Therapeutic Solutions
International Completes Phase 1 Clinical Trial in
Advanced Cancer Patients for Right to Try Access
of its StemVacs Product for American Cancer Patients
Company to use Phase I Data of its
Cancer Stem Cell Immunotherapy to Allow for use in the USA under
President Donald Trump's
Right to Try Law
Oceanside, CA -- September 04, 2018 --
InvestorsHub NewsWire -- Therapeutics Solutions International,
Inc., (OTC
Markets: TSOI) announced today completion of a
Phase I clinical trial in advanced cancer patients using its
StemVacs cellular immunotherapy. The clinical trial was aimed at
establishing the safety of StemVacs, an immunotherapeutic
cell-based drug that instructs the immune system to seek and
destroy cancer stem cells. It is believed that cancer stem cells
are responsible for initiating the growth of tumors.
"Through our collaborators at the Pan Am Cancer
Treatment Centers, we have been able to successfully administer the
StemVacs cellular cancer immunotherapeutic to 10 patients with
various types of advanced cancers. We have observed no
treatment-associated adverse events, and in some cases,
stabilization of tumors and stimulation of immunity were observed
and noted" said Timothy Dixon, President, and CEO of Therapeutic
Solutions International. "This Phase I safety data strongly
supports our continued clinical development of StemVacs, of which
part of the development pathway includes providing patients access
to it now under the Right to Try Law."
Dendritic cells (DC), which are the main
ingredient in StemVacs, are cells of the immune system whose
primary function is to initiate immune responses against different
pathogens (1,2). In the context of cancer, DC's activate immune
responses that in some cases are capable of killing cancer cells
(3,4). Unfortunately, in cancer patients, many times the dendritic
cells are not functionally active (5-7). This is because cancer
cells produce factors such as VEGF, which inhibit the ability of
the DC to perform their job of activating T cells (8,9). The
StemVacs product is comprised of DC that are generated under
laboratory conditions so as to render them resistant to the
inhibitory effects of cancer. Additionally, the StemVacs DC's are
designed so as to induce an immune response against cancer stem
cells.
"Immunotherapy is the greatest advancement in the
area of clinical oncology. FDA approved immunotherapies include the
DC based product Provenge, the T cell based products Yescarta and
Kymriah, and antibody based therapies such as Opdivo and Keytruda"
said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic
Solutions International. "To our knowledge, StemVacs is the only
clinical stage immunotherapeutic that kills cancer stem cells.
This, combined with the safety and signals of efficacy obtained
from the current Phase I clinical trial, support us to expand the
use of StemVacs under President Trump's recently passed Right to
Try Law."
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 more active) or
downregulate (make less active) one's immune system. The Company's
corporate website is www.therapeuticsolutionsint.com.
References
1. Steinman, R. M. (2012) Decisions about
dendritic cells: past, present, and future. Annu Rev Immunol 30,
1-22
2. Steinman, R. M., and Banchereau, J. (2007) Taking dendritic
cells into medicine. Nature 449, 419-426
3. Palucka, K., and Banchereau, J. (2012) Cancer immunotherapy via
dendritic cells. Nat Rev Cancer 12, 265-277
4. Rolinski, J., and Hus, I. (2014) Breaking immunotolerance of
tumors: a new perspective for dendritic cell therapy. J
Immunotoxicol 11, 311-318
5. Ma, Y., Shurin, G. V., Peiyuan, Z., and Shurin, M. R. (2013)
Dendritic cells in the cancer microenvironment. J Cancer 4,
36-44
6. da Cunha, A., Michelin, M. A., and Murta, E. F. (2014) Pattern
response of dendritic cells in the tumor microenvironment and
breast cancer. World J Clin Oncol 5, 495-502
7. Liu, Q., Zhang, C., Sun, A., Zheng, Y., Wang, L., and Cao, X.
(2009) Tumor-educated CD11bhighIalow regulatory dendritic cells
suppress T cell response through arginase I. J Immunol 182,
6207-6216
8. Osada, T., Chong, G., Tansik, R., Hong, T., Spector, N., Kumar,
R., Hurwitz, H. I., Dev, I., Nixon, A. B., Lyerly, H. K., Clay, T.,
and Morse, M. A. (2008) The effect of anti-VEGF therapy on immature
myeloid cell and dendritic cells in cancer patients. Cancer Immunol
Immunother 57, 1115-1124
9. Strauss, L., Volland, D., Kunkel, M., and Reichert, T. E. (2005)
Dual role of VEGF family members in the pathogenesis of head and
neck cancer (HNSCC): possible link between
angiogenesis and immune tolerance. Med Sci Monit 11,
BR280-292
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