UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
February 8, 2019
HEMISPHERX BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 0 - 27072 | 52-0845822 | ||
| (state or other jurisdiction | (Commission | (I.R.S. Employer | ||
| of incorporation) | File Number) | (Identification No.) |
| 2117 SW Highway 484, Ocala FL | 34473 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (215) 988-0080
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item 8.01 Other Events
On February 11, 2019, Hemispherx Biopharma, Inc. issued a press release about the commencement of a clinical trial combining Ampligen and Merck’s Keytruda in the treatment of recurrent ovarian cancer.
The press release is attached as Exhibit 99.1 to this report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
||
| 99.1 | Press Release dated February 11, 2019 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| HEMISPHERX BIOPHARMA, INC. | ||
| February 11, 2019 | By: | /s/ Adam Pascale, CFO |
| Adam Pascale, CFO | ||
Exhibit 99.1
Hemispherx Biopharma Announces Commencement of a New 45 Subject Clinical Trial Combining Ampligen and Merck’s Keytruda in the Treatment of Recurrent Ovarian Cancer
OCALA, Fla., February 11, 2019 — Hemispherx Biopharma, Inc. (NYSE American: HEB), an immuno-pharma company focused on unmet medical needs in immunology and oncology, announced today the start at the UPMC Hillman Cancer Center in Pittsburgh, PA of a new clinical study supported by Merck that will combine the company’s Ampligen with Merck’s Keytruda for the treatment of recurrent, platinum-sensitive, ovarian cancer. The study will enroll up to 45 participants and be conducted at UPMC, which is sponsoring the study, by Robert Edwards, MD, director of the Ovarian Cancer Program at UPMC Magee Womens Hospital. The overall funding and support for the clinical trial and the supply of Keytruda is based upon a collaboration between Merck and UPMC. Hemispherx is not funding the clinical trial and its collaboration obligation relates to supplying the Ampligen needed for the clinical trial. Over the past year, Hemispherx has produced 16,000 vials of Ampligen, including all of the supply of Ampligen needed for this clinical trial. Hemispherx shipped Ampligen for the clinical trial to UPMC on January 29, 2019 and the first subject was enrolled. The company believes the study will be an important and more extensive test of Ampligen as an immune system primer that can convert “cold” tumors into “hot” tumors, thereby making the formerly “cold” tumors more responsive to Keytruda. https://clinicaltrials.gov/ct2/show/NCT03734692?term=rintatolimod&cond=Ovarian+Cancer&cntry=US&state=US%3APA&city=Pittsburgh&rank=1
This clinical trial will study how well Ampligen-based combination therapy works when given with Cisplatin and Keytruda in treating participants with recurrent ovarian cancer compared to historical controls. Drugs used in this combination therapy work by either direct antitumor activity, or by unleashing or enhancing the cancer immune responses that already exist. So called “checkpoint inhibitors” such as Merck’s Keytruda interfere with the ability of tumor cells to grow and spread when present in a “hot” tumor microenvironment. The clinical trial tests whether the combination therapy will work better than Keytruda alone in treating participants with ovarian cancer. Studies from UPMC and the Roswell Park Comprehensive Cancer Center, in human tumor explants, have demonstrated that Ampligen is a TLR3 restricted and targeted immune modulator that can facilitate the transformation of some “cold” tumor microenvironments into “hot” tumor microenvironments (Cancer Res. 2018 Aug 1;78(15):4292-4302).
“At Hemispherx we are determined to pursue a comprehensive R&D program focused on improved immune therapies for lethal malignancies such as recurrent ovarian cancer. We at Hemispherx are deeply grateful for the attention and support we are getting from Merck and the world-class ovarian cancer team at UPMC in this important major clinical trial,” said Hemispherx CEO Thomas K. Equels. “We believe this clinical study at UPMC is an important step in Hemispherx’ overall clinical plan in immuno-oncology and just one of the major milestones we have recently announced. We believe that the clinical trials that are now underway are very important to our company. We have seen a clear synergistic effect in our animal laboratory studies in several different solid tumors. Data from human tumor explants indicate this phenomenon may extend to humans. In addition to the already existing large IV safety profile, we have established that Ampligen is generally well tolerated intraperitoneally. To the extent this follows through in vivo with humans in these clinical trials, we believe the expected synergy with the checkpoint inhibitors in humans has the potential to position Ampligen as a medical translational breakthrough in immuno-oncology. We believe the Ampligen clinical data are important first and foremost to those in need of such enhanced immuno-therapeutic response in recurrent cancers as well as a long-term driver for stockholder value. “
Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. Among other things, no assurance can be given as to whether the trial at UPMC or other ongoing or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the sponsoring Universities or Cancer Centers. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
Contacts:
Hemispherx Biopharma, Inc.
Phone: 800-778-4042
Email: IR@hemispherx.net
Or
LHA Investor Relations
Miriam Weber Miller
Senior Vice President
Phone: +1-212-838-3777
Email: mmiller@lhai.com