How Big Pharma and the Cost of Phase III clinical trials results in needless delays and deaths !!!

[NPfisherman]

Greetings FPC amigos,

I guess this article has been simmering inside me for a bit and I just had to let it go... As you are all aware, I follow promising drugs under development in treating PCa and I thought you should know what has happened to some of them and why they have not marched on to Phase III and headed towards you...

A little background info first, a Phase I/II trial involves testing safety,drug side effects, and best treatment dose for a new drug candidate. Phase III determines if the drug is better than what is offered currently, and should it be approved for use in the population. The ACS does a nice explanation of this in the artcle below:

cancer.org/treatment/treatm...

A nice breakdown on what is involved and the cost of clinical trials is given below:

sofpromed.com/what-is-the-c...

The problem involved with the clinical trial system is that by the time small biotech companies get through Phase 1/2, then they face the huge cost of Phase 3. That is the rub so to speak... These trials cost in the neighborhood of 40+ million dollars and by the time the small company finishes Phase1/2, then they are usually cash strapped... and need a partner... Enter Big Pharma with their offer to be a partner and make a fortune off these drugs.... Big Pharma looks at all the data, runs the numbers by some bean counter, and decides whether a new drug will get a shot or not...

Where are some of the drugs and companies that I followed that could make a real difference at in development?? See below:

1) Veyonda (idronoxil)--seems to be in Phase 2 --has found some partners

investor.noxopharm.com/site...

2) RV001-the lead cancer vaccine I posted on with positive phase 2 results--stuck waiting on a partnership deal:

rhovac.com/product-developm...

3) Osteodex-a drug brought to my attention by TheTopBanana--completed phase 2 and raising money for Phase 3 (how long will that take??) This drug could make a huge difference for those with MCRPC and bony metastasis--see below:

dextechmedical.com/en/candi...

4) ADXS PSA and ADXS 504--GROUNDED--like a lot of biotechs--Advaxis has run out of money... the stock sells for under a dime and the company may not recover--so much for 2 vaccine candidates...

5)CCS1477--CellCentric's drug...bromodonain inhibitor... I had thought it moved onto phase 3, but still seems phase 2...

Taking over 10 years on promising drug candidates while hundreds of thousands of people die is ridiculous. Look at how fast we had CoVid vaccines, and yet a vaccine for prostate cancer is stuck in the mud... This is where the government could do more to help...

This is all in my opinion of course, and feel free to agree or disagree....

Don Pescado

[cujoe]

Dangerous Dave,

As always, we look to you to keep us informed on the drug and treatment pipeline.

I've taken recently to reading less research papers and more books. In fact, just in time for your post, I this morning finished reading the book, The Truth in Small Doses: Why We're Losing the War on Cancer - and How to Win It, by Clifton Leaf. It is now a bit dated, having been published in 2013, but still eye-opening in its focus on the cumbersome, complex process in use in the US for the development and approval of new drugs & treatments. (For example: While a more recent medical technology, and of course not mentioned in the book, why have PSMA scans been available in Europe and Australia since at least 2015, yet just approved by the FDA for use in the US late last year?)

As with Siddhartha Mukherjee's excellent history of cancer, The Emperor of All Maladies: A Biography of Cancer, Leaf's book is a historical perspective and provides not only emotionally charged stories of patients, researchers, MDs, and agency administrators, it also shines a light on the critical flaws in the current system of research funding and treatment development while offering an outline for changing it. It is a good read and especially well-written, with one of the few long "Acknowledgements" that I have ever read start to finish. You can download it and Mukherjee's Emperor in ePub format for zero cost via the following links:

The Truth in Small Doses

usa1lib.org/book/2838981/61...

The Emperor of All Maladies

usa1lib.org/book/931307/48b9e7

Always stronger together, we openly share our experiences and knowledge.

Be Safe and Well,

Ciao - K9 Terror

[NPfisherman in reply to cujoe]

K9 Terror,

I'll have to look into getting the book....I am a bound book kind of guy....guess there is something from my youth in that I always enjoyed reading, turning pages, etc..... Yes, how sad is the fact that the government makes it so hard to get cancer treatments approved, but can approve arms sales for mass destruction and death so easily... If they would just pump a billion into some of the drugs stalled in entering Phase 3 for PCa, then we would have double the number of current drugs at least...Crazy stuff....

Fish

[cujoe in reply to NPfisherman]

Yessireeee! How much medical research could these two over-priced, under-performing aeronautical sea-anchors have purchased for the good of humankind?

theregister.com/2022/01/28/...

[NPfisherman in reply to cujoe]

K9 Wonder,

A fabulous example of government performance... I'll trade a bird for completing Phase III on RV001 and Osteodex every day of the week... Save 1,000's of people's lives every year... Sadly, that kind of logic would be lost at upper government levels...

Fish

[cujoe]

Nal,

1 st off, I owe you a thoughtful reply to your last chat message. Maybe later today as it seems winter has returned to the coast. Cold, overcast, and drizzling today with a high temp 25 F below avg for 05/08. I guess it must be down parka weather over there in the Blue Ridge.

As for Covid vaxs, had I not had a blood cancer, as well as PCa, I might have been more circumspect about such a quick roll-out of a new vaccine development "technology" to the general population. As it happened, I got the luck of the draw with Moderna and got jabbed at first opportunity. I am now glad of it and headed for my second booster next week.

Pfizer's original agreement that allowed for a 75 year release of the trial data by the FDA was an outright insult to the intelligence of anyone not confined to a mental ward. It eventually took litigation to overturn that ridiculous agreement. There also seems to be an issue of cost sharing and return of profit from investment based on the government partnership (i.e., US tax payers) in the development of one or more of the vaccines. Best special-interest-run government money can buy.

Stay dry (weatherwise) over there in those beautiful mountains,

Shalom, Captain K9

[GreenStreet]

Thanks for the update which is disappointing. With rising interest rates I guess this will make it even more difficult for companies to be able to borrow money to finance trials. I thought the vaccine ones showed great potential. Maybe a role for govt to part fund some trials in exchange for a royalty payment?

[NPfisherman in reply to GreenStreet]

I feel somewhat let down by the giving of this information also.... I do think RV001 amd Osteodex will make it across the finish line, but the question is when, and will it take years to enter Phase 3??? I hope not for all the poor suffering members here who are running out of options... Could Phase 3 be changed to less people or could blockbuster drugs receive govt funding, and eliminate the need to find a partner and reach a deal...??? Those kind of changes could really make a difference...

Fish

[NPfisherman]

Nal,

I enjoyed your article on PNI invasion....indeed, as you put it....the insidiousness of the disease... The vaccines are limited therapeutics as you said... the government spent tens of billions of dollars om CoVid vaccines... in the cases I stated ...100 million could bring both Osteodex and RV001 through Phase III and both are metastasis blockers... real game changers... life savers... this is where I say the government could make a real difference...

Fish

[GreenStreet]

Yes I agree or some kind of joint venturing approach with govt. we are all hanging on in there and the science is probably getting there but the commercial issue is a big problem. Keep on hanging in!

[NPfisherman in reply to GreenStreet]

The Science is Coming!!!...but Big Pharma wants their cut of the dollars....Could the government do a similar type of deal as Big Pharma and change the course of medicine development forever?? The government actually doing something right....what a thought...

Fish

[Magnus1964]

That is exactly why drug trials are set up the way they are. Big pharma doesn't want some upstart company coming along with a new drug that puts their drugs out of business.

[NPfisherman in reply to Magnus1964]

Exactly right....Not holding my breath waiting for our cure...

Fish

[George71]

There is a newly announced cancer "moon shot"(government funding program) for bringing breakthrough drugs to trial.

As far as government trying to change decades of big pharma driven legislation designed to block competition -- big pharma have the congress people they supported in place that block every effort to reform anything. The big pharma elected representatives in congress and the big pharma owned senators block campaign finance reform at every turn.

Now, big pharmas elected representatives say government can no longer afford to pay out social security insurance medicare, medicaid that we paid into all our lives.

Big pharma funds and own the politicians who block every effort to reform anything.

[NPfisherman in reply to George71]

Big Pharma and the government hand in hand.... and we wonder why there is no cure for PCa yet??? Nope... we know why...

Good to hear from you, George...

Take care,

Fish

[MateoBeach]

Note to self: Buy more stock shares in *** (Big Pharma). Vote them as stockholder activist to change culture.

[NPfisherman in reply to MateoBeach]

Yes, an activist at one of the big pharmas or two might get some of the breakthrough drugs across the finish line... Stopping metastasis is everything !!!... RV001 and Osteodex will make a huge difference .... and yet....we wait...

Fish

[cujoe in reply to MateoBeach]

Paul,

Either that or we could all move to AU. Safe travels and enjoy the visit with the M&R clan in Sydney. I say we chip in to start a Medical Airbnb in OZ for us Yanks and let Marnie and crew run it.

Best of Luck on the travel, treatments, and tourism in between. There are lots of us patients watching you way out there on the treatment edge. Those of us challenging playbook-SOC here in the US are the real pioneers in treatment strategies - you much more so than most.

Keep It Safe & Well - Ciao - K9 Terror

[MateoBeach in reply to cujoe]

Thanks K9. Yes this is way out of the box. But the opportunity was offered and we know what happens as natural course. So must go for it. Just hope my bone marrow does not get too much damage.

[Hidden]

Meanwhile, biiotech, the conglomeration of small stocks of which you speak, is in a full fledged stock crash, with stock prices even lower than cash on hand! so we should be seeing Big Pharma once again come in and scoop plenty up for discount prices. Big fish eat little fish

[NPfisherman in reply to Hidden]

True...and this is where the govt funding promising breakthrough drugs could even the playing field for small biotechs...or changing the Phase 3 requirements....let some promising biotech push several drugs across the finish line and grow...it will change the big Pharma dynamic... all IMHO...

Don Pescado

[Spyder54]

Agreed. Check up Dr Thomas Seyfried of Boston College who cannot get funding for a Human Trial. He believes there is clear evidence that Cancer starts from damage to the Mitochondria then becomes a genetic mutational disease. He has proven in his lab that by strengthening our Mitochondria (every cell has it), that he can stop the Metastisis process. Different than curing Cancer, but points out it is the Metastisis process that kills us!

Mike

[NPfisherman in reply to Spyder54]

Exactly right !!! It is not the primary that kills, but the secondaries--metastasis... Both RV001 and Osteodex block metastasis, but they do not move forward due to belonging to biotech companies and the need for 50 million dollars or so... I will check out Dr Seyfried... hope he can get the money... stop metastasis and we have a chronic disease with reduced loss of life... Thanks for the reply...

Fish

[CAMPSOUPS in reply to NPfisherman]

Well I should have been depressed enough not to look up the mechanisms/activity of Osteodex but I did lol.

I had trouble finding more of the detailed descriptions of its means but finding it has components of Bisphosphate's (goes to the bone), a glutamine component (attract PC cells? ) and a component to modify protein (deconstruct PC cells?) . One description seemed to indicate an immune component as well.

Bear with me. My degree was in learning everything I know about flexographic printing and flexo printing presses.....thru osmosis. No biology except the osmotic learning of printing lol. Maybe during Hospital Corpsman training 47 years ago one day maybe spent on the cell level and definitely nothing on cancer lol.

Do you have at your fingertips a summary of the method of action for it?

How it works? You seem excited about it and what little I have seen more than raises my eyebrows (what's left of them).

[NPfisherman in reply to CAMPSOUPS]

All I can tell you is from the DexTech website-see below:

dextechmedical.com/en/candi...

It prevents bone resorption and remodeling while also increasing apoptosis in PCa cells--a toxic effect. Thus, blocking bony metastasis and killing PCa cells at the same time...For those of us with lytic lesions, this is a real breakthrough.... read through the information I provided...So frustrating this is being held up... Could patients use this on and off for years??? Potentially....YES !!!! Part of a cure??? MAYBE !!!

Fish