Provectus Biopharmaceuticals, Inc. (OTCQB:PVCT,http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company,
announced that data will be presented by researchers from Moffitt Cancer
Center in a poster presentation at the American Association for Cancer
Research Annual Meeting in San Diego, California.
The poster, based upon abstract #630, entitled "Induction of
anti-melanoma immunity after intralesional ablative therapy," authored
by Hao Liu, Krithika Kodumudi, Amy Weber, Amod A. Sarnaik and Shari
Pilon-Thomas, will be presented on Sunday, April 6, 2014, from 1:00 p.m.
to 5:00 p.m. in Hall A-E, Poster Section 27.
The abstract reads:
Immunotherapeutic strategies incorporating intralesional (IL) ablative
therapy to elicit a tumor specific immune response are under
investigation as a non-surgical option to induce tumor regression of
cutaneous neoplasms. Rose Bengal (RB) is a water-soluble xanthene dye
that was originally used as an intravenous liver diagnostic and is in
use by ophthalmologists to stain damaged cells in the eye. In murine
models of breast cancer and melanoma, we have shown that IL injection of
PV-10 (10% RB in saline solution) leads to ablation of injected tumors
and regression of non-injected bystander tumors. In these models,
increased anti-tumor T cell responses were measured, supporting the
induction of systemic anti-tumor immunity after tumor ablation with
PV-10. In our ongoing phase I clinical trial exploring melanoma
regression in patients, IL PV-10 has led to a significant decrease of
melA positive melanoma cells in the biopsies of both PV10-injected and
non-injected lesions. This regression correlated with increased
circulating CD3+T cells (p=0.03) in peripheral blood
mononuclear cells (PBMC). T cells purified from PBMC from a melanoma
patient produced increased IFN-gamma in response to autologous tumor
after treatment with PV-10. Ex vivo models implemented to
investigate this phenomenon indicate that the cytotoxicity induced by
PV-10 is not apoptosis-dependent as evidenced by Annexin staining of
melanoma cells following PV-10 treatment. PV-10 directly induced
necrosis of melanoma cells at 50 uM, but was not toxic to healthy
fibroblasts at the same dose. Further preclinical translational testing
has shown that treatment of murine B16 cells with PV-10 leads to release
of HMGB1, a soluble Damage Associated Molecule Pattern (DAMP) that is
important for activation of dendritic cells (DCs). In the murine B16
melanoma model, there is a significant increase in the number of DCs
infiltrating the tumor-draining lymph nodes after IL injection of PV-10.
These findings suggest that PV-10 treatment leads to the release of DC
activating factors and DC recruitment. Further studies to determine the
role of PV-10 on T cell activation are ongoing. In sum, these clinical
and preclinical results increase our understanding of the cytotoxic and
immunological mechanisms that may play a role in systemic immunity
induced by PV-10 tumor ablation.
Please see link:
http://www.abstractsonline.com/Plan/ViewAbstract.aspx?mID=3404&sKey=9a90b661-024e-4702-894a-d3f419f9925e&cKey=3ee0b61c-784a-4e56-8ec7-c9b3d868a8b6&mKey=6ffe1446-a164-476a-92e7-c26446874d93
Craig Dees, Ph.D., CEO of Provectus Pharmaceuticals said, "These data
from the translational medicine team at Moffitt represent an important
corroboration of last year’s mouse data in patients with recurrent
locoregionally advanced melanoma. It is virtually unprecedented for a
small molecule ablative agent like PV-10 to modulate a melanoma
patient’s immune response. This healthy tissue sparing, tumor specific
immune response coupled with rapid tumor burden reduction is a one-two
punch against melanoma. Thanks to the innovative team at Moffitt, we can
better explain the consistent “bystander response” (uninjected tumor
regression) observed in our clinical studies. More data will follow with
the poster.”
Provectus’s PV-10, a 10% solution of Rose Bengal, is currently being
examined as a novel cancer therapeutic. It is designed to selectively
target and destroy cancer cells without harming surrounding healthy
tissue, significantly reducing potential for systemic side effects. In
melanoma patients, intralesional (IL) injection of PV-10 has led to
regression of injected lesions as well as distant metastases (i.e.,
bystander response).
About the American Association for Cancer Research
The AACR is the oldest and largest scientific organization in the world
focused on every aspect of high-quality, innovative cancer research. Its
reputation for scientific breadth and excellence attract the premier
researchers in the field. The programs and services of the AACR foster
the exchange of knowledge and new ideas among scientists dedicated to
cancer research, provide training opportunities for the next generation
of cancer researchers, and increase public understanding of cancer.
About Moffitt Cancer Center
Located in Tampa, Moffitt is one of only 41 National
Cancer Institute-designated Comprehensive Cancer Centers, a
distinction that recognizes Moffitt’s excellence in research, its
contributions to clinical trials, prevention and cancer control. Moffitt
is the No. 1 cancer hospital in Florida and has been listed in U.S. News
& World Report as one of “America’s Best Hospitals” for cancer since
1999. With more than 4,200 employees, Moffitt has an economic impact on
the state of nearly $2 billion. For more information, visit MOFFITT.org,
and follow the Moffitt momentum on Facebook,
Twitter
and YouTube.
About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals specializes in developing oncology and
dermatology therapies. Its novel oncology drug PV-10 is designed to
selectively target and destroy cancer cells without harming surrounding
healthy tissue, significantly reducing potential for systemic side
effects. Its oncology focus is on melanoma, breast cancer and cancers of
the liver. The Company has received orphan drug designations from the
FDA for its melanoma and hepatocellular carcinoma indications. Its
dermatological drug PH-10 also targets abnormal or diseased cells, with
the current focus on psoriasis and atopic dermatitis. Provectus has
recently completed Phase 2 trials of PV-10 as a therapy for metastatic
melanoma, and of PH-10 as a topical treatment for atopic dermatitis and
psoriasis. Information about these and the Company's other clinical
trials can be found at the NIH registry, www.clinicaltrials.gov.
For additional information about Provectus please visit the Company's
website at www.pvct.com
or contact Porter, LeVay & Rose, Inc.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained
herein are subject to certain risks and uncertainties that could cause
actual results to differ materially from those reflected in the
forward-looking statements. Readers are cautioned not to place undue
reliance on these forward-looking statements, which reflect management's
analysis only as of the date hereof. The company undertakes no
obligation to publicly revise these forward-looking statements to
reflect events or circumstances that arise after the date thereof.
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