• Welcome to Phoenix Rising!

    Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of and finding treatments for complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia (FM), long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.

    To become a member, simply click the Register button at the top right.

Biovista and CAA identify candidate drug for repurposing

Sasha

Fine, thank you
Messages
17,863
Location
UK
Has this already been posted and I've not seen it?

http://www.drugs.com/clinical_trial...ca-reach-milestone-pre-ind-meeting-15606.html

Biovista and CFIDS Association of America Reach Milestone with Pre-IND Meeting

CHARLOTTESVILLE, Virginia and CHARLOTTE, North Carolina, May 29, 2013
/PRNewswire/ --

Biovista and the CFIDS Association of America announced today the
successful completion of the first phase of their collaboration.
Funded as part of the CFIDS' Research Institute Without Walls,
Biovista identified candidate treatments for CFS using its
state-of-the-art COSS approach. Two candidate treatments, including a
combination therapy, were identified and are being prepared for
proof-of-concept clinical trials, with an FDA pre-IND meeting
scheduled in Q3 2013.

"We are very excited to have reached this stage within a year of
starting our collaboration. We look forward to furthering our
understanding of this complex disease and developing a treatment that
will improve CFS patients' quality of life," said Dr. Andreas
Persidis, Biovista's CEO. "Our work is an example of things to come in
terms of novel collaboration models that promise to accelerate
treatment development and, through the drug repositioning approach, do
so cost effectively," Dr Persidis added.

"There is a big gap in the pipeline that moves basic laboratory
research into safe and effective treatments. Without a bridge to bring
discoveries to the clinic, laboratory research rarely becomes more
than a paper. We are providing the means for basic researchers to move
discoveries through the translational research pipeline with our
Research Institute Without Walls," said Kim McCleary, president and
CEO of CFIDS.

"Therapies for ME/CFS are an unmet medical need. This is largely due
to the lack of translating the scientific knowledge into meaningful
impact for patients," added Dr. Suzanne D. Vernon, Scientific Director
of CFIDS. "We understand the ME/CFS knowledgebase and know how to fill
this gap. Biovista recognized the opportunity for discovery. This drug
repositioning project is an excellent example of effective use of
existing information to make a new treatment discovery."

About Biovista

Biovista finds novel uses for existing drugs and profiles their side
effects using mechanism of action analysis. Biovista develops its own
pipeline in CNS, oncology, auto-immune and rare diseases and
collaborates with biopharmaceutical companies and Patient Groups on
indication expansion, portfolio de-risking, and adverse event
prediction. (http://www.biovista.com).

About CFIDS

The CFIDS Association of America is at the leading edge of ME/CFS
research. For more information, please visit The Association's web
site at http://www.cfids.org or their research blog at
http://www.Research1st.org

Contacts
Biovista
Dr. Andreas Persidis
andreasp@biovista.com
T: +1-434-242-6514

The CFIDS Association of America
Dr. Suzanne D. Vernon
sdvernon@cfids.org

Posted: May 2013
 

Nielk

Senior Member
Messages
6,970
They spoke about this at the FDA meeting last month without mention of what the name of the drug is.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
I was very displeased when listening to the video of that conference that the names of the two drugs were withheld. I am very surprised this wasn't raised by those in the audience.

What's the big secret? Hopefully we aren't talking antidepressants!
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
I was very displeased when listening to the video of that conference that the names of the two drugs were withheld. I am very surprised this wasn't raised by those in the audience.

What's the big secret? Hopefully we aren't talking antidepressants!


It seems to be some sort of regulatory or contractual thing, but I'd like to know the reasoning behind it. I agree it's frustrating.

I remember reading that in the early days of AIDS clinical trials, which were double-blind and placebo controlled, patients were so desperate for the active drug that they cut their doses in half and swapped a half with another patient so that they'd both have some chance at least of getting the active drug. I'm starting to feel like that.
 

Navid

Senior Member
Messages
564
I remember reading that in the early days of AIDS clinical trials, which were double-blind and placebo controlled, patients were so desperate for the active drug that they cut their doses in half and swapped a half with another patient so that they'd both have some chance at least of getting the active drug.


this brings tears to my eyes......1) that ppl who are dying still maintain compassion and decency to help their fellow human 2) that the medical/science world is so f'd up that ppl have to go to these extremes in order to bypass the bureacracy that is literally killing us (them-the AIDS pts)


how much longer do we have to wait for some treatments that may actually help us while not costing us an arm and a leg just to take a chance that something may give us our lives back (ampligen, ritux, seeing cheney, gc-maf.....etc). yes hope is nice but we need concrete help...NOW!!!!
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
The secrecy is standard commercial caution. If you tell someone about something, then you can publish first and maybe win a contract. I don't know how these things work exactly, but its not a surprise. However its likely that the patent is owned by a major company, so there will be negotiating behind the scenes.
 

Desdinova

Senior Member
Messages
276
Location
USA
What's the big secret? Hopefully we aren't talking antidepressants!
I sincerely hope that it's nothing along the lines of antidepressants. I shudder at the thought of how the ME/CFS community at large would react. It would IMO be a bad PR move on the part of the CFIDS Association of America.
 
Messages
15,786
I remember reading that in the early days of AIDS clinical trials, which were double-blind and placebo controlled, patients were so desperate for the active drug that they cut their doses in half and swapped a half with another patient so that they'd both have some chance at least of getting the active drug. I'm starting to feel like that.
:(

... You can have half of my sublingual B12 :hug:
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
The secrecy is standard commercial caution. If you tell someone about something, then you can publish first and maybe win a contract. I don't know how these things work exactly, but its not a surprise. However its likely that the patent is owned by a major company, so there will be negotiating behind the scenes.

Hi Alex,

From what I understand about how these two drugs were arrived at - by trawling the data of published studies, and from the clinician survey etc. - these drugs are not new. Therefore I can't quite understand the need for secrecy due to patent/s. Will try and ask CFIDS about this later.
 

taniaaust1

Senior Member
Messages
13,054
Location
Sth Australia
Im almost ready to bet they will be antidepressants.. that's probably what they are going to come up with seeing (as far as I know) a Canadian consensus defination wasnt being used (let me know someone if Im wrong with that). While crappy CFS definations which are mostly just "fatigue" patients are used, things for the rest of us can never move forward.

Maybe for once I'll end up being surprised, but I doubt it.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Hi Alex,

From what I understand about how these two drugs were arrived at - by trawling the data of published studies, and from the clinician survey etc. - these drugs are not new. Therefore I can't quite understand the need for secrecy due to patent/s. Will try and ask CFIDS about this later.

Its not about patents, mostly. Its about where biovista is being funded from. It is likely though that the patent holder will be doing some funding, or collaboration, or something. Also there is a new tendency to reformulate and repackage an old drug, give it a new name, and file a new patent.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
Its not about patents, mostly. Its about where biovista is being funded from. It is likely though that the patent holder will be doing some funding, or collaboration, or something. Also there is a new tendency to reformulate and repackage an old drug, give it a new name, and file a new patent.

My understanding from the talk (an article of which will be published shortly) that this is a combination therapy. I understand from that to mean - two drugs used together to combat a couple of (unidentified - again, why?) CFS symptoms. So where's the issue? These are drugs that are known. They are approved already.

I don't understand what a 'proof-of-concept' clinical trial is other than that it will seek to do in practice what BioVista and it's database has supposedly shown through 'trawling'. It just seemed to undermine Vernon's talk. She spoke a heck of a lot of detail about the 'how' this was achieved and then the climax was, well, let's just say that even I have had better :)
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
I do understand why secrecy is an issue to many of us. Transparency is far better in many respects. In time we may know the answers. In any case it might turn out to be as simple as wanting to publish and therefore not reveal results ... but that only applies if they want to publish the theoretical finding in advance of the testing.

Personally I would like to see most medical research be completely open ... including raw data. So much of medical research is wrong, the place to start is to put as much as possible in the public domain, and use open publishing. You can't fix a problem you can't see, so to prevent or fix problems you need to be able to see as much as possible. I hate secrecy.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
I do understand why secrecy is an issue to many of us. Transparency is far better in many respects. In time we may know the answers. In any case it might turn out to be as simple as wanting to publish and therefore not reveal results ... but that only applies if they want to publish the theoretical finding in advance of the testing.

Personally I would like to see most medical research be completely open ... including raw data. So much of medical research is wrong, the place to start is to put as much as possible in the public domain, and use open publishing. You can't fix a problem you can't see, so to prevent or fix problems you need to be able to see as much as possible. I hate secrecy.

It is then ironic that in the speech prior to Vernon's, Munos was exhorting the medical and scientific communities to be open in terms of sharing data...

Just seems very 'odd' to me that CFIDS would do all the build-up in the talk and then skip over naming the two drugs. Very strange and the announcement of this trial came across as a damp-squib as a result.

Maybe you are right and CFIDS wanted to write an article that dealt with it specifically - in conjunction with BioVista. And were holding back before the article was published. I'll try and see what gives. Others may well have discovered more about the identity of these two 'magic mushrooms' :)
 

SOC

Senior Member
Messages
7,849
It is then ironic that in the speech prior to Vernon's, Munos was exhorting the medical and scientific communities to be open in terms of sharing data...

Just seems very 'odd' to me that CFIDS would do all the build-up in the talk and then skip over naming the two drugs. Very strange and the announcement of this trial came across as a damp-squib as a result.

Maybe you are right and CFIDS wanted to write an article that dealt with it specifically - in conjunction with BioVista. And were holding back before the article was published. I'll try and see what gives. Others may well have discovered more about the identity of these two 'magic mushrooms' :)

My guess is that this is strictly a commercial issue. Read a bit at Biovista's website to pick up some clues.

Pharmaceutical companies make money when they have something new, most generally patentable. It is likely that the pharma company involved wants to get their product, or combination product, on the market and approved for ME/CFS before their competitors.

This is reasonable if they paid for the research to find this combination -- they ought to be able to benefit from that investment. Once it's known what the combo is, other pharma companies will jump on the bandwagon using their own similar products -- without having spent the research money. They can charge less because they didn't have the initial investment in research. It's a lousy process, but that's the way it works. If we want pharma to do research, we have to support them making up the cost of research somehow.

So, I'm guessing Biovista is keeping mum so that their client, the pharma, can have a few months/years jump on their competitors in getting the product(s) to market.
 

jspotila

Senior Member
Messages
1,099
This question was asked over on the Association's Facebook page, and here is what they said in response:

The CFIDS Association of America fosters research that will lead to safe and effective treatments for ME/CFS. We are pleased to be working with Biovista to advance the study of a combination therapy we hope will help advance treatment options for people with ME/CFS. At this time, the safety and effectiveness of the drug combination have not been tested. We are seeking approval from FDA to conduct the first study as an investigational new drug (IND). As soon as we receive approval from the FDA for the trial and complete all other due diligence steps, we will share the details of the clinical trial, including the drug names, with the community and more broadly on www.ClinicalTrials.gov.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
This question was asked over on the Association's Facebook page, and here is what they said in response:

Thanks Jenny :) I still don't understand however. When Vernon made her presentation she was talking about existing drugs being repositioned. I had assumed from this that there was no 'new drug' (IND). Sure the two drugs concerned might go through a 'rebranding' exercise as their original purpose will presumably change (though perhaps not), but their target audience presumably has changed.

Anyway, their trawling of the existing literature, the databases, and the survey revealed drugs that were seemingly effective at helping to manage one or two symptoms - we could be talking headache and muscle pain or something. So again I can't understand this 'secrecy'.

It's my understanding at fault here. I'm not suggesting any of this is intentional on their part.

Thanks again.