Rexahn Pharmaceuticals, Inc. (RNN) Initiates Clinical Trial to Evaluate the Safety and Efficacy of Supinoxin


Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) announced that is has begun enrolling patients into a Phase IIa clinical study of Supinoxin™ in metastatic triple negative breast cancer (TNBC).  The study will evaluate the safety and efficacy of Supinoxin™ in patients with metastatic TNBC who have failed prior treatments.

“The dosing of the first patient in the Phase IIa clinical trial with Supinoxin™ is a major milestone for the program,” said Peter D. Suzdak, Ph.D., Chief Executive Officer of Rexahn. “Our decision to focus initially on triple negative breast cancer underscores our commitment to developing our targeted treatments for cancers that are difficult to treat and for which there are limited treatment options.  There is currently no approved drug treatment for TNBC, and no established standard of care, so there is a tremendous unmet medical need.”

“Supinoxin™ has a unique mechanism of action,” said Ely Benaim, M.D., Chief Medical Officer.  “It targets a key biological pathway implicated in cancer cell proliferation.  We have seen very promising activity in our preclinical models of triple negative breast cancer so we look forward to the preliminary readout from this first clinical study, which we anticipate later this year.”

“This is the first Phase IIa study with Supinoxin™ and our initial proof of concept study in triple negative breast cancer,” continued Dr. Benaim.  “We plan also to evaluate Supinoxin™ in combination with other cancer treatments in triple negative breast cancer and in other solid tumors.”

The Phase IIa clinical proof-of-concept study is an open-label evaluation of the safety and efficacy of Supinoxin™ monotherapy in patients with metastatic triple negative breast cancer who have failed multiple prior chemotherapeutic regimens.  The study will recruit an initial 10 patients and can be extended up to 50 patients, if warranted, based on the data readout from the initial cohort of patients. The primary endpoint is progression free survival.  Patients will be enrolled at seven study sites in the United States. Based on the initial clinical data, we may conduct additional clinical studies looking at the combination of Supinoxin together with other anti-cancer agents in TNBC.

Supinoxin™ (RX-5902) is an orally administered, potential first-in-class, small molecule modulator of the β-catenin pathway — a key biological pathway that is activated in tumor cells leading to production of multiple cancer oncogenes and tumor proliferation and metastasis. Supinoxin™ modulates the pathway through inhibition of the interaction of phosphorylated p68 (a regulatory protein) with β-catenin.

Supinoxin™ has been shown to significantly inhibit tumor growth in a preclinical xenograft model of triple negative breast cancer. In addition, it was shown to have markedly synergistic effects when used in combination with a range of commonly used cytotoxics including paclitaxel, cisplatin and doxorubicin against triple negative breast cancer cell lines in in vitro studies.

Supinoxin™ has been evaluated in a Phase I dose-escalation study in patients with a diverse range of metastatic, treatment-refractory tumors including breast, ovarian, colorectal  and neuroendocrine tumors.  Supinoxin™ was safe and well tolerated at the doses tested with no dose limiting toxicities or treatment-related serious adverse events.  The most frequently reported drug related adverse events were mild nausea, vomiting and fatigue. The study showed preliminary evidence of clinical activity with seven patients experiencing disease stabilization and three patients continuing treatment beyond one year.

Shares of Rexahn losed yesterday at $0.229, up $0.01 or 4.27%. RNN has a 1-year high of $0.39 and a 1-year low of $0.13. The stock’s 50-day moving average is $0.19 and its 200-day moving average is $0.20.

On the ratings front, FBR analyst Vernon Bernardino reiterated a Buy rating on RNN, in a report issued on January 24. According to TipRanks.com, Bernardino has a yearly average loss of 17.3%, a 24% success rate, and is ranked #4433 out of 4494 analysts.

Rexahn Pharmaceuticals, Inc. operates as a clinical stage biopharmaceutical company. It dedicates to the discovery, development and commercialization of innovative treatments for cancer and other medical needs. The firm have three clinical stage oncology candidates: Archexin, RX-3117, and Supinoxin and a robust pipeline of preclinical compounds to treat multiple types of cancer. It has also developed proprietary drug discovery platform technologies in the areas of nano-medicines, 3D gold and times.