PV-10 Data Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting Defines Path Forward for Provectus Bi...
June 03 2014 - 8:22AM
Business Wire
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT),
(http://www.pvct.com), a development-stage oncology and dermatology
biopharmaceutical company, announced today that data on its
investigational agent PV-10 for intralesional (IL) treatment of
solid tumors were featured in two presentations in the Poster
Highlights Session, Melanoma/Skin Cancers, on June 2, 2014 during
the American Society of Clinical Oncology (ASCO) annual meeting in
Chicago, IL.
The first highlighted abstract, presented by Sanjiv S. Agarwala,
MD, of the St. Luke's Cancer Center, Bethlehem, PA, entitled
"Efficacy of intralesional rose bengal in patients receiving
injection in all existing melanoma in phase II study PV-10-MM-02"
(abstract 9027), may be viewed at:
http://abstracts.asco.org/144/AbstView_144_132320.html.
The second highlighted abstract, presented by Amod A. Sarnaik,
MD, of Moffitt Cancer Center, Tampa, FL, entitled "Assessment of
immune and clinical efficacy after intralesional PV-10 in injected
and uninjected metastatic melanoma lesions" (abstract 9028), may be
viewed at:
http://abstracts.asco.org/144/AbstView_144_132288.html.
In the phase 2 PV-10 trial, when all existing lesions were
injected with PV-10, tumors were no longer detectable (complete
response) in 50% of the patients (Confidence Interval: 31-69%).
This subgroup analysis supports the potential of PV-10 as a single
agent and provides a rationale for a PV-10 phase 3 randomized
controlled trial in locally advanced melanoma patients.
This phase 3 randomized controlled trial of PV-10 in patients
with unresectable locally advanced cutaneous melanoma will assess
response to PV-10 vs that of systemic chemotherapy in patients who
have disease limited to cutaneous and subcutaneous sites and who
have failed or are ineligible for systemic immunotherapy.
Progression-free survival and complete response rate will be
assessed using standard criteria (RECIST 1.1). Overall survival and
exploratory assessment of patient reported outcomes related to
lesion pain and other melanoma symptoms will also be assessed. The
study is expected to commence this year, and will allow for interim
assessment when 50% of the required events have occurred (i.e.,
disease progressions).
The Moffitt abstract provided interim results of a pilot
clinical trial designed to investigate the local and immunologic
effects of tumor ablation with PV-10. Lead author, Dr. Sarnaik,
noted “In the peripheral blood of patients after PV-10 injection,
we saw a significant increase in circulating T-cells, including
CD3+ and cytotoxic CD8+ cells. This suggests an
immunologic-mediated antitumor response is engendered by PV-10. We
are hoping to undertake combination trials that combine PV-10 with
the promising systemic immunotherapies being developed by our
medical oncology colleagues.”
Eric Wachter, Ph.D., Chief Technology Officer of Provectus,
observed that these results delineate two development paths to
generate data sufficient for a new drug application (NDA) for PV-10
in melanoma.
Dr. Wachter concluded, “Our focus this year will be initiation
of the phase 3 randomized controlled trial. We also expect to begin
the more exploratory combinatorial work that potentially addresses
the needs of patients with more advanced metastatic disease.”
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: This press release contains
“forward-looking statements” as defined under U.S. federal
securities laws. These statements reflect management’s current
knowledge, assumptions, beliefs, estimates, and expectations and
express management’s current views of future performance, results,
and trends and may be identified by their use of terms such as
“anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “predict,” “project,” “will,” and other similar
terms. Forward-looking statements are subject to a number of risks
and uncertainties that could cause our actual results to materially
differ from those described in the forward-looking statements.
Readers should not place undue reliance on forward-looking
statements. Such statements are made as of the date hereof, and we
undertake no obligation to update such statements after this
date.
Risks and uncertainties that could cause our actual results to
materially differ from those described in forward-looking
statements include those discussed in our filings with the
Securities and Exchange Commission (including those described in
Item 1A of our Annual Report on Form 10-K for the year ended
December 31, 2013, and in our Quarterly Report on Form 10-Q for the
quarter ended March 31, 2014), and the following:
- our determination, based on guidance
from the FDA, whether to proceed with or without a partner with a
phase 3 trial of PV-10 to treat locally advanced cutaneous melanoma
and the costs associated with such a trial if it is necessary;
- our determination whether to license
PV-10, our melanoma drug product candidate, and other solid tumors
such as liver cancer, if such licensure is appropriate considering
the timing and structure of such a license, or to commercialize
PV-10 on our own to treat melanoma and other solid tumors such as
liver cancer;
- our ability to license our dermatology
drug product candidate, PH-10, on the basis of our phase 2 atopic
dermatitis and psoriasis results, which are in the process of being
further developed in conjunction with mechanism of action studies;
and
- our ability to raise additional capital
if we determine to commercialize PV-10 and/or PH-10 on our own,
although our expectation is to be acquired by a prospective
pharmaceutical or biotech concern prior to commercialization.
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper, CFO,
COO866-594-5999 #30orPorter, LeVay & Rose, Inc.Marlon Nurse,
DM, SVP – Investor Relations212-564-4700orBill Gordon – Media
Relations212-724-6312
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