LEXINGTON, Mass. -- Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the first patient has been treated in a Phase I combination trial of CUDC-101. The Phase I trial is the Company’s first CUDC-101 combination study and is designed to test CUDC-101 when administered concurrently with radiation and cisplatin in human papillomavirus negative (HPV-) locally advanced head and neck cancer patients. CUDC-101 is a first-in-class small molecule drug candidate that has been designed as an inhibitor of epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (Her2) and histone deacetylase (HDAC).
There are plenty of other products within the Dimplex range. These include electronic panel heaters, tubular heaters and radiators. All of these products offer the same efficiency and value for money that the storage heaters provide. The panel heaters are ultra compact and can provide rapid heat at the flick of a switch. They are well insulated and provide a continuous background heat in any room they are situated in. They can be mounted on the wall and the different designs and stylish appearance makes them attractive to look at too.Other Dimplex ProductsCuris data suggest that CUDC-101’s mechanism of action involves the sensitization of cancer cells to EGFR and Her2 inhibition through HDAC inhibition. CUDC-101 is designed to simultaneously inhibit both EGFR and Her2 at the receptor level while inhibiting downstream HDAC activity within the cancer cells. Despite the existence of other multi-targeted inhibitors, CUDC-101 is unique in its choice of targets, which may enable a synergistic attack on multiple nodes or points in the overall cancer pathway network that are used by tumors to survive, grow, and invade surrounding tissue.About Gamma Knife® PerfexionTMAbout CUDC-101Dan Passeri, Curis’ President and Chief Executive Officer, added, “This trial is significant for Curis as it provides the first combination study of CUDC-101 with other agents in a clinical setting, and it also advances the development of this molecule in a front-line indication that we believe is ideally-suited for CUDC-101. It has been shown that most head and neck cancers overexpress EGFR and that a portion of these tumors also overexpress Her2, both molecular targets of CUDC-101. Furthermore, CUDC-101 has demonstrated clinical activity in head and neck cancer in Curis’ previous dose escalation and expansion studies. In addition, preclinical data suggests that HDAC inhibition, the third target of CUDC-101, can enhance the effects of both radiation and cisplatin therapy. A majority of head and neck cancers are HPV-, and patients with these tumors experience a poorer clinical outcome than patients whose tumors are HPV positive. We are pleased to have begun this important trial and we look forward to providing updates on our progress in the future.”Dimplex Storage HeatersSafe Harbor StatementUpon determination of the MTD and assuming the otherwise successful completion of this Phase I combination trial, Curis plans to conduct a randomized Phase II two-arm clinical trial in which head and neck cancer patients will receive cisplatin and radiation plus or minus CUDC-101. It is currently expected that the Phase II study would seek to evaluate whether the addition of CUDC-101 can improve the efficacy and/or durability of cisplatin and radiation therapy in this patient population.About AMSCUDC-101 is designed as a first-in-class therapeutic to simultaneously inhibit EGFR, Her2 and HDAC. In preclinical studies, CUDC-101 demonstrated the potential to inhibit all three molecular targets resulting in the potent killing of a wide range of cancer cell lines that are representative of a variety of human cancer types, many of which have demonstrated resistance to various approved targeted agents.American Shared Hospital Services (www.ashs.com) provides turnkey technology solutions for advanced radiosurgical and radiation therapy services. Since 1991, AMS' creative financing solutions have enabled its clinical partners to make the latest advances in radiation oncology available to patients at an affordable price. AMS is the world leader in providing Gamma Knife® Radiosurgery equipment, a non-invasive treatment for malignant and benign brain tumors, vascular malformations and trigeminal neuralgia (facial pain). The Company also offers the latest IGRT and IMRT systems, as well as its proprietary Operating Room for the 21st Century® concept. AMS also is a leader in proton beam radiation therapy (PBRT), the next great growth opportunity in radiation oncology. AMS currently is developing PBRT centers in Dayton, Ohio (Kettering Medical Center), Boston (Tufts Medical Center), Orlando (Orlando Regional Healthcare) and Long Beach, California (Long Beach Memorial Medical Center), and is negotiating additional projects. AMS also owns a preferred stock investment in Still River Systems, developer of the compact Monarch 250 PBRT system, which has not yet been approved by the FDA.
Curis Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the potential benefit of CUDC-101 in treating locally advanced head and neck cancers and other cancers, Curis’ plans and expectations for the continued development of CUDC-101, including with respect to future studies in head and neck cancer, and the potential of CUDC-101 to effectively and therapeutically attack and disrupt cancer pathway networks . Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "assumes", "will", "may," “could” or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements including, among other things:
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