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Major points from today's News: FDA submission is on the way, then the approval for human trial:
Dr. Charles Maitz presented a summary of the results of our clinical study on canine sarcoma at the University of Missouri. That study demonstrated the safety of IsoPet® therapy for the patient, therapist, and pet parents, while delivering a very high dose of therapeutic radiation directly to the tumor with negligible dose to surrounding normal tissues.
The primary objective of the study was to evaluate safety and dose delivery. The PET-CT images showed good distribution of IsoPet® within the tumor. The additional data on clinical outcomes collected in this study confirm that IsoPet® is effective at killing tumor cells. In addition, based on the study results and as part of our ongoing work to further develop and refine the Isopet® therapy, we intend to put greater emphasis on treating the margins surrounding the primary tumor to further reduce the chance of recurrence. A detailed scientific article on this study and the results from the feline sarcoma study at Washington State University is expected to be published soon in the journal Cancer Biotherapy & Radiopharmaceuticals.
Overall, feedback and interest in IsoPet® was very positive. Veterinarians that we spoke with confirmed that IsoPet® is the only therapy that can deliver high single dose radiation to the tumor site with minimal impact to adjacent normal tissue. This contrasts with external beam therapy, that can only deliver a fraction of the prescribed dose and involves multiple treatments. In addition, external beam therapy requires substantial capital investment to be made by the treatment facility. Veterinarians were impressed that IsoPet® can be shipped on-demand and treatment can be delivered in a 15-minute, one-time procedure. The up-front capital and set-up costs are minimal, especially for facilities that already possess a radioactive material license.
We first introduced IsoPet® at last year’s conference. At that time, we had minimal data on a single dog that had been treated for sarcoma. This year we presented much more data and built on the momentum of experience gained over the year. We had significantly more interest from clinics across the country and internationally. These are promising contacts for establishing additional regional clinics in the future.
One theme we heard repeatedly is that veterinary professionals expect to see more data on new technologies. We are committed to complement our current commercial development strategy with additional clinical studies that will generate data to be reported in professional publications and at future conferences.
IsoPet® is an exciting new tool offering a solution that can extend the life of many beloved pets suffering from cancerous tumors.
Do not sell cheap, the current SP is much undervalued, and it is already priced in for the need of funding! Surely it is back to higher. Patience is the key!
yes, I noticed that, which is significantly important!
Thank you for the honest opinion, I see this as a great milestone of RDGL.
Surely they will revise the procedures or improve the treatment, the summary report submission to FDA will be nodded soon. I am quite confident the smart investors are lining up to invest in this company, the funding will be closed soon.
By the way, I am jealous you have 4M shares after RS, which is wonderful!
where did you get that? I am thinking big pharma especially those have animal care businesses, will look at this.
You are completely right on this expection! The good news is on the way!
I really hope so, I will buy a boatload of shares!
that is right, let logic prevail:
What are the two truths?
1st Truth: Isopet approved for animal solid cancer therapy, the
publication proved its convenient application and solid
effectiveness;
2nd Truth: Isopet works for the animal, its human version, Radiogel
will also work for human, it is just a matter of time;
Getting on the bus with tickets, when it is moving, it moves quick, patience is the key;
Share more about meeting, Champ, for sure you joined the conference there!
Expected catalysts in the near future or later:
1. PR of the publication of animal treatments and the submission to FDA for human trial approval;
2. Closing of the offering, and we may see private investment replacement of equity;
3. Opening of new animal clinics of isopet treatment;
4. Good deals of partnership with renown biopharma or biotech company with decent upfront payment;
5. Licensing deals of isopet or radiogel to other countries or regions;
The important thing is getting the ticket on board, the road may be still bumpy and for sure it is heading to the north, right now it is much undervalued, but it won't be long until it is up at a higher level.
The publication of the animal clinic results is much worthy of a PR.
It is the milestone of isopet clinical indications (human version will be radiogel), It is the great approval of the effectiveness of isopet and soon radiogel to human. It would be not wise if there were no PR of it. Dr. Korenko needs to build a better investor relationship while doing all the diligent CEO work there.
You are right, always buy low and hold, do not sell, it may rocket up quickly with no way to chase!!!
Yes, we are here to support and will be rewarded hugely.
News is expected on Monday!!!
90Y-radiogel was designed to provide the highest possible
therapeutic index for treating nonresectable or radiationresistant solid tumors in vivo. PET/CT imaging showed that 90Y-radiogel could be administered without significant outmigration of 90Y-particles to normal organs and tissues. PET/CT confirmed that injected 90Y(YPO4) particles perfused tumor tissue in a manner that provided a homogenous
radiation dose to most of the tumor mass. The authors’ experience confirmed that 90Y-radiogel can be prepared and administered safely for therapy of nonresectable solid tumors in man and animals, including deeply seated tumors accessible via needle as well as tumors at or near skin surfaces. Feline vaccine-associated sarcoma and canine softtissue sarcoma serve as excellent models for testing 90Yradiogel properties, safety, and clinical efficacy. Microscopic extension of sarcomas or metastatic migration into surrounding tissues may limit this model, as the therapy is mainly designed to treat gross disease; microscopic disease extension was likely the reason for edge-of-field recurrence
in the first dog, which was later retreated.
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 Treated cats and dogs experienced no radiation-related
illness associated with interstitially placed 90Y-radiogel
therapy. The authors observed no adverse tissue reactions in
any adjacent or distal normal organ or tissue beyond adjacent skin. With subcutaneous tumor tissue receiving an
absorbed dose of about 320 Gy or less, they observed only
mild skin erythema (reddening) with tumors in close contact
with skin, and minor skin irritation in a few cases, partly due
to brief surface contamination (easily removed with an alcohol wipe). In one dog, the draining tract healed completely within 6 weeks. In another dog, the nonhealing
wound persisted for 4 months, after which surgical debulking was advised.
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.
https://www.liebertpub.com/doi/pdf/10.1089/cbr.2019.2947
wonderful details about the isopet preparation and its clinical application, the publication of this paper indicated the final report is ready for submission to FDA. I hope the fund will be ready for human clinical trial soon.
Like always I said, patience is the key!!!
Though they are not related, the gel matrix for radiogel is proved safe, biocompatible and biodegradable, so it is guaranteed to move to human clinics soon.
Hope to have the powder to scoop in, now it is too cheap!!!
from the L2, somebody is playing the game entertaining themselves!!!
Great decision but you should do your DD. The road is still bumpy but heads to the north.
Very reasonable!!! With the approved treatment of isopet for aminals, and the near path to human trials, this is much undervalued. Longs will be rewarded hugely.
A great milestone for being uplifted to OTCQB.
Expecting the next great steps!!!
1. Gets the finalization of equity investment from potential investors;
2. Submits final canine treatment report to FDA;
3. Expose to the broader community after Oct. conferences;
4. Report on more cases of treatments from the animal treatment center;
5. Potential partnerships or licensing deals;
......
Thank you for sharing this information, hope RDGL continue doing well. I trust in the CEO and his dedication. Much better than the previous one.
The road is bumpy now but the destination is promising!!!
What a bumpy road RDGL is taking to success! Patience is the key. This approved cancer treatment for solid cancers on the animal is so much undervalued now. Any successful treatment on animals paves the way to human clinics trial. Future is bright!!!
You are a great man! Pray for those families who lost their beloved.
Congratulations for the not far bright future of financial freedom!!!
Dr. Mike Korenko stated “Obtaining this approval is an important step to set the stage for selling IsoPet to the private clinics for animal therapy. By being labeled a device there are no other regulatory approvals necessary for treating skin cancer, the most common cancer in animals. We chose a conservative path of obtaining FDA classification early with full and open communication on our intent in order to remove any future uncertainty in the regulatory space.”
The strategic market sector of RDGL is isotope applications. Currently, the Company is engaged in the development of RadioGel, an Yttrium-90 based brachytherapy device, for the treatment of tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside the treatment area.
The company is engaging the FDA for permission to use RadioGel for the treatment of advanced basal and squamous cell skin cancers. The IsoPet Solutions division of RDGL is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. RDGL is positioning itself so that after this demonstration phase, The Company can begin to generate revenues through the sale of RadioGel to private animal clinics.
The company currently is outsourcing material aspects of manufacturing of its product in the United States and intends to enter into licensing arrangements outside of the United States for the manufacturing and distribution of RadioGelTM in other countries.
RadioGel is a hydrogel liquid containing tiny Yttrium-90 phosphate particles to be injected into a tumor. This hydrogel is a liquid at temperatures below body temperature but begins to gel, harden, upon injection as the temperature increases to normal body temperature, thereby locking the particles in place. The particles emit a very high concentrated and contained beta irradiation to kill the tumor. The beta radiation has a short penetration distance so there is minimal collateral damage to healthy tissues outside of the injected area.
I am very patient with this holding, won't sell it when it gets to at least $10.
Yes, they are lining up and will drop soon
quite possibly, maybe we will get the final report on dog treatments as well.
I agree with you on this point, Vivos needs the partnership.
Based on the recent 10Q
How will Dr. Korenko be compensated depends on company performance:
Under the terms of the Employment Agreement, the Company shall pay to Dr. Korenko a base compensation of $180,000. Of this amount, $120,000 is booked in monthly intervals and the remaining balance is only paid upon the Company achieving a cash balance that exceeds $1,000,000. The Company has elected to record the compensation as $120,000, and upon achieving the milestone of $1,000,000 in cash balances, will record the deferred compensation at that time.
In addition to the cash compensation, the Company has granted 2,625,000 stock options under the Company’s 2015 Omnibus Securities and Incentive Plan to Dr. Korenko. The granting of the stock options occurs 10 days after the approval of the Company’s recent 1 for 8 reverse stock split that occurred on June 28, 2018. The vesting of the options are as follows: (i) 50% vested in equal amounts at the end of each of the four successive calendar quarters (12.50% for each of the quarters September 30, 2019, December 31, 2019, March 31, 2020 and June 30, 2020); (ii) 25% upon the Company closing a financing of $1,000,000 or more; and (iii) 25% upon the first commercial sale of IsoPet ® , with all vesting to accelerate and all unvested options to be vested upon a Change of Control, as defined in the Employment Agreement.
So Dr. Korenko as CEO and insider got and will be getting lots of shares:
which means he and the team got to work hard and deliver, means not only their jobs on the line, their savings also on the line if they screw up. They knew this is a winning investment otherwise it is like shooting themselves in the foot. This is a good indicator that this stock will start climbing and will hit human trials sooner or later.
Got more cheap shares! If Dr. Korenko got huge shares for his compensation, I know it will be good eventually and I do not have any worry about holding shares for long!!! Getting closer to 900K
short term pain but we are in good hand.
The same here grabbing cheap shares!
Great DD, and we all know when it will be approved as a device for human solid cancer treatment. It may take time and effort there, but when it is there, it will be huge!
yes, load more and we are waiting patiently
Hold on tight, the train is leaving:) We are heading to north pole!!!
That is great legal writing, I learned.
Thank you, Champ for your strong statement which showed confidence, sincerity and true yourself here, I hope I can do the same thing as you to support the company and Dr. Korenko, he is a nice CEO but truly needs lots of support from nice people. We are here investing in good company with huge potential, not only for money (when it is enough it is only paper), more importantly also in support of good cancer treatment option for our human being. Please send me your email by private text if possible as I would like to connect with you. Thank you for being faithful and supporting here.
As it is also said in 10q
The Company has 950,000,000 shares of common stock authorized, with a par value of $0.001, and as of June 30, 2019 and December 31, 2018, the Company has 177,710,821 and 163,445,736 shares issued and outstanding, respectively.
On March 28, 2019, the Company’s board of directors approved a reverse 1-for-8 stock split, and a decrease in the authorized shares from 2,000,000,000 to 950,000,000. The reverse stock split went effective by FINRA on June 28, 2019.