Provectus Biopharmaceuticals Inc. Submits Application to FDA to Receive Breakthrough Therapy Designation for PV-10 for Treatm...
March 24 2014 - 6:05AM
Business Wire
FDA Expected to Make Determination within 60
Days upon Receipt
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.
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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