CHARLOTTESVILLE, Va., June 08, 2016 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (OTCQX:DFFN), a clinical
stage biotechnology company focused on the development of novel small molecule therapeutics for cancer, today announced that a U.S.
patent application, entitled “Bipolar Trans Carotenoid Salts and Their Uses,” was allowed by the United States Patent and
Trademark Office.
This application, which is expected to issue in the second half of 2016, expands coverage of the therapeutic use
of trans sodium crocetinate (TSC) and other related compounds to five hypoxia-related conditions including congestive
heart failure, chronic renal failure, acute lung injury (ALI), chronic obstructive pulmonary disease (COPD), and respiratory
distress syndrome (RDS). Diffusion’s patent estate currently includes the use of TSC in oncology, stroke, and
neurodegenerative disease (such as Alzheimer’s disease) indications.
David Kalergis, Chairman and Chief Executive Officer of Diffusion, remarked, “The allowance of this patent
application is a significant milestone for Diffusion as it expands our patent estate and underscores the potential of TSC to serve
as a primary therapeutic agent in many conditions involving hypoxia. Over the long term, we look forward to evaluating development
opportunities across the five new indications covered by the patent. We are currently focused on expanding the clinical
development pipeline for TSC from treatment for glioblastoma (GBM) to include treatment for pancreatic cancer.”
About Diffusion Pharmaceuticals
Diffusion Pharmaceuticals is a clinical stage biotechnology company focused on extending the life expectancy of cancer patients by
improving the effectiveness of current standard-of-care treatments including radiation therapy and chemotherapy. The
Diffusion technology is a paradigm shift in the approach to the treatment of cancer and other diseases involving hypoxia, or oxygen
deprivation, in that it facilitates the diffusion of oxygen to the hypoxic tissues. Diffusion is developing its lead drug,
trans sodium crocetinate (TSC), for use in the many cancer types in which tumor hypoxia is known to diminish the
effectiveness of current treatments. TSC targets the cancer’s hypoxic micro-environment, re-oxygenating treatment-resistant
tissue and making the cancer cells more vulnerable to the therapeutic effects of treatments such as radiation therapy and
chemotherapy, without the apparent addition of any serious side effects.
A Phase 2 clinical program, completed in the second quarter of 2015, evaluated 59 patients with newly diagnosed
glioblastoma multiforme (GBM). This open label, historically controlled study demonstrated a favorable safety and efficacy
profile for TSC combined with standard of care. The U.S. Food and Drug Administration has agreed upon the design of a Phase 3
trial in newly diagnosed GBM. Additional planned studies, subject to receipt of necessary financing, include the Phase 2
trial in pancreatic cancer and a study in brain metastases. Due to its novel mechanism of action, TSC has safely re-oxygenated a
range of tumor types in our preclinical and clinical studies. The Company believes its therapeutic potential is not limited to
specific tumors, thereby making it potentially useful to improve standard-of-care treatments of other life-threatening cancers.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that are not historical facts, these
are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not
limited to, statements about the company’s plans, objectives, expectations and intentions with respect to future operations and
products, the potential of the company’s technology and product candidates, the continued development of TSC in GBM, pancreatic
cancer and possibly other indications, and other statements that are not historical in nature, including those that utilize
terminology such as “would,” “will,” “plans,” “possibility,” “potential,” “future,” “expects,” “anticipates,” “believes,”
“intends,” “continue,” “estimates,” “targets,” “projects,” “intends,” and similar expressions, derivations of such words and the
use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain and
involve both known and unknown risks. These uncertainties and risks may cause the Company’s actual results to be materially
different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include:
general business and economic conditions; the Company’s need for and ability to obtain additional financing; the Company’s ability
to satisfy regulatory requirements with respect to its product candidates; the Company’s ability to maintain and defend its
intellectual property; the conduct and success of the Company’s clinical trials, including successful enrollment in those trials;
the safety and efficacy of the Company’s product candidates; the Company’s ability to retain and recruit qualified personnel; the
difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; and the
other factors discussed in the Company’s public filings, including the risk factors included in the Company’s most recent
Annual Report on Form 10-K. All forward-looking statements in this news release speak only as of the date of this
news release and are based on Company management’s current beliefs and expectations. Investors, potential investors
and other readers are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not
to place undue reliance on such forward-looking statements. The Company undertakes no obligation to update or revise any
forward-looking statement, whether as a result of new information, future events or otherwise after the date of this
release, except as required by applicable law.
Diffusion Pharmaceuticals Contacts David Kalergis Chief Executive Officer Diffusion Pharmaceuticals Inc. (434) 220-0718 dkalergis@diffusionpharma.com Stephanie Carrington ICR Inc. (646) 277-1282 Stephanie.Carrington@icrinc.com
