Provectus Biopharmaceuticals, Inc. (OTCQB:PVCT) (http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company,
announced today that it has applied to the FDA for Breakthrough Therapy
Designation (BTD) for PV-10 for the treatment of melanoma. FDA
guidelines state that the Agency will make a decision on the application
within 60 days of receipt. The Agency’s records for FY 2013 show that
the Agency’s Center for Drug Evaluation and Research (CDER) met that
guideline 97% of the time.
Craig Dees, PhD, CEO of Provectus said, "The decision to apply for BTD
stems from our Type C meeting held with the FDA’s Division of Oncology
Products 2 in December 2013. At the meeting FDA expressed willingness to
work with Provectus toward initial approval for the novel
investigational oncology drug PV-10 in locally advanced cutaneous
melanoma. This included a statement in the minutes that data in a cohort
of patients that received PV-10 to all existing lesions should be
submitted in a formal BTD application.”
Dees continued, “I want to make clear to our shareholders, the media and
the market as a whole that BTD is not guaranteed and if the designation
is conferred on PV-10 for melanoma, it does not bypass the need for a
new drug application (NDA) and review, as both are required for
commercialization of any drug. As I have stated previously, the Agency
may yet recommend and it may be in the best interest of Provectus to
undertake a small, short bridging study in patients where all tumor
burden can be injected. This could occur either before or after we have
approval to sell PV-10. Provectus has over $16 million in cash reserves
and would not require additional capital or the resources of a partner
to conduct such a study. If such a study is conducted, it also fits with
needs for an international study supportive of licensure in Australia,
Europe, China and India.”
Dees concluded, “We are confident that the studies done thus far
illustrate the effectiveness and safety of PV-10: if you inject PV-10
into melanoma tumors, the tumors go away. For recurrent, aggressive skin
cancers this unique mechanism confers tangible benefit to patients.”
In addition to PV-10 for melanoma, Provectus has recently initiated
patient enrollment at St. Luke’s Hospital in Bethlehem, PA, for protocol
PV-10-LC-01, which is assessing safety and preliminary efficacy of PV-10
for treatment of tumors of the liver. This is the third site
participating in the study, in addition to Sharp Memorial Hospital, San
Diego, CA and The Southeastern Center for Digestive Disorders &
Pancreatic Cancer, Tampa, FL.
Furthermore, St. Luke’s, Sharp Memorial, M.D. Anderson Cancer Center in
Houston, TX, and the University of Louisville in Louisville, KY, as well
as key Australian centers, are participating in the expanded access
study PV-10-EA-02, which affords access to PV-10 to patients with
cutaneous or subcutaneous cancers who have exhausted all other treatment
options.
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.
Copyright Business Wire 2014