Three clinical trials ongoing with key milestones expected in Q4 2014
"We continue to enroll patients in each of our three clinical trials as expected, and as planned for," stated Rexahn's Chief Executive Officer, Peter D Suzdak, Ph.D. "By the end of 2014, we expect to achieve key milestones in each trial. In the fourth quarter we expect to have data from our Phase I trial of Supinoxin™ in cancer patients with solid tumors. We are also scheduled to complete enrollment of patients in our Phase Ib clinical trial of RX-3117 by the end of 2014. During the fourth quarter of this year, we anticipate completing the safety portion of our Phase II trial for metastatic renal cell carcinoma."
The Company initiated a Phase I clinical trial of Supinoxin in cancer
patients with solid tumors in
Rexahn initiated a Phase Ib clinical trial of RX-3117 in cancer patients
with solid tumors in
Rexahn continues to enroll metastatic renal cell carcinoma patients in its Phase IIa proof-of-concept clinical trial for Archexin. Rexahn has previously received orphan drug designation for this indication. The trial is a multi-center study designed to evaluate the efficacy of Archexin in combination with everolimus (Afinitor®) to treat metastatic RCC patients and will be conducted in two stages. The first stage will be dose ranging, with up to three cohorts of three RCC patients to determine its MTD in combination with everolimus. Once the MTD has been determined, thirty RCC patients will be randomized to either Archexin in combination with everolimus or everolimus alone, in a ratio of 2:1. Rexahn plans to complete the initial safety component of this study in the fourth quarter of 2014.
Additional Highlights from First Quarter 2014:
Cash Position - Rexahn's cash and investments totaled
R&D Expenses - Research and development expenses were
G&A Expenses - General and administrative expenses
Net Loss - Rexahn's net loss was
About Supinoxin™ (RX-5902)
Supinoxin (RX-5902) is an orally administered, potential first-in-class, small molecule inhibitor of phosphorylated-p68 RNA helicase (P-p68). P-p68, which is selectively expressed in cancer cells and is absent in normal tissue, increases the activity of multiple cancer related genes including cyclin D1, c-jun and c-myc, and plays a role in tumor progression and metastasis. Over-expression of P-p68 has been observed in solid tumors, such as melanoma, colon, ovarian and lung tumors. In preclinical studies, Supinoxin has been shown to inhibit proliferation of cancer cells in 18 human cancer cell lines including breast, colon, pancreas, ovarian, and stomach cancers, and showed potent activity in drug-resistant cancer cells. In an animal model, where human cancer cells from melanoma, pancreas, renal or ovarian cancers were grafted into animals, treatment with Supinoxin resulted in a significant reduction in tumor growth.
RX-3117 is a small molecule nucleoside analog that is activated (phosphorylated) by the enzyme Uridine Cytidine Kinase (UCK) and inhibits both DNA and RNA synthesis, which induces apoptotic cell death of tumor cells. UCK is overexpressed in multiple human tumors, but has a limited presence in normal tissues. This unique specificity for cancer cells may lead to an improved efficacy and safety profile in cancer patients. RX-3117 also mediates the down regulation of DNA methyltransferase 1 (DNMT1), an enzyme responsible for the methylation of cytosine residues on newly synthesized DNA and also a target for anticancer therapies. Preclinical studies have shown RX-3117 to be effective in both inhibiting the growth of various human cancer xenograft models, including colon, lung, renal and pancreas, as well as overcoming chemotherapeutic drug resistance.
RX-3117 has demonstrated a broad spectrum anti-tumor activity against 50
different human cancer cell lines and efficacy in 12 different mouse
xenograft models. The efficacy in the mouse xenograft models was
superior to that of gemcitabine. In addition, RX-3117 still retains its
full anti-tumor activity in human cancer cell lines made resistant to
the anti-tumor effects of gemcitabine. In
Archexin is a unique anti-cancer drug candidate which inhibits the cancer cell signaling protein Akt-1, which is involved in cancer cell growth, survival, angiogenesis, and drug resistance. Rexahn has completed a Phase I clinical trial of Archexin in cancer patients with solid tumors and was shown to be safe and well tolerated. The dose-limiting toxicity was a grade 3 fatigue. In a small Phase IIa trial in advanced pancreatic cancer patients, Archexin in combination with gemcitabine was shown to be safe and well tolerated and demonstrated a preliminary efficacy signal with a median survival of 9.1 months in evaluable patients.
To the extent any statements made in this press release deal with
information that is not historical, these are forward-looking statements
under the Private Securities Litigation Reform Act of 1995. Such
statements include, but are not limited to, statements about Rexahn's
plans, objectives, expectations and intentions with respect to future
operations and products and other statements identified by words such as
"will," "potential," "could," "can," "believe," "intends," "continue,"
"plans," "expects," "anticipates," "estimates," "may," other words of
similar meaning or the use of future dates. Forward-looking statements
by their nature address matters that are, to different degrees,
uncertain. Uncertainties and risks may cause Rexahn's actual results to
be materially different than those expressed in or implied by Rexahn's
forward-looking statements. For Rexahn, particular uncertainties and
risks include, among others, the difficulty of developing pharmaceutical
products, obtaining regulatory and other approvals and achieving market
acceptance; the marketing success of Rexahn's licensees or sublicensees;
the success of clinical testing; and Rexahn's need for and ability to
obtain additional financing. More detailed information on these and
additional factors that could affect Rexahn's actual results are
described in Rexahn's filings with the
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