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

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.

THE WINNERS OF 2009

Jazz Pharmaceuticals, Inc. (NASDAQ: JAZZ) has jumped over 1,400% from its 2009 lows in March.  Shares closed out 2008 at $1.93, giving this one returns in excess of 300% for 2009 and a market cap of $250 million.  It has Xyrem and Luvox already on the market, and it has a fybromyalgia under a new application at the FDA.

Targacept, Inc. (NASDAQ: TRGT) has jumped over 1,000% from lows.  At $3.56 at the close of 2008, this one is up roughly sixfold for the year and the market cap is about $581 million.  The company is now expected to be profitable in 2010 according to Thomson Reuters, although we would caution that the range of estimates is massive with some still listed as expecting a wide loss in 2010 (possible not updated).  The huge catalyst here is the AstraZeneca buying the rights for its depression drug.

Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) has popped over 2,300% from its lows with shares close to $11.50.  With shares at $0.50 at the end of 2008, this stock is up over 2,000% for 2009.  Even after this run, the market cap is only $312 million.  Its payment of $200 million and its agreement giving Novartis exclusive commercialization rights to Fanapt(TM) for schizoprhrenia in the U.S. and Canada.

Dendreon Corp. (NASDAQ: DNDN) closed out at $4.58 on Dec 31, 2008 but traded as low as $2.55 during the March market meltdown.  That makes this one a 10-bagger off the lows and up close to 500% for 2009.  The stock briefly traded over $30.00 this year.  Dendreon’s market cap may be more because of secondary offerings we have not calculated in the float, but the market cap is now at least $3 billion.  The pending FDA Approval (assuming it is approved) of PROVENGE as a last line of defense in prostate cancer patients is on tap for 2010.

Human Genome Sciences, Inc. (NASDAQ: HGSI) was under $0.50 in March at the lows, making those fortunate few who bought after the March price tank have a gain of 60-fold if had they still held on today.  Shares closed out 2008 at $2.12, giving the year-long holders a gain of close to 1,500%.  The market cap is now over $5 billion.  Having a very promising drug candidate for lupus, where no effective new treatments have come in a generation, is what HGSI holders have to thank for this gain.

THE RECENT NEWS TRADE SET-UP STOCKS

Compugen Ltd. (NASDAQ: CGEN) has rallied sharply and even a secondary offering did not hit it much.  We have a market cap listed as $141 million, but we’d note that it just closed upon the $19 million in shares sales.  At $4.94 today, its 52-week trading range is $0.39 to $5.86.  Technically that is a 10-bagger already, but the second wave of the price run-up came in December when shares rose from under $3.00 to as high as $5.86.  The Israel-based company has raised capital twice but ran after it announced positive therapeutic effects of a novel peptide in an animal model of treating inflammatory bowel disease.  Then came the next wave for the company.

Bionovo, Inc. (NASDAQ: BNVI) is not exactly a household name and is a penny stock, but the publication of results from its study on the anti-tumor mechanism of BN107 in the International Journal of Cancer describing the potential molecular mechanisms mediating the selective pro-apoptotic effect induced by BN107 on estrogen receptor negative breast cancer cells was the culprit.  Shares are back down under the post-pop news at $0.47 in the last day of 2009.  The 52-week trading range is $0.17 to $1.15 and the market cap is only $51 million.

Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) ran sharply before Christmas as the FDA now considers that the firm has provided a complete response to all prior action letters for its supplemental New Drug Application to market H.P. ActharGel for the treatment of infantile spasms. The FDA has set the PDUFA in June 2010 for this sNDA, giving this an upcoming binary event for options traders.  At $4.77 it has a $306 million market cap and its 52-week trading range is $3.10 to $9.63.

Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) ran earlier in December on “proof of concept data” as a hepatitis C fighter.  Brokerage firm Roth Capital currently expects to see exponential gains in this stock on an as-is basis.  At $3.20 after a big gain on December 31, the 52-week trading range is $0.65 to $3.89.  The market cap here is a mere $85 million.

pSivida Corp. (NASDAQ: PSDV) also ran late in December.  Shares were up over 65% to $5.83 giving the company a market cap of $106 million at the time the news of the 24 month results from the Phase III FAME study of Iluvien for the treatment of Diabetic Macular Edema.  This one is back down to $3.80 and has a market of $69 million; the 52-week range is $0.60 to $6.25.  Technically, this already became a 10-bagger briefly, but the market cap is tiny here.

Athersys, Inc. (NASDAQ: ATHX) soared in December after it entered into a development and commercialization pact with Pfizer Inc. (NYSE: PFE) for MultiStem(R) for the treatment of Inflammatory Bowel Disease.  Athersys shares were up 192% at $2.92 on the day the news broke.   The stock doubled again after that and hit as high as $6.40 before Christmas and shares sit at $4.30 on the last day of 2009 with a market cap of about $81 million.

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) is a micro-cap stock with a market cap of almost $38 million with shares at $1.10 on the last day of 2009.  It has a 52-week trading range of $0.05 to $2.43, so the crazy volume around this one now is easy to see.  The catalyst was positive data from its two Phase II clinical trials showing strong efficacy and safety profile when used as a single agent or in combination with chemotherapy in patients with difficult to treat acute myeloid leukemia.  The volume went exponential on this when the news was out.

AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) first surged when Zenvia™ in the treatment of pseudobulbar affect among patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS) was announced.  Then it took the leaderboard again in December on additional drug data.  Shares are well off of the highs here. At $1.88 on the last day of 2009 the market cap is small at $156 million and the 52-week trading range is $0.25 to $4.09.  This stock has been around since the early 1990’s and briefly traded above $30.00 earlier this decade.

OTHER LESS-COVERED CANDIDATES, MAYBE

Biodel Inc. (NASDAQ: BIOD) is at $4.47 after an 8% gain on the last day of 2009 on massive volume.  Wedbush Morgan reiterated its outperform rating and $17.00 target.  The market cap is only $106 million and the 52-week trading range is $3.29 to $6.02.  The catalyst here is an upcoming FDA hopeful acceptance of the VIAject NDA filing in Q1 2010.  That wouldn’t mark a ten-bagger return, but it would make an exponential return.

Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) has submitted its NDA for Staccato® loxapine to the FDA and has a PDUFA expected date in late-2010.  This is an inhalation product candidate being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.  At $2.34 the market cap is $120 million and the 52-week trading range is $1.40 to $3.40.  This has been public since 2006 and traded up from $10 to $15 very briefly in 2007.

Cell Therapeutics, Inc. (NASDAQ: CTIC) cancer drug received an orphan status in Europe and has a FDA Oncologic Drugs Advisory Committee decision in February 2010 and an expected decision in what appears to be April-2010..  At $1.14 and at a $654 million market cap, this one has a 52-week trading range of $0.05 to $2.23. This one has been around since the 1990’s and it used to trade far higher… unbelievably higher.

You can join the 24/7 Wall St. free daily email list for updates on many biotech and non-biotech issues.  We cover major picks each day, as well as analyst upgrades and downgrades, day trading and active trader alerts, key news on Buffett and other gurus, Mergers and acquisitions, and even IPOs and secondary offerings.

You probably noticed how little coverage was given on stem cell stocks, obesity and diabetes candidates and more.  We are covering these individually in sectors again in January for 2010 and 2011 outlooks.  As always on these stocks, we have featured some stocks which have already moved based on the big trader chases we have seen in 2009.  Some of the stock moves have been outright silly, but some will have very large trading days based upon FDA news and presentation of news and events in 2010.  Some of these might become the next ten-baggers, but there is always the chance that none of these will live up to great expectations.

Have a great 2010!  Stay tuned.

JON C. OGG

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 (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.

Novarax (NVAX) has traded almost 1.5 million shares, at $5.11, down 2%. The company announced that its H1N1 test drug had shown promise in ferrets. The market did not see terribly impressed.

Human Genome Sciences (HGSI) is up 5% on 1.6 million shares to $18.13. There have been some positive notes on the company’s pipeline, but no recent news. The shares seem to be part of an overall market interest in biotech.

BioCryst Pharmaceuticals (BRCX) is down 2% on over one million shares, trading at $12.38. The government’s comments about speeding H1N1 vaccines to market may be helping the stock

Douglas A. McIntyre

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

• 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.

Add    ALLION HEALTHCARE INC (ALLI)
Add    ARYX THERAPEUTICS INC (ARYX)
Add    ASPECT MEDICAL SYSTEMS (ASPM)
Add    ATS MEDICAL INC (ATSI)
Add    AVANIR PHARMACEUTICALS (AVNR)
Add    AVI BIOPHARMA INC (AVII)
Add    BIOCRYST PHARMACEUTICALS (BCRX)
Add    BIODELIVERY SCIENCES (BDSI)
Add    BIOSCRIP INC (BIOS)
Add    BIOSPECIFICS TECHNO CORP (BSTC)
Add    BOVIE MEDICAL CORP (BVX)
Add    CARDIOVASCULAR SYS INC (CSII)
Add    CARDIUM THERAPEUTICS INC (CXM)
Add    CELL THERAPEUTICS INC (CTIC)
Add    CHELSEA THERAPEUTICS INT (CHTP)
Add    CLARIENT INC (CLRT)
Add    CORNERSTONE THERAPEUTICS (CRTX)
Add    CURIS INC (CRIS)
Add    CUTERA INC (CUTR)
Add    DELCATH SYS INC (DCTH)
Add    ELECTRO-OPTICAL SCIENCES (MELA)
Add    ENDOLOGIX INC (ELGX)
Add    ENTEROMEDICS INC (ETRM)
Add    HARVARD BIOSCIENCE INC (HBIO)
Add    HEARTWARE INTL INC (HTWR)
Add    HEMISPHERX BIOPHARMA INC (HEB)
Add    HI-TECH PHARMACAL CO INC (HITK)
Add    HOME DIAGNOSTICS INC (HDIX)
Add    IMPAX LABORATORIES INC (IPXL)
Add    INFINITY PHARMACEUTICALS (INFI)
Add    INSMED INC (INSM)
Add    ISTA PHARMACEUTICALS INC. (ISTA)
Add    LANNETT CO INC (LCI)
Add    LCA-VISION INC (LCAV)
Add    MAKO SURGICAL CORP (MAKO)
Add    MATRIXX INITIATIVES INC. (MTXX)
Add    MEDQUIST INC (MEDQ)
Add    MERGE HEALTHCARE INC (MRGE)
Add    MICROMET INC (MITI)
Add    NEUROGESX INC (NGSX)
Add    NOVAMED INC (NOVA)
Add    ONCOGENEX PHARMAS INC (OGXI)
Add    OXIGENE INC (OXGN)
Add    PONIARD PHARMA INC (PARD)
Add    REPROS THERAPEUTICS INC (RPRX)
Add    ROCHESTER MEDICAL CORP (ROCM)
Add    ROCKWELL MEDICAL TECH (RMTI)
Add    SANTARUS INC (SNTS)
Add    SCICLONE PHARMACEUTICALS (SCLN)
Add    SPECTRUM PHARMACEUTICALS (SPPI)
Add    STEMCELLS INC (STEM)
Add    SUPERGEN INC (SUPG)
Add    TRANSCEND SERVICES INC (TRCR)
Add    UTAH MED PRODS INC (UTMD)
Add    VANDA PHARMACEUTICALS (VNDA)
Add    VASCULAR SOLUTIONS INC (VASC)
Add    VICAL INC (VICL)

Delete    ACADIA PHARMACEUTICALS (ACAD)
Delete    ALEXZA PHARMACEUTICALS (ALXA)
Delete    BIOFORM MEDICAL INC (BFRM)
Delete    CALIPER LIFE SCIENCES (CALP)
Delete    CELL GENESYS INC (CEGE)
Delete    COLUMBIA LABORATORIES (CBRX)
Delete    JAZZ PHARMACEUTICALS INC (JAZZ)
Delete    MARSHALL EDWARDS INC (MSHL)
Delete    REXAHN PHARMACEUTICALS (RNN)
Delete    TARGACEPT INC (TRGT)
Delete    VISION-SCIENCES INC (VSCI)
Delete    XOMA LTD (XOMA)

Jon C. Ogg
June 20, 2009

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

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.

Abraxis BioScience, Inc. (NASDAQ: ABII) will present data on multiple clinical studies of the chemotherapy agent ABRAXANE® for Injectable Suspension. Clinical results will be shown from an ongoing study evaluating three dosing regimens of nab®-paclitaxel in combination with targeted agent bevacizumab for first-line treatment of metastatic breast cancer.  Around $50.00, its 52-week range is $42.40 to $78.95 and its market cap is $2 billion.

AEterna Zentaris Inc. (NASDAQ: AEZS) will show results supporting the evaluation of its targeted cytotoxic peptide conjugate compound, AEZS-108, in prostate cancer in a poster presentation.  At $1.30, its 52-week range is $0.26 to $1.48 and its market cap is only $69 million.

Allos Therapeutics, Inc. (NASDAQ: ALTH) is not seen yet, but it gave data demonstrating the anticancer activity of pralatrexate in colon, ovarian, lung, prostate, and head and neck cancer cell lines already at the at the 2009 American Association for Cancer Research (AACR) Annual Meeting in April.  At almost $7.00, its market cap is $605 million and its 52-week trading range is $3.82 to $10.19.

Amgen Inc. (NASDAQ: AMGN) will present new data from its oncology portfolio of approved and investigational cancer products. Data will be presented from several programs, including Vectibix(R) (panitumumab), Neulasta(R) (pegfilgrastim), Aranesp(R) (darbepoetin alfa), denosumab, conatumumab (AMG 655), dulanermin (rhApo2L/TRAIL) and AMG 479.  This stock has been down and out for some time.  At $50.00, its 52-week range is $42.26 to $66.51.

A.P. Pharma, Inc. (Nasdaq: APPA) will show data on the pivotal phase 3 trial of APF530 for the prevention of chemotherapy-induced nausea and vomiting. APF530 is a long-acting formulation of granisetron that utilizes its Biochronomer drug delivery system.  A.P. Pharma recently announced that it had completed an NDA submission to the FDA.  At $1.00, its 52-week range is $0.30 to $1.68 and its market cap is only $31 million.

Arqule Inc. (NASDAQ: ARQL) is still not definite, but may have interim data from a mid-stage trial of ARQ-197 against a group of cancers that tend to effect younger adults. At $4.34, its market cap is $193 million and its 52-week trading range is $1.75 to $4.91.

Bristol-Myers Squibb (NYSE: BMY) will show interim results from two Phase II studies of SPRYCEL (dasatinib) which demonstrate that the medicine may have potential as a treatment for a certain type of advanced prostate cancer. SPRYCEL is currently indicated for the treatment of adults with resistance or intolerance to prior therapy for chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia. At $19.68, its 52-week trading range is $16.00 to $23.98.

Celldex Therapeutics (NASDAQ: CLDX) will be presenting safety and immune activity data from its first antibody-based dendritic cell targeted vaccine, CDX-1307, in combination with multiple immune modulators.  At $8.45 its market cap is $134 million and its 52-week trading range is $4.24 to $19.79.

Celgene Corporation (NASDAQ: CELG) is going to be hard to quantify for which will be the most important.  The company has 59 presentations and posters according to its most recent release. At $40.82, its 52-week range is $36.90 to $77.39 and its market cap is almost $19 billion.

Cell Therapeutics (NASDAQ: CTIC) is set to present its Pixantrone Phase III study results in June 1.  At $1.23 its market cap is still listed around $560 million.  That may have changed due to a tender, but its 52-week range is listed as $0.05 to $6.50.  “Volatility is our middle name!”

Cougar Biotechnology, Inc. (NASDAQ: CGRB) was recently an acquisition target, which will draw extra attention to its results of its Phase 3 trial of CB7630 in chemotherapy-naïve castration-resistant prostate cancer patients.

Eli Lilly and Company (NYSE:  LLY) will unveil data from more than 50 studies continuing to support Lilly’s leadership in thoracic cancer research. The company will present the latest research findings on ALIMTA (pemetrexed for injection), as well as GEMZAR, and enzastaurin, an investigational, oral, targeted therapy.  At $33.84, its 52-week range is $27.21 to $49.82.

Exelixis, Inc. (NASDAQ: EXEL) is expected to show data in XL184 from early Phase 2 studies for the treatment of progressive or recurrent form of brain cancer (glioblastoma multiforme).  Bristol-Myers Squibb Co. (BMY) has a co-development pact with EXEL on this one, signed in 2008.  At $4.53, its 52-week range is $2.11 to $7.35 and its market cap is $481 million.

Genomic Health, Inc. (NASDAQ: GHDX) said that its QUASAR colon cancer validation study for individualized recurrence risk will be presented in an oral presentation and full results will be highlighted as a noteworthy abstract in ASCO’s advance ‘presscast.’  With shares under $19.00, its market cap is $538 million and its 52-week trading range is $16.00 to $27.22.

GlaxoSmithKline (NYSE: GSK) will present data on nine oncology molecules. It will show data on kidney, gastric, breast, and leukemia.  TYKERB, AVODART(R), elesclomol, eltrombopag, topotecan and GSK923925 will all have presentations.  Its ADR’s are at $33.86 and the 52-week range for the US listed shares is $27.15 to $49.48.

Immunogen (NASDAQ: IMGN) is a Roche partner for T-DM1 in breast cancer, and there is expected to be some final data from the phase II study.  Roche is already running pivotal phase III study of the drug, so the 2010 data will be newer than what is likely seen here as ASCO.  At around $7.60, it is at the high-end of its $2.47 to $8.04 range and the market cap is $389 million.

Medarex (NASDAQ: MEDX) is supposed to have multiple candidates that are going to have abstracts out, from melanoma to prostate cancer to malignancies. At $6.97, its 52-week range is $3.40 to $10.12 and its market cap is $895 million.

Medivation, Inc. (NASDAQ: MDVN) is set to report on its MDV3100, which it has received permission from the FDA to initiate a pivotal Phase 3 trial of MDV3100 in castration-resistant prostate cancer in men who were previously treated with docetaxel-based chemotherapy.  It will have an abstract for oral presentation and the MDV3100 abstract was selected for the ‘Best of ASCO(R)’ program, an educational initiative covering highlights.  At $22.77 after a 9% drop today, its 52-week trading range is $11.27 to $34.40 and its market cap is $684 million.

Micromet, Inc. (NASDAQ: MITI) has a poster presentation for adecatumumab for patients with metastatic breast cancer and new data will include an update of the data presented at the European Society of Oncology meeting in October of 2008.  At $3.75, its 52-week range is $2.22 to $7.74 and the market cap is $190 million.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) will give an oral presentation showing final survival data from a randomized Phase 2 trial evaluating OGX-011 in combination with docetaxel versus docetaxel alone as first-line chemotherapy in patients with metastatic castration-resistant prostate cancer.  This was recently a micro-cap which just had a huge break-out in the last two weeks.  At $19.41, its 52-week range is $2.00 to $22.40 and the market cap is $107 million.

OSI Pharmaceuticals (NASDAQ: OSIP) has not been a winner and is close to its 52-week lows.  But this stock is one of the mid-cap biotechs ($2 billion market cap) that investors are looking at and hoping for positive data at ASCO.  It will show data from two phase III studies looking at Tarceva as front-line maintenance therapy in patients with non-small cell lung cancer, but the drug is already a second-line drug.  Investors have some hope that doctors may use it for maintenance.  At $34.90, its 52-week range is $31.05 to $53.71 and its market cap is $2 billion.

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) is hitting new recent highs, yet it is a penny stock.  This one has completed enrollment in its Phase II trial evaluating bavituximab in combination with docetaxel in advanced breast cancer patients; this data from a 46-patient study will be shown in an oral presentation there.  At $0.56, its 52-week trading range “was” $0.22 to $0.53 and its market cap is $128 million.

Pfizer Inc. (NYSE: PFE) will present new data on its personalized approach to oncology clinical research.  This will be over the evaluating PF-002341066 across a variety of solid tumor types and anaplastic lymphoma kinase (PHASE 1 data). It also will show a Phase 2 study of figitumumab (CP-751,871) in squamous cell lung cancer.  At $14.71, its 52-week range is $11.62 to $20.13.

Rosetta Genomics (NASDAQ: ROSG) is presenting two different items: “A Validated New MicroRNA-Based Diagnostic Test for Identification of Tumor Tissue Origin.” The other is a posted session and dicussion called “MicroRNA-Based Assay for Differential Diagnosis of Squamous from Non-Squamous Non Small Cell Lung Carcinoma.”  At $3.60, its 52-week range is $1.08 to $5.10 and its market cap is almost $44 million.

Synta Pharmaceuticals (NASDAQ: SNTA) is presenting results from a Phase 3 clinical trial of its drug elesclemol in melanoma patients. In late February there was very disappointing data that caused its stock to fall from over $6.00 to under $2.00, but shares have come back to $4.83.  Its 52-week trading range is $1.20 to $10.30.

Trubion Pharmaceuticals, Inc. (NASDAQ: TRBN) has just seen a major move.  It has three presentations:  Phase 1 data showing encouraging results that were observed in CLL patients treated with low doses of TRU-016.  It will also show preclinical efficacy for TRU-016 is additive or synergistic in combination with established therapeutics.  Also to be shown is the preclinical mechanism apoptosis in CLL Cells occurs via distinct mechanism compared with other therapeutics. At $2.53, its 52-week range is $1.00 to $6.89 and its market cap is $45 million.  This is a VERY thin volume stock.

ZIOPHARM Oncology (NASDAQ: ZIOP) will present data for all three of its clinical-stage product candidates: darinaparsin (ZinaparTM or ZIO-101), palifosfamide (ZymafosTM or ZIO-201) and indibulin (ZybulinTM or ZIO-301).  ZIOPHARM is a micro-cap stock with a market cap of under $30 million. With shares having climbed in the last two weeks to $1.30, its 52-week trading range is $0.50 to $2.73.

ZymoGenetics, Inc. (NASDAQ: ZGEN) will present final results from a Phase 2 clinical trial in patients with renal cell cancer in a poster presentation, which evaluated Interleukin 21 (IL-21) in combination with Nexavar (sorafenib) tablets.  At $4.36, its 52-week range is $2.06 to $9.29 and its market cap is $300 million.

If you want to conduct any advanced searches, you can go to http://www.abstract.asco.org/ to find more data.

JON C. OGG
May 27, 2009

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:

Abraxis BioScience, Inc. (NASDAQ:ABII) will present data on multiple clinical studies of the chemotherapy agent ABRAXANE® for Injectable Suspension. Clinical results will be shown from an ongoing study evaluating three dosing regimens of nab®-paclitaxel in combination with targeted agent bevacizumab for first-line treatment of metastatic breast cancer.

Allos Therapeutics, Inc. (NASDAQ: ALTH) is not seen yet, but it gave data demonstrating the anticancer activity of pralatrexate in colon, ovarian, lung, prostate, and head and neck cancer cell lines already at the at the 2009 American Association for Cancer Research (AACR) Annual Meeting in April.  At almost $6.50, its market cap is $525 million and its 52-week trading range is $3.82 to $10.19.

Arqule Inc. (NASDAQ: ARQL) is still not definite, but may have interim data from a mid-stage trial of ARQ-197 against a group of cancers that tend to effect younger adults. At $3.87, its market cap is $172.8 million and its 52-week trading range is $1.75 to $4.91.

Celldex Therapeutics (NASDAQ: CLDX) will be presenting safety and immune activity data from its first antibody-based dendritic cell targeted vaccine, CDX-1307, in combination with multiple immune modulators.  At $8.26 its market cap is $130 million and its 52-week trading range is $4.24 to $19.79.

Cell Therapeutics (NASDAQ: CTIC) is set to present its Pixantrone Phase III study results in June 1.  At $1.13 its market cap is still listed around $500 million.  That may have changed due to a tender, but its 52-week range is listed as $0.05 to $6.50.  “Volatility is our middle name!”

Cougar Biotechnology, Inc. (NASDAQ: CGRB) is set to present mid-stage data on its Abiraterone in the possible treatment of prostate cancer. The company at the end of April announced that it had initiated its Phase 3 trial of CB7630 in chemotherapy-naïve castration-resistant prostate cancer patients.  At $35.00-ish, it is at the top of its $16.35 to $40.00 trading range and its market cap is $about $730 million.

Eli Lilly and Company (NYSE:  LLY) will unveil data from more than 50 studies continuing to support Lilly’s leadership in thoracic cancer research. The company will present the latest research findings on ALIMTA (pemetrexed for injection), as well as GEMZAR, and enzastaurin, an investigational, oral, targeted therapy.

Exelixis (NASDAQ: EXEL) is expected to show data in XL184 from early Phase 2 studies for the treatment of progressive or recurrent form of brain cancer (glioblastoma multiforme).  Bristol-Myers Squibb Co. (BMY) has a co-development pact with EXEL on this one, signed in 2008.  At $4.42, its 52-week range is $2.11 to $7.35 and its market cap is $470 million.

Genomic Health, Inc. (NASDAQ: GHDX) said that its QUASAR colon cancer validation study has been accepted for oral presentation at the ASCO annual meeting and full results will be highlighted as a noteworthy abstract in ASCO’s advance ‘presscast.’  With shares under $19.00, its market cap is $535 million and its 52-week trading range is $16.00 to $27.22.

GlaxoSmithKline (NYSE: GSK) will present data on nine oncology molecules. It will show data on kidney, gastric, breast, and leukemia.  TYKERB, AVODART(R), elesclomol, eltrombopag, topotecan and GSK923925 will all have presentations.

Immunogen (NASDAQ: IMGN) is a Roche partner for T-DM1 in breast cancer, and there is expected to be some final data from the phase II study.  Roche is already running pivotal phase III study of the drug, so the 2010 data will be newer than what is likely seen here as ASCO.  At around $7.50, it is at the high-end of its $2.47 to $8.04 range.

Medarex (NASDAQ: MEDX) is supposed to have multiple candidates that are going to have abstracts out, from melanoma to prostate cancer to malignancies. At $6.40, its 52-week range is $3.40 to $10.12.

Medivation, Inc. (NASDAQ: MDVN) is set to report on its MDV3100, which it has received permission from the FDA to initiate a pivotal Phase 3 trial of MDV3100 in castration-resistant prostate cancer in men who were previously treated with docetaxel-based chemotherapy.  It will have an abstract for oral presentation and the MDV3100 abstract was selected for the ‘Best of ASCO(R)’ program, an educational initiative covering highlights.  At $20.00-ish, its 52-week trading range is $11.27 to $34.40.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) will give an oral presentation showing final survival data from a randomized Phase 2 trial evaluating OGX-011 in combination with docetaxel versus docetaxel alone as first-line chemotherapy in patients with metastatic castration-resistant prostate cancer.  This is a micro-cap with a $40 million market cap, and at $7.30 it is toward the top of its $2.00 to $9.38 trading range of the last 52-weeks.

OSI Pharmaceuticals (NASDAQ: OSIP) has not been a winner and is close to its 52-week lows.  But this stock is one of the mid-cap biotechs ($2 billion market cap) that investors are looking at and hoping for positive data at ASCO.  It will show data from two phase III studies looking at Tarceva as front-line maintenance therapy in patients with non-small cell lung cancer, but the drug is already a second-line drug.  Investors have some hope that doctors may use it for maintenance.

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) has completed enrollment in its Phase II trial evaluating bavituximab in combination with docetaxel in advanced breast cancer patients; this data from a 46-patient study will be shown in an oral presentation there.  This $0.45 stocjk is a small-cap with a $102 million market cap, and its 52-week trading range is $0.22 to $0.53.

Pfizer Inc. (NYSE: PFE) will present new data on its personalized approach to oncology clinical research.  This will be over the evaluating PF-002341066 across a variety of solid tumor types and anaplastic lymphoma kinase (PHASE 1 data). It also will show a Phase 2 study of figitumumab (CP-751,871) in squamous cell lung cancer.

Synta Pharmaceuticals (NASDAQ: SNTA) is presenting results from a Phase 3 clinical trial of its drug elesclemol in melanoma patients. In late February there was very disappointing data that caused its stock to fall from over $6.00 to under $2.00.  Its 52-week trading range is $1.20 to $10.30.

ZIOPHARM Oncology (NASDAQ: ZIOP) will present data for all three of its clinical-stage product candidates: darinaparsin (ZinaparTM or ZIO-101), palifosfamide (ZymafosTM or ZIO-201) and indibulin (ZybulinTM or ZIO-301).  ZIOPHARM is a micro-cap stock with a market cap of under $20 million. With shares around $0.75, its 52-week trading range is $0.50 to $2.73.

As a reminder, this data will be updated likely more than once per company between now and the actual ASCO conference.

JON C. OGG