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AMLN..HALTED
CHTP..down 25 cents..800k volume
Can't beat them join them...doubled shares of ALXA @ .96
ALXA 500,000 @1.23 after hours.....looks like someone went stop hunting on ALXA and then loaded up
ALXA ..what the heck is going on??
Please get you facts straight..I am giving the press release
lol added @ 7
YMI BMISSISAUGA, ON, Oct. 31, 2011 /PRNewswire via COMTEX/ -- Phase II Study of Nimotuzumab in Pediatric Patients with Recurrent Diffuse Intrinsic Pontine Glioma (DIPG)
YM BioSciences Inc. /quotes/zigman/23376/quotes/nls/ymi YMI -1.15% /quotes/zigman/23391 CA:YM +0.59% today announced that preliminary results of a Phase II study evaluating the safety and efficacy of nimotuzumab in pediatric patients with recurrent diffuse intrinsic pontine glioma (DIPG) were reported at the 43rd Congress of the International Society of Paediatric Oncology (SIOP) conference being held in Auckland, New Zealand.
"Nimotuzumab is an anti-EGFR antibody that has shown promising activity in a previous Phase II study in patients with recurrent/refractory DIPG, a particularly severe, inoperable form of cancer for which there are currently no lifesaving effective treatments," said Dr. Ute Bartels at The Hospital for Sick Children in Toronto, Canada. "In the study we conducted, nimotuzumab was found to be safe and well tolerated. In this very challenging disease, a small subset of patients showed prolonged survival and benefit from nimotuzumab."
The study was a Phase II, open-label, single-arm, multi-center study conducted at multiple sites in the US, Canada, and Israel. It was designed to evaluate the efficacy and safety of nimotuzumab in patients aged three to 18 years of age with clinically and radiologically confirmed recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their disease. All had received prior radiotherapy and 25 had received chemotherapy. Nimotuzumab (150 mg/m2) was administered intravenously once weekly from week one to seven and once every two weeks from week eight to 18. Patients with Partial Response (PR) or Stable Disease (SD) were allowed to continue nimotuzumab.
Of 46 patients enrolled, 44 received at least one dose of nimotuzumab. Nineteen patients (43.2%) completed the induction phase, five patients (11.4%) completed the consolidation phase, and three patients (6.8%) continued to receive nimotuzumab after completing the consolidation phase. Seven patients (15.9%) died due to disease progression. Treatment with nimotuzumab was well tolerated with most adverse events reported as mild or moderate in severity. The majority of Adverse Events (AEs) were associated with CNS disorders and not related to study drug. The most commonly reported events related to study drug were rash and lymphopenia occurring in 9.1% and 6.8% of patients respectively. Study drug discontinuation was reported in four patients overall due to AEs. Only one patient experienced serious Adverse Events (Grade 5 intracranial tumor hemorrhage and tumor necrosis), assessed as possibly related to nimotuzumab.
No Complete Responses (CR) were observed. At week 8, a PR was reported in two patients, SD in six patients and Progressive Disease (PD) in 11 patients who were evaluable for response, resulting in a Clinical Benefit Rate (CR+PR+SD) of 18.2%. At week 18, one patient continued to have a PR and three patients continued with SD, giving an Overall Response Rate of 2.3%. The Median Duration of Response, Time to Progression, and Overall Survival were 2.1 months, 1.7 months and 3.2 months respectively.
Nimotuzumab is designated an Orphan Drug for adult and pediatric glioma by the FDA as well as the EMEA for Europe.
About Nimotuzumab: Nimotuzumab is a humanized monoclonal antibody targeting EGFR with an enhanced side effect profile over currently marketed EGFR-targeting antibodies. Nimotuzumab reportedly has been approved in 27 countries and more than 15,500 patients have been treated with the drug to date in 35 countries.
Nimotuzumab is licensed to YM's majority-owned joint venture, CIMYM BioSciences Inc., for Western and Eastern Europe, North America and Japan, as well as Australia, New Zealand, Israel and certain Asian and African countries. The drug is currently being evaluated in several Phase II and III trials in these territories by various licensees of the drug.
About YM BioSciences YM BioSciences Inc. is a drug development company advancing three products: CYT387, a small molecule, dual inhibitor of the JAK1/JAK2 kinases; nimotuzumab, an EGFR-targeting monoclonal antibody; and CYT997, a vascular disrupting agent (VDA).
CYT387 is an orally administered inhibitor of both the JAK1 and JAK2 kinases, which have been implicated in a number of immune cell disorders including myeloproliferative neoplasms and inflammatory diseases as well as certain cancers. CYT387 is currently in a 166 patient Phase I/II trial in myelofibrosis that has completed enrollment, as well as a 60 patient Phase II BID trial that is recruiting patients. Nimotuzumab is a humanized monoclonal antibody targeting EGFR with an enhanced side-effect profile over currently marketed EGFR-targeting antibodies. Nimotuzumab is being evaluated in numerous Phase II and III trials worldwide. CYT997 is an orally-available small molecule therapeutic with dual mechanisms of vascular disruption and cytotoxicity, and has completed a Phase II trial in glioblastoma multiforme. In addition to YM's three clinical stage products, the Company has several early-stage research programs underway with candidates from its library of novel compounds identified through internal research conducted at YM BioSciences Australia.
This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand; and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that CYT387, nimotuzumab and CYT997 will generate positive efficacy and safety data in ongoing and future clinical trials, and that YM and its various partners will complete their respective clinical trials and disclose data within the timelines communicated in this release. Except as required by applicable securitieslaws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a
ioSciences Nimotuzumab Results Reported at SIO
YMI YM BioSciences Nimotuzumab Results Reported at SIOP Conference
http://t.co/sTtRdO70
PCRX Gekkowire PCX Analysis for what it is worth
http://t.co/3OLsVwsu
s ..A few shares traded uh.....154 million
Here’s to the crazy ones. The misfits. The rebels. The troublemakers. The round pegs in the square holes. The ones who see things differently. They’re not fond of rules. And they have no respect for the status quo. You can quote them, disagree with them, glorify or vilify them. About the only thing you can’t do is ignore them. Because they change things. They push the human race forward. And while some may see them as the crazy ones, we see genius. Because the people who are crazy enough to think they can change the world, are the ones who do....
Steve Jobs
AMRN submits NDA
Amarin Announces NDA Submission for AMR101 for the Treatment of Patients With Very High Triglycerides
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AMRN 10.63 0.00
{"s" : "amrn","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Amarin Corporation plc On Monday September 26, 2011, 4:00 am EDT
BEDMINSTER, N.J. and DUBLIN, Ireland, Sept. 26, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN - News), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of AMR101 for treatment of patients with very high triglycerides. The submission is based on the entire data set from the Company's AMR101 development program, including safety and efficacy data from the Phase 3 MARINE and ANCHOR studies.
"This is another significant milestone achieved for Amarin. Data from our two pivotal Phase 3 studies show that, unlike other triglyceride-lowering therapies, AMR101 does not increase LDL-cholesterol and, in certain cases, significantly decreases it," said Joseph S. Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The submission of this NDA moves AMR101 one step closer to commercial launch. If AMR101 is approved, we believe it can play a significant role in cardiovascular health management."
It is estimated that 75 million people in U.S. alone have triglyceride levels greater than 150mg/dL, including 4 million people with very high triglyceride levels (the triglyceride range studied in the MARINE trial) and 36 million people with high triglyceride levels (the triglyceride range studied in the ANCHOR trial). Elevated triglycerides are clinically stratified into three groups: very high triglycerides (>=500 mg/dL), high triglycerides (>=200 and <500 mg/dL) and borderline high triglycerides (>=150 and <200 mg/dL). Clinical treatment guidelines include recommendations for triglyceride reductions in each of these groups and each group represents a multi-billion dollar market opportunity. In the top seven world markets it is estimated that the number of people with elevated triglyceride levels is at least two times that of the U.S. alone.
The treatment of patients with very high triglycerides was studied in the Company's MARINE trial. The treatment of patients with high triglycerides on statin therapy was studied in the Company's ANCHOR trial. Amarin plans to separately seek approval for the treatment of high triglycerides in patients on statin therapy (the population studied in the ANCHOR trial) after its REDUCE-IT cardiovascular outcomes trial is substantially underway, which the Company expects will occur before the end of 2012 (final results of the REDUCE-IT outcomes study are not required for approval of the very high triglyceride indication).
In both the MARINE and ANCHOR trials, AMR101 achieved all primary endpoints and was well tolerated with a safety profile comparable to placebo. Each trial was conducted under a Special Protocol Assessment (SPA) agreement from the FDA. As recently announced, an SPA agreement was also reached for the REDUCE-IT cardiovascular outcomes study.
About AMR101
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl), that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (>=500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>=200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Triglycerides are fats in the blood. Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP without increasing LDL-C. AMR101 demonstrated a safety profile comparable to placebo in two complete Phase 3 clinical trials.
About Amarin
Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (icosapent ethyl). Amarin reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [>=500 mg/dL]), as reported on November 29, 2010, and the ANCHOR trial (investigation of AMR101 for the treatment of patients on statin therapy with high triglycerides [>=200 and <500mg/dL] with mixed dyslipidemia), as reported on April 18, 2011. Both the MARINE and ANCHOR trials were conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development.
Disclosure Notice
This press release contains forward-looking statements, including statements about the efficacy, safety and market opportunities of AMR101, the clinical importance of AMR101, regulatory submissions and approvals and the commercial opportunity and competitive positioning for AMR101. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: the risk that the
IGXT
I think $heff posted a well written response to Adam Feurstein's article with plenty of DD in it.$heff also posted comments from the IGXT last conference. With a partnership to be announced before the PUFA date I see a nice run coming. Patience here and the risk/reward should turnout another winner for $heff.
If I understand right even with no patent they still have until around 2021 before generics can kick in. Patent would take it to around 2030. Of course this would hurt ARMN's valuation but the patent issue will not be settled until the end of 2012 according to one of the anylists that covers AMRN.(do not remmeber who it is.)Anyway look at my screen name and you can see what my opinion is worth.
AMRN
My opinion only but ABT and AZN cardio drugs failed. Crestor does not work better than Lipotor. All this is good news for AMRN.
AMRN Highlights from the American Journal of Cardiology
Current Issue 15 September 2011 | Vol. 108, No. 6
Issue Highlights.
Preventive Cardiology
Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Patients with Very High Triglyceride Levels (From the MARINE Trial)
AMR101 is an omega-3 fatty acid agent containing >96% eicosapentaenoic acid (EPA) ethyl ester and no docosahexaenoic acid (DHA). Previous smaller studies suggested that highly purified EPA lowers triglyceride (TG) levels without raising low-density lipoprotein cholesterol (LDL-C) levels. TG-lowering therapies such as fibrates and fish oils containing both EPA and DHA may substantially increase LDL-C when administered to patients with very high TG levels (=500 mg/dL). This double-blind study randomized 229 diet-stable patients with fasting TG =500 mg/dL and =2000 mg/dL (with or without background statin therapy) to AMR101 4 g/day, AMR101 2 g/day, or placebo. The primary end point was placebo-corrected median percent change in TG from baseline to week 12. Baseline TG levels were 680, 657, and 703 mg/dL for AMR101 4 g/day, AMR101 2 g/day, and placebo. AMR101 4 g/day reduced placebo-corrected TG levels by 33.1% (n=76, p<0.0001) and AMR101 2 g/day by 19.7% (n=73, p=0.0051). For baseline TG >750 mg/dL, AMR101 reduced placebo-corrected TG levels by 45.4% (n=28, p=0.0001) and AMR101 2 g/day by 32.9% (n=28, p=0.0016). AMR101 did not significantly increase placebo-corrected median LDL-C levels at 4 g/day (-2.3%) or 2 g/day (+5.2%) (both p=NS). AMR101 significantly reduced non–high-density lipoprotein cholesterol, apolipoprotein B, lipoprotein-associated phospholipase A2, very–LDL-C, and total cholesterol. AMR101 was generally well tolerated with a safety profile similar to placebo. In conclusion, this randomized, double-blind trial in patients with very high TG levels demonstrated that AMR101 significantly reduced TG levels and improved other lipid parameters without significantly raising LDL-C levels.
Heart Failure
Prediction of Response to Cardiac Resynchronization Therapy Combining 2 Different 3-Dimensional Analyses of Left Ventricular Dyssynchrony
Tri-plane tissue synchronization imaging (TSI) and real-time 3-dimensional echocardiography (RT3DE) provide different characterization of LV mechanics and dyssynchrony. Tri-plane TSI assesses differences in time to peak systolic segmental myocardial tissue velocities, whereas RT3DE evaluates differences in time to minimum end-systolic regional volumes. Whether an approach using both 3-dimensional (3D) modalities predicts better significant reverse remodeling after cardiac resynchronization therapy (CRT) remains unknown. In 166 patients (mean age 66±9 years, 78% male) treated with CRT, baseline LV dyssynchrony was assessed using RT3DE and tri-plane TSI. LV dyssynchrony was defined by systolic dyssynchrony index (SDI) =6.4% when assessed with RT3DE and standard deviation of time to peak velocity of 12 segments (Ts-SD-12) =33 ms with tri-plane TSI. CRT response was defined by =15% reduction in LV end-systolic volume at 6 months follow-up. Mean Ts-SD-12 LV dyssynchrony was 48±26 ms and mean SDI was 8.51±3.81%. Response to CRT was observed in 86.3% of patients showing LV dyssynchrony with both methods. In contrast, 97% of patients who did not show significant LV dyssynchrony with any of the modalities were non-responders (P<0.001). Importantly, SDI and Ts-SD-12 LV dyssynchrony were both independent predictors of response to CRT (P<0.001 for each modality respectively). The assessment of LV dyssynchrony with both modalities showed incremental value for prediction of significant LV reverse remodeling over its assessment with only one modality (chi-square 90.18; P<0.001). In conclusion, the combined use of 2 different 3D modalities to assess LV dyssynchrony permits accurate prediction of response to CRT.
AMRN
Someone was asking if there was additional data going to be presented Monday. The answer is yes.
http://t.co/MXKJOuV
AMRN Jason Npododano talked to AMRN this was on his twitter
Jason Napodano, CFA
Ok - just spoke to $AMRN -->Mgt has not seen the final rejection letter yet, but was firm in their stance that the words "final rejection" are doubly misleading. Fist off, the letter is not "final", they will apeal. Secondly, there's no "rejection" of the IP. AMRN has filed "hundreds" of patents around MARINE and ANCHOR. This is just one of many. The issue is with data exclusivity. A company in Japan has previously studied the drug in 200-500mg population. MARINE was >500mg population. USPTO sees this as the "same" patients. AMRN disagrees, and will apeal. Long story short, there's nothing in this rejection that puts the IP at risk, still many applications pending and patents active, including applications around ANCHOR.
AMRN CC
New info I picked up on conference call with Webush:
Should get some patent clarity by the end of the year. Most of the clarity for the patents will come next year with news on acouple this year. NDA filed by end of September
lol just added at $15.12
AMRN
Joseph Zakrzewski, Amarin's Executive Chairman and Chief Executive Officer, will present at the Wedbush Securities 2011 Life Sciences Management Access Conference to be held at Le Parker Meridien in New York City. The presentation will take place at 12:40pm ET on Aug. 17, 2011. A live webcast of the presentation will be available at the following URL:
http://wsw.com/webcast/wedbush17/amrn/
REGN up over 5% again today $57.24
REGN moving again today up over 5%
AMRN getting a little pre-market action. $12.53 with 7150 traded
AMRN I like this part
• Multiple additional patent applications filed based on positive but unexpected findings from ANCHOR trial
$heff have you done an approval assessment of REGN ...I bought the stock a couple of weeks ago. UGH
I couldn,t stand it IGXT so cheap I had to add today
Portfoilo swung 5% today from up in the morning too down this afternoon. That is with 7 stocks in it.
SPPI
Bought a few shares on the rumor of takeover. Also in finacial times
http://www.theflyonthewall.com/permalinks/entry.php/SPPIid1453519/SPPI-Spectrum-expected-to-preannounce-Q-revenue-beat-at-RBC-Capital
AMRN bought at $13.98 when the buyout rumour started a week or two ago. It had been holding $14-$14.50 until today
Had been looking at REGN for a while ...I just bought at $53.22.
IGXT .76 the bottom????? Hope so. I put a large bid in at .76 to add on but no takers.
PATH a little volume today. I have been out of this stock for a few days because of low volume and debt crisis.Love the low float.
AMRN HOD $14.50
Thanks Wrinkles....I am watching it very close
AMRN I will bite for a day in @ $13.95
AIS bought in at $2.21