Day

June 9, 2015

ROCKVILLE, Md., June 8, 2015 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today 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.

NCI developed the NCL to facilitate the translation of promising nanotechnology-based therapeutics for the treatment of cancer, working in concert with the National Institute of Standards and Technology (NIST) and the U.S. Food and Drug Administration (FDA). 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.

“We are very pleased that NCI selected RX-21101 for its NCL program. We believe RX-21101 holds the potential to address the patient population currently being treated with docetaxel in a manner that offers higher efficacy with reduced systemic side effects. Rexahn welcomes the opportunity to work with NCI to advance RX-21101 toward clinical development,” commented Rexahn’s CEO, Peter D. Suzdak, Ph.D.

CAESAREA, Israel, June 8, 2015 /PRNewswire/ — LabStyle Innovations Corp. (DRIO), developer of the Dario™ Diabetes Management Solution, presented a Late Breaking Poster titled, “Performance of Dario Blood Glucose Monitoring System Evaluated in a Clinical Study in Compliance with the New ISO 15197:2013 Standard,” at the ADA’s 75th Anniversary Scientific Sessions.

Dr. Paul Rosman, a member of the LabStyle Innovations Scientific Advisory Board, delivered the presentation at the ADA’s Scientific Session that brings together over 14,000 participants from 124 countries. The poster revealed the results of a 368 patient Diabetes Type 1 and Type 2 study that was performed in the United States.

Results of the study, which was carried out in Ohio, showed that the Dario™ Blood Glucose Monitoring System meets the acceptance criteria of new more stringent ISO 15197:2013. 97.8% of the Dario glucose results fall within + 0.83 mmol/L (15 mg/dL) at glucose concentrations + 15% at glucose concentrations >5.5 mmol/L (>100 mg/dL).

In addition the study demonstrated that usage of the Dario Diabetes Management Solution is simple and intuitive and that the instructional material provided with the device is sufficient to allow a layperson to easily use it.

“I am very excited to have this opportunity to present the very positive results of the performance study that was done at the prestigious ADA scientific session. Dario has been proven to deliver superb accuracy and excellent patient usability which is in line with the experiences patients are having when using Dario to manage their diabetes in their daily lives.” stated Dr. Rosman.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) (“CEL SCI” or the “Company”) today announced that CEL-SCI is now cleared to start patient enrollment in Thailand in its ongoing Phase 3 trial with its investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary (not yet treated) head and neck cancer. Thailand is the 24th country to authorize CEL-SCI’s Phase 3 trial for patient enrollment.

“We have now completed enrollment of over 50% of the anticipated 880 patients in our Phase 3 trial and continue to expand the trial into more sites to increase the rate of enrollment. In the past month alone, we have added Spain and Italy as participating countries in our trial. We plan to have approximately 100 clinical centers around the world in about 25 countries screening and treating patients,” stated CEL-SCI Chief Executive Officer Geert Kersten.

As of May 31, 2015, 463 patients had been enrolled in the global Phase 3 study.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care (“SOC”) vs. subjects who are treated with SOC only.