Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing next generation therapeutics for the treatment of cancer, announced today that Phase I and/or Phase II clinical data from each of its novel oncology programs were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, June 3-7, 2016.
“The accumulating clinical data for RX-3117, Supinoxin™, and Archexin®, which were presented at ASCO, highlight the unique mechanism of action of these investigational compounds and continue to support their safety, tolerability and potential clinical activity in the treatment of solid tumors,” said Peter D. Suzdak, Ph.D., Chief Executive Officer.
“The latest clinical data from our three studies is consistent with the preliminary findings announced last fall, showing single agent activity of both RX-3117 and Supinoxin, and clinical activity of Archexin in combination with everolimus, as demonstrated by both tumor reduction and stable disease. Based on these findings, we recently commenced a Phase Ib/IIa proof-of-concept clinical trial of RX-3117 in advanced pancreatic and muscle-invasive bladder cancer, and have advanced Archexin into Stage 2 of an ongoing Phase II study in metastatic renal cell carcinoma (RCC). In addition, we anticipate commencing a Phase Ib/IIa proof-of-concept clinical trial of Supinoxin in triple negative breast cancer and advanced ovarian cancer shortly,” said Dr. Suzdak.
RX-3117 Phase Ib Clinical Data
The final results from a Phase Ib clinical trial of RX-3117 were presented on Sunday, June 5, 2016 in a poster presentation entitled “Phase I Data of Single Agent RX-3117, an Oral Antimetabolite Nucleoside,” authored by Drs. Drew W. Rasco, Jaime R. Merchan, and Rexahn collaborators.
The final data show promising evidence of the potential clinical activity of RX-3117. In the Phase Ib study, 12 patients had stable disease persisting for up to 276 days. Patients participating in the Phase Ib program had advanced metastatic disease and were heavily pre-treated. Notably, approximately 44% of patients had received four or more therapies prior to their enrollment in the clinical trial.
At the doses tested to date, RX-3117, administered orally, appeared to be safe and well tolerated with a predictable pharmacokinetic profile for an orally-administered route of therapy. The most frequently reported treatment emergent adverse events were moderate to severe anemia, mild to moderate fatigue and nausea, mild diarrhea, vomiting, and anorexia.
Supinoxin™ (RX-5902) Phase I Clinical Data
Updated clinical data from an ongoing Phase I study of Supinoxin™ (RX-5902) were presented on Sunday, June 5, 2016 in a poster presentation entitled “Results of a Phase I Study of RX-5902, an Orally Bioavailable Inhibitor of Phosphorylated p68, Targeted Solid Tumors,” authored by Drs. S. Gail Eckhardt, W. Larry Gluck, Martin Gutierrez, and Rexahn collaborators.
The updated results from the ongoing Phase I clinical trial continue to show intriguing evidence of single-agent, clinical activity of Supinoxin. In this study, stable disease was observed in five patients, persisting up to 732 days. As of May 25, 2016, three patients have had stable disease for more than a year, or 504 days, 514 days, and 746 days, respectively, and each of these patients continues to remain on active treatment in the study. Notably, approximately 56% of the patients in the study had received four or more therapies prior to their enrollment in the Phase I clinical study.
At the dose levels tested to date, Supinoxin, administered orally, appeared to be safe and well tolerated with no dose limiting toxicities or treatment-related serious adverse events. The most frequently reported drug related adverse events were mild nausea, vomiting and fatigue. Pharmacokinetic analyses of the current data show a predictable pharmacokinetic profile for an orally-administered route of therapy.
Archexin® Phase Ib/II Clinical Data
Phase Ib/II clinical trial results for Archexin were presented on Sunday, June 5, 2016, in a poster presentation entitled, “Results from a Phase Ib/II Study of RX-0201 (Archexin®), A Novel Akt-1 Antisense Combined with Everolimus to Treat Metastatic Clear Cell Renal Carcinoma.”
The results from Stage 1 of the Phase Ib/II study presented at ASCO showed that in metastatic RCC patients that have previously received multiple anti-cancer therapies, Archexin treatment produced both stable disease, which persisted for up to 383 days or a median of 165.5 days, and a reduction in tumor burden.
Compared to baseline CT scans, three patients experienced reductions in the size of their tumors of up to 36%. At the lowest dose level of Archexin administered (125 mg/m2/day), one patient had stable disease for over one year and a 16% tumor reduction after four cycles of treatment. At the second dose level (200 mg/m2/day), one patient experienced a 36% tumor reduction after two cycles of treatment. At the highest dose level (250 mg/m2/day), which has been determined to be the maximum tolerated dose, one patient had a 17% overall reduction in lesions (RECIST v 1.1) with a range of 6% to 37.5% following two cycles of treatment.
Archexin, administered in combination with everolimus, appeared to be safe and well tolerated at each of the dose levels tested with no dose limiting adverse events. The most commonly reported adverse event in patients taking the combination of Archexin and everolimus was thrombocytopenia.
“We continue to be very encouraged by the clinical data emerging from each of the ongoing studies of RX-3117, Supinoxin and Archexin,” said Ely Benaim, M.D., Chief Medical Officer for Rexahn. “These data suggest that our compounds appear to be safe and well tolerated and offer an early efficacy signal suggesting their potential utility in the treatment of solid tumors. We are especially encouraged given that these patients have very advanced disease, and have stopped responding to other therapies, yet we are seeing evidence of stable disease — in certain cases persisting for over a year — in these early clinical trials.”
“Given the ability to specifically target cancer cells and spare normal, healthy cells, each of these programs, if successful, has the potential to meaningfully change the oncology treatment paradigm and improve the quality of life of cancer patients. Together with the support and encouragement of our clinical investigators, we are moving RX-3117, Supinoxin and Archexin into advanced clinical development to more fully understand their clinical activity. We look forward to the results of these studies,” said Dr. Benaim. (Original Source)
Shares of Rexahn Pharmaceuticals closed last Friday at $0.31, down $0.01 or -2.76%. RNN has a 1-year high of $0.73 and a 1-year low of $0.25. The stock’s 50-day moving average is $0.29 and its 200-day moving average is $0.35.
On the ratings front, Rexahn has been the subject of a number of recent research reports. In a report issued on May 19, FBR analyst Vernon Bernardino reiterated a Buy rating on RNN, with a price target of $3, which implies an upside of 858.2% from current levels. Separately, on February 26, Roth Capital’s Joseph Pantginis maintained a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Joseph Pantginis have a total average return of -12.4% and 9.3% respectively. Bernardino has a success rate of 35% and is ranked #3850 out of 3894 analysts, while Pantginis has a success rate of 39% and is ranked #179.
Rexahn Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company. It dedicates to the discovery, development and commercialization of innovative treatments for cancer and other medical needs. The company currently has three clinical stage oncology candidates, Archexin, RX-3117, and Supinoxin and a robust pipeline of preclinical compounds to treat multiple types of cancer. It has also developed proprietary drug discovery platform technologies in the areas of nano-medicines, 3D gold and times.