Rexahn Pharmaceuticals, Inc. Appoints Peter Brandt as Chairman of the Board
Jun 22 15
Rexahn Pharmaceuticals, Inc. announced the appointment of Peter Brandt as Chairman of the Board. Dr. Chang Ahn, Rexahn’s founder, will remain on the Board as Chairman Emeritus and will continue in his role as the company’s Chief Scientist. A Director of Rexahn since 2010, Mr.Brandt previously served as President and Chief Executive Officer of Noven Pharmaceuticals until its acquisition by Hisamitsu Pharmaceutical in 2009.
National Cancer Institute Selects RX-21101 of Rexahn Pharmaceuticals, Inc for its Preclinical Characterization Program
Jun 8 15
Rexahn Pharmaceuticals, Inc. announced that its drug candidate RX-21101 was selected by the National Cancer Institute's (NCI) Nanotechnology Characterization Laboratory (NCL) for its preclinical characterization program to help facilitate the advance of RX-21101 towards human clinical trials. RX-21101 is a polymer conjugated form of docetaxel that contains a signaling moiety which directs the drug into the tumor. This approach may maximize the level of docetaxel in the tumor and may minimize the level of freely circulating docetaxel in the body, which may result in increased anti-tumor activity and a reduction of adverse events. NCL will conduct an extensive series of preclinical studies on RX-21101 including physiochemical characterization, in-vitro cytotoxicity/hematology/immunology studies, and in vivo rodent pharmacokinetic studies. These studies, together with the additional work being performed by Rexahn scientists, will provide the foundation for filing an investigational new drug (IND) application to start Phase I clinical testing.
Rexahn Pharmaceuticals, Inc. Reports Earnings Results for the First Quarter Ended March 31, 2015; Provides an Update of its Three Clinical Development Programs
May 11 15
Rexahn Pharmaceuticals, Inc. reported earnings results for the first quarter ended March 31, 2015. The company loss from operations was $4.4 million and $2.8 million for the three months ended March 31, 2015 and 2014, respectively. The company's net loss was $4.3 million, or $0.02 per share, for the three months ended March 31, 2015, compared to a net loss of $14.6 million, or $0.09 per share, for the three months ended March 31, 2014. Included in the net loss for the three months ended March 31, 2015 and 2014 is an unrealized gain (loss) on the fair value of warrants of $0.1 million and $11.7 million, respectively. The fair value adjustments are primarily a result of the changes in the stock price between reporting periods. Cash and investments totaled $29.4 million as of March 31, 2015, compared to $32.7 million as of December 31, 2014. The decrease of $3.3 million was primarily due to $4.0 million of cash used in
operating activities, offset by $0.7 million in proceeds received from the exercise of stock options. The company expects that its cash and investments as of March 31, 2015 will be sufficient to fund the company's cash flow requirements for its current activities into the second half of 2016.
The company provided an update of its three clinical development programs. Supinoxin (RX-5902): An ongoing Phase I dose-escalation clinical trial of Supinoxin is designed to evaluate the safety, tolerability, dose-limiting toxicities and maximum tolerated dose (MTD) in cancer patients with solid tumors. Secondary endpoints include pharmacokinetic analysis and evaluating the preliminary anti-tumor effects of Supinoxin. 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. Depending upon the number of dose groups needed to determine the MTD, Rexahn expects to complete this trial in the first half of 2015. Supinoxin continues to preliminary demonstrate safety and tolerability, requiring higher dose levels than expected to achieve the MTD. RX-3117: An ongoing Phase Ib dose-escalation clinical trial of RX-3117 is designed to evaluate the safety, tolerability, dose-limiting toxicities and MTD in cancer patients with solid tumors. Secondary endpoints include pharmacokinetic analysis 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, 1,000 and 1,500 mg). The MTD of RX-3117 has not yet been achieved. Rexahn expects to complete this trial in the first half of 2015. RX-3117 continues to preliminary demonstrate safety and tolerability, requiring higher dose levels than expected to be tested to achieve the MTD. To date, no dose-limiting toxicities have been associated with RX-3117 treatment. Archexin: The Phase IIa proof-of-concept clinical trial of Archexin in metastatic renal cell carcinoma (RCC) patients is ongoing. The first stage of this study is dose ranging, with up to three dose groups with three RCC patients each, to determine the MTD of Archexin in combination with everolimus, an FDA approved drug for the treatment of RCC. Patient enrollment is ongoing. Rexahn has orphan drug designation for this indication.