Press Releases
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March 06, 2023 09:00 AM Eastern Standard Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International (TSOI) announced today plans to initiate ten patient proof-of-concept clinical trial aimed at demonstrating the ability of FloraStilbene™ to stimulate the immune system in advanced breast cancer patients.
The Company has previously been granted a patent on utilization of pterostilbene and pterostilbene compositions for synergy with cancer immunotherapy such as interleukin-21, as well as suppression of cancer derived immune inhibitory agent enzymes such as indolamine 2,3 dioxygenase2. By combining previous experiences with immune modulation, the Company announced the creation of a novel immune stimulatory adjuvant combining pterostilbene with RU-486, termed “FloraStilbene”. Preclinical data, for which intellectual property has been filed, demonstrated FloraStilbene overcame immune suppression induced in the 4T1 mouse model of triple negative breast cancer.
“FloraStilbene™ represents a non-toxic approach to overcoming breast cancer induced immune suppression, which acts as a significant barrier to efficacy of oncology immunotherapy,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “I am eager to lead this clinical trial, which if successful, will serve as the basis for a new approach to increase efficacy of drugs such as Herceptin and checkpoint inhibitors.”
“Therapeutic Solutions International has been working on, and filing patents, in the area of cancer immunotherapy with internationally renowned opinion leaders such as Dr. Santosh Kesari since 2015,” said Famela Ramos, President and Chief Executive Officer of Res Nova Bio. “We are excited to leverage these deep and broad resources to rapidly enter the clinic to address such a major unmet medical need.”
“One of the guiding principles of our Company has been to bring hope to patients for which limited options exist,” said Timothy Dixon, President, and Chief Executive Officer of Therapeutic Solutions International. “We strongly believe that immuno-adjuvant approaches such as FloraStilbene™ will greatly increase the potency of numerous existing therapies, as well as reducing various toxicities.”
About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com.
About Res Nova Bio, Inc.
Res Nova Bio is a San Diego Biotechnology Cancer Immunotherapy Company dedicated to addressing the unmet medical need in the treatment of advanced breast cancer. Our Company is a place where problems get solved and the lives, of our employees and our patients, are transformed. The Company's corporate website is www.resnovabio.com.
1 Augmentation of oncology immunotherapies by pterostilbene containing compositions 2 Nutraceuticals for suppressing indolamine 2,3 deoxygenase
Contacts
Timothy G. Dixon ir@tsoimail.com
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January 03, 2024 09:00 AM Eastern Standard Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International, Inc. (TSOI), announced today that its Subsidiary Company Res Nova Biologics, successfully treated four advanced cancer patients with FloraStilbene™. The patients had no adverse events from drug administration and clinical signals of tumor response were observed. All patients have been followed-up with for more than three months.
FloraStilbene™ is a drug comprising of a proprietary formulation of the abortion pill’s active ingredient (RU486) and pterostilbene. The drug is manufactured by Compounding Pharmacy Cure Stat1 and is available by prescription under Right To Try. Previously, the Company has demonstrated efficacy of FloraStilbene in stimulating immune responses in animal models of various cancers, with an emphasis on triple negative breast tumor models2.
The use of pterostilbene for cancer immunotherapy was patented by Therapeutic Solutions International in 20173, subsequent to which, numerous independent groups have shown the ability of this compound to block prostate4, breast5, melanoma6, glioma7, and lung cancers8.
“This is a major step forward in Res Nova’s development plan for FloraStilbene™. These data, combined with existing preclinical and animal studies will serve as the basis for future clinical trials which will provide the basis for FDA sales approval,” said Dr. James Veltmeyer, Chief Medical Officer and the Physician who administered the drug. “From an ethical perspective, we are proud to have the support of several major leaders of the Pro-Life Movement including Bishop Joseph L Coffey (of the Military Archdiocese)9 and Dr. George Delgado (Inventor of the Abortion Pill Reversal) who sit on the Company’s Advisory Board10.”
“The brilliant founders of Res Nova, with a miraculous stroke of genius, are turning a drug that destroys life into a 'weapon' that destroys cancer to saves lives,” said Deacon Keith Esshaki, Member of the Company’s Advisory Board.
“The rapid translation of FloraStilbene™ from a laboratory discovery to a compounded drug speaks volumes to the power of the team that Ms Ramos has assembled,” said Timothy Dixon, President and CEO of Therapeutic Solutions International. “Through leveraging relationships and resources provided by TSOI, we anticipate accelerated availability of FloraStilbene™ to the multitude of drug resistant cancer patients.”
“Breast cancer is a major epidemic for which novel treatments and research directions are urgently needed. We are thankful to our colleagues but most importantly to the brave patients who participated in this study, which we anticipate will be the foundation for a paradigm shifting approach to this dreadful disease,” said Famela Ramos, President and CEO of Res Nova Bio, Inc.
About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com.
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October 20, 2023 09:00 AM Eastern Daylight Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International, Inc. (TSOI), announced today the successful first treatment of a patient with FloraStilbene™, a patent pending formulation of the abortion pill’s active ingredient, RU486, and pterostilbene.
“I have worked with Dr. Ramesh Chigurupati, President, and CEO of Cure Stat Rx for many years and have always been impressed by the efficiency and excellence in ability to provide compounded drugs and formulations”
The Company has been utilizing pterostilbene, a naturally occurring analog of resveratrol, found in blueberries, for the treatment of cancer and immune modulation for several years, including being granted a patent on synergies with conventional immunotherapies1. In May of this year, Res Nova signed a collaborative agreement with compounding pharmacy Cure Stat Rx for developing a compounded formulation of FloraStilbene™2.
“I have worked with Dr. Ramesh Chigurupati, President, and CEO of Cure Stat Rx for many years and have always been impressed by the efficiency and excellence in ability to provide compounded drugs and formulations,” said Dr. James Veltmeyer, Chief Medical Officer of Res Nova Bio. “We look forward to offering FloraStilbene™ to all patients taking immunotherapy, chemotherapy, or radiation therapy that can benefit from immune stimulation of NK cells, T cells, and dendritic cells.”
FloraStilbene™ has previously been shown to enhance immunotherapy of various tumors3, as well as chemotherapy efficacy4.
“The strategic objective of Therapeutic Solutions International is to develop intellectual property, use it to seed a subsidiary company, and let the subsidiaries grow and flourish,” stated Timothy Dixon, President, and CEO of Therapeutic Solutions International. “I am extremely proud of the leadership role of Ms. Ramos who in the period of less than a year was able to take FloraStilbene™ from concept to patient. This is literally unheard of in traditional biotechnology development models.”
In addition to Res Nova, Therapeutic Solutions International has multiple subsidiaries including a) Campbell Neurosciences, focused on the identification of suicidal propensities using a proprietary test and various interventions5; b) Breath Biologics, which is in discussions with the FDA for its filed Phase I/II trial in COPD6; c) CTE Biologics, which is advancing its clinical stage technology for treating Chronic Traumatic Encephalopathy7; and d) VasoSome Vascular, which is in preclinical development of mesenchymal stem cell derived exosomes for treatment of aortic aneurysms8.
“I am thankful for our translational medicine team that has worked closely with Drs Veltmeyer and Chigurupati for making this first patient treatment a reality,” said Famela Ramos, President, and CEO of Res Nova Bio. “Although we plan on performing clinical trials to formally establish a level of efficacy, we believe it is imperative to get this drug into the hands of physicians as soon as possible, and we are thankful for having the opportunity to do this today.”
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October 17, 2023 09:00 AM Eastern Daylight Time
ELK CITY, Idaho--(BUSINESS WIRE)--The original source-language text of this announcement is the official, authoritative version. Translations are provided as an accommodation only, and should be cross-referenced with the source-language text, which is the only version of the text intended to have legal effect.Therapeutic Solutions International, Inc. (TSOI), announced today its breast cancer focused immunotherapy subsidiary company, Res Nova Bio, has recruited internationally renowned medical doctor George Delgado to its Scientific Advisory Board.
Dr. Delgado is an expert in the biology of pregnancy and the abortion pill, being the founder of “Abortion Pill Reversal” and having been the first to publish in the peer-reviewed literature successful reversal of mifepristone administration using progesterone treatment1.
Res Nova is developing FloraStilbene™, a proprietary formulation of RU-486 and pterostilbene which has been shown to overcome tumor associated immune suppression2 and increases responsiveness to chemotherapy and immunotherapy3. The Company has signed a collaborative agreement with Cure Stat Rx4, a premiere compounding pharmacy and plans to eventually commercialize through the 505b2 pathway.
“The similarities between pregnancy and oncology, including angiogenesis, immune modulation, and rapid growth are striking,” said Dr. George Delgado. “In my opinion the concept of leveraging the effects of the abortion pill in life-saving as opposed to a life-taking scenario is extremely exciting. I am proud to join such a specialized team of therapeutic developers in advancing this novel approach to tumor immunotherapy.”
“Dr. Delgado is a medical visionary whose passion is protecting and preserving life,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International. “We are honored to have Dr. Delgado join Famela and her team in addressing the problem of tumor associated immune suppression, which is a major hurdle to widespread implementation of immune therapy of cancer.”
“Having known the work of Dr. Delgado for many years and his great success in defending both the mother and the baby, it is exciting to have the opportunity to utilize his scientific and medical expertise in this unique intersection of reproductive medicine, immunology, and oncology,” said Famela Ramos, President, and CEO of Res Nova Bio.
Dr. Delgado received his undergraduate degree at St. Mary’s College of California where he graduated summa cum laude and received the biology department’s top honor — the Carlos Freitas Award. He attended medical school at UC Davis and completed his residency training at Santa Monica Hospital/UCLA. He has given numerous presentations to various groups on medical and bioethical topics.
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Stem Cell Modification of Cancer Microenvironment Shown to Increase Ability of Immune System to Stop Breast Cancer
September 15, 2023 09:00 AM Eastern Daylight Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International, Inc. (TSOI) announced today new data and a patent filing from its Subsidiary Company Res Nova Bio which, according to Company scientists, is a potential breakthrough in the field of immunotherapy of cancer.
The conventional dogma, which is supported by numerous well performed studies, is that stem cell administration helps cancer to grow. This is because cancer cells thrive on growth factors generated by stem cells.
To the surprise of Res Nova scientists, administration of multiple types of mesenchymal stem cells increased the efficacy of immunotherapies which act through activation of T cells. Based on preliminary data it is believed that administration of regenerative cells results in altering the tumor environment which makes it easier for T cells to enter the cancer.
“Given that our founding company possesses a wealth of clinical data on mesenchymal stem cells, including FDA Phase III in ARDS, we are currently seeking partners to explore this potentially game-changing discovery,” said Famela Ramos, President, and CEO of Res Nova.
“As a practicing physician I see first-hand the urgent need for out of the box approaches to cancer,” said Dr. James Veltmeyer, Chief Medical Officer. “To think that in less than a year Res Nova has leveraged technologies ranging from stem cells to the abortion pill to create preclinical and early clinical products is unparallel in my opinion.”
“We live in the Golden Age of cancer immunotherapy, and we are at the forefront. Unfortunately, some of the most effective of these therapies cannot enter solid tumors. For example, CAR-T cells have produced miraculous results in leukemias and lymphomas, but they lack efficacy in the majority of cancers,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International.
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Res Nova Bio Reports Landmark Oncology Findings Supporting Clinical Translation of its Pterostilbene-Abortion Pill Cancer Adjuvant
August 21, 2023 09:30 AM Eastern Daylight Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International, Inc. (TSOI) reported that its breast cancer immunotherapy spin-off company, Res Nova Bio, released data showing synergistic suppression of breast cancer growth when used in combination with anti-PD1 and anti-CTLA4 antibodies, which represent clinically used checkpoint inhibitors such as Keytruda and Yervoy, respectively. Additionally, the Company demonstrated that FloraStilbene™ administration increased efficacy of the standard chemotherapies Taxotere and Cytotoxan which are used in breast cancer.
The data were filed in a patent application covering adjuvant use of FloraStilbene™ in radiotherapy, oncolytic virus therapy, adoptive cellular therapy, chimeric antigen receptor therapy, chemotherapy and immunotherapy.
“I have witnessed first-hand the devastating suffering, both mental and physical, that patients with advanced breast cancer go through,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “The findings announced today are a major accomplishment in our development of non-toxic immunotherapies of breast cancer. By leveraging similarities between pregnancy and cancer we have successfully been able to turn the abortion pill, a drug associated with death, into something that potentially saves lives.”
Studies have shown that the abortion pill reduces activity of the cytokine TGF-beta1,2, which is involved in protecting the fetus from the maternal immune response, as well as protecting cancer cells from immunity of the body3. At a cellular level immature dendritic cells, which are found in both cancer and pregnancy seem to be stimulated to maturation by treatment with the abortion pill4.
“I congratulate Ms. Famela Ramos and her team who has already initiated treating advanced breast cancer patients with ValloVax and is now rapidly racing towards the clinic with FloraStilbene™,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International. “The fact that Res Nova already has secured a manufacturing and distribution partner for FloraStilbene™, Cure Stat5 supports our hope of rapidly entering the clinic and perhaps even accelerated sales through a 505b2 mechanism.”
“At Res Nova Bio we are fixated on providing hope for patients who currently have very limited hope,” said Famela Ramos, President, and CEO of Res Nova Bio. “Knowing the detailed mechanisms of action of our products ensures not only solid intellectual property protection but also respect and credibility of potential acquisition partners and regulators. I am thankful to our scientific team and collaborators for their unceasing dedication to patients and shareholders.”
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Protection of T Cells from Tumor-Induced Suppression Suggests Potential for Enhancing Efficacy of Checkpoint Inhibitor and CAR-T Therapies
Company Plans to Initiate Phase I/II Clinical Trial in Advanced Breast Cancer Patients
July 18, 2023 09:00 AM Eastern Daylight Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International, Inc. (TSOI), announced today that its breast cancer focused immuno-oncology subsidiary, Res Nova Bio, Inc., has identified and filed a patent on a novel mechanism of action of its immunotherapy-enhancing product FloraStilbene™.
The Company has demonstrated that administration of FloraStilbene™, which is a proprietary combination of pterostilbene and the active ingredient in the abortion pill, mifepristone, suppresses loss of T cell activity caused by growing breast cancer. In a series of experiments, it was demonstrated that FloraStilbene™ stopped degradation of a protein called “T cell receptor zeta chain” which has previously been shown to be inactivated by the enzyme caspase-31. Breast cancer patients with higher levels of T cell receptor zeta chain have been reported to possess superior survival as compared to patients with lower levels2.
“Breast cancer takes an incredible toll on patients, which I have witnessed firsthand,” said Dr. James Veltmeyer, Chief Medical Officer of the Company, and co-inventor on the patent. “The data presented today, which is the basis for our proposed clinical trial, potentially will help to enhance efficacy of the brand-new type of medicine called 'immunotherapy' which to date has resulted in many cures of cancers which were previously considered incurable.”
“Therapeutic Solutions International has a long history of advancing the field of cancer immunotherapy, dating back to 2015 when we filed our now issued patent # 9682047 entitled 'Augmentation of oncology immunotherapies by pterostilbene containing compositions' which covers the utilization of pterostilbene and various derivatives in increasing the therapeutic index of immunotherapy,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International and co-inventor. “I am honored to see the work led by Ms. Ramos which has advanced our science to the point where it is close to initiating clinical trials.”
“Immunology has revolutionized cancer therapy. Now that the concept has been established that the immune system can be trained to kill cancer, it is time to optimize the existing medications whether they be proteins, cells, or oncolytic viruses,” said Famela Ramos, President and CEO of Res Nova Bio and co-inventor. “Overcoming systemic immune defects induced by the cancer seems to us to be the first step in the optimization of immunotherapy. This is what we are aiming to accomplish in the clinical development of FloraStilbene™.”
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Clinical Stage Biotech Company Partners with Premier Compounding Pharmacy to Provide Doses for IRB Cleared Phase I/II Clinical Trial
May 15, 2023 09:00 AM Eastern Daylight Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International (TSOI) spin-off Res Nova Bio announced today a collaboration with Cure Stat Rx, a premiere compounding Pharmacy in the manufacture of initiate doses of FloraStilbene™ for a planned 12 patient Phase I/II trial aimed at assessing immunomodulatory activity of the drug candidate in advanced breast cancer patients.
“I have worked with Chigurupati for many years in delivering personalized medicine to patients”
The Company previously announced Institutional Review Board clearance to initiate the clinical trial. As part of the collaboration, Ramesh Chigurupati, President of Cure Stat Rx has joined the Advisory Board of Res Nova.
“I am honored to partner with Chigurupati and the team at Cure Stat Rx who have second-to-none expertise in compounding and drug formulation across a range of therapeutic indications,” said Famela Ramos, President, and CEO of Res Nova Bio. “Based on our preclinical and pilot clinical data, we are confident that our proposed Phase I/II trial will support the use of FloraStilbene as an immune enhancer in general and specifically a stimulator of natural killer cell activity in advanced cancer patients.”
“I have worked with Chigurupati for many years in delivering personalized medicine to patients,” said Dr. James Veltmeyer, Chief Medical Officer of Res Nova. “Having seen first-hand the potent therapeutic effects of the Res Nova immunotherapy product ValloVax, I look forward to working with Cure Stat Rx to translate FloraStilbene into the clinical domain.”
Cure Stat Rx is an accredited compounding pharmacy specializing in cancer treatments. Cure Stat Rx clinical and compounding staff is knowledgeable and well trained in immuno-oncology.
“Despite significant advances in cancer immunotherapy, many approaches do not induce responses because patients have low immune responses to begin with. By leveraging the significant body of work developed by TSOI in the area of pterostilbene and immuno-oncology, it is exciting to watch how rapidly Famela Ramos and her team are moving towards treating patients with this first in class approach,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International and Chairman of Res Nova Bio.
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ValloVax Cancer Endothelial Stem Cell Technology Repositioned to Overcome Limitations on Multibillion Dollar Cancer Immunotherapy Market
May 22, 2023 09:00 AM Eastern Daylight Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International (TSOI) announced today its Spin-Off Company, Res Nova Bio, achieved successful delivery of a cancer killing virus to breast cancer, resulting in shrinkage of the tumor without induction of side effects.
The Company, which is currently manufacturing the FDA-cleared ValloVax endothelial cell vaccine, has demonstrated that intravenous administration of viral infected ValloVax cells results in direct delivery to the breast cancer, causing regression and generation of immunity. The company plans to generate “next generation” tumor targeting cell therapies based on specific properties of the blood vessels that feed the cancer.
“Cancer cells are selectively sensitive to killing by viruses because in their decision to multiply excessively and metastasize, they forgo antiviral molecular defenses that are present in non-cancer cells,” said Dr. James Veltmeyer, Chief Medical Officer. “The FDA has approved one viral derived product, T-Vec by Amgen for treatment of melanoma, however this requires injection directly into the tumor, which has some level of impracticality since not all tumors can be accessed1. The data presented today provides a means of intravenously delivering the virus using cells that selectively deliver it to cancer blood vessels.”
ValloVax was cleared by the FDA for a clinical trial for treatment of lung cancer2, and detailed scientific mechanisms of its ability to selectively interact with new tumor blood vessels has been published3. Res Nova Bio collaborates with the Veltmeyer Institute to provide access to ValloVax to no option breast cancer patients4.
“I commend CEO Famela Ramos and her team of collaborators at Res Nova for expanding the “pregnancy-cancer” connection into the area of oncolytic virus delivery, which opens numerous doors for therapeutic possibilities and partnerships,” stated Timothy Dixon, President, and CEO of Therapeutic Solutions International, the company from which Res Nova spun-out of. “It is important to remember that the virus used in these studies, Newcastle Disease Virus, is well characterized and has a very favorable safety profile, making this an ideal “proof-of-concept” experiment.
“The focus of Res Nova is finding a cure for breast cancer. We see this new data as providing a potentially new weapon in the armamentarium of the brave clinicians who are waging war against this merciless killer,” said Famela Ramos, President, and CEO of Res Nova.
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Company Receives Institutional Review Board Approval for 10 Patient Proof of Concept Oncology Trial
March 06, 2023 09:00 AM Eastern Standard Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International (TSOI) announced today plans to initiate ten patient proof-of-concept clinical trial aimed at demonstrating the ability of FloraStilbene™ to stimulate the immune system in advanced breast cancer patients.
The Company has previously been granted a patent on utilization of pterostilbene and pterostilbene compositions for synergy with cancer immunotherapy such as interleukin-21, as well as suppression of cancer derived immune inhibitory agent enzymes such as indolamine 2,3 dioxygenase2. By combining previous experiences with immune modulation, the Company announced the creation of a novel immune stimulatory adjuvant combining pterostilbene with RU-486, termed “FloraStilbene”. Preclinical data, for which intellectual property has been filed, demonstrated FloraStilbene overcame immune suppression induced in the 4T1 mouse model of triple negative breast cancer.
“FloraStilbene™ represents a non-toxic approach to overcoming breast cancer induced immune suppression, which acts as a significant barrier to efficacy of oncology immunotherapy,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “I am eager to lead this clinical trial, which if successful, will serve as the basis for a new approach to increase efficacy of drugs such as Herceptin and checkpoint inhibitors.”
“Therapeutic Solutions International has been working on, and filing patents, in the area of cancer immunotherapy with internationally renowned opinion leaders such as Dr. Santosh Kesari since 2015,” said Famela Ramos, President and Chief Executive Officer of Res Nova Bio. “We are excited to leverage these deep and broad resources to rapidly enter the clinic to address such a major unmet medical need.”
“One of the guiding principles of our Company has been to bring hope to patients for which limited options exist,” said Timothy Dixon, President, and Chief Executive Officer of Therapeutic Solutions International. “We strongly believe that immuno-adjuvant approaches such as FloraStilbene™ will greatly increase the potency of numerous existing therapies, as well as reducing various toxicities.”
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Therapeutic Solutions International Announces Positive Preclinical Results in “Patient Ready” FloraVax Therapy
February 14, 2023 09:00 AM Eastern Standard Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International (TSOI) announced today paradigm shifting findings leveraging the age-old immunological paradigm that cancer is an uncontrolled replica of pregnancy. Pregnancy has historically been regarded as an immunological mystery due to the survival of the offspring, which contains foreign paternal derived proteins in the mother. Founders of Res Nova have previously published that vaccination with placental tissues results in immune mediated tumor regression in animal models and have been previously granted FDA clearance for clinical trials.
“It is generally accepted that cancer and pregnancy both utilize molecules such as VEGF to produce new blood vessel, IL-10 and HLA-G to suppress immune attack, and matrix metalloproteases to invade tissues”
Data disclosed and patented today reveal that specific formulations of RU-486, the original abortion pill, can enhance the therapeutic effects of multiple immunotherapies. The Company has created the “FloraVax” platform which comprises various formulations and combinations of RU-486 and cancer targeting antigens which has been shown to enhance effects of therapies which function in whole or in part through immune modulation.
“From a biological perspective cancer and pregnancy share many similarities such as the ability to escape immune attack and metastasis in that fetal cells invade maternal tissues and can be found even in the mother’s skin, as well as rapid growth,” said Dr. James Veltmeyer, Chief Medical Officer, and co-inventor of the patent. “While it has previously been shown that vaccinating with placental tissues has an anticancer effect, we were shocked at the profound responses we have observed when combining the abortion pill active ingredient with our immune modulating approach.”
“It is generally accepted that cancer and pregnancy both utilize molecules such as VEGF to produce new blood vessel, IL-10 and HLA-G to suppress immune attack, and matrix metalloproteases to invade tissues,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International, the founding company of Res Nova. “This is not the first time that agents which stimulate breakdown of the maternal-fetal immune tolerance also possess anticancer activity. This has been seen with inhibitors of indolamine 2,3 dioxygenase, as well as several checkpoint inhibitors.”
“From the regulatory perspective, RU-486 formulations fall under the 505b2 pathway which significantly shortens time to commercialization,” said Famela Ramos, CEO of Res Nova Bio. “I find it very interesting that a compound with such a controversial history appears to be on the path for repositioning to something that everyone can agree on.”
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First in Class Antiangiogenic Immunotherapy Offered under Right to Try Law to No Option Patients
November 07, 2022 09:00 AM Eastern Standard Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International (TSOI) announced today that its breast cancer focused spin-off, Res Nova Bio, Inc., initiated a collaboration with Veltmeyer MD Inc. aimed at providing access to the anti-angiogenic immunotherapy ValloVax.
ValloVax was subject of a cleared FDA Investigational New Drug application and has been demonstrated safe in numerous clinical uses.
There are several peer reviewed publications supporting the use of ValloVax: a) Proof of concept that the ValloVax immunotherapy inhibits tumor growth in various animal models of cancer (lung cancer, melanoma, and breast cancer)1; b) Review of independent support for the concept of immunologically killing tumor blood vessels to starve the cancer2; c) Clinical data showing that ValloVax induces immune response to proteins only found on cancer blood vessels3; d) Demonstration of synergy of ValloVax with checkpoint inhibitors and mechanism of action data4.
“Having previously used ValloVax to treat patients under the Right to Try Law, I am excited to offer this new treatment option to patients that currently have no other options,” said Dr. James Veltmeyer, Chief Medical Officer of Res Nova Bio. “To my knowledge this is the first clinical therapy that immunologically targets the process of angiogenesis, which is considered the 'Achilles' Heel' of cancer.”
Res Nova Bio, Inc. is a spin off company of Therapeutic Solutions International, which is currently running a Phase III stem cell clinical trial in COVID-19 associated acute respiratory distress syndrome (ARDS). Therapeutic Solutions International licensed breast cancer related technologies to Res Nova Bio including StemVacs-V, an inducible pluripotent stem cell derived cancer endothelial cell vaccine which is seen as a “Second Generation ValloVax”.
“Therapeutic Solutions International is an 'innovation factory' in the area of cellular therapy and immunotherapy,” said Timothy Dixon, President, and CEO of the Company. “The ability of Res Nova Bio to rapidly make an impact in the lives of patients while accelerating its pipeline products is unique in biotechnology. Previously the Company has treated COVID-19 patients under Right to Try concurrent with its clearance to enter Phase III. At the end of the day, we are all here for one important cause: to cure the uncurable as quickly and efficiently as possible.”
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Breast Cancer Angiogenesis Targeting Immunotherapy Company Aims for a Cure without Toxicity of Conventional Therapies
January 30, 2023 09:00 AM Eastern Standard Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International (TSOI) announced today the recruitment of Ms. Famela Ramos as Chief Executive Officer of Res Nova Bio, Inc., as well as formation of an Advisory Board to guide the Company. The Company was created as a spinoff of Therapeutic Solutions International with the goal of commercializing StemVacs-V in the field of breast cancer.
“I have been following Famela’s work for several years now and was honored to join the Company due to the progressive and innovative nature of their approach to breast cancer”
StemVacs-V is an “off the shelf” cancer immunotherapy that trains the immune system to selectively kill the blood vessels that feed cancer. In contrast to the first generation of a cancer anti-angiogenesis immunotherapy which relied on placental cells, and had received FDA clearance for clinical trials, StemVacs-V utilizes an established pluripotent stem cell as a stable and reproducible source of the immunogen.
“It is my pleasure to have nominated Famela Ramos to the position of Chief Executive Officer. Ms. Ramos has been working at Therapeutic Solutions International in the position of Vice President of Business Development for two years and has been instrumental in several licensing deals and collaborations,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International. “Famela’s passion for treating cancer comes in part from her years of experience as a hospice nurse, as well as having been involved in clinical research in several cell therapy clinical trials.”
Famela has published 7 peer reviewed papers with top notch universities including University of California San Diego, University of Utah, and Indiana University and is inventor/co-inventor on multiple patent applications. She currently sits on the board of two foundations and previously ran for the US Congress. Ms. Ramos is currently the President of the Right to Try Foundation which has collaborated with the Company in providing access to cutting edge medicines to end stage patients.
“I have been following Famela’s work for several years now and was honored to join the Company due to the progressive and innovative nature of their approach to breast cancer,” said Davis Gammage, Advisory Board Member of Res Nova Bio. “Famela has an unparalleled combination of leadership, scientific knowledge, and a burning desire to make a difference in breast cancer. I look forward to our work together in this very important area.”
“Breast cancer is the second leading cause of death in woman. In many cases, the traditional and current interventions used to treat these tumors are ineffective and toxic. Women deserve better than the usual stale approaches that target singular aspects of this devastating disease process and I believe this company's innovative science can result in better outcomes,” stated Famela Ramos.
“As a woman who has had a breast cancer scare and who has taken care of patients who have succumbed to this illness, it gives me great joy to serve this company and the women who can potentially be saved with our technology. I am humbled that Mr. Dixon and his team chose me to lead this exciting venture. I can't name any other corporate leader who possesses such an excellent balance of scientific, medical, and financial knowledge as Mr. Dixon. I look forward to hyper-accelerating the Company's growth. Through leveraging collaborations and licenses, we want to enhance shareholder value and provide our new discoveries to patients who need them as rapidly as possible,” added Ms. Ramos.
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Company to Develop StemVacs-V Anti-Angiogenesis Immunotherapy for Initial Treatment of Breast Cancer
October 27, 2022 09:00 AM Eastern Daylight Time
ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International (TSOI) announced today formation of a Spin-Off Company, Res Nova Bio, Inc., dedicated to the development of cancer inhibiting anti-angiogenesis immunotherapies.
“Therapeutic Solutions International can be seen as an 'innovation factory' containing multiple assets at different stages of development”
Res Nova Bio has licensed from Therapeutic Solutions International intellectual property covering StemVacs-V which is an iPSC derived platform technology announced in May of 20211 and discussed with potential corporate partners in September 20212.
The technology utilizes pluripotent stem cells called iPSCs in order to generate new cells which resemble tumor blood vessels that are made to act as a “therapeutic vaccine”. Specifically, the administration of StemVacs-V stimulates the immune system to selectively kill blood vessels that feed the tumor but not healthy blood vessels. It is believed that for every 1 tumor blood vessel cell that is killed, 200-300 tumor cells are also killed as a result.
“I have previously been involved in the original studies using placental cells to stimulate immunity to cancer endothelium (blood vessels), using a product called “ValloVax”. Having administered ValloVax to cancer patients I have seen the potency of this product firsthand. Unfortunately, despite receiving FDA clearance, commercial development of ValloVax ceased, therefore, in collaboration with scientists at Therapeutic Solutions International we developed a second generation ValloVax called StemVacs-V,” said Dr. James Veltmeyer, co-inventor and Chief Medical Officer of Therapeutic Solutions International. “In contrast to previous approaches, StemVacs-V allows for creating all doses from one standardized cell type, which alleviates the need for multiple placentas, avoiding variability in production. Additionally, because StemVacs-V is derived from iPSC, gene editing can be performed in order to increase therapeutic efficacy.”
“Therapeutic Solutions International can be seen as an 'innovation factory' containing multiple assets at different stages of development,” said Timothy Dixon, co-inventor, President, and CEO of the Company. “We believe that spinning off separate companies allows for hyper-accelerated development of the various technologies in our pipeline. We are confident that Res Nova Bio, Inc., will commercialize this radically new approach to cancer that combines the two most promising treatment approaches, suppression of angiogenesis and immunotherapy.”