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News Breaks
June 16, 2014
08:58 EDTADXSAdvaxis evaluated higher dose, repeat cycles of ADXS-HPV in Phase 1/2 trial
Advaxis announced that the Georgia Regents University, or GRU, Cancer Center has received Institutional Review Board, or IRB, approval to initiate a Phase 1/2 trial evaluating higher doses and repeat cycles of ADXS-HPV in patients with recurrent cervical cancer. The trial will be conducted at GRU under the direction of Dr. Samir Khleif, Director, GRU Cancer Center. ADXS-HPV is Advaxis's lead Lm-LLO cancer immunotherapy product candidate, designed to target HPV-associated cancers. This Phase 1/2 study is designed to evaluate the safety, efficacy and immunological effect of the highest-tolerated dose of ADXS-HPV administered in repeat cycles of treatment to patients with cervical cancer whose disease recurred after receiving one prior cytotoxic treatment regimen. Advaxis's earlier Phase 2 clinical study in 110 women with recurrent cervical cancer had already demonstrated that a single cycle of ADXS-HPV at a dose of 1x109 colony forming units, or CFU, is well-tolerated with complete and partial tumor responses as well as an apparent survival benefit. Building on this data, among the purposes of this study is to evaluate the effect of repeat cycles of treatment of ADXS-HPV at higher doses.
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August 25, 2014
16:13 EDTADXSOn The Fly: Closing Wrap
Stocks began the session in positive territory and proceeded to tack on gains throughout the morning. Despite a disappointing report on new home sales in July, the S&P surpassed the 2,000 level for the first time before noon. The market pared its gains shortly after the milestone was reached and drifted for the remainder of the session on light volume, as trading activity may be restrained all week ahead of the Labor Day weekend. ECONOMIC EVENTS: In the U.S., the Chicago Fed's National Activity index jumped to 0.39 in July from an upwardly revised 0.21 in June. Markit's preliminary August services PMI came in at 58.5, which was down from a prior reading of 60.8 but above the 58.0 consensus projection. New home sales dropped 2.4% to a 412K rate in July, missing expectations for them to have risen to a 430K annualized rate. COMPANY NEWS: Shares of InterMune (ITMN) surged $19.05, or 35.41%, to $72.85 after the company agreed to be acquired by Roche (RHHBY) for $74.00 per share in an all-cash transaction. The deal announcement comes less than two weeks after Bloomberg reported that Roche, along with big pharma peers Sanofi (SNY) and GlaxoSmithKline (GSK), had made takeover bids for the smaller drugmaker. A number of other biotech companies gained following the deal announcement, including bigger names like Gilead (GILD) and Celgene (CELG) and smaller ones such as Achillion Pharmaceuticals (ACHN) and Receptos (RCPT)... Burger King (BKW) shares rose $5.29, or 19.51%, to $32.40 after the company confirmed it is in talks regarding a potential strategic transaction with Canadian donut chain Tim Hortons (THI). Shares of Tim Horton's trading in New York also gained $11.88, or 18.91%, to $74.72 following the confirmation of news first reported by The Wall Street Journal. MAJOR MOVERS: Among the other notable gainers was Advaxis (ADXS), which advanced 75c, or 23.08%, to $4.00 after announcing it has entered into a clinical trial collaboration agreement with Merck (MRK). Also rising were shares of Comtech (CMTL), which jumped $1.70, or 4.84%, to $36.81 after Reuters said the company is working with Citigroup to explore a potential sale. Among the noteworthy losers was Chinese internet and software company Qihoo 360 Technology (QIHU), which fell $7.88, or 7.74%, to $93.87 despite reporting second quarter earnings and revenue that beat analysts' estimates. Also lower were shares of GrubHub (GRUB), which fell $3.60, or 8.42%, to $39.16 after filing to sell 10M shares of common stock. INDEXES: The Dow gained 75.65, or 0.44%, to 17,076.87, the Nasdaq rose 18.80, or 0.41%, to 4,557.35, and the S&P 500 advanced 9.54, or 0.48%, to 1,997.94.
09:11 EDTADXSOn The Fly: Pre-market Movers
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05:17 EDTADXSAdvaxis, Merck enter clinical trial collaboration agreement
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