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Rexahn Announces Poster Presentations at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting

ROCKVILLE, Md., May 13, 2015 (GLOBE NEWSWIRE) -- Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced it will present three posters at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting taking place at the McCormick Place Convention Center in Chicago, Illinois on May 29-June 2, 2015. An additional abstract will be available on-line.

The details of the poster sessions are as follows:

Trials in Progress Presentation
Title: A phase 1 study of RX-5902, an oral agent targeting phosphorylated p68, to treat subjects with advanced solid tumors.
Date: Saturday, May 30, 2015
Poster Viewing Session: 8:00 – 11:30a.m. CDT
Location: S Hall A
Poster Number: 319B
Abstract: TPS2608
Lead Author: S. Gail Eckhardt, MD, University of Colorado School of Medicine, Anschutz Medical Campus

Trials in Progress Presentation
Title: A phase I study of RX-3117, an oral agent activated by uridine cytidine kinase 2, to treat subjects with advanced solid tumors.
Date: Saturday, May 30, 2015
Poster Viewing Session: 8:00 – 11:30a.m. CDT
Location: S Hall A
Poster Number: 319A
Abstract: TPS2605
Lead Author: Drew Warren Rasco, MD, START Center for Cancer Care, San Antonio Texas

Trials in Progress Presentation
Title: A multicenter, open-label, proof of concept phase 1b/2 study to evaluate the safety and efficacy of RX-0201 in combination with everolimus to treat subjects with advanced renal cell carcinoma.
Date: Monday, June 1, 2015
Poster Viewing Session: 1:15 PM - 4:45 PM CDT
Location: S Hall A
Poster Number: 249A
Abstract: TPS4580
Lead Author: Christine Peterson, PhD, on behalf of the Rexahn Renal Cancer Study Team

On-line publication
Title: A phase 1 exploratory study of RX-3117 to determine oral bioavailability in cancer subjects with solid tumors.
Abstract: e13545
Location: www.asco.org and jco.ascopubs.org
Lead Author: Istvan Udvaros, MD, Phase I Clinical Pharmacology Unit, PRA Hungary Ltd

About Supinoxin™ (RX-5902)

Supinoxin™ (RX-5902) is an orally administered, potential first-in-class, small molecule inhibitor of phosphorylated-p68 (P-p68). P-p68, which is selectively overexpressed 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 phosphorylated-p68 has been observed in solid tumors, such as melanoma, colon, ovarian and lung tumors. In preclinical studies, Supinoxin has been shown to inhibit proliferation of cells in 18 human cancer cell lines including breast, colon, pancreas, ovarian, and stomach cancers, and showed potent activity in drug-resistant cancer cells. In preclinical animal model, where human cancer cells from melanoma, pancreas, renal or ovarian tumors were grafted into animals, treatment with Supinoxin resulted in a significant reduction in tumor growth.

Supinoxin is undergoing a Phase I dose-escalation clinical trial in cancer patients with solid tumors designed to evaluate the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD). Secondary endpoints include pharmacokinetic analysis and evaluating the preliminary anti-tumor effects of Supinoxin. This trial is being conducted at 3 clinical oncology centers in the United States. Each patient has the ability to continue on the drug up to six cycles of treatment (a dosing cycle is defined as 3 weeks of drug treatment followed by 1 week off) if no disease progression is seen. Patients are assessed by CT or MRI prior to the start of therapy and after every two cycles of therapy to assess tumor progression. The decision to escalate dose is made after completion of one cycle of treatment based on safety and tolerability. Patients have the possibility to receive up to 6 cycles of treatment if the disease does not progress. Tumor biopsy samples are taken to assess the biomarker phosphorylated-p68. Patients in seven dose groups (25, 50, 100, 150, 225, 300 and 425 mg) have been enrolled, and the MTD has not yet been reached. In preliminary pharmacokinetic data, Supinoxin has approximately 51% oral bioavailability. The ongoing Phase I clinical trial is expected to be completed in the first half of 2015 once the MTD has been achieved.

About RX-3117

RX-3117 is a novel small molecule nucleoside compound that once activated (phosphorylated) by UCK2 is incorporated into DNA or RNA of cells and inhibits both DNA and RNA synthesis which induces apoptotic cell death of tumor cells. UCK2 is overexpressed in various human cancer 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 gemcitabine resistant cancer cells.

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, RX-3117 still retains its full anti-tumor activity in human cancer cell lines made resistant to the anti-tumor effects of gemcitabine. 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.

RX-3117 is undergoing a Phase Ib clinical trial in cancer patients with solid tumors. The Phase Ib clinical trial is a multi-center dose-escalation study that will evaluate the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) of RX-3117 in patients with solid tumors. Secondary endpoints will include characterizing the pharmacokinetic profile of RX-3117 and evaluating the preliminary anti-tumor effects of RX-3117. Patient enrollment has been completed in eight dose groups (30, 60, 100, 150, 200, 500, 1000 and 1500 mg). The MTD of RX-3117 has not yet been achieved. The ongoing Phase I clinical trial is expected to be completed in the first half of 2015 once the MTD has been achieved.

About Archexin®

Archexin® is a specific inhibitor of the cancer cell signaling protein Akt-1. The activated form of Akt-1 (phospho-Akt-1) has been shown to be involved in cancer cell growth, survival, angiogenesis, and drug resistance. Phospho-Akt-1 has been shown to be significantly increased in more than 12 different human cancer cell lines including human renal cell carcinoma (RCC) cells. Archexin has shown to inhibit the growth of human RCC cells in tissue culture and produce a substantial survival benefit in animal xenograft models of RCC. Archexin also exhibits additive anti-tumor effect when combined with other cancer drugs in inhibiting the growth of human RCC cells in tissue culture. In addition, resistance to the anti-cancer effects of clinically used mTOR inhibitors such as everolimus (Afinitor®), which is used as second line therapy in RCC patients, has been attributed to an increase in Akt-1 activity. Thus, treatment with Archexin may both inhibit the growth/proliferation of RCC and overcome the resistance to mTOR inhibitors such as everolimus, resulting in an increase in efficacy. Rexahn has initiated a Phase IIa proof-of-concept clinical trial designed to evaluate the efficacy of Archexin in combination with everolimus (Afinitor®) to treat metastatic RCC patients that will be conducted in two stages. Stage 1 will be dose ranging with up to 3 cohorts of 3 RCC patients to determine its maximum tolerated dose in combination with everolimus. Based on previous clinical data the target dose of Archexin is anticipated to be no more than 250 mg/m2 per day. The decision to enroll the next group of patients and escalate the dose will be made after completion of the first 21 day cycle of treatment. Patient assessments will include safety, pharmacokinetics, laboratory and physical exams. Once the maximum tolerated dose of Archexin in combination with everolimus has been determined, stage 2 will be initiated with thirty RCC patients being randomized to either Archexin in combination with everolimus or everolimus alone, in a ratio of 2:1.

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, SupinoxinTM (RX-5902), RX-3117 and Archexin® 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 cash flow requirements, future operations and products, enrollments in clinical trials, the path of clinical trials and development activities, 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 success and design 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 Chad Rubin (646) 378-2953 crubin@troutgroup.com

Source:Rexahn Pharmaceuticals