ROCKVILLE, Md., Jan. 6, 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 the online publication of preclinical results for RX-3117 in the peer reviewed medical journal, Anticancer Research, in an article titled, “A Novel Cytidine Analog, RX-3117, Shows Potent Efficacy in Xenograft Models, Even in Tumors that are Resistant to Gemcitabine”. The article was coauthored by Dr. G.J. Peters of the VU University of The Netherlands and Rexahn scientists.

In this study, the efficacy of orally administered RX-3117 was examined in nine different human tumor Xenograft models that had differing degrees of resistance to gemcitabine. In the four high gemcitabine resistant models gemcitabine treatment resulted in 0% to 30% tumor growth inhibition, whereas oral treatment with RX-3117 induced tumor growth inhibition between 62% to 100%. RX-3117 was also evaluated in a primary low passage Champions Tumorgraft(TM) model derived from biopsy samples from pancreatic cancer patients with known resistance to gemcitabine. In this model, RX-3117 produced a 76% inhibition of tumor growth, as compared to gemcitabine which had tumor growth inhibition of 38%.

Dr. Staffan Eriksson, MD, PhD, Professor, Department of Anatomy, Physiology and Biochemistry at The Swedish University of Agricultural Sciences commented, “The Champions Tumorgraft(TM) model used cancer cells, and their microenvironment, taken from individual cancer patients and then transplanted directly into a mouse Xenograft model, making the results potentially more predictive for the outcome of clinical trials. The fact that RX-3117 was active against cells partially resistant to gemcitabine makes these results very promising for future drug development efforts which may be of great benefit to many cancer patients.”

Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer, commented, “The ability of RX-3117 to inhibit the growth of gemcitabine resistant human cancers cells is very exciting. Moreover, the pronounced anti-tumor effects of RX-3117 in the Champions Tumorgraft(TM) model are of particular importance because the cancer cells used in this model are derived directly from biopsies taken from pancreatic cancer patients who have shown gemcitabine resistance. Resistance to the anti-cancer effects of gemcitabine represents a major clinical issue in the treatment of cancer patients. Up to 40% of cancer patients receiving one or more cycles of gemcitabine rapidly become resistant to its anti-cancer activity. Based on study results to date, both preclinical and clinical, we believe RX-3117 holds the potential to be used for the treatment of tumors that do not respond to gemcitabine.”

PETACH TIKVA, Israel, Jan. 6, 2015 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, today announced its anticipated clinical milestones for calendar 2015.

“We are looking forward to a very active year in terms of clinical developments and release of data from key trials including late stage studies for psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman.

Q1 2015 Data release from Phase II/III psoriasis trial

In the first quarter of 2015, Can-Fite plans to announce top line results from its Phase II/III trial of its lead drug candidate CF101 in the treatment of psoriasis. The Company completed enrollment of over 300 patients at 17 clinical centers in the U.S., Europe, and Israel. Previously announced interim results for the first 100 patients were positive. The psoriasis therapeutic market was worth $3.6 billion in 2010 and is forecast to grow to $6.7 billion by 2018, according to estimates of GlobalData.

Q1 2015 Completion of commercial A3AR biomarker blood test kit

In the first quarter of 2015, Can-Fite anticipates completion of its biomarker blood test kit for the A3 adenosine receptor (A3AR) as a biomarker to predict patient’s response to CF101. The kit is designed to test A3AR expression levels prior to treatment with CF101, thereby predicting a patient’s response to the drug and providing more personalized medicine. The U.S. Patent and Trademark Office issued Can-Fite a patent for the utilization of A3AR as a biomarker to predict patients’ response to CF101 in all autoimmune inflammatory indications.

H2 2015 Data release from analysis of Phase II glaucoma trial

During the first half of 2015, Can-Fite expects to announce results from its Phase II study of CF101 in the treatment of glaucoma. The 88 patient study is planned to be conducted in two European countries by Can-Fite’s subsidiary OphthaliX Inc. (OPLI). The global glaucoma market was estimated by GlobalData to be worth approximately $3 billion in 2010 and CF101 is one of only a few oral drugs developed for glaucoma. The market currently consists primarily of generic eye drop drugs. Oral administration is expected to improve patient compliance.

Q4 2015 Completion of patient enrollment for Phase II liver cancer trial

By the end of 2015, Can-Fite anticipates completing enrollment of approximately 78 patients in its Phase II trial for its drug candidate CF102 in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. In December 2014, Can-Fite dosed its first patient in the randomized, double-blind, placebo controlled trial to be conducted in the U.S., Europe and Israel. CF102 has been granted Orphan Drug Status by the U.S. Food and Drug Administration and it is also approved for Compassionate Use for Liver Cancer by Israel’s Ministry of Health. According to Global Industry Analysts the global market for liver cancer is projected to exceed $2 billion by 2015.

Q4 2015 Completion of a working plan for Phase I Sexual Dysfunction trial

During 2015 Can-Fite, plans to implement a pre-clinical development program of its next generation drug CF602 for the indication of sexual dysfunction and develop a working plan to file an IND with the U.S. FDA for a Phase I study. In December 2014, Can-Fite received positive pre-clinical data from experimental animal models demonstrating that CF602 improved sexual dysfunction in a dose dependent manner. GlobalData estimates the value of the erectile dysfunction therapeutic market is approximately $2.7 billion with few drugs on the market which includes Viagra, Cialis and Levitra.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT:CVM) today announced that in 2014 it enrolled close to 200 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). This annual enrollment represents an eight-fold increase over enrollment of 24 patients in 2013, the year during which CEL-SCI dismissed its prior clinical research organization (CRO) and replaced it with new CROs, Aptiv and Ergomed. Twenty one (21) patients were enrolled in the study during the month of December.

“During 2014 we enrolled more patients than we did in several years when we worked with our prior CRO. As we continue to work with our new CROs, we expect strong continued growth in monthly and quarterly patient enrollment for the balance of 2015,” stated CEL-SCI Chief Executive Officer Geert Kersten.

A total of 880 patients are expected to be enrolled through approximately 100 clinical centers in about 20 countries by the end of 2015 in the world’s largest Phase III trial for head and neck cancer. 328 patients have been enrolled in the study by the end of December 2014.

HAIFA, Israel, Jan. 6, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today that it has been issued Patent No. 2013/07160, titled “Methods and Systems for Harvesting Adherent Stromal Cells”, in South Africa. This patent addresses Pluristem’s methods for using vibration to harvest cells grown on three-dimensional scaffolds, the harvested cells themselves, and devices developed for this process. The lack of an effective technology for harvesting live cells from these carriers was a longstanding roadblock to three-dimensional growth of cell therapy products.

Pluristem’s invention for harvesting manufactured cells from three-dimensional scaffolds is a central element of its technology platform. The scaffolds, contained within proprietary bioreactors, use a high surface-to-volume ratio to make possible an extraordinarily efficient cell growth system. This degree of efficiency is necessary for cost-effective production of commercial quantities of therapeutic products, and could potentially provide Pluristem with a significant advantage.

“Our vibrational harvesting technology works with our patented technology platform to create a high-yield of cells that have high viability and vitality. From cell growth to cell harvesting, Pluristem’s patented and patent-pending methods may enable cell therapy to become a marketable technology on a scale that we believe is unmatched in the cell therapy industry,” stated Pluristem CEO Zami Aberman.