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HEB's FDA approval update
The FDA Calendar is on the front page story here:
http://biomedreports.com/
Latest FDA approval info for CTIC
The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 115 entries through 4/14/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.
Story on the front page here:
http://biomedreports.com/
FDA, Clinical Trial Calendar Updates: SOMX
http://biomedreports.com/articles/most-popular/778-fda-clinical-trial-calendar-updates-somx-epix-hluky-arktf.html
FDA, Clinical Trial Calendar Update: EPIX
http://biomedreports.com/#module
Are you still buying up shares or just trading them?
For those who trade medical FDA, Clinical Trial Calendar Updates for THRX, GILD, TEVA, ALNY, RNUGF
http://biomedreports.com/articles/most-popular/771-fda-clinical-trial-calendar-updates-thrx-gild-teva-alny-rnugf.html
FDA, Clinical Trial Calendar Update for TEVA
http://biomedreports.com/
Must read article on CTIC at BiomedReports:
http://biomedreports.com/bloglist/542.html
THE FDA APPROVAL calendar is here:
http://www.biomedreports.com
I would imagine that because they are preferred stocks, they would be protected if a BK would occur.
Wow! That's very good news.
CTIC Exercises Its Option to Sell Interest in Zevalin Joint Venture to Spectrum Pharmaceuticals for $18 Million
CTI to focus on Pixantrone and OPAXIO Approval and Commercialization
SEATTLE, Feb. 20 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it exercised its option to sell its 50% ownership interest in the Zevalin joint venture to Spectrum Pharmaceuticals, Inc. (Spectrum) for $18 million. CTI and Spectrum established a joint venture in December 2008 to develop and commercialize Zevalin. At that time CTI contributed all of the Zevalin related assets to the joint venture and sold to Spectrum a 50% membership interest in the joint venture for $15 million, plus certain milestone payments.
The Company will focus its resources on the approval of pixantrone for relapsed aggressive non-Hodgkin's lymphoma (NHL) and OPAXIO for non-small cell lung and ovarian cancer. CTI estimates that as a result of the sale of the Zevalin interest it will reduce expenses by approximately $15 million annually from activities previously associated with Zevalin while providing CTI with non-dilutive source of operating capital.
"CTI continues to believe in the value of Zevalin as a commercially attractive product and effective form of cancer therapy; however, with the impressive clinical trial results for pixantrone and given the company's need for operating capital, we are compelled to exercise our option and focus our resources on pixantrone," noted James Bianco, MD, CEO of CTI. "CTI has been proud to have provided Zevalin to patients since we acquired it in December, 2007 and having the foresight to bring the first line consolidation for indolent NHL data to the FDA for potential label expansion in the front line consolidation setting. With the progress we made in removing many of the barriers that prevent its more widespread use, we are confident Spectrum will be able to ultimately make Zevalin a commercially attractive product."
At the closing of the sale of CTI's 50% membership interest in the joint venture to Spectrum, CTI will receive $6 million, with the remainder of the $18 million to be paid within 90 days following such closing. The closing of the sale option transaction is contingent upon the satisfaction of certain closing conditions, including the delivery of a legal opinion from counsel to CTI, as specified in the operating agreement for the Zevalin joint venture. CTI believes that it will be in a position to promptly satisfy all of the closing conditions.
About Zevalin(R)
Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, lowgrade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan(R)) infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
Patients and healthcare professionals can visit www.zevalin.com for more information.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms - aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.
XL on fire...
Next resistance $3.89
Jump on!
CTIC - Non-Hodgkin's Lymphoma Treatment!
Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin's Lymphoma
Feb 18, 2009 01:30:00 (ET)
SEATTLE, Feb 18, 2009 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced today that updated safety and efficacy data from the phase III trial of pixantrone provides further support for a robust clinical benefit for pixantrone when used as single agent therapy in the treatment of multiple relapsed aggressive non-Hodgkin's lymphoma (NHL). On an intent-to-treat analysis, pixantrone recipients who achieved a complete remission did so during the first 2 cycles of therapy, compared to 4 cycles among standard chemotherapy recipients, (1.9 months vs. 3.6 months, pixantrone vs. standard chemotherapy). The duration of response in the patients was similar in the 37% of pixantrone patients who had either a partial or complete response compared to the 14% of comparator patients with a major response. However, the overall progression free survival (PFS) was significantly longer in the pixantrone arm (4.7 months vs. 2.6 months, hazard ratio = 0.6; p = 0.0074, pixantrone vs. standard chemotherapy). Thirty-two percent (32%) of pixantrone patients received all 6 cycles of therapy, with 84% receiving 5 of 6 cycles of treatment. Pixantrone recipients had a low incidence of severe neutropenia complicated by either fever or documented infections, or severe vomiting or diarrhea. Pixantrone patients also experienced a low incidence of hair loss, a very common side effect of other drugs in this class. Overall, the incidence of serious adverse events was similar between pixantrone and the control arm. The pixantrone patients had a higher incidence of leucopenia and neutropenia and numerically more severe cardiac events (4 vs 2) than in the control arm. Disease progression reported as an adverse event was less frequent in the pixantrone than in the control arm (1.5% vs. 13.4%).
"We were impressed to see that 84% of patients received at least 5 cycles of pixantrone therapy with a median total dose of 1,475 mg, despite having had significant prior therapy with doxorubicin, an agent in a similar class with cumulative cardiotoxicity," noted Jack Singer, M.D., Chief Medical Officer at CTI. "The rapid time-to-response data coupled with the relatively low incidence of traditional anthracycline toxicities and a safety profile that compares favorably to standard chemotherapy, positions pixantrone to live up to the promise of providing patients with relapsed aggressive NHL a meaningful clinical benefit."
CTI announced in November 2008 that it had achieved the primary efficacy endpoint of its phase III EXTEND (PIX301) trial of pixantrone (BBR2778). Patients randomized to treatment with pixantrone achieved a high rate of confirmed and unconfirmed complete remissions compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02). No patient (0%) in the standard chemotherapy arm achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients.
CTI expects to begin submission of a rolling New Drug Application (NDA) and request priority review for pixantrone to treat relapsed aggressive non- Hodgkin's lymphoma ( NHL) in the first quarter of 2009. If granted priority review a decision on the NDA could occur before the end of 2009.
The study received Special Protocol Assessment approval from the U.S. Food and Drug Administration (FDA) in 2004, and pixantrone has received fast track designation for this indication.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains an aza- anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.CellTherapeutics.com .
Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_news.htm
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the Company's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
http://www.CellTherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.282.7100
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
http://www.CellTherapeutics.com/investors
SOURCE Cell Therapeutics, Inc.
http://www.celltherapeutics.com
CTIC - Non-Hodgkin's Lymphoma Treatment!
Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin's Lymphoma
Feb 18, 2009 01:30:00 (ET)
SEATTLE, Feb 18, 2009 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced today that updated safety and efficacy data from the phase III trial of pixantrone provides further support for a robust clinical benefit for pixantrone when used as single agent therapy in the treatment of multiple relapsed aggressive non-Hodgkin's lymphoma (NHL). On an intent-to-treat analysis, pixantrone recipients who achieved a complete remission did so during the first 2 cycles of therapy, compared to 4 cycles among standard chemotherapy recipients, (1.9 months vs. 3.6 months, pixantrone vs. standard chemotherapy). The duration of response in the patients was similar in the 37% of pixantrone patients who had either a partial or complete response compared to the 14% of comparator patients with a major response. However, the overall progression free survival (PFS) was significantly longer in the pixantrone arm (4.7 months vs. 2.6 months, hazard ratio = 0.6; p = 0.0074, pixantrone vs. standard chemotherapy). Thirty-two percent (32%) of pixantrone patients received all 6 cycles of therapy, with 84% receiving 5 of 6 cycles of treatment. Pixantrone recipients had a low incidence of severe neutropenia complicated by either fever or documented infections, or severe vomiting or diarrhea. Pixantrone patients also experienced a low incidence of hair loss, a very common side effect of other drugs in this class. Overall, the incidence of serious adverse events was similar between pixantrone and the control arm. The pixantrone patients had a higher incidence of leucopenia and neutropenia and numerically more severe cardiac events (4 vs 2) than in the control arm. Disease progression reported as an adverse event was less frequent in the pixantrone than in the control arm (1.5% vs. 13.4%).
"We were impressed to see that 84% of patients received at least 5 cycles of pixantrone therapy with a median total dose of 1,475 mg, despite having had significant prior therapy with doxorubicin, an agent in a similar class with cumulative cardiotoxicity," noted Jack Singer, M.D., Chief Medical Officer at CTI. "The rapid time-to-response data coupled with the relatively low incidence of traditional anthracycline toxicities and a safety profile that compares favorably to standard chemotherapy, positions pixantrone to live up to the promise of providing patients with relapsed aggressive NHL a meaningful clinical benefit."
CTI announced in November 2008 that it had achieved the primary efficacy endpoint of its phase III EXTEND (PIX301) trial of pixantrone (BBR2778). Patients randomized to treatment with pixantrone achieved a high rate of confirmed and unconfirmed complete remissions compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm, p = 0.02). No patient (0%) in the standard chemotherapy arm achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients.
CTI expects to begin submission of a rolling New Drug Application (NDA) and request priority review for pixantrone to treat relapsed aggressive non- Hodgkin's lymphoma ( NHL) in the first quarter of 2009. If granted priority review a decision on the NDA could occur before the end of 2009.
The study received Special Protocol Assessment approval from the U.S. Food and Drug Administration (FDA) in 2004, and pixantrone has received fast track designation for this indication.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy. Pixantrone is a novel DNA major groove binder that contains an aza- anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.CellTherapeutics.com .
Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_news.htm
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the Company's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
http://www.CellTherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.282.7100
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
http://www.CellTherapeutics.com/investors
SOURCE Cell Therapeutics, Inc.
http://www.celltherapeutics.com
Even on a terrible market day, HEB continues upward...
Why?
Because they've got an FDA approval coming in a few days.
:)
http://www.marketwatch.com/quotes/heb
Smart man!
Speaking of hydrogen powered vehicles...
Hydrogen Fuel From Woodchips And Other Non-food Sources
http://www.sciencedaily.com/releases/2009/02/090211162026.htm
Speaking of hydrogen powered vehicles...
Hydrogen Fuel From Woodchips And Other Non-food Sources
http://www.sciencedaily.com/releases/2009/02/090211162026.htm
SEC 13 G Filings Posted. BOOM
http://finance.google.com/group/google.finance.663887/browse_thread/thread/cc33dbba3b5af42a#
Great.. Now if they could open up for actual trading this might be worth something.
That's incredible.
Charter to file for bankruptcy as part of debt restructuring deal
http://www.stltoday.com/stltoday/business/stories.nsf/0/21E52B200E14D8048625755B0072F287?OpenDocument
Been saying it for months.. If you got caught in this stock, you weren't reading the writing on the walls. Good luck to you.
Just a few days until FDA approval -- HEB
HEB's ( HEB ) drug Ampligen, used to treat Chronic Fatigue Syndrome, has an excellent chance of gaining FDA approval in about two weeks due to the effectiveness and safety profile observed during clinical trials.
Stock just got some profit taking from a run earlier in the week. Nice point to jump in?
FDA Calendar:
http://3.bp.blogspot.com/_Du0YWLylHeA/SZDJjbqrA-I/AAAAAAAAA4s/5ZZF_mhlEQY/s1600-h/fdac9feb09.JPG
Just a few days until FDA approval
HEB's ( HEB ) drug Ampligen, used to treat Chronic Fatigue Syndrome, has an excellent chance of gaining FDA approval in about two weeks due to the effectiveness and safety profile observed during clinical trials.
Stock just got some profit taking from a run earlier in the week. Nice point to jump in. It's expected to run up past $1 before the announcement.
FDA Calendar:
http://3.bp.blogspot.com/_Du0YWLylHeA/SZDJjbqrA-I/AAAAAAAAA4s/5ZZF_mhlEQY/s1600-h/fdac9feb09.JPG
What do you guys make of this?
Someone posted news-- but it's in Italian..
http://finance.google.com/group/google.finance.660734/browse_thread/thread/20b5da9b7685ec3
I was going to ask that. You guys think there is more run left on this baby? What's a realistic target given what was announced during earnings (since I didn't even know about them)?
Yeah. It's strange. I just got it.
So anyway.. Any predictions on what will happen with CTIC?
To what do we owe all this gain?
Found this.. Thought I'd share it with those not familiar...
Biography
William A. Carter, M.D.
William A. Carter, M.D., is Chairman, CEO of HEMISPHERx Biopharma, Inc.,
(NASDAQ: HEMX). He is the co-inventor of Ampligen, and is a co-inventor of
record on over 200 patents relating to the Company's technology. Dr. Carter
was a leading innovator in the development of human interferon for a variety
of treatment indications including various viral diseases and cancer. In this
context, he received the first FDA approval to initiate clinical trials on a
beta interferon product manufactured in the U.S. under his supervision.
His interest in CFS/CFIDS goes back to 1987 when he and several board members
became acquainted with PWC's and their severely debilitating disease. He
regularly attends scientific meetings and presentations on research about the
diagnosis and treatment of CFS/CFIDS, most recently the American Association
for Chronic Fatigue Syndrome (AACFS) annual conference in San Francisco on
October 13-16, 1996.
Dr. Carter serves as Professor of Medicine at Allegheny University, PA., a
position he has held since 1980. He is also director of Clinical Research for
the University's Institute for Cancer and Blood Diseases. Dr. Carter has
served as professor at Johns Hopkins School of Medicine, Hahnemann
University, and the State University of New York at Buffalo.
Dr. Carter received his degree from Duke University and underwent his
post-doctoral training at the National Institutes of Health and Johns Hopkins
University. He is currently a consultant to the NIH. He is the author of over
125 published sceintific articles including the Co-Editor, Handbook of
Experimental Pharmacology on Interferon, Springer-Verlag, Publisher. In
addition, Dr. Carter has authored or co-authored nearly 40 book sections.
Contacts:
William A. Carter, CEO, HEMISPHERx Biopharma, Inc. (215) 988-0080
This is OLD news?
I just got that ballot today. WTH?
Here is a copy of the ballot:
So this is about a reverse split- somehow?
No prob. :)
Heads up! FDA approval coming for HEB
Someone just took profits from last night's .80 AH high.
It's in a dip right now, so it's a good buying opportunity.
FDA approval is scheduled in late Feb.
Shares are expected to run to $1.00+ before that announcement.
HEB -- Heads up! FDA approval coming
Someone just took profits from last night's .80 AH high.
It's in a dip right now, so it's a good buying opportunity.
FDA approval is scheduled in late Feb.
Shares are expected to run to $1.00+ before that announcement.
HEB -- Heads up! FDA approval coming
Someone profit took from last night's .80 AH high.
It's in a dip right now if you want to jump in.
FDA approval is scheduled in late Feb.
Shares are expected to run to $1.00+ before that announcement.
Good buying opportunity right now.
Actually, there is still more "short" interest in this financial stock than any other. Check it out:
http://www.shortsqueeze.com/?symbol=c&submit=Short+Quote%E2%84%A2