19:44 , May 9, 2019 |  BC Extra  |  Clinical News

May 9 Clinical Quick Takes: Polyphor, BMS, Cel-Sci, University of Pittsburgh, Merck, Scholar Rock, Promethera

Polyphor halts Phase III enrollment of pneumonia therapy  Polyphor Ltd. (SIX:POLN) said late Thursday it will suspend enrollment in the Phase III PRISM-MDR and PRISM-UDR trials of pneumonia antibiotic murepavadin (POL7080) after observing a 56%...
00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
18:53 , Oct 27, 2017 |  BC Week In Review  |  Clinical News

FDA lifts hold on Cel-Sci's Ph III trial of Multikine in SCCHN

Cel-Sci Corp. (NYSE-M:CVM) said FDA lifted a clinical hold on the Phase III IT-MATTERS trial of Multikine leukocyte interleukin injection to treat squamous cell carcinoma of the head and neck (SCCHN). The open-label, international trial...
19:38 , Jun 23, 2017 |  BC Week In Review  |  Clinical News

Cel-Sci submits response regarding FDA's hold on Phase III trial of Multikine

Cel-Sci Corp. (NYSE-M:CVM) said it responded to a May communication from FDA regarding a partial clinical hold the agency placed in September 2016 on a Phase III trial of Multikine leukocyte interleukin injection to treat...
07:00 , Oct 3, 2016 |  BC Week In Review  |  Clinical News

Multikine leukocyte interleukin injection: Phase III hold

Cel-Sci said it received verbal notice from FDA that the agency placed a clinical hold on an open-label, international Phase III trial comparing Multikine plus standard of care (SOC) vs. SOC alone. Cel-Sci said patients...
07:00 , Oct 26, 2015 |  BC Week In Review  |  Company News

Cel-Sci, Aptiv Solutions, Ergomed deal

Cel-Sci and Ergomed amended an April 2013 deal and Ergomed will increase to $12 million from $10 million its contribution to the ongoing Phase III trial of Cel-Sci’s Multikine in patients with advanced primary head...
08:00 , Jan 19, 2015 |  BC Week In Review  |  Company News

Cel-Sci, inVentiv Health cancer news

Cel-Sci said an arbitration trial regarding its claim against inVentiv’s CRO, inVentiv Health Clinical, is scheduled for May 4. In November 2013, Cel-Sci initiated the arbitration claim against the CRO alleging breach of contract and...
07:00 , Oct 27, 2014 |  BC Week In Review  |  Clinical News

Leukocyte interleukin injection: Phase I started

Cel-Sci and the U.S. Navy's Naval Medical Center San Diego (NMCSD) began a dose-escalation, U.S. Phase I trial to evaluate 200 and 400 IU perilesional injections of Multikine in up to 15 patients with peri-anal...
08:00 , Feb 10, 2014 |  BC Week In Review  |  Clinical News

Multikine leukocyte interleukin injection: Phase I start

Cel-Sci said that this month the U.S. Navy's Naval Medical Center San Diego (NMCSD) will begin a dose-escalation, U.S. Phase I trial to evaluate Multikine in 15 patients with peri-anal warts co-infected with HIV and...