Cell Therapeutics Facing Tougher FDA (CTIC)
Cell Therapeutics, Inc. (NASDAQ: CTIC) is getting clipped on Pixantrone this morning. The company was told by the FDA that there is limited clinical data on its proposed cancer drug, and that there were higher side effects and higher death incidents. Unfortunately, this comes ahead of a panel review date that is set for Wednesday, February 10, 2010. We have late April, on or about April 23, 2010, as the final decision date from the FDA for Pixantrone.
Pixantrone is the company’s pending treatment of relapsed and refractory non-Hodgkin’s lymphoma, although this is indicated for those who have seen their disease progress after having received treatment with at least two other therapies.
Cell Therapeutics had raised about $30 million in January via securities sales. Pixantrone was under FDA Fast Track and it has an Orphan Drug designation under EMEA in Europe.
The FDA noted that the main trial arm ended early due to a smaller number of enrollment, which is always a concern. This may not be a dead outcome yet, but this sets a bias of extreme caution going into Wednesday’s event.
At 9:45 AM EST we have shares down 29.4% at $0.743 on 23 million shares. Average volume is 12 million shares and the 52-week trading range is $0.05 to $2.23.
JON C. OGG
Quest For 10-Baggers in BioHealth in 2010 (JAZZ, TRGT, VNDA, DNDN, HGSI, CGEN, BNVI, QCOR, ACHN, PSDV, ATHX, SNSS, AVNR, BIOD, ALXA, CTIC)
If one thing was noticed in biotech stocks, or BioHealth stocks as we often say, it was that investors, traders, and speculators all piled into the chase for the next ten-bagger late in the year. When you have as many biotech and BioHealth stocks that ran over 1,000% in 2009 that is only to be expected…. hence the 10-bagger comments. We had many biotech and biohealth shares rally from their lows significantly this year, with companies such as Jazz Pharmaceuticals, Inc. (NASDAQ: JAZZ), Targacept, Inc. (NASDAQ: TRGT), Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA), Dendreon Corp. (NASDAQ: DNDN), and Human Genome Sciences, Inc. (NASDAQ: HGSI) all being in or having been in the 10-bagger club this year.
But late in 2009 we started seeing an onslaught of low-priced stocks with small cap or micro-cap values running rapidly higher on news. In some cases these faded, and in some not. We saw the traders run up shares of Compugen Ltd. (NASDAQ: CGEN), Bionovo, Inc. (NASDAQ: BNVI), Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR), Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN), pSivida Corp. (NASDAQ: PSDV), Athersys, Inc. (NASDAQ: ATHX), Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS), and AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) on news late in 2009. Also covered as potentials for this are Biodel Inc. (NASDAQ: BIOD), Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA), and Cell Therapeutics, Inc. (NASDAQ: CTIC).
We have reviewed each of these and given a synopsis for each to see if these could be the 10-baggers for 2010.
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Cell Therapeutics Advances non-Hodgkin’’s Lymphoma in E.U. (CTIC)
Cell Therapeutics, Inc. (NASDAQ: CTIC) is running higher on the report that it has advanced its Pixantrone filing process in Europe. It has submitted a Pediatric Investigation Plan to the European Medicines Agency as part of the required filing process.
This is required to seek approval of pixantrone as a treatment for relapsed or refractory aggressive non-Hodgkin’’s Lymphoma in Europe.
The PIP outlines how the company proposes to study the drug in children in order to benefit child health. The company noted that anthracyclines are a mainstay in the treatment of childhood leukemias, lymphomas and solid tumors but long-term cardiotoxicity represents a significant issue. Cell Therapeutics plans to evaluate safety and efficacy of pixantrone in pediatric cancer patients.
CTI recently received a prescription drug user fee act action date of April 23, 2010 in the U.S. regarding CTI’s New Drug Application for pixantrone as potential treatment for relapsed or refractory, aggressive non-Hodgkin’s lymphoma.
Right before the open we have seen over 1 million shares and shares are up close to 6% at $1.45. The 52-week high is $2.23
JON C. OGG
September 15, 2009
Cell Therapeutics (CITC), Novarax (NVAZ), Human Genome (HGSI) Move
Several biotechs are trading on huge volume early in the session:
Cell Therapeutics (CTIC) has traded almost four million shares, and is up 2% to $1.69. The Food and Drug Administration accepted its application for review of pixantrone for refractory aggressive non-Hodgkin’s lymphoma, a form of cancer, yesterday. Read more
Cell Therapeutics (CTIC) Jumps On News
Cell Therapeutics, Inc. (CTIC) announced today that the U.S. Food and Drug Administration (FDA) has accepted and has filed for review the Company’s New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL).
Pixantrone (BBR 2778), is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from currently marketed anthracyclines and other related chemotherapy agents.
The market is still skeptical about the company’s actions. Shares are up only 4% to $1.77, but volume is large at almost 10 million shares
Douglas A. McIntyre
BioHealth & Healthcare Score Major Win in Russell Index Rebalance (AVII, CTIC, CEGE, IPXL, STEM, SUPG, VICL, XOMA)
This year’s Russell 3000 Index rebalancing and reconstitution may end up being the mother of all index rebalances. Because of the billions managed by Russell and because of the billions of outside funds that benchmark to the various Russell indexes, this year has many changes. All in all, there are over 400 additions and deletions to the Russell 3000 alone. The count was overwhelmingly “good” for healthcare. We screened out a few stocks under the Russell “Health Care” sector as they were not classic companies in the “BioHealth” space. But even after we screened those out, the ratio was huge by our own individual count:
- Healthcare additions were 57 and deletions were only 12… Yep a ratio of almost 5:1 for Health Care in the Russell 3000 alone.
Many of these additions or deletions were very surprising and based mostly on recent share price changes. Some of those standouts are are AVI Biopharma, Inc. (NASDAQ: AVII), Cell Therapeutics, Inc. (CTIC), Cell Genesys, Inc. (CEGE), Impax Laboratories Inc. (IPXL), StemCells Inc. (STEM), SuperGen Inc. (SUPG), Vical Inc. (VICL), and XOMA Ltd. (XOMA). We have broken out the fullist of additions and deletions below, and we started with the additions first as they may see more benefit between now and next Friday’s adjustments.
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Cell Therapeutics, Inc. Releases Phase III Trials Results of Non-Hodgkin’s Lymphoma Drug: Pixantrone (CTIC)
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) ended trading on June 1st up 0.67 (46.85%) on a huge volume of over 100 million shares. This increased activity is in response to CTI’s announcement of the results of its phase III clinical trial of its Non-Hodgkin’s lymphoma (NHL) drug, Pixantrone.
At the 2009 American Society for Clinical Oncology (ASCO) meeting in Orlando, the lead investigator of the PIX 301 EXTEND trial, Ruth Pettengell, M.D. of St. George’s Hospital, University of London, announced that, “These results represent a breakthrough in that pixantrone could extend our ability to use a highly active anthracycline-like drug in such patients and deserves to be examined in anthracycline naïve patients as a potential alternative to currently available standard anthracycline drugs.” Anthracycline related drugs have been effective agents used to treat aggressive Non- Hodgkin’s lymphoma, but their use is “highly limited by the significant increase in risk of cardiac failure associated with high cumulative doses of these drugs.”
The PIX 301 EXTEND trial was a phase III single-agent trial of pixantrone for patients with relapsed or refractory, aggressive NHL who already received two or more prior therapies and who were sensitive to treatment with anthracycline. The trial enrolled 140 patients who were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of NHL.
In the PIX 301 EXTEND trial, 57% of the randomized patients were refractory to prior treatments with 50% of patients having failed three prior chemotherapy treatments. Fifty-three percent of pixantrone patients received four or more cycles of therapy compared to a median of three cycles in the control group. Data from repeated evaluations of Left Ventricular Ejection Fraction (“LVEF”) by MUGA (Multi Gated Acquisition) scan demonstrated no consistent dose related decline (as has been described for doxorubicin, another anthracycline) with median LVEF values at baseline of 58% and an end of treatment median LVEF of 59%. Consistent across the primary and subgroup analyses, treatment with pixantrone resulted in superior clinical benefits over standard of care chemotherapy treatment.
James A. Bianco, M.D., Chief Executive Officer of CTI is quoted, “We are pleased that the PIX 301 EXTEND trial of pixantrone demonstrated a long-lasting clinical benefit in this heavily pretreated relapsed/refractory group of patients with aggressive NHL and look forward to completing the New Drug Application submission later this month. Given the lack of approved therapies for this resistant group of patients with aggressive NHL, we believe pixatrone offers a valuable therapy for this unmet medical need. “
Intent to treat Analysis results per FDA agreed upon Statistical Analysis Plan
• Significant Increase in Complete Remission Rates 20% vs. 5.7%; p=0.021
• Significant Increase in Overall Response Rate 37.1% vs. 14.3%; p=0.003
• Significant increase in percent of all patients whose response lasted greater than or equal to four months 25.7% vs. 8.6%; p=0.012
• Significant Increase in Progression Free Survival 4.7 months vs. 2.6 months; p=0.007
• Positive trend in Overall Survival even though data not fully mature with median 8.1 month vs. 6.9 month, p=0.544
Joshua Sherman
Full 2009 ASCO Cancer & Oncology Primer (ABII, AEZS, ALTH, AMGN, APPA, ARQL, BMY, CLDX, CELG, CTIC, CGRB, LLY, EXEL, GHDX, GSK, IMGN, MEDX, MDVN, MITI, OGXI, OSIP, PPHM, PFE, ROSG, SNTA, TRBN, ZIOP, ZGEN)
We have already seen a massive round of abstracts ahead of the huge American Society of Clinical Oncology, or ASCO meeting for 2009, which is scheduled to start this weekend. ASCO is usually thought of as the Holy Grail of cancer conferences and these abstracts and presentations are viewed by investors, analysts, clinicians, doctors, and by cancer patients.
We compiled a brief synopsis for the following drug and biotech companies: Abraxis BioScience, Inc. (NASDAQ:ABII), AEterna Zentaris Inc. (NASDAQ: AEZS), Allos Therapeutics, Inc. (NASDAQ: ALTH), Amgen Inc. (NASDAQ: AMGN), A.P. Pharma, Inc. (Nasdaq: APPA), Arqule Inc. (NASDAQ: ARQL), Bristol-Myers Squibb (NYSE: BMY), Celldex Therapeutics (NASDAQ: CLDX), Celgene Corporation (NASDAQ: CELG), Cell Therapeutics (NASDAQ: CTIC), Cougar Biotechnology, Inc. (NASDAQ: CGRB), Eli Lilly and Company (NYSE: LLY), Exelixis (NASDAQ: EXEL), Genomic Health, Inc. (NASDAQ: GHDX), GlaxoSmithKline (NYSE: GSK) , Immunogen (NASDAQ: IMGN), Medarex (NASDAQ: MEDX), Medivation, Inc. (NASDAQ: MDVN), Micromet, Inc. (NASDAQ: MITI), OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), OSI Pharmaceuticals (NASDAQ: OSIP), Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), Pfizer Inc. (NYSE: PFE), Rosetta Genomics (NASDAQ:ROSG), Synta Pharmaceuticals (NASDAQ: SNTA), Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN), ZIOPHARM Oncology (NASDAQ: ZIOP), and ZymoGenetics, Inc. (NASDAQ: ZGEN).
Be advised that some of the data may have been changed since the first abstracts came out, but this is an expansive list of companies with data.
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ASCO's Pre-Abstract Previews (ABII, ALTH, ARQL, CLDX, CTIC, CGRB, LLY, EXEL, GHDX, GSK, IMGN, MEDX, MDVN, OGXI, OSIP, PPHM, PFE, SNTA, ZIOP)
The first massive round of abstracts ahead of the huge American Society of Clinical Oncology, or ASCO meeting for 2009, is due out 6:00PM EST. This is thought of as the Holy Grail of cancer conferences and these abstracts are being picked apart all night by hundreds of investors, analysts, clinicians, doctors, and even by cancer patients. We have brief data here for the following biotech and drug companies, and you can bet there will be more than this: Abraxis BioScience, Inc. (NASDAQ:ABII), Allos Therapeutics, Inc. (NASDAQ: ALTH), Arqule Inc. (NASDAQ: ARQL), Celldex Therapeutics (NASDAQ: CLDX), Cell Therapeutics (NASDAQ: CTIC), Cougar Biotechnology, Inc. (NASDAQ: CGRB), Eli Lilly and Company (NYSE: LLY), Exelixis (NASDAQ: EXEL), Genomic Health, Inc. (NASDAQ: GHDX), GlaxoSmithKline (NYSE: GSK) , Immunogen (NASDAQ: IMGN), Medarex (NASDAQ: MEDX), Medivation, Inc. (NASDAQ: MDVN), OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), OSI Pharmaceuticals (NASDAQ: OSIP), Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), Pfizer Inc. (NYSE: PFE), Synta Pharmaceuticals (NASDAQ: SNTA), and ZIOPHARM Oncology (NASDAQ: ZIOP).
Be advised that there may be new data from many of these companies between now and the May 29 to June 2, 2009 meeting in Orlando, Florida. We have already compiled a pre-ASCO cheat sheet to get in ahead of some of these abstracts, and the brief notes are as follows:
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