 2013.
http://www.fiercebiotech.com/story/mirna-rallies-some-major-players-418m-round-hitting-gas-immuno-oncology/2015-04-30
It is part of the group holdings. I don't know how it's distributed. But look at that % increase in $PMCB shares!
Over 2000%...
http://whalewisdom.com/filer/fisher-asset-management-llc
Cool, rereading that interview actually cleared up some things for me too in understanding the two phase 1 trials... That interview and GCs explanation of the different causes of pain really made the need for 2 separate trials more clear. Thanks GC... :)
It also makes more sense why we combined the pain and quality of life with the 2b trials...
"The trial design also includes several secondary endpoints. Among the most important are: (i) the onset of pain and the patient’s need for pain medications; (ii) whether the inoperable tumors become operable as a result of the treatment; (iii) the change in tumor size; and (iv) the patient’s overall quality of life during the treatment".
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117889505
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117889114
http://ih.advfn.com/p.php?pid=nmona&article=68966185&symbol=PMCB
Here is how Ken explained the difference between the 2 trials...
2. ...Phase 1/2 clinical trial on the effectiveness of PharmaCyte’s pancreatic cancer treatment dealing with pain associated with advanced pancreatic cancer.
3. ...Phase 1/2 clinical trial on the effectiveness of PharmaCyte’s pancreatic cancer treatment in slowing the accumulation of malignant ascites fluid.
http://www.pharmacytebiotech.com/qa-with-pharmacyte-ceo-kenneth-l-waggoner-on-pmcbs-new-direction/
efood, they combined the pain phase 1 with the 2b. However, ascites will be a separate trial, phase 1.
Yeah, volume is still pretty low here...
Love it! I agree, all signs point to a rewarding ride for all stakeholders and in my opinion, we have the very astute leadership of Dr Von Hoff taking on this amazing journey.
It is a 13-F that companies are required to file quarterly. From my experience, it may take over a month for the holdings to show so I always watch to see if any thing has changed... Fidelity is consistent with their investment in PMCB and their reporting is always the first to show...
I don't know Pete...
LONGS, is this foretelling of what is soon to come?
Fisher Management Group, LLC increased their holdings from 11,300 shares to 344,843 last quarter.
Happy Dance!
http://finance.yahoo.com/q/mh?s=PMCB+Major+Holders
I have a completely different take on that... I see that Dr Von Hoff saw the data and he is a Celgene consultant. He decides that he wants to see if we really have something in Cell in a Box. (See no matter what companies he works with, his patients are always on the forefront of his mind.)
So he does clinical studies and likes the results. So he comes up with a plan that is a win win for all. Cell in a Box gets to help his patients in a multitude of ways and doesn't go head to head with Celgene's Gold standard and now, he gets to enroll his eligible patients in the upcoming human trials. And, this trial will take a lot less time than it would have taken with CNS...
What are your thoughts about the p & d investigation with the SEC? I was interested until I heard about that. Your thoughts on their management team?
TIA
That is pretty evident. No news flash there.
Fros, I wouldn't bullshit you. The first time we learned how TD2 got involved was back in 2014 in this radio interview with Ken Waggoner and Dr Crabtree. Ken told us that Dr Von Hoff contacted him via email. And it was Dr Von Hoff who wanted to do trials with Cell in a Box for pain and malignant ascites. "It was never our idea", he said... Listen circa 10:10 in this radio interview. http://www.stockmarketmediagroup.com/wp-content/uploads/2014/06/NVLX-CEO-COO-Interview.mp3
Like you, many refused to believe what our CEO said so when we did the corporate interview recently, we learned the same thing. The president and CEO of TD2, Stephen Gately told us that actually Dr Von Hoff saw the data and reached out to KW.
Circa 17:00 minutes on the video... http://www.pharmacytebiotech.com/pharmacyte-biotech-corporate-video-june-1-2015/
So, we would have been crazy not to select TD2 as our US CRO. Dr Von Hoff wanting to work with Cell in a Box... Yes we selected them...
We did not seek out Dr Von Hoff. He came to PMCB because he saw something in previous studies with Cell in a Box technology. He thought it may work and apparently he is even more convinced after doing clinical studies. He and his team now want to oversee our 2b. I think he has the best and most informed view of what Cell in a Box can do.
Well, certainly Dr Von Hoff, Dr Hidalgo, TD 2 and FDA ODD are new. In fact, conducting trials in the the United States is also new. Also, trials for pain associated with PC will be new in the upcoming 2B.
I would love to hear about a partnership here as we head into human trials... Maybe Celgene will want to help with the "consolidated therapy" since they are the "gold-standard" treatment that Cell in a Box will be enhancing...
Blessings to you as well. I agree, no assumptions here. Everything that can be disclosed has been completely disclosed to shareholders including the fact that we are waiting on cGMP and an interim inspection went well.
What is so encouraging here is that Dr Von Hoff has decided not only to stay on with phase 2b but TD2 will be overseeing the trials and enrolling patients. They likely do have access to all PC patients currently in treatment. This also means Dr Von Hoff and Team are ready to get this to patients ASAP as this new trial design will speed up human trials for sure.
I think we, as shareholders, are all blessed to be part of Cell in a Box's journey...
Have a good day Promised Land...
Really good news today, bull... Dr Von Hoff must really like what he saw in the preclinical studies to want to now be a leader in the clinical trials...