Rexahn Pharmaceuticals, Inc. (NYSE:RNN), a clinical stage biopharmaceutical company developing next generation therapeutics for the treatment of cancer, announced today that it has identified a maximum tolerated dose and completed Stage 1 of a dose-escalation Phase IIa clinical trial of Archexin in combination with everolimus, a widely used chemotherapy drug, in patients with metastatic renal cell carcinoma (RCC). In addition, Rexahn also announced that it has commenced enrollment in Stage 2 of the Phase IIa Archexin clinical trial to evaluate safety and efficacy of the combination.
“Data from the first phase (Stage 1) of the Archexin clinical trial have yielded exciting preliminary clinical findings suggesting that Archexin, in combination with everolimus, showed evidence of a potential dose and time-dependent clinical benefit in patients with advanced, metastatic kidney cancer,” said Dr. Ely Benaim, Chief Medical Officer for Rexahn. “The data from Stage 1, which were recently presented at the American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium, show three patients who have experienced stable disease for 383, 191, and 122 days, respectively, and two patients who experienced a tumor burden reduction of 16% and 36%, respectively as of January 6, 2016.”
The results indicated that at the dose levels tested to date, Archexin appeared to be safe and well tolerated. The most commonly reported adverse event in patients taking both Archexin and everolimus is thrombocytopenia. To date, no adverse events have been dose limiting.
Dr. Benaim continued, “While preliminary, we are particularly excited about the results from this study as these are heavily pre-treated patients who have not previously responded to other cancer therapies. Consequently, we are pleased to begin enrollment in Stage 2 of the Phase IIa clinical trial to further evaluate the potential anti-cancer effects of Archexin in patients with advanced, metastatic kidney cancer.”
Stage 2 of the Phase IIa clinical study — which has commenced enrolling patients, is a randomized, open-label, two-arm dose expansion study of Archexin in combination with everolimus, versus everolimus alone to determine safety and efficacy of the combination. The trial is anticipated to enroll up to 30 RCC patients who will be randomized to receive either Archexin in combination with everolimus, or everolimus alone, in a ratio of 2:1. The maximum tolerated dose of 250 mg/m2/day of Archexin — identified in Stage 1, will be administered along with 10 mg of everolimus versus 10 mg everolimus alone.
The primary endpoint of Stage 2 is the percentage of progression free patients following eight cycles of therapy. Patients are scanned (CT or MRI) for the assessment of tumor progression after every 2 cycles of therapy. Secondary endpoints include pharmacokinetic profile, incidence of adverse events, changes in clinical laboratory tests and vital signs over time, tumor response, duration of response, time to response, and response rate. Exploratory endpoints include blood levels of AKT pathway biomarkers, tumor apoptosis biomarkers, or other relevant biomarkers.
In preclinical studies, Archexin has been shown to inhibit the growth of human renal cell carcinoma cells in tissue culture. Also in preclinical studies, Archexin has also been shown to exhibit an additive anti-tumor effect when combined with other cancer drugs in inhibiting the growth of human RCC cells in tissue culture. (Original Source)
Shares of Rexahn Pharmaceuticals closed last Friday at $0.36. RNN has a 1-year high of $0.85 and a 1-year low of $0.26. The stock’s 50-day moving average is $0.35 and its 200-day moving average is $0.47.
On the ratings front, Roth Capital analyst Joseph Pantginis maintained a Buy rating on RNN, with a price target of $3, in a report issued on November 6. The current price target represents a potential upside of 733.3% from where the stock is currently trading. According to TipRanks.com, Pantginis has a total average return of -14.3%, a 28.9% success rate, and is ranked #3572 out of 3584 analysts.
Rexahn Pharmaceuticals Inc is a clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization of treatments for cancer and other medical needs.