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July 8, 2014
08:15 EDTCVMCEL-SCI receives regulatory clearance to expand Phase III trial into Austria
CEL-SCI Corporation announced that it has received regulatory clearance from the Austrian Federal Office for Safety in Health Care to begin patient enrollment in the companyís Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine. Austria is the 14th country to participate in CEL-SCIís trial which is already active in numerous clinics around the world. CEL-SCIís Phase III trial is assessing the use of the companyís Multikine immunotherapy as a first line treatment for patients diagnosed with advanced primary head and neck cancer, prior to standard of care, which involves surgery, chemotherapy, and/or radiation therapy. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. Further expansion of CEL-SCIís Phase III head and neck cancer trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers through by the end of 2015. Over 200 patients are already enrolled in, and being treated with Multikine.
News For CVM From The Last 14 Days
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May 22, 2015
09:25 EDTCVMOn The Fly: Pre-market Movers
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09:08 EDTCVMCEL-SCI prices $16M of common stock and warrants at 79c
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08:29 EDTCVMFBR scuttled CEL-SCI offering after 'CEO meddling,' Feuerstein says
FBR scuttled its role in a CEL-SCI (CVM) offering due to "inappropriate CEO meddling," leaving Dawson James to be "brought on to salvage something," according to TheStreet's Adam Feuerstein citing a source. The Fly notes CEL-SCI announced last night a proposed offering of common stock and warrants, with no amount given and Dawson James Securities acting as the sole placement agent on a "best efforts" basis. IsoRay (ISR) tried to raise money yesterday too, Feuerstein reported on Twitter, citing an investor source.
May 21, 2015
18:49 EDTCVMOn The Fly: After Hours Movers
UP AFTER EARNINGS: Hewlett-Packard (HPQ), up 1%. ALSO HIGHER: Autobytel (ABTL), up 14.1% after acquiring Dealix Corporation and Autotegrity from CDK Global (CDK) for $25M and raising fiscal 2015 guidance... StemCells (STEM), up 2.5% after being initiated with a Buy at Cantor... PTC Therapeutics (PTCT), up 2.3% after a Benefit Assessment by Germany's Federal Joint Committee indicated that Translarna provided a benefit for ambulatory patients... CBOE Holdings (CBOE), up 1.6% after raising share repurchase authorization by $100M... Cypress Semiconductor (CY), up 1.2% after being initiated with a Buy at Mizuho. DOWN AFTER EARNINGS: Aeropostale (ARO), down 18.5%... Brocade (BRCD), down 2.1%... Marvell Technology (MRVL), down 2.9% after reporting quarterly results and departure of CFO. ALSO LOWER: Otonomy (OTIC), down 17.7% following report of Phase 2b topline data for OTO-104... Viggle (VGGL), down 18.8% after filing to sell common stock... CEL-SCI (CVM),down 2.7% after announcing a proposed offering of common stock and warrants.
16:35 EDTCVMCEL-SCI announces proposed offering of common stock, warrants, no amount given
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May 13, 2015
09:00 EDTCVMCEL-SCI receives authorization to conduct Phase 3 Multikine trial in Italy
CEL-SCI Corporation announced that the Italian Medicines Agency has authorized the company to commence patient enrollment for its ongoing Phase 3 trial of its investigational immunotherapy Multikine in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer. Italy is the 23rd country to authorize CEL-SCIís Phase 3 trial for patient enrollment. Having surpassed its originally planned milestone of receiving authorization to conduct the Phase 3 study from 21 countries, CEL-SCI is now aiming to expand the trial into a total of approximately 100 clinical centers in about 25 countries. As of April 30, 2015, 437 patients had been enrolled in the global Phase 3 study. The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care vs. subjects who are treated with SOC only.
May 11, 2015
08:05 EDTCVMCEL-SCI receives authorization to conduct Phase 3 Multikine trial in Spain
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May 8, 2015
17:03 EDTCVMCEL-SCI reports Q2 EPS (17c), consensus (11c)
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