The FDA has just approved the use of Gilotrif (afatinib) to treat patients with non-small cell lung cancer (NSCLC) who have certain epidermal growth factor receptor (EGFR) gene mutations in their tumors. Lung cancer is one of the leading cancer-killers, with an estimated 159,480 people dying from the disease this year in the U.S. alone… …read more
Tag Archives: NSCLC
ARIAD Presents New Preclinical Data Showing Ponatinib is a Potent Inhibitor of RET and FGFR, Two Onc
By Business Wirevia The Motley Fool
Filed under: Investing
ARIAD Presents New Preclinical Data Showing Ponatinib is a Potent Inhibitor of RET and FGFR, Two Oncogenic Drivers of Non-Small Cell Lung Cancer
CAMBRIDGE, Mass. & WASHINGTON–(BUSINESS WIRE)– ARIAD Pharmaceuticals, Inc. (NAS: ARIA) today announced the presentation of preclinical data on ponatinib (Iclusig™) , at the American Association for Cancer Research (AACR) Annual Meeting 2013, in Washington. In separate studies, ponatinib is shown to potently inhibit RET, a clinically proven oncogenic driver of medullary thyroid cancer (MTC) and non-small cell lung cancer (NSCLC), and FGFR, which is commonly mutated in endometrial, lung and other cancers.
The first preclinical study, “Ponatinib is a highly-potent inhibitor of activated variants of RET found in MTC and NSCLC,” shows that ponatinib inhibits naturally occurring activating mutants of RET found in MTC and NSCLC at clinically achievable plasma concentrations. The potency of ponatinib was found to substantially exceed that of other approved tyrosine kinase inhibitors with RET activity. These results provide strong support for the clinical evaluation of ponatinib in patients with RET-driven cancers.
“The unique design features that allow ponatinib to overcome mutation-based resistance in CML, including the gatekeeper mutation, also apply to its activity against its other tyrosine kinase targets including RET, FGFR and KIT,” stated Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. “These preclinical data strongly support moving forward with evaluating ponatinib in RET-positive cancers, and we look forward to the start of a Phase 2 investigator-sponsored trial in patients with RET-positive NSCLC in this second quarter of 2013.”
In the second preclinical study, “Ponatinib potently inhibits the activity of mutant variants of FGFR commonly found in endometrial, lung and other cancers,” the ability of ponatinib to inhibit a broad panel of naturally occurring mutant variants of FGFR1, 2, 3, and 4 was evaluated. Ponatinib potently blocked a variety of mutant variants of FGFR, with particularly promising activity against mutant variants of FGFR2 that have been observed in endometrial and squamous cell carcinomas (SCCs) of the lung. Specifically, ponatinib inhibits the eight mutants that make up more than 90 percent of the mutations observed in endometrial cancer patients, and six mutants observed in SCC at clinically achievable plasma concentrations. Ponatinib also shows encouraging activity against FGFR1/3 fusion proteins found in glioblastoma multiforme. These data support clinical evaluation of ponatinib in FGFR-driven cancers, including a Phase 2 investigator-sponsored trial of ponatinib in patients with SCCs that is currently underway and enrolling patients.
About ARIAD
…read more
Source: FULL ARTICLE at DailyFinance
Synta Announces Presentations at the 2013 Annual Meeting of the American Association of Cancer Resea
By Business Wirevia The Motley Fool
Filed under: Investing
Synta Announces Presentations at the 2013 Annual Meeting of the American Association of Cancer Research
LEXINGTON, Mass.–(BUSINESS WIRE)– Synta Pharmaceuticals Corp. (NAS: SNTA) announced today that poster presentations related to studies with ganetespib, a selective Hsp90 inhibitor in clinical development by the company, will be presented at the 2013 Annual Meeting of the American Association of Cancer Research in Washington, D.C. Presentations include:
Inhibition of mTOR enhances the activity of HSP90 inhibitors in part through cessation of heat shock protein synthesis
Presentation: Sunday, April 7, 1:00 – 5:00 PM ET
Abstract number: 1038
Authors: He, et al.
Ultra-deep sequencing of circulating free DNA to identify predictive, mutated HSP90 clients in the GALAXY Trial (NCT01348126): a randomized phase IIB/III study of ganetespib (STA-9090) in combination with docetaxel versus docetaxel alone in subjects with stage IIIb/IV NSCLC
Presentation: Monday, April 8, 1:00 – 5:00 PM ET
Abstract number: 2012
Authors: Fennell, et al.
The importance of dose schedule with HSP90 inhibitors: Results from a Phase II study in dogs with mast cell tumors
Presentation: Tuesday, April 9, 8:00 AM – 12:00 PM ET
Abstract number: 3369
Authors: London, et al.
Differential sensitivities to heat shock protein 90 (HSP90) inhibitors in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) cells
Presentation: Tuesday, April 9, 8:00 AM – 12:00 PM ET
Abstract number: 3272
Authors: Lee, et al.
Heat shock protein 90 functional inhibition regulates epithelial to mesenchymal transformation, invasion and migration via NF-kB and HIF-1α signaling in colorectal cancer
Presentation: Tuesday, April 9, 8:00 AM – 12:00 PM ET
Abstract number: 2707
Authors: Ganji, et al.
About Ganetespib
Ganetespib is an inhibitor of heat shock protein 90 (Hsp90) that is structurally unrelated to first-generation, ansamycin-related Hsp90 inhibitors. In preclinical experiments, ganetespib has shown activity in multiple tumor models …read more
Source: FULL ARTICLE at DailyFinance
Wall Street Is Out of Patience With This Biotech
By David Williamson, The Motley Fool
Filed under: Investing
Geron had a rough go of it over the last two years, as shares have lost over 70% of their value. The company controversially sold off its stem-cell business to focus on hot cancer drug candidate imetelstat. If imetelstat were a success, management would look brilliant for backing the right horse while avoiding the stem cell R&D black hole. Unfortunately, that proved to be a big if. Imetelstat’s Phase 2 trial for breast cancer was cancelled, and Geron decided not to advance it to Phase 3 in NSCLC.
As Geron presses ahead with imetelstat, it is losing support from Wall Street. A Stifel Nicolaus analyst ripped the company’s plans apart, calling them “flawed and sluggish,” while dropping its rating all the way to sell.
Watch and find out what Motley Fool health-care analyst David Williamson thinks about Geron’s downgrade, and what it means for investors.
What macro trend was Warren Buffett referring to when he said, “This is the tapeworm that’s eating at American competitiveness?” Find out in our free report, What’s Really Eating at America’s Competitiveness. You’ll also discover an idea to profit as companies work to eradicate this efficiency-sucking tapeworm. Just click here for free, immediate access.
The article Wall Street Is Out of Patience With This Biotech originally appeared on Fool.com.
David Williamson has no position in any stocks mentioned. Follow David on Twitter @MotleyDavid.
The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.
(function(c,a){window.mixpanel=a;var b,d,h,e;b=c.createElement(“script”);
b.type=”text/javascript”;b.async=!0;b.src=(“https:”===c.location.protocol?”https:”:”http:”)+
‘//cdn.mxpnl.com/libs/mixpanel-2.2.min.js’;d=c.getElementsByTagName(“script”)[0];
d.parentNode.insertBefore(b,d);a._i=[];a.init=function(b,c,f){function d(a,b){
var c=b.split(“.”);2==c.length&&(a=a[c[0]],b=c[1]);a[b]=function(){a.push([b].concat(
Array.prototype.slice.call(arguments,0)))}}var g=a;”undefined”!==typeof f?g=a[f]=[]:
f=”mixpanel”;g.people=g.people||[];h=[‘disable’,’track’,’track_pageview’,’track_links’,
‘track_forms’,’register’,’register_once’,’unregister’,’identify’,’alias’,’name_tag’,
‘set_config’,’people.set’,’people.increment’];for(e=0;e<h.length;e++)d(g,h[e]);
a._i.push([b,c,f])};a.__SV=1.2;})(document,window.mixpanel||[]);
mixpanel.init("9659875b92ba8fa639ba476aedbb73b9");
function addEvent(obj, evType, fn, useCapture){
if (obj.addEventListener){
obj.addEventListener(evType, fn, useCapture);
return true;
} else if (obj.attachEvent){
var r = obj.attachEvent("on"+evType, fn);
return r;
}
}
addEvent(window, "load", function(){new FoolVisualSciences();})
addEvent(window, "load", function(){new PickAd();})
var themeName = 'dailyfinance.com';
var _gaq = _gaq || [];
_gaq.push(['_setAccount', 'UA-24928199-1']);
_gaq.push(['_trackPageview']);
(function () {
var ga …read more
Source: FULL ARTICLE at DailyFinance
ArQule Reports Fiscal 2012 Year End and Fourth Quarter Results
By Business Wirevia The Motley Fool
Filed under: Investing
ArQule Reports Fiscal 2012 Year End and Fourth Quarter Results
Conference call scheduled today at 9:00 a.m. eastern time
WOBURN, Mass.–(BUSINESS WIRE)– ArQule, Inc. (NAS: ARQL) today announced its financial results for the year and for the fourth quarter ended December 31, 2012.
The Company reported a net loss of $10,872,000 or $0.18 per share, for the year ended December 31, 2012, compared with a net loss of $10,762,000, or $0.20 per share, for the year ended December 31, 2011. For the quarter ended December 31, 2012, the Company reported a net loss of $5,296,000 or $0.09 per share, compared with net income of $3,768,000, or $0.07 per share, for the quarter ended December 31, 2011.
At December 31, 2012, the Company had a total of approximately $130,599,000 in cash and marketable securities.
Operational Milestones
Tivantinib (ARQ 197)
- Presentation of data at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) from a randomized, double-blind, controlled Phase 2 trial of tivantinib in second-line hepatocellular carcinoma (HCC) that met the primary endpoint of time to progression, with pronounced improvements observed in median overall survival and progression free survival in MET-high patients;
- Dosing of the first patient in the pivotal Phase 3 METIV-HCC trial of tivantinib as a single agent in second-line HCC MET-high patients in January 2013;
- Agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of the METIV-HCC trial;
- Discontinuation of the Phase 3 MARQUEE trial of tivantinib and erlotinib in non-squamous non-small cell lung cancer (NSCLC), conducted by our partner Daiichi Sankyo Co., Ltd., following an interim analysis, with patients already on treatment and re-consented continuing to receive treatment;
- Permanent suspension of enrollment in the Phase 3 ATTENTION trial of tivantinib and erlotinib in non-squamous NSCLC in Asia conducted by our partner, Kyowa Hakko Kirin Co., Ltd., with patients already enrolled and re-consented continuing to receive treatment;
- Announcement of top-line …read more
Source: FULL ARTICLE at DailyFinance
CAPScall of the Week: Clovis Oncology
By Sean Williams, The Motley Fool
Filed under: Investing
For years, satirical late-night TV host Stephen Colbert has been running a series on his show called “Better Know a District,” which highlights one of the 435 U.S. congressional districts and its representative. While I am no Stephen Colbert, I am brutally inquisitive when it comes to the 5,000-plus listed companies on the U.S. stock exchanges.
That’s why I’ve made it a weekly tradition to examine one seldom-followed company within the Motley Fool CAPS database, and make a CAPScall of outperform or underperform on that company.
For this week’s round of “Better Know a Stock,” I’m going to take a closer look at Clovis Oncology .
What Clovis Oncology does
As Clovis’ name would imply, there’s no smoke-and-mirror tricks here regarding what it does: It’s a biotechnology company engaged in researching anti-cancer compounds. It has three compounds currently in its pipeline: CO-1686 — which is an oral phase I/II epidermal growth factor receptor, or EGFR, inhibitor for the treatment of non-small-cell lung cancer, or NSCLC — that it’s partnered with Roche in developing; Rucaparib — which is a poly ADP-ribose polymerase, or PARP, inhibitor in phase I/II trials for ovarian and breast cancer; and a preclinical cKIT inhibitor for gastrointestinal stromal tumors that it’s partnered with Array BioPharma on.
In Clovis’ most recently ended fourth quarter, it reported a loss of $21.1 million compared to a loss of just $14.9 million in the year-ago period as its total cash level rose modestly to $144.1 million from the $140.2 million it ended with in 2011.
Whom it competes against
This is one of those cases where I say there are a ton of competitors in NSCLC, but few that target the T790M mutation that CO-1686 is being developed to treat. In fact, there are no FDA-approved treatments to specifically target the mutation at the moment. However, that may change very shortly as Boehringer Ingelheim does have an experimental drug known as Afatinib under an accelerated FDA review for EGFR mutation-positive NSCLC. With Clovis still early in its development, Afatinib could have a chance to clean up before CO-1686 even gets to late-stage enrollment.
Something similar can be said for Clovis’ competition in breast cancer with regard to PARP inhibitors. However, unlike with NSCLC, advancements in PARP inhibitors are still very slow, so a drug like Rucaparib that is still being studied in phase 1 trials has just as much chance of success as AbbVie‘s Veliparib, which is being tested as a combination PARP inhibiting therapy in phase 1/2 trials.
The call
After carefully reviewing Clovis Oncology‘s prospects, I’ve decided to place a CAPScall of underperform on the company for a number of reasons.
The primary reason for my distaste of this recent run relates to its complete failure with CO-101 for metastatic pancreatic cancer. The results from the phase 1/2 trial were noted by CEO Patrick Mahaffy to be “even more ambiguous than we could have imagined,” as CO-101 was …read more
Source: FULL ARTICLE at DailyFinance