Off to the teepee to celebrate Thanksgiving, this is a great Thanksgiving bonus for investors and patients, cutting across both sexes.
Best to all longs,
Hi Chief, new to the board, but have followed and been in and out of IMMC for a couple of years. I have amasses a position over the last several months because I believe in the technology as I know you do. Unfortunately, I'm losing my patience with managemant and was wondering if you would give your opinion on why this important announcement, that was quarters overdue wasn't trumpeted to the market by management ? Not even mentioned on the comoany website. I look forward to heariong your thoughts and I appreciate the quality and intergrity of your posts. Have a Happ Thanksgiving.
Hi Med, Sorry to just get back you and my fellow tribes men and women gathered at the investor's fire.
I believe your frustrations for how quickly CellSearch CRC FDA approval was received are shared by IMMC's mgmt team. However, FDA approvals currently reside with IMMC's marketing partner. More rapid approvals would occur if that responsibility were solely in IMMC's hands, a situation that could change in March 2008, as I am sure you are aware from following IMMC's Q108 date with current partner JNJ.
Nonetheless, the FDA approval is a great coup and success, offering further validation of Immunicon's key product/service/technology for monitoring and guiding oncology treatment in metastatic: breast, CRC, and soon prostate cancer.
I also believe that Immunicon's management team have been keeping very, very busy aligning its strategic and marketing ship for its end of 2007 and full year 2008 strategy. As eluded to in the investor's call, I expect we will hear of more pharma deals before year end, if I heard correctly on the call. I will have the investor's call transcript by Monday of next week, but it would behoove you to listen to the Q307 investor's call online, if you haven't already.
I share your frustration with the present stock price, but I believe a very good buying opportunity/value proposition is on the table today, witness the 400K + shares traded today @ 1-1.10 today, no lack of buyers to take those shares.
Are you taking a risk, sure, but the upside is IMMC's technology alone has a high market value to many potential suitors in 2008 and beyond. The upside of a successful, full thrust marketing campaign in 2008 for CRC, breast, and prostate is shaping up very nicely.
see today's Immunicon Press Release -- http://www.immunicon.com/investor/pressrelease_pdf/11.26.07%20CRC%20clearance%20FINAL.pdf
November 26, 2007
CellSearch� Circulating Tumor Cell Kit Receives FDA Clearance for Monitoring Patients with Metastatic Colorectal Cancer
Data is consistent with that seen in breast cancer and broadens the clinical utility of the CellSearch test.
Oh Great Chief!
Wonderful to hear from you.
We wish you much happiness and joy with your family at the teepee.
FDA Clears Advanced Test For Monitoring Metastatic Colorectal Cancer
Capable of detecting minute numbers of circulating cancer cells in 40 billion blood cells, the CellSearch� test can help guide patient care decisions
Warren, NJ (November 20, 2007) � Veridex, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch� System to be used as an aid in the monitoring of metastatic colorectal cancer. CellSearch� is currently approved for monitoring metastatic breast cancer.
The CellSearch� System identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic colorectal or breast cancer, and can do so earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch� System, in conjunction with other clinical methods for monitoring, can help physicians assess disease progression, thereby guiding more informed care decisions earlier.
"We are very excited that we can now offer the CellSearch� test to patients who have metastatic colorectal cancer," said Dr. Ravi Patel of the Comprehensive Blood and Cancer Center in Bakersfield, California, which will become the first clinical site in the U.S. to offer the test under the new indication. "CellSearch� will have a very positive impact on the care of these patients, in the same way it has positively impacted the care of our patients with metastatic breast cancer over the last year."
The CellSearch� System is the first diagnostic test to automate the detection and enumeration of CTCs, cancer cells that detach from solid tumors and enter the blood stream, and is the standard in a new class of diagnostic tools. The system's specificity, sensitivity and reproducibility allow for serial assessment of CTCs as early as the first cycle of treatment to help evaluate disease progression sooner.
According to the American Cancer Society, colorectal cancer claims approximately 55,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic colorectal cancer occurs when tumor cells spread to other locations in the body and grow. Although there are several options for the treatment of metastatic colorectal cancer, oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient. The CellSearch� System helps physicians to predict disease progression and patient survival any time during therapy through its ability to locate minute numbers of circulating tumor cells in the approximately 40 billion cells contained in a 7.5 ml sample of blood � an achievement never before documented in any diagnostic tool.
The CellSearch� System was originally cleared by the FDA in January 2004 as a diagnostic tool for identifying and counting CTCs in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer.
A prospective, multi-center clinical trial was conducted to validate the expanded clearance for CellSearch�. The study, which took place in 55 clinical centers in the United States and Europe, involved 430 metastatic colorectal patients about to enter first- or second-line therapy. Data showed that patients with less than three CTCs at baseline had significantly better survival rates versus patients with more than three CTCs � an overall finding consistent with metastatic breast cancer patients. Data also showed that CTCs are a strong independent predictor of progression-free survival and overall survival, and that the combination of CTC analysis and radiological assessment may provide the most accurate assessment of prognosis.
"Clinical research validates the significance of circulating, cancer tumor cells," said Robert McCormack, Ph.D., Vice President of Medical and Scientific Affairs, Veridex. "Elevated CTCs in the blood stream are associated with lower survival rates. We believe, based on the clinical research, that identifying CTCs as soon as possible can lead to improved patient outcomes."
The CellSearch� test works by using antibodies that are joined to microscopic iron particles, called ferrofluid. These antibody/ferrofluid combinations attach very specifically to CTCs. Powerful magnets then "pull" the CTCs out of the blood sample. They are then stained with additional bio-molecules and chemicals so that they can be positively identified as CTCs. The CellSearch� test differs from the current standard of care because it can be used much earlier than traditional imaging (e.g., CT scans), and is not subject to the variation observed with other blood tests, called serum tumor markers.
In August 2004, a clinical study using the CellSearch� test in metastatic breast cancer patients was published in The New England Journal of Medicine. The authors of this study concluded "the very short median progression-free survival in patients with elevated circulating tumor cells at the first follow-up visit suggests that these patients are receiving ineffective therapy." In addition, as recently as November 2006, a metastatic breast cancer study was published in Clinical Cancer Research where the authors concluded: "The results reported here indicate that the evaluation of CTCs is an accurate measure of treatment efficacy." Additionally, the authors said: "The ability to serially quantitate and interrogate CTCs in patients with breast cancer makes possible new ways of managing and investigating the disease."