Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
DCTH has the potential to break-out to the 7-10 range. We should be hearing about trial data soon.
Argot is located at 118 Spring Street, NYC. Is that one of the buildings that IMCL has a lease option on? The address sounds very familiar.
Wishing you the best...
And a very happy and healthy one to all of my IMCL friends.
I have been following this story since it broke a few days ago. Remember ther IMCL hearing? Remember 2 things that came out.
1)Eric Ende - ML's top analyst wrote a story about the probable failure of Erby. When queried, they couldn't find a problem He then took retirement from ML and all his files were taken off their server (I know because I was a ML account).
2) Pazdur admitted that he had lunch with BMY's attorney and told him beforehand. Nothing happened to him.
I hope that this thing generates a full blown investigation.
Not 1 post in the last 10 days on this MB?
Walk-good post. BMY should be ruled out as a buyer, because they will have huge manufacturing in MA, where they are constructing a large plant. Merck Kgaa doesn't buy product from IMCL for their sales---whose making it for them?
Manufacturing plants are also big overhead.
I am assuming that in off label use the patient will not get reimbursed or covered for Avastin. Wouldn't this be a huge out of pocket expense and wouldn't there be considerable legal exposure to the Dr. for off label use?
Wonder if the Brocade decision-re back dating options is going to reach out for Kies, Lynch or Howie?
You folks (biophud and Jbog) are terrific-a wealth of information. Just for curiousity, what other stocks do you see performing well within a 6 month window?
I recall them having meetings in June and July.
1. Don't they have to give at least 30 days notice for this meeting? This is way less.
2. We're going upscale again--having it in NYC. I strongly suspect that there will be a major announcement before then.
Why are you worrying about Andrea? (I still can't believe that she's still pulling a paycheck) Guess Icahn hasn't discovered that she's on the payroll (or doesn't care).
The recent disclosure of the results from the SWOG Pancreatic trial-in which Erby failed to meet survival endpoints has been misinterpreted IMHO by the press. This population was "patients with locally advanced unresectable or metastatic pancreatic cancer"
It will be extremely interesting to see the results of the following studdy, in which patients that had successful resections were used: Even though it was a phase II, I believe that some results are already in.
"Phase II Randomized Study of Adjuvant Therapy Comprising Bevacizumab Versus Cetuximab in Combination With Gemcitabine Hydrochloride, Capecitabine, and Radiotherapy in Patients With Completely Resected Carcinoma of the Pancreas"
NCI
ECOG-E2204
NCT00305877, CALGB-ECOG-E2204, NCCTG-ECOG-E2204, SWOG-ECOG-E2204
This was a "faceoff" of ERBY vs. Avastin - both arms having Gen. and radiation.
My condolences to you and your family.
I believe that you are correct on that, regarding Bev. pulling out. I didn't realize that only 52 patients received treatment. Any way to confirm this? She was interested as to why that trial had ended (it was after she completed all treatments). Her oncologist didn't know why it was halted.
Correction - it was a Phase 2.
Here's the trial
Clinical Trials (PDQ®)
Last Modified: 1/11/2007 First Published: 3/17/2006
Page Options
Print This Page
E-Mail This Document
Quick Links
Director's Corner
Dictionary of Cancer Terms
NCI Drug Dictionary
Funding Opportunities
NCI Publications
Advisory Boards and Groups
NIH Calendar of Events
Español
Questions about cancer?
1-800-4-CANCER
LiveHelp® online chat
E-mail
NCI Highlights
Ifosfamide Extends Life in Uterine Sarcoma
Toxicity Impact of IP Chemo for Ovarian Cancer
Past Highlights
Related Links
Learning About Clinical Trials
Clinical Trials: Questions and Answers
Questions to Ask Your Doctor
Drug Information from MedlinePlus
Bevacizumab or Cetuximab Combined With Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery
Alternate Title
Basic Trial Information
Trial Description
Purpose
Eligibility
Treatment/Intervention
Trial Contact Information
Related Information
Registry Information
Alternate Title
Phase II Randomized Study of Adjuvant Therapy Comprising Bevacizumab Versus Cetuximab in Combination With Gemcitabine Hydrochloride, Capecitabine, and Radiotherapy in Patients With Completely Resected Carcinoma of the Pancreas
Basic Trial Information
Phase
Type
Status
Age
Sponsor
Protocol IDs
Phase II
Biomarker/Laboratory analysis, Treatment
Temporarily closed
18 and over
NCI
ECOG-E2204
NCT00305877, CALGB-ECOG-E2204, NCCTG-ECOG-E2204, SWOG-ECOG-E2204
Special Category: NCI Web site featured trial, NCI - CMS pilot project trial
Trial Description
Purpose:
Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether bevacizumab is more effective than cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating pancreatic cancer.
This randomized phase II trial is studying bevacizumab to see how well it works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery.
Eligibility:
Eligibility criteria include the following:
At least 18 years old
Has undergone surgery to completely remove the tumor more than 4 weeks but no more than 8 weeks ago
No metastatic cancer
No previous chemotherapy or radiation therapy for this cancer
For more information about the eligibility criteria for this trial, refer to the Health Professional version.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment/Intervention:
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
Patients in group one will receive a 1- to 2-hour infusion of cetuximab once a week for approximately 6 months. They will also receive an infusion of gemcitabine once a week in weeks 1-3, 13-15, 17-19, and 21-23. Patients will receive capecitabine by mouth twice a day 5 days a week in weeks 5-10 and at the same time, they will also undergo radiation therapy once a day 5 days a week for approximately 5½ weeks.
Patients in group two will receive a 60- to 90-minute infusion of bevacizumab once every 2 weeks for approximately 6 months. They will also receive an infusion of gemcitabine once a week in weeks 1-3, 13-15, 17-19, and 21-23. Patients will receive capecitabine by mouth twice a day 5 days a week in weeks 5-10 and at the same time, they will also undergo radiation therapy once a day 5 days a week for approximately 5½ weeks.
Tumor samples will be collected from patients in both groups and are examined in the laboratory.
After finishing treatment, patients will be evaluated periodically for up to 3 years.
Important:
For more details about this trial, refer to the Health Professional version of the trial summary.
If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.
Trial Contact Information
Trial Lead Organizations
Eastern Cooperative Oncology Group
Jordan Berlin, MD, Protocol chair Ph: 615-322-4967; 800-811-8480
Email: jordan.berlin@vanderbilt.edu
Cancer and Leukemia Group B
Arthur William Blackstock, MD, Protocol chair Ph: 336-713-6501; 800-446-2255
Southwest Oncology Group
Andrew Lowy, MD, Protocol chair Ph: 513-584-8900; 888-640-CARE
Email: andrew.lowy@uc.edu
North Central Cancer Treatment Group
Robert McWilliams, MD, Protocol chair Ph: 507-284-2511
Related Information
Featured trial article
Registry Information
Official Title An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination with Gemcitabine and in Combination with Chemoradiation (Capecitabine and Radiation) in Patients with Completely-Resected Pancreatic Carcinoma
Trial Start Date 2006-02-17
Registered in ClinicalTrials.gov NCT00305877
Date Submitted to PDQ 2005-11-28
Information Last Verified 2006-11-15
NCI Grant/Contract Number CA21115
Back to Top
NCI Home | Text-Only Version | Contact Us | Policies | Accessibility | FOIA | Site Help | Site Map
A Service of the National Cancer Institute
Sorry for not responding, I was away for a few days. She was part of a trial in NJ in which it was a "faceoff" Centux plus Gemz. against Avastin plus Gemz. It was a Phase 3 trial.
We had recently heard that the trial closed.
(she was in the Centux. group)
My friend received Erbitux with Genz. for pancreatic cancer over 6 months ago. Her rash was intense, but then it eventually cleared up.
Latest tests indicate "cancer free." Her Dr. was amazed with her levels. Yes, it has only been 6 months, but we are hoping....
I find it very hard to believe that infusion reactions differ between regions - and may be attributable to altitude or environment.
May it appear that they are "circling the wagons" and don't want to deal with other companies that may muddle up and confuse negotiations, concerning their sale?
This is probably great news for BMY.
What will it mean for IMCL, is the big question? \Will Cark use it as leverage in the SNY-BMY deal?
Will BMY finally let go of their rights to IMCL?
Will BMY attempt to negotiate with Carl to obtain his shares, so they will own more?
Will IMCL be put back in the closet, like it was a bad stepchild, as before?
Something has to give here.
Isn't it very common for analysts to upgrade 1 "notch" at a time, rather than go from a sell to a buy?
Is 250 MM a truly accurate figure for 2015 for H&N? I would have thought that it would be much greater for that indication. What is the current contribution to yearly sales for this indication?
I Cahn, now that it was Kiesd goodbye?
No activity on this board??
This is a weird proposal to handle Yeda, but perhaps it could work.
1. Since the Israeli government won't enable their citizens to receive this drug - much to the frustration of their population, couldn't IMCL offer a tremendous discount for this drug to their country? This would put YEDA in the hotseat. IS this proposal "Kosher"?
Sidransky is finally being recognized as an up and coming expert in this field. I wouldn't mind seeing him as the CEO of IMCL. Rumor is that he clashed with Lynch and Kies. I believe that he is an Icahn supporter.
WHY ?? Don't tell me that they have not been an impediment to a more positive realtionship with the public?
Please tell me what they have done in the last 1 - 2 years?
From a historical look at this company, how many other directors actually purchased significant amount of shares, as did Icahn? Yes, he has some options, due to being on the board, but the majority of his holdings in IMCL is through direct purchase. As far as I'm concerned, once the reamining 2 bozos leave, they could take Andrea with them (if not before) and we should not even bother to fill their seats.
AM 1st QTR 07 - isn't that weird - considering we just had the AM?
Now that Fischer resigned - does he get his 500MM severence?
To put this in another perspective:
IMCL paid Dan Lynch as a severance, the equivalent of all of the royalties that they earned from Merck Kgaa in the 3rd qtr of 2006 !!!
Do you think that Howie resigned because of a wrong doing?
``A number of employees are voting with us, a number of highly placed employees,'' Icahn said. ``This board has absolutely messed the company up.''
Note-According to a friend that is a principal in a health care search firm, he has been inundated with "feelers" from many IMCL employees. Problem is that they are making in excess of 20% of what the industry is paying - and that is including major pharmas. Bottom line - I hope that Carl or his associates read this. For years, these folks have lived off the shareholders and delivered very little. Nowhere are there that many VP slots.
Pay cuts are coming and employee count will diminish either by attrition or otherwise. Carl - I hope you increase shareholder value by cutting these expenses. (Oh yeah - check their brief cases - IMCL defintely has the security staff to do it - office supply expenditures have increased.
Only wish that Carl wouyld have done this over 1 year ago!!
Don't forget these expenditures:
11 million in severence for Lynch.
500K for Fischer when he goes (shortest tenure I bet)
The "gang of 4 should have been ousted a long time ago."
We owe them for the pitiful performance of this company over the many years. These were the folks that 1) allowed the nontaxable scenario regarding employee options. 2) These are the folks that elected Lynch. Don't forget-it was under Lynch's watch when he was CFO that all of the accounting questions were allowed to develop. 3) Wonder why Howie resigned? Hope that accounting irregularities don't start to develop now.
The IMCL press release is a very feeble attempt to justify their wrong turns and general inertia with this company.
"Mr. Icahn's criticisms ignore the fact that the incumbent
directors whom he seeks to remove have had to surmount a cascade ofserious problems that were the legacy of the previous management,including the FDA's refusal to file the Company's application forapproval of Erbitux(R), an insider trading investigation centering around the Company's founder and then-CEO who ultimately pled guilty
to criminal charges including securities and bank fraud, and failure to withhold and improper accounting for taxes relating to options exercised by the founder, its then-Chairman, and certain other executives along with the resulting restatements of the Company's financials and threatened delisting of the Company's stock."
Which bozo's recently granted a huge severence package to Fischer - another do nothing? You would have thought that they would have tightened the reins after giving Lych 10 Million in severence? At least he was there for a few years!!
It is amazing that in the last few weeks, more communications to the street has happened than when we actually had a successful launch and acceptance of Erby. What other press releases have we had in the last 12 months? I only regret that DeVita, Fazio, Fischer and Miller can't be put in jail. Rumor is that Howie is very nervous about what may be uncovered.
IMCL has to start the layoffs now - at least 15 VP's have to be put out to pasture immediately. Thay will send a strong signal to the street that they are interested in increasing the bottom line and at the same time facilitate another firm looking to purchase them. Quality firms have no interest in IMCL's personnel and bloated overhead.
Only wish that Kies and Crouse could pack up at least 15 VP's on IMCL payroll and take them with them. Hope security at IMCL checks their bags - they probably took all the office supplies and plasticware from the cafeteria. (Oh, that's right, they still dine at Club 22 on their expense account).
Happy day - Crouse and Kies have made no contribution to IMCL. They only took from shareholders. This is the start of the exodus. Too bad they got options.