PROVECTUS BIOPHARMACEUTICALS, INC. (OTCMKTS:PVCT) Files An 8-K Regulation FD DisclosureItem 7.01.
During its annual meeting of stockholders to be held on June 27, 2018, Provectus Biopharmaceuticals, Inc. (the “Company”) will discuss, among other things, the recently initiated program of single patient expanded access (compassionate use) to PV-10, the Company’s lead investigational oncology drug and small molecule oncolytic immunotherapy.
Physician requests for the treatment use of PV-10 for four patients under single patient expanded access have been approved by the Company since the initiation of this program in January 2018, as follows:
| ● | PV-10 in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 drug, for mucosal melanoma of the vagina (refractory to the combination of YERVOY® (ipilimumab) and KEYTRUDA), |
| ● | PV-10 in combination with BAVENCIO® (avelumab), an anti-PD-L1 drug, for Merkel cell carcinoma (refractory to BAVENCIO), |
| ● | PV-10 in combination with KEYTRUDA for metastatic melanoma (refractory to IMLYGIC® (talimogene laherparepvec), an oncolytic virus drug), and |
| ● | PV-10 in combination with OPDIVO® (nivolumab), an anti-PD-1 drug, for breast cancer (refractory to OPDIVO). |
In each case, single patient expanded access to PV-10 was granted under 21 CFR 312.310(b)(2), which provides for individual patient expanded access (i) within a sponsor’s existing investigational new drug application with the U.S. Food and Drug Administration (the “FDA”) and (ii) with oversight from the respective governing institutional review board. Prior to reporting each case to the FDA, the Company reviewed eligibility in existing Provectus-sponsored clinical trials with the respective patient’s treating physician and Company clinical trial personnel.
Provectus previously provided expanded access to PV-10 for cutaneous and subcutaneous malignancies under 21 CFR 312.315 (treatment of intermediate-size patient populations). This program facilitated access to PV-10 for nearly 190 melanoma and non-melanoma skin cancer patients in the U.S. and Australia from 2009 to 2016.
to the rules and regulations of the Securities and Exchange Commission, the information in this Item 7.01 disclosure is deemed to have been furnished and shall not be deemed to be “filed” under the Securities Exchange Act of 1934, as amended.
About PROVECTUS BIOPHARMACEUTICALS, INC. (OTCMKTS:PVCT)
Provectus Biopharmaceuticals, Inc. is a development-stage biopharmaceutical company. The Company is engaged in developing pharmaceuticals for oncology and dermatology indications. The Company is focused on developing its prescription drug candidates, PV-10 and PH-10. It is developing PV-10 for treatment of several life threatening cancers, including metastatic melanoma, liver cancer and breast cancer. It is developing PH-10 to provide minimally invasive treatment of chronic severe skin afflictions, such as psoriasis and atopic dermatitis, a type of eczema. In addition to clinical trials, patients enrolled in the expanded access or compassionate use program for PV-10 are also receiving PV-10 treatments for cutaneous and subcutaneous cancer indications. The Company also focuses on over-the-counter (OTC) products and various other non-core technologies. PV-10 is a sterile injectable form of rose bengal disodium (Rose Bengal), for direct injection into tumors.
