PROVECTUS ANNOUNCES GRANT OF ORPHAN DRUG DESIGNATION IN U.S. TO PV-10 FOR TREATMENT OF OCULAR MELANOMA
KNOXVILLE, TN, Feb. 12, 2019 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that orphan drug designation (ODD) status was granted by the U.S. Food and Drug Administration (FDA) to small molecule oncolytic immunotherapy PV-10 (to include all melanoma disease affecting the eye and orbit). Intratumoral injection of small molecule oncolytic immunotherapy PV-10 can yield immunogenic cell death (ICD) in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells.1-4
Ocular melanoma is a general category of melanoma disease affecting the eye and orbit. Its most common form, uveal melanoma, is an intraocular affliction originating in melanocytes in the iris, ciliary body, or choroid. Together with melanomas that form in the conjunctiva, cornea, retina, and orbit, these melanomas constitute ocular melanoma. Approximately half of ocular melanoma patients develop metastatic disease despite successful treatment of their primary tumors. Metastatic disease has historically been, and remains, generally fatal.
Preliminary data from Provectus’ uveal melanoma expansion cohort of its Phase 1 “basket study” of PV-10 for the treatment of cancers metastatic to the liver were presented in a poster presentation at the 15th International Congress of the Society for Melanoma Research (SMR 2018 Congress) in late-2018: a total of four patients had received PV-10 for at least one uveal melanoma liver tumor, two patients had received a second round of PV-10 treatment to an additional liver tumor, and one patient initiated standard of care immunotherapy (Opdivo® + Yervoy®) between PV-10 treatments; treatment-related adverse events were consistent with established patterns; and, tumor reduction was observed in 5 of 6 PV-10-injected tumors.
The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. ODD status qualifies companies for benefits that include seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.
ODD status previously was granted to PV-10 for the treatments of , , and .
About PV-10
Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, . PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and .
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company leading the development of a new class of drugs based on halogenated xanthenes, which are chemical small molecules. Information about the Company’s clinical trials can be found at the NIH registry, . For additional information about Provectus, please visit the Company's website at .
References
1. Wachter et al. . Proceedings of SPIE 4620, 143, 2002.
2. Liu et al. . Oncotarget 7, 37893, 2016.
3. Qin et al. . Cell Death and Disease 8, e2584, 2017.
4. Liu et al. . PLoS One 13, e0196033, 2018.
Trademarks
OPDIVO® and YERVOY® are registered trademarks of Bristol-Myers Squibb, New York, New York, U.S.A.
FORWARD-LOOKING STATEMENTS
This 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 ).
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Contact:
Provectus Biopharmaceuticals, Inc.
Tim Scott, Ph.D.
President
Phone: (866) 594-5999
