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Could be good news for RDGL if implemented:
https://www.fiercebiotech.com/biotech/fda-oncology-chief-eyes-accelerated-approval-earlier-cancer-treatment-under-planned-project
Just published:
https://www.frontiersin.org/articles/10.3389/fonc.2022.773708/full
RadioGel can deliver much higher doses than 125I seeds.
A good time to read Dr. Maitz's paper again and "know what you own":
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044762/
"Performance of the 90Y-radiogel met or exceeded design expectations. After injection, the 90Y- hydrogel composite solution gelled within interstitial spaces upon reaching body temperatures to contain the 90Y activity intratumorally. 90Yphosphate particles remained in treated tumor tissue through complete decay without migrating vascularly to any normal organ or tissue"
"As seen on histopathology, tumor tissues responded well to treatment, with strong evidence of tumor cell killing associated with localized radiation dose. Animal subjects recovered quickly from the injection procedure. With uniform placement at high dose, the authors achieved complete remission
or stable disease (at 1–2 months posttreatment). These results confirm the substantial opportunity for using 90Y-polymer composite (radiogel) to treat solid tumors in both human and veterinary patients."
Cleveland Clinic has started a trial combining low-dose brachytherapy and a check-point inhibitor (Opdivo). If successful, it could be a major boost for RadioGel long-term.
https://clinicaltrials.gov/ct2/show/NCT04620603
Here are interesting reviews to help speculate on IDE and final approval:
Dosimetry: https://pubmed.ncbi.nlm.nih.gov/33458336/
It may explain why the FDA is requesting a separate meeting
Clinical end-points: https://pubmed.ncbi.nlm.nih.gov/33988475/
Study duration: https://pubmed.ncbi.nlm.nih.gov/30933235/
They will need 10-12 patients for the EFS and it may take a while to enroll all the subjects (6-12 months). Then they will have to conduct the pivotal study, assuming they can go straight from the EFS. Study duration will depend on number of subjects treated and end-points. If overall survival is one of them then they most likely will have to follow each subject for up to 2 years.
Final approval most likely won't happen before 2025 unless the EFS data look really good.
Agree. Near-term BO is unlikely.
Varian reported $3B sales in radio-oncology in 2020 (https://www.varian.com/).
Siemens Healthineers and Boston Scientific would be the most likely buyers. Siemens recently acquired Varian for $16.4B. I wonder what they would offer for RDGL once they have generated clinical data.
You are correct, they only submitted a draft. It may be close to final though and only minor revisions may be needed. Let's hope this is the case and the IDE is filed before Christmas.
Radioembolization is almost exclusively used for liver cancer and has its own risks such as gastro-intestinal ulcers, liver failure, leukopenia, or radiation damage to the lungs. Radiogel will have a much broader application.
There is a protocol currently under internal review at the Mayo Clinic, so this is where the opening clinical trial will be run. The main question is how fast can they enroll patients once they have FDA and IRB approval. For an EFS only 10-15 patients are needed but there are currently so many trials in oncology that recruitment can be sluggish. It is possible that being a major oncology center the Mayo Clinic already has a good number of patients who did not (or no longer) respond to standard of care or any experimental therapies. Radiogel may be their last hope.
Agree with the safety concern around miss-injections but that wouldn't be a reason for IDE rejection, particularly since the FDA recommended a path forward.
Could anyone give me a scientific, technical, or safety reason why the FDA would not approve the (EFS) IDE?
On the positive side, let's not forget that we are closer to approval than ever before! The FDA has suggested an approach and a draft EFS IDE has been submitted, including a clinical protocol. I wish Dr K had been less ambiguous in his PR, but I think we all agree that PRs have never been his strength.
The FDA is very familiar with Radiogel, and unless Dr K botches the IDE there is no technical or safety reason why they would not approve. He will probably get feedback on the draft IDE which will be helpful with the final submission. Unfortunately for us Dr K is slow moving (he reminds of the tortoise of La Fontaine) and we will most likely have to wait until 1Q22...
Fully agree. I went through many submissions (INDs, not IDEs) and when the FDA suggests an approach it basically leads to approval if you follow the recommendation.
My guess is that the original intend was to submit a standard IDE in 2021. However the improvements in the manufacturing process needed additional testing that would have delayed the filing of a standard IDE (per the May 24 PR: Submitting the IDE after these manufacturing process enhancements were completed creates a much stronger submission with FDA and greatly reduces the risk and expense of having to do repeat testing). The FDA must have suggested the EFS IDE since it allows to run clinicals trials while these tests are being run in parallel. Given the excellent results and safety profile of Isopet in pets, the FDA is probably eager to see how Radiogel can benefit cancer patients who may have failed other therapies. IMO, approval is imminent.
The FDA has 30 days to respond with questions. IDE approval may take longer depending on how fast Vivos takes to address the questions. It shouldn't take months though. Under the EFS paradigm Radiogel should be ready to dose so the only hang-up could be related to the design of the clinical trial.
The path forward was recommended by the FDA so approval is almost guaranteed if all the questions are adequately addressed. Hopefully it won't take to many iterations.
Based on the PR, the FDA recommended an EFS IDE application. Dr. K complied and filed accordingly. Now the FDA will come their questions. Since they are familiar with Radiogel the questions will most likely be focused on the design of the exploratory human trial, which they have not seen before.
Out of curiosity, how many INDs or IDEs have you ever filed with the FDA?
Same here!
And David Swanberg is their Chief Technical Manager. He knows something about bringing a device to market:
https://www.accessdata.fda.gov/cdrh_docs/pdf3/k030162.pdf
The secondary allowance for chemotherapy or radiation treatment by Nationwide is $2,400. There is also primary allowance specific to the type of neoplasia, typically $400-600.
Hopefully the jump in PPS will get others who have not been paying attention excited as well and drive the PPS further up.
Application acceptance is not application approval. It only means that the FDA has acknowledged receipt of the application and that it will be reviewed. At least it wasn't outright rejected for major deficiencies.
Nice to see the PPS go up though. We can only imagine what will happen if/when the application is approved.
From FDA.gov:
"You can expect to receive a letter communicating the FDA's decision to grant or deny the Breakthrough Device designation request within 60 calendar days of the FDA receiving your request."
It is supposed to happen this month.
https://www.webcaster4.com/Player/Index?webcastId=36586&g=c7311028-4080-46b8-8a94-50747fd819a4&uid=6060072&sid=
The IDE pre-submission meeting is coming in Nov and I don't expect any news until after that. Dr. K. released a nice summary after the last meeting. I hope he will do the same again.
It looks like they have done all that the FDA required. The only unknown is whether the FDA will agree with the new indication they are targeting for entry in the clinic. Having the Mayo experts participate in the meeting should help.
Here's the summary from the previous pre-submission meeting:
https://irdirect.net/prviewer/release/id/2681284
Looks like they have fulfilled all the FDA requirements. Reclassification to Class II would be nice.
I don't think so. I'd be very happy though with only $3.2 which I think can be achieved in a not too distant future.
Check out VRML between July 2009 and March 2010.
I don't expect to hear much until after the IDE pre-submission meeting with the FDA. Korenko and Co will be busy preparing for the meeting which will require submission of background material and include the preliminary results from the biocompatibility testing. I have been involved in similar meetings with the FDA and it will take them time and careful preparation to ensure a productive discussion and set the stage for a successful IDE submission. The good thing is that they have been talking to the FDA for a long time now and this is not new to them.
The outlook is bright though IMO since the brachytherapy market is predicted to grow at a good pace in the years to come:
https://www.grandviewresearch.com/industry-analysis/brachytherapy-devices-market
Approval of the IDE will be a huge leap forward. I am hoping for a repeat of the Vermillion story: from 0.02 to $32 in share price in only a few months!!!
Sorry for the very late response. I was blocked at first and then things got crazy for a while. I have been following RDGL for almost 2 years now and have been accumulating little by little.
Things are going in the right direction for Vivos now. I have been working on several oncology programs. Most are tumoristatic and none achieve the level of efficacy observed with IsoPet. Once RadioGel is in humans and clinicians learn how to use it I would not be surprised if the demand will grow quickly since it can kill any solid tumor. I hope the share price will move accordingly and then we can all retire...
Agree.
Here's a publication about brachytherapy in India. Looks like there could be a great opportunity for Vivos to penetrate that market.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4200190/pdf/JCB-6-23620.pdf
They need IRB approval to conduct clinical studies. This is not an option. I have been involved in many IND submissions to the FDA and this is typically not an issue. I assume this must the same for IDEs (I've never submitted an IDE though and I could be wrong).
Intratumoral injections for lung cancer have been reported. Here's a good recent review:
https://journal.chestnet.org/article/S0012-3692(16)49258-5/pdf
Here is information straight from FDA.gov:
FDA Action on IDE Applications
Approval or Disapproval §812.30
FDA will notify the sponsor via email of the date it receives an IDE application. FDA may approve, approve with modification, or disapprove an IDE application. FDA may request additional information about an investigation. The sponsor may provide the requested information or the sponsor may treat such a request as a disapproval of the application and request a hearing in accordance with 21 CFR 16. The clinical investigation may begin after FDA and the IRB approves an IDE for the investigation. An investigation may begin 30 days after FDA receives the IDE application for the investigation of a device if IRB approval has been obtained unless FDA notifies the sponsor that the investigation may not begin.
IRB review can take up to a month. Hopefully Vivos will submit the application before or at the same time as the IDE.
Thanks. I have read a lot of uninformed nonsense and had to join...
There is much to learn about how to best use Radiogel but it will kill/shrink tumors in humans. Combination therapy may be the way to go to achieve best results, which may be of interest to big pharma or biotechs at some point.
Getting the Mayo Clinic involved is big news. They may already have the necessary permits to handle yttrium-90 since it is an approved radiotherapy and could initiate trials soon after IDE approval.
Once clinical trials have begun Vivos will be a different company. Thanks to Dr. Korenko's hard work they are almost there.
Submitting for a new application probably means that as they were looking for clinical collaborators they were advised by experts at the Mayo Clinic and/or others on their SAB that inaccessible (non-resectable) cancerous lymph nodes was a better initial clinical indication with potentially higher POS. I have worked on many drug development projects and these changes can happen with little to no detriment or delays in the program if properly justified.
Given that Radiogel is a single day therapy, the biocompatibility testing should be well on its way and could be completed soon. Once the IDE has been submitted, the FDA has 30 days to respond. Radiogel/Isopet has been very well tolerated in animals and appears to have a high benefit/risk ratio. There is no obvious reason why the FDA would not allow for clinical testing. The ultimate device classification (II/III) is another issue and could hold up approval but it should not keep Vivos from running clinical trials and generating data.