Saturday, October 24, 2015 4:53:49 AM
I do agree and believe your right in your thought process of why PharmaCyte's CIAB is no longer going head to head with Celgene's Gemzar plus Abraxane currently (GS) treatment. PharmaCyte would fail miserably.
Quote:
"Celgene reported at the symposium that it has new and better results by simply administering the GS biweekly as opposed to weekly. The numbers used by PMCB on their website reference the Mean Overall Survival (OS) of 8.5 months for the GS, but that was based on a weekly dosage rate. The new OS is 11.1 months. Which actually beats CIB by 0.1 months. The 1 year survival rates were already pretty much even. So then you move to side effects and pain levels and the article addresses that as well basically stating that by administering biweekly that the pertinent negatives decrease as well as logic would assume. So I believe now I see why they are no longer going head to head vs The GS anymore."
Celgene's (GS) average (PFS) 4.8 that btw sure wasn't "accidentally" left out hmmm...
So after those 5 months or so pass and patients no longer respond to the (GS) treatment what are the chances that those patients will be eligible to meet (CIAB)'s criteria of their trials? Not very likely looking at the trial prerequisites and PC statistics.
Quote:
"The audio interview does mention Progression Free Survival (PFS) as an end point to the study and the biweekly treatment of the GS is 4.8 months. According to the interview the PFS for CIB will be measured at the 6 and 12 month mark."
It's obvious to myself and majority of the market that TD2 along with the beloved Dr. Von Hoff and associates have advised PharmaCyte that they don't stand a chance putting (CIAB) up agains Celgene's (GS) treatment. If this new trial design was believed to be set for even a hint of success then PMCB's shares would be up significantly on anticipation alone.
As I've said before the writing is and has been on the wall.
Common sense really all it is. When a company who is supposedly close to trials that according to some would prove (CIAB) can cure 2 of the biggest diseases but yet is only trading at .10 cents decides to then back out of their initial claims then run! Run far and fast as you can!
Quote:
"For me CIB is counterproductive if you are having to inject it everywhere in the abdominal cavity so a prerequisite for it to be useful is that the cancer cannot have mestasticized by the time CIB is considered for use. What I found interesting before reading this article was that PMCB was conceding now that a prerequisite for the upcoming trial was that eligible patients had to have localized inoperable cancer AND had been taking the the GS for 4-6 months. I found that astonishing that PMCB was basically admitting that the GS was and still is the primary drug to treat pancreatic cancer, if not you would not need these patients to have taken the GS previously."
With the eligibility requirements that their new trial design I highly doubt end results would fare any better though. We're dealing with a disease that grows spreads and statistically ends in death in an average of 6 months. By the time the GS is of no effect the cancer will undoubtedly be to far progressed to allow patients to enter (CIAB)'s "planned" trials.
Looking at the American Cancer Society (ACS) pancreatic cancer statistics alone sets PharmaCyte's (CIAB) up for certain and total disaster. Factor in the fact they would have to wait for the Celgene's GS treatment to take its course and hope that those same patients will still be eligible for (CIAB)'s trials afterwards. By that time I highly doubt and regrettably there will be that many patients left who are eligible.
ACS FACTS (2014)
The average life expectancy after diagnosis with metastatic disease is just three to six months.
Pancreatic cancer has the highest mortality rate of all major cancers. 94% of pancreatic cancer patients will die within five years of diagnosis – only 7% will survive more than five years. [/color]74% of patients die within the first year of diagnosis.[/color]
http://www.pancreatic.org/site/c.htJYJ8MPIwE/b.5050503/k.40C9/Pancreatic_Cancer_Facts.htm
According to (ACS)
For all stages of pancreatic cancer combined, the one-year relative survival rate is 20%, and the five-year rate is 6%. These low survival rates are attributable to the fact that fewer than 20% of patients' tumors are confined to the pancreas at the time of diagnosis; in most cases, the malignancy has already progressed to the point where surgical removal is impossible.
http://www.pancreatic.org/site/c.htJYJ8MPIwE/b.891917/k.5123/Prognosis_of_Pancreatic_Cancer.htm
PharmaCyte Press release:
Two of the most important factors in the trial design are: (i) the eligibility criteria for accepting patients into the trial; and (ii) the factors to be considered to determine whether PharmaCyte’s treatment has been successful in achieving its goals (endpoints).
Eligibility Criteria:
The patients accepted into the trial must have pancreatic cancer that is inoperable, but that has not yet spread from the pancreas where it first started to another place in the body (metastatic cancer). These patients must also have tumors that no longer respond to the combination chemotherapy treatment of Abraxane® + gemcitabine and that have been on the treatment for a period of between four and six months.
Endpoints of the Trial: The primary endpoints will be: (i) progression-free survival; and (ii) the side effects from the treatment that occur in the patients. Progression-free survival (PFS) is the time that elapses from the first day of treatment until the disease gets worse. PFS will be determined at 6 and 12 months. The occurrence of any side effects will be monitored throughout the trial.
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.
There's a reason that no Big Pharma was interested in Cell in a box (CIAB) or it other former names (CapCell), (NovaCaps). These multi billion dollar company's do their homework. I don't understand how some believe, believed an attorney who has no medical background, pharmaceutical or biotechnology is going to outsmart Big Pharma. The only ones he's outsmarted are those who bought into these ridiculous dreams. There are no free lunches!
PMCB is going down to trips (.000x's) but may be good for a few well timed flips along the way. We all know the amount of cash that is spent pumping this company so why not use it to ones advantage.
Recent PMCB News
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- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 08:38:38 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:02:21 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:01:45 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:01:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/22/2023 10:00:10 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 11/09/2023 10:25:09 PM
- PharmaCyte Biotech Provides Corporate Update on Cell-in-a-Box Technology • Business Wire • 10/31/2023 01:15:00 PM
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