$TSOI another COVID19 drug submitted to the FDA fo
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Posted On: 06/22/2020 10:08:01 AM
$TSOI another COVID19 drug submitted to the FDA for Phase 1 trails OCEANSIDE, CA -- June 22, 2020 -- InvestorsHub NewsWire -- Therapeutics Solutions International, Inc., (OTC Markets: TSOI) announced today plans to utilize its clinical-stage cancer immunotherapy StemVacs™ for treatment of COVID-19 patients.
Previously the Company has filed data with the FDA, as part of IND #17448, which demonstrated that treatment of cancer patients with StemVacs™ resulted in enhanced activity of a type of immunological cell called "natural killer" cells, otherwise known as "NK cells [1]".
NK cells have been published to inhibit SARS-CoV-2, the virus which causes COVID-19 [2]. More importantly, companies such as Celularity have been cleared by the FDA to administer pre-made NK cells for the treatment of COVID-19 as part of clinical trials [3].
"We are very excited by the potential of us offering to COVID-19 patients a new cellular therapy which has already demonstrated safety and immune-stimulating activity in a small 10 patient trial in cancer," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "Dendritic cell-based therapies have been proven safe for over a decade and various companies have FDA clearance for clinical trials using these cells, including one company, Dendreon, which has obtained marketing approval [4]. In contrast to previous dendritic cell approaches, StemVacs uses a proprietary means of "supercharging" the dendritic cells, which we believe makes our approach uniquely suited for application in virology."
The rationale described in the patent application and regulatory documents being generated for potential clinical trials is based on the finding that dendritic cells instruct the body to generate natural killer cells. The Company believes that natural killer cells generated by the body will be more potent than infusions of artificially generated cells that other approaches are currently utilizing.
"We are very thankful to our internationally renowned Scientific Advisory Board who pointed out the advanced stage of our StemVacs™ clinical program, and the possibility of "repositioning" this cellular therapy for use in COVID-19," said Timothy Dixon, President, and CEO of the Company. "Given that the innate immune system is the first line of protection against viruses, we see our repositioned StemVacs product as being developed both as stand-alone immunotherapy, as well as an adjuvant product to enhance the efficacy of stimulators of the adaptive immune responses."
About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. Immune modulation refers to the ability to upregulate (make mor
Previously the Company has filed data with the FDA, as part of IND #17448, which demonstrated that treatment of cancer patients with StemVacs™ resulted in enhanced activity of a type of immunological cell called "natural killer" cells, otherwise known as "NK cells [1]".
NK cells have been published to inhibit SARS-CoV-2, the virus which causes COVID-19 [2]. More importantly, companies such as Celularity have been cleared by the FDA to administer pre-made NK cells for the treatment of COVID-19 as part of clinical trials [3].
"We are very excited by the potential of us offering to COVID-19 patients a new cellular therapy which has already demonstrated safety and immune-stimulating activity in a small 10 patient trial in cancer," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "Dendritic cell-based therapies have been proven safe for over a decade and various companies have FDA clearance for clinical trials using these cells, including one company, Dendreon, which has obtained marketing approval [4]. In contrast to previous dendritic cell approaches, StemVacs uses a proprietary means of "supercharging" the dendritic cells, which we believe makes our approach uniquely suited for application in virology."
The rationale described in the patent application and regulatory documents being generated for potential clinical trials is based on the finding that dendritic cells instruct the body to generate natural killer cells. The Company believes that natural killer cells generated by the body will be more potent than infusions of artificially generated cells that other approaches are currently utilizing.
"We are very thankful to our internationally renowned Scientific Advisory Board who pointed out the advanced stage of our StemVacs™ clinical program, and the possibility of "repositioning" this cellular therapy for use in COVID-19," said Timothy Dixon, President, and CEO of the Company. "Given that the innate immune system is the first line of protection against viruses, we see our repositioned StemVacs product as being developed both as stand-alone immunotherapy, as well as an adjuvant product to enhance the efficacy of stimulators of the adaptive immune responses."
About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. Immune modulation refers to the ability to upregulate (make mor
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