|Rexahn Initiates Dosing in Phase I Trial of Supinoxin; Cleveland BioLabs and Incuron Announce Start of US Trial With CBL0137|
|By Staff and Wire Reports|
|Wednesday, 07 August 2013 18:51|
Rexahn Pharmaceuticals, Inc. (NYSE: RNN) a clinical stage biopharmaceutical company announced today the commencement of patient dosing with SupinoxinTM (RX-5902) in a Phase I clinical trial designed to study safety and efficacy in patients with solid cancer tumors.
Supinoxin is an orally administered, 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.
The Supinoxin Phase I trial is a multi-center dose-escalation study which will evaluate the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) in patients with solid tumors. Secondary endpoints will include characterizing the pharmacokinetic profile of Supinoxin and evaluating the preliminary anti-tumor effects of Supinoxin.
Dr. Joe J. Stephenson, MD, Medical Director, Institute for Translational Oncology Research (ITOR), Greenville Health Systems commented, “Supinoxin represents a very interesting new approach for the treatment of cancer patients with solid tumors. We are excited about investigating its potential as a novel therapy in cancer patients.”
Peter D. Suzdak, Ph.D., Rexahn's Chief Executive Officer commented, “The start of Supinoxin dosing represents an important milestone for Rexahn. Supinoxin is Rexahn's third oncology compound to enter into clinical development and represents an important part of our expanding clinical development pipeline.”
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.
Cleveland BioLabs, Inc. (Nasdaq: CBLI) and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, today announced that a multi-center, Phase 1, single agent, dose escalation trial evaluating intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers and lymphomas is open for enrollment and that treatment of the first patient has been initiated.
The primary objective of the study is to determine the maximally tolerated dose and recommend a Phase 2 dose for CBL0137 in these patients. Secondary objectives include describing the dose limiting toxicity, adverse event and pharmacokinetic profile of CBL0137, as well as documenting any objective responses. Exploratory objectives for the study include examining the relationship between tumor expression of Facilitates Chromatin Transcription (FACT), the molecular target of CBL0137, tumor response and the effect of CBL0137 on FACT expression in peripheral blood mononuclear cells and on soluble factors in serum. FACT expression will also be tested on patient's tumor tissue retrospectively to determine if the tumor signal can help guide patient selection for future studies.
The Company recently announced the publication of studies describing FACT as an accelerator of tumor transformation and a potential marker and target for aggressive cancers in Cell Reports. The published work concluded that FACT's role in cancer likely involves selective chromatin remodeling of genes that stimulate proliferation, inhibit cell death and differentiation, and regulate cellular stress responses, making it an enabler of oncogene-induced transformation. Further studies are underway to determine if this biomarker can serve as a companion diagnostic to screen patients for CBL0137 treatment.
Jean Viallet, M.D., Chief Development Officer at Cleveland BioLabs, commented, "We are excited to have a second study with CBL0137 underway. The role of FACT as an enhancer of oncogenic transcription supports the clinical potential for CBL0137."
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