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July 16, 2014
08:32 EDTOMEDOncoMed initiates Phase 2 ALPINE trial of tarextumab
OncoMed Pharmaceuticals announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "ALPINE", or Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety, clinical trial of its anti-Notch 2/3 cancer stem cell antibody, tarextumab, being studied for the treatment of pancreatic cancer. Tarextumab is being tested in combination with Abraxane plus gemcitabine in patients with previously untreated stage IV pancreatic cancer. The ALPINE trial is being conducted at up to 30 sites in the U.S. and is expected to enroll approximately 124 patients. The Phase 2 clinical trial will compare the progression-free survival, or PFS, of 15 mg/kg tarextumab administered every two weeks versus placebo in combination with Abraxane plus gemcitabine in all patients. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary and exploratory endpoints, including overall survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated.
News For OMED From The Last 14 Days
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February 8, 2016
08:10 EDTOMEDOncoMed: FDA says PINNACLE trial should continue under supervision
Following notification of the ALPINE DSMB's findings, OncoMed (OMED) initiated interactions with tarextumab clinical investigators, partner GlaxoSmithKline (GSK), the FDA and the PINNACLE trial's DSMB chairperson to assess potential impact of these results on the overall development program, including the ongoing Phase 2 PINNACLE trial in small-cell lung cancer patients. PINNACLE trial investigators received an addendum to the informed consent form that included a description of the interim analysis from ALPINE. The FDA and the PINNACLE DSMB were provided unblinded data from both Phase 2 trials, a description of OncoMed's exploratory analysis of the ALPINE results and related trial materials for review. The independent analyses of the FDA and PINNACLE DSMB indicated that the PINNACLE trial could continue under the supervision of the PINNACLE DSMB monitoring for safety and efficacy and that appropriate safeguards are in place. OncoMed is conducting the PINNACLE Phase 1b/2 clinical trial of tarextumab for the treatment of small cell lung cancer. The randomized Phase 2 trial is comparing progression-free survival outcomes for patients treated with tarextumab administered at 15 mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive placebo plus chemotherapy. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients. Results from the Phase 2 PINNACLE trial are anticipated in 2017.
08:09 EDTOMEDOncoMed discontinues dosing in ALPINE trial, unblinds study
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January 25, 2016
16:14 EDTOMEDOn The Fly: Top stock stories for Monday
Stocks began the session in negative territory and remained there throughout the day. The market has yet to de-couple from oil prices, as stocks continue to move in the direction of the commodity. The averages almost made it back to positive ground in the early afternoon, but with oil down more than 4% the sellers emerged and pushed the market toward session lows. The market continued to lose ground as oil fell further, giving up nearly 6% by the close on the New York Mercantile Exchange, bringing stocks' two day win streak to an end. ECONOMIC EVENTS: In the U.S., the economic calendar was light. The Dallas Fed manufacturing survey, the lone report of note, came in at -34.6, below the revised prior reading of -21.6 and short of the consensus -14.5 forecast. West Texas Intermediate for March delivery fell $1.85, or 5.8%, to close at $30.34 a barrel on the NYMEX. COMPANY NEWS: Shares of McDonald's (MCD) advanced 0.7% to $119.20 after the fast food giant reported better than expected earnings and comparable sales growth for the fourth quarter, powered by the launch of All Day Breakfast in the U.S... Twitter (TWTR) fell 4.6% to $17.02 after CEO Jack Dorsey confirmed on Sunday night the departure of four company executives, leading research firm Stifel to downgrade the shares... Tyco (TYC) jumped 11.6% to $34.15 after reaching a merger agreement with Johnson Controls (JCI) which will see Johnson shareholders owning 56% of the combined company's equity. Johnson Controls fell 3.9% to $34.21 following the merger announcement. MAJOR MOVERS: Among the notable gainers was Valeant (VRX), which rose 4.55% to $92.63 after hospitalized CEO Michael Pearson said he is "on the road to recovery" after a bout of pneumonia. The news was followed by announcements that Valeant has sold three of its skincare brands and received FDA acceptance of its biologics license application for psoriasis drug Brodalumab. Also higher was SunEdison (SUNE), which advanced 2.6% to $2.72 after the Wall Street Journal reported that the company is set to give David Einhorn's Greenlight Capital a seat on its board. Meanwhile, energy savings firm EnerNOC (ENOC) jumped 69.5% to $7.05 after the Supreme Court ruled in favor of FERC's so-called "demand response" rule, sending energy generators Dynegy (DYN) and Talen Energy (TLN) down a respective 11.6% and 6.2%. Among the noteworthy losers was OncoMed (OMED), which plunged 42.9% to $10.04 after its Phase 2 trial of tarextumab in pancreatic cancer showed futility in an interim analysis. Also lower were containerboard and paper makers KapStone (KS), WestRock (WRK) and Packaging Corp (PKG), which dropped about 21%, 15% and 13%, respectively, after an industry publication reported that prices in the sector had declined. Additionally, Caterpillar (CAT) was the Dow's biggest decliner Monday, sinking 5% to $57.90 after being downgraded to Sell at Goldman Sachs. INDEXES: The Dow fell 208.29, or 1.29%, to 15,885.22, the Nasdaq lost 72.69, or 1.58%, to 4,518.49, and the S&P 500 declined 29.82, or 1.56%, to 1,877.08.
12:17 EDTOMEDOn The Fly: Top stock stories at midday
Stocks on Wall Street were lower at midday as oil prices resumed their slide, giving up some of the surge the commodity saw to close out last week. The stock market, which has been highly correlated with oil lately, continues to be led around by energy prices once again today. ECONOMIC EVENTS: In the U.S., the economic calendar was light with the Dallas Fed manufacturing survey the lone report of note. The survey came in at -34.6, below the revised prior reading of -21.6 and short of the consensus -14.5 forecast. WTI crude oil dropped about 5% to trade near $30.50 per barrel near midday. COMPANY NEWS: Shares of McDonald's (MCD) advanced a bit over 1% after the fast food giant reported better than expected earnings and comparable sales growth for the fourth quarter, powered by the launch of All Day Breakfast in the U.S. On the other side of the Dow was Caterpillar (CAT), which fell nearly 4% to lead the bluechip index on the down side after its stock was downgraded to Sell at Goldman Sachs... Twitter (TWTR) fell about 4% after CEO Jack Dorsey confirmed on Sunday night the departure of four company executives, leading research firm Stifel to downgrade the shares. MAJOR MOVERS: Among the notable gainers was Tyco (TYC), which rallied 10.8% after it announced that it entered into a definitive merger agreement with Johnson Controls (JCI). Johnson shares fell 2% after the deal announcement. Also higher was Williams Partners (WPZ), which gained 7% after it lowered its estimate of its 2016 growth capital funding needs to $2B, 32% lower than its previous plans. Among the noteworthy losers was OncoMed (OMED), which fell 46% after the company said its Phase 2 ALPINE clinical trial showed futility on an interim analysis. Also lower were KapStone (KS), WestRock (WRK), and Packaging Corp (PKG), which dropped 20%, 13%, and 11%, respectively, after an industry publication reported that prices in the sector had declined. INDEXES: Near midday, the Dow was down 78.00, or 0.48%, to 16,015.51, the Nasdaq was down 23.34, or 0.51%, to 4,567.84, and the S&P 500 was down 11.89, or 0.62%, to 1,895.01.
11:07 EDTOMEDOncoMed downgraded with $11 price target at Leerink
Leerink analyst Paul Matteis downgraded OncoMed to Market Perform from Outperform and cut his price target for the shares to $11 from $27 after the company said its Phase II study of Tarextumab in Pancreatic Cancer showed futility on an interim analysis.
11:05 EDTOMEDOncoMed price target lowered to $29 from $43 at Piper Jaffray
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10:28 EDTOMEDOncoMed downgraded to Market Perform from Outperform at Leerink
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09:03 EDTOMEDOn The Fly: Pre-market Movers
HIGHER: Tyco (TYC) and Johnson Controls (JCI), up 9% and 1%, respectively, after announcing a definitive merger agreement. Johnson Controls shareholders will own approximately 56% of the equity of the combined company, while current Tyco shareholders will own approximately 44%... SunEdison (SUNE), up 10% after the Wall Street Journal reported that the company is set to give David Einhorn's Greenlight Capital a seat on its board... Affimed Therapeutics (AFMD), up 26% after entering a clinical research collaboration in immuno-oncology with Merck (MRK). UP AFTER EARNINGS: McDonald's (MCD), up 3%... LOWER: Twitter (TWTR), down 5% after its CEO Jack Dorsey confirmed in a tweet last night that several executives are departing the company. Media reports also indicate that, as part of its shake-up, Twitter intends to bring in two new members to its board as soon as this week... OncoMed (OMED), down 38% after an independent data safety monitoring board remarked on several findings regarding futility of the company's Phase 2 ALPINE clinical trial... Medivation (MDVN), down 7% after FDA places investigational new drug application for MDV9300 on partial clinical hold... International Paper (IP), down 4.8%, Packaging Corp. (PKG), down 4.8%, WestRock (WRK), down 6%, after Pulp & Paper Week reduced January kraftliner and corrugated medium prices... Caterpillar (CAT), down 4% after Goldman cuts rating to sell... Regeneron (REGN), down 3% after downgraded at Chardan to sell. DOWN AFTER EARNINGS: Kimberly-Clark (KMB), down 2.5%.
08:02 EDTOMEDOncoMed to host conference call
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07:33 EDTOMEDOncoMed: DSMB recommends Phase 2 ALPINE Trial proceed to completion
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