Hemispherx Announces Progress Toward Opening of Prostate Cancer Study at Roswell Park Comprehensive Cancer Center
May 13 2019 - 8:30AM
Hemispherx Biopharma Inc., (NYSE American: HEB), an immuno-pharma
company focused on the research and development of therapeutics to
treat multiple types of cancers and immune-deficiency diseases,
announced progress toward the opening of Roswell Park Comprehensive
Cancer Center’s clinical study incorporating Ampligen as part of a
treatment combination for prostate cancer. Roswell Park now has FDA
authorization to proceed with its Phase 2 study investigating the
effectiveness and safety of aspirin and Ampligen with or without
interferon-alpha 2b (Intron A) compared to no drug treatments in a
randomized three-arm study of patients with prostate cancer before
undergoing radical prostatectomy.
See full details of the study at ClinicalTrials.gov.
In January of this year, Roswell Park’s Institutional Review
Board approved the protocol, designed by two Roswell Park faculty
members, Gurkamal Chatta, MD, and Pawel Kalinski, MD, PhD, for
treatment of up to 60 patients.
Aspirin may help to keep the prostate cancer from recurring,
while Ampligen may stimulate the immune system and interfere with
the ability of tumor cells to proliferate. Interferon-alpha 2b may
improve the body’s natural response to infections and may slow
tumor growth. It is not yet known how well Ampligen, aspirin, and
interferon-alpha 2b will work in treating patients with prostate
cancer undergoing surgery. This FDA authorization to proceed sets
the stage for opening enrollment in the study.
“This positive progress in commencing a new prostate cancer
clinical trial is just one more step in our focused plan for
R&D success," said Hemispherx CEO Thomas K. Equels.
“When our management team began three years ago, Hemispherx
identified four significant steps we needed to take to make our
company a success. First, raise the funds necessary to produce our
drug candidate, Ampligen, for use in immuno-oncology clinical
trials and other programs. Second, produce adequate supplies of
Ampligen to conduct such trials. Third, initiate multiple
immuno-oncology clinical trials. We have now accomplished each of
these steps and are using Ampligen to treat cancers in clinical
trials. Now is the time for us to seek out big pharma partners who
share our excitement and enthusiasm for the potential of Ampligen.
We believe that success in these trials will create the environment
for that goal. Accomplishing success in R&D is based on such
progress."
Our ongoing clinical trials:
- Phase 1 / 2 study of intraperitoneal chemo-immunotherapy in
recurrent ovarian cancer at University of Pittsburgh Medical
Center. Dr. R. Edwards, PI. Eleven of 12 planned patients enrolled
in Stage I. See full details of the study at
ClinicalTrials.gov.
- Phase 2a study of Ampligen as component of chemokine modulatory
regimen on colorectal cancer metastatic to liver at Roswell Park
Comprehensive Cancer Center. Dr. P. Boland, PI. Six of 12 planned
patients enrolled. See full details of the study at
ClinicalTrials.gov.
- Phase 2 study of metastatic triple-negative breast cancer using
chemokine modulation therapy, including Ampligen and pembrolizumab
at Roswell Park Comprehensive Cancer Center. Dr. M. Opyrchal, PI.
See full details of the study at ClinicalTrials.gov.
- Phase 2 study of advanced ovarian cancer using cisplatin,
pembrolizumab, plus Ampligen at University of Pittsburgh Medical
Center. Dr. R. Edwards, PI. Up to 45 patients to be enrolled. See
full details of the study at ClinicalTrials.gov.
- FDA-authorized Expanded Access Program (AMP-511) to treat
ME/CFS patients.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma company focused
on the research and development of therapeutics to treat multiple
types of cancers. Hemispherx's flagship products include the
Argentina-approved drug rintatolimod (trade names Ampligen® or
Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on
results of published, peer-reviewed pre-clinical studies and
clinical trials, Hemispherx believes that Ampligen® may have
broad-spectrum anti-viral and anti-cancer properties. Clinical
trials of Ampligen® already conducted include studies of the
potential treatment of cancer patients with renal cell carcinoma
and malignant melanoma. These and other potential uses will require
additional clinical trials to generate the safety and effectiveness
data necessary to support regulatory approval and additional
funding. Rintatolimod is a double-stranded RNA being developed for
globally important debilitating diseases and disorders of the
immune system.
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. 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: 800-778-4042Email:
IR@hemispherx.net
Or
LHA Investor RelationsMiriam Weber MillerSenior Vice
PresidentPhone: +1-212-838-3777Email: mmiller@lhai.com
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