Rexahn Pharmaceuticals Provides a Clinical Development and Financial Update

Fortified balance sheet to fund initiation of three clinical trials in 2013 with data expected in 2014

Business Wire

ROCKVILLE, Md.--(BUSINESS WIRE)--

Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, is providing an update today on its three clinical development programs: RX-3117 (DNA synthesis inhibitor), Supinoxin™ (RX-5902, p68 RNA Helicase inhibitor), and Archexin® (Akt-1 inhibitor). In addition to its three drug candidates in Phase I and Phase II trials, Rexahn has a portfolio of additional compounds, including three in pre-clinical studies.

Clinical Development Highlights:

  • RX-3117 IND Cleared with Phase I Clinical Trial to Begin in Q4 2013

The Investigational New Drug (IND) application for RX-3117 filed in July 2013 has now cleared the 30 day review period by the US Food and Drug Administration (FDA). Rexahn expects to initiate a Phase I clinical trial in cancer patients during the fourth quarter of 2013. Additionally, Rexahn will be exploring potential partnering opportunities with oncology focused pharmaceutical companies.

On August 28, 2013, Rexahn announced that Teva Pharmaceutical Industries did not exercise its option to license RX-3117, for strategic reasons. Teva had invested $9.1M in the development of RX-3117. According to Teva, “RX-3117 appears to have potential in various indications, but does not align with Teva’s new Oncology strategy.” As a result, Rexahn retains all development and commercial rights to RX-3117.

In August 2012, Rexahn reported the completion of an exploratory Phase I clinical trial of RX-3117 in cancer patients conducted in Europe, to investigate the oral bioavailability, safety and tolerability of the compound. In this study, oral administration of RX-3117 demonstrated an oral bioavailability of 56% and a plasma half-life (T1/2) of 14 hours. In addition, RX-3117 was safe and well tolerated in all subjects throughout the dose range tested

  • Supinoxin™ (RX-5902) Phase I Clinical Trial in Progress

Enrollment in a Phase I clinical trial with Supinoxin™ (RX-5902) in cancer patients with solid tumors began in August. This trial is a multi-center study, designed to evaluate the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) in patients with solid tumors. Rexahn anticipates updating investors on this Phase I trial in early 2014.

The trial is being conducted in three clinical oncology centers in the United States with a dose escalation design. Patients will receive doses of Supinoxin on days 1, 8 and 15 and the decision to escalate the dose will be made after one cycle of treatment, based on safety and tolerability. Each patient will then have the ability to continue on drug for a total of six cycles of treatment. Patients will be assessed by CT or MRI prior to the start of therapy and after every two cycles of therapy for tumor progression.

  • Archexin® Phase IIa Clinical Trial Design Being Developed

A scientific, clinical and business analysis of potential indications for a Phase IIa clinical trial with Archexin® was completed following the Phase I trial. Rexahn is now working with key clinical opinion leaders to finalize the design of a Phase IIa clinical trial in a selected tumor type. Rexahn anticipates updating investors on the tumor type selection and Phase IIa trial timeline in the fourth quarter of 2013.

Financial Update:

As of September 1, 2013, Rexahn’s cash and cash equivalents on hand totaled approximately $15.7 million and the Company had approximately 134.2 million shares of common stock outstanding. For the six month period ended June 30, 2013, total operating expenses were $3.8 million.

On July 26, 2013, Rexahn completed a $5.7 million registered direct offering with a single healthcare-focused institutional investor for a purchase price of $0.50 per share. The proceeds of this offering will be used for further research and development of the Company’s pipeline.

“We are excited to continue into the second half of 2013, and to advance our strong pipeline of oncology drug candidates into the clinic,” commented Rexahn’s Chief Executive Officer Peter D. Suzdak, PhD. "We are also pleased that we were able to strengthen the balance sheet recently which will allow us to increase the momentum for the clinical development of our pipeline. Rexahn’s treatments address the global targeted oncology market which is estimated to reach $51 billion by 2015, according to Decision Resources. We are optimistic for successful outcomes of the Phase I clinical trials for Supinoxin and RX-3117, and the Phase IIa clinical trial for Archexin. We anticipate that we will have results from each of these trials in 2014.”

About RX-3117

RX-3117 is a novel small molecule anti-metabolite that is incorporated into DNA or RNA of cells and inhibits both DNA and RNA synthesis which induces apoptotic cell death of tumor cells. RX-3117 also mediates the downregulation of DNA methyltransferase 1 (DNMT1), an enzyme responsible for the methylation of cytosine residues on newly synthesized DNA and also a target for anticancer therapies. Preclinical studies have shown RX-3117 to be effective in both inhibiting the growth of various human cancer xenograft models, including colon, lung, renal and pancreas, as well as overcoming chemotherapeutic drug resistance.

RX-3117 has demonstrated a broad spectrum anti-tumor activity against 50 different human cancer cell lines and efficacy in 12 different mouse xenograft models. The efficacy in the mouse xenograft models was superior to that of gemcitabine. In addition, in human cancer cell lines made resistant to the anti-tumor effects of gemcitabine, RX-3117 still retains its full anti-tumor activity. These findings have either been previously presented (American Association of Cancer Research Meeting in 2012) or will be the subject of a peer reviewed publication to be published in early 2014.

About Supinoxin™ (RX-5902)

Supinoxin is an orally administered, first-in-class, small molecule inhibitor of phosphorylated-p68 RNA helicase (P-p68). P-p68, which is selectively expressed in cancer cells and is absent in normal tissue, increases the activity of multiple cancer related genes including cyclin D1, c-jun and c-myc, and plays a role in tumor progression and metastasis. Over-expression of P-p68 has been observed in solid tumors such as melanoma, colon, ovarian and lung.

About Archexin®

Archexin® is a unique anti-cancer drug candidate which inhibits the cancer cell signaling protein Akt-1, which is involved in cancer cell growth, survival, angiogenesis, and drug resistance. Archexin has completed a Phase I clinical trial in cancer patients with solid tumors and was shown to be safe and well tolerated. The dose-limiting toxicity was a grade 3 fatigue. In a small Phase IIa trial in advanced pancreatic cancer patients, Archexin in combination with gemcitabine was shown to be safe and well tolerated and demonstrated a preliminary efficacy signal with a median survival of 9.1 months in evaluable patients.

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to developing best-in-class therapeutics for the treatment of cancer. Rexahn currently has three clinical stage oncology candidates, Archexin®, RX-3117, and SupinoxinTM (RX-5902) and a robust pipeline of preclinical compounds to treat multiple types of cancer. Rexahn has also developed proprietary drug discovery platform technologies in the areas of Nano-Polymer-Drug Conjugate Systems (NPDCS), nano-medicines, 3D-GOLD, and TIMES. For more information, please visit www.rexahn.com.

Safe Harbor

To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about Rexahn’s plans, objectives, expectations and intentions with respect to future operations and products and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Rexahn’s actual results to be materially different than those expressed in or implied by Rexahn’s forward-looking statements. For Rexahn, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of Rexahn’s licensees or sublicensees; the success of clinical testing; and Rexahn’s need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect Rexahn’s actual results are described in Rexahn’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. Rexahn undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:
The Trout Group LLC
Tricia Truehart, 646-378-2953
ttruehart@troutgroup.com

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