DNDN - Sector: Healthcare---Industry: Biotechnology & Drugs

[boatguy]

Up 12% premarket-

In at 2.07

[stocks2watch2]

CTIC Trade
News 1.84 0
XYOTAX(TM) has FDA Fast Track Designation for Women With Advanced Lung Cancer Who are Performance Status 2

February 08, 2006 07:01:09 (ET)


SEATTLE, Feb 08, 2006 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics, Inc. (CTI) (CTIC, Trade) announced that the U.S. Food and Drug Administration (FDA) confirmed that XYOTAX, a novel biologically-enhanced version of one of the most used cancer drugs, Taxol(R), qualifies for fast track designation for the treatment of PS2 (poor performance status) women with first-line advanced non-small cell lung cancer (NSCLC), which is currently being studied in the PIONEER clinical trial. The Company has initiated a number of clinical sites and is currently enrolling patients on the PIONEER trial, the first approval trial for lung cancer exclusively targeting women.

[setravis]

I seen that one taking a bounce this morning.
I wonder if we got something cooking?



AP
Cell Therapeutics Gets Xyotax Fast Track
Wednesday February 8, 7:42 am ET 
Cell Therapeutics Gets Fast Track Designation From FDA for Xyotax Cancer Drug


SEATTLE (AP) -- Cell Therapeutics Inc. said Wednesday that the Food and Drug Administration has given its cancer drug Xyotax a fast track designation.
Shares of Cell Therapeutics rose 16 cents, or 8.7 percent, to $2 in premarket activity.

A fast track designation allows a company to submit data to the FDA as it becomes available and to receive agency feedback rather than having to wait to submit the data all at once.

The drug is currently being tested as a first-line treatment for women with advanced non-small cell lung cancer. Xyotax is a biologically enhanced version of paclitaxel, the active ingredient in Bristol-Myers Squibb Co.'s cancer drug Taxol, designed to cut down on the toxic effect to normal tissue.

[setravis]

Well, I posted to the new thread that was started, and wouldn't know it,
We already have this one!
I see this is taking a bounce this morning.
I wonder if we have something in the making for a run north?

[stocks2watch2]

I doubt I buy this one,but I'll watch it.I bought CNVX yesterday and it's up in pre mkt. Haven't had the time to research it much, only bought 1000 shares.
CancerVax (CNVX, Trade) was up sharply the second day in a row, leaping 15% to $2.85. The company is slated to be acquired by German drug developer Micromet in the second-half of 2006.





WASHINGTON, Feb 3 (Reuters) - Cell Therapeutics Inc. (CTIC,Trade) filed with regulators on Friday to periodically sell up to $150 million in common and preferred stock, debt securities, and warrants.

The company said in a registration statement with the U.S. Securities and Exchange Commission that it will use the proceeds from the offering for clinical development, commercialization activities, and general corporate purposes.

Under a shelf registration, a company may sell securities in one or more separate offerings with the size, price and terms to be determined at the time of sale.

[setravis]

CELL THERAPEUTICS (NasdaqNM:CTIC) Delayed quote data 

Pre-Market (RT-ECN): 2.00  0.16 +(8.70%) 

Strong Volume in the pre-market @....4,531,733

[sir_joke]

Today's Fast Track announcement of CTIC's drug Xyotax is a ground-breaker for directed-group research (in this case ... women) (also a first)

Lung cancer treatment works better in women.  This could/will be cool!

Cheers,
SJ

ps. watch for trading opportunities $1.90 to $2.20 range.  Long term accumulations above $3.50 is a good bet.


Cell Therapeutics cancer drug on FDA fast track
Wed Feb 8, 2006 7:19 AM ET

NEW YORK, Feb 8 (Reuters) - Cell Therapeutics Inc. (CTIC.O: Quote, Profile, Research) said on Wednesday the Food and Drug Administration has confirmed that XYOTAX, its version of cancer drug Taxol, qualifies for fast-track designation for treating women with first-line advanced non-small cell lung cancer.

Fast-track designation means the FDA will facilitate and expedite the development and review of the application for the approval of a new drug if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need.

[boatguy]

I see there are already a couple threads running on CTIC, I didn't check to see if a thread had been started. OOps, thought we might have a runner and wanted to post quick.

I have never seen so many shares traded without some price movement, although I am still in I don't feel to hot about this trade so far. I expect the gap will fill below and hopefully bounce from there and in my dreams fill the gap above.

Oh well.

[higherstocks]

I was in this one also pre hours.  I cant believe that it only popped 10% on 20x volume.  O'well we will have to see I like the pick though even without the news.  I bought because I believe that the market cap has got to catch up with enterprise value at least without the news today.  The target pps for now is $4.25 that will get the stock back in line where it should be even without today s news.

[Melf Elf]

DNDN continues to act bearish for now, though. 

The 4.79 target MADE on Monday.  On Friday, we came within eight cents of the 4.43 target still IN PLAY.  DNDN is in full-blown bearish "knife catching" mode at this point.  It's been in a waterfall decline since the last pattern break.  Longs are capitulating, so we could be nearing some sort of bottom here. 

This chart would have a nice look to it if we could go down there and put in the right leg of a BIG "W"-Bottom .  The middle of the "W" would be the September 15 high of 7.37. EDIT: The rally from the May low to the mid-Septermber high was 4½ months, so if we put in a right leg here at the end of January/early February, that also would be 4½ months. Nice symmetry, if we get it.

Still watching for that.  We're in the latter end of that time-frame. 

There's no support for the stock here.   Horizontal support is nine months back, the left leg of the "possible" W-bottom, which is the print low of 4.31 back on May 2 of last year. 

Everyone who bought DNDN since early May, 2005 now is holding a loser, so what we might see at the end of this waterfall decline is an exhaustion move to the downsde.  "Nobody wants to be long this stock."  A final capitulation selloff on heavy volume, with an upside reversal by the end of the session.  A Bullish Doji Star, or a Bullish Hammer candlestick day.  Something like that. 

On December 7, for example, we had an open at 4.87, near the low of the day, then a rally all day with a close near the high of the day on very heavy volume.  That produced a short-term rally (that failed), to 5.92. 

[la-onda]

just FYI  :


CTIC: Q4 Results (27c) vs (72c); Beats (39c) Est; No Guidance
Thursday , March 09, 2006 08:52 ET

QUARTER RESULTS
Cell Therapeutics Inc (CTIC) reported Q4 results ended December 2005. Q4 Revenues were $1.19M; -85.36% vs yr-ago; BEATING revenue consensus by +1,090.00%. Q4 EPS was (27c); +62.50% vs yr-ago; BEATING earnings consensus by +30.77%.

Q4 RESULTS      Reported      Year-Ago     Y/Y Chg      Estimate    SURPRISE
----------  ------------  ------------  ----------  ------------  ----------
Revenues:         $1.19M        $8.13M     -85.36%        $0.10M  +1,090.00%
----------  ------------  ------------  ----------  ------------  ----------
EPS:               (27c)         (72c)     +62.50%         (39c)     +30.77%
----------  ------------  ------------  ----------  ------------  ----------

QUARTERLY GUIDANCE:
Company provided NO Revenue guidance for next quarter.

Company provided NO EPS guidance for next quarter.


YEAR-END RESULTS
Co. also reported Year-End results ended December 2005. FY Revenues were $16.09M; -45.62% vs yr-ago; BEATING revenue consensus by +10.58%. FY EPS was ($1.59); +65.95% vs yr-ago; BEATING earnings consensus by +18.46%.


FY RESULTS      Reported      Year-Ago     Y/Y Chg      Estimate    SURPRISE
----------  ------------  ------------  ----------  ------------  ----------
Revenues:        $16.09M       $29.59M     -45.62%       $14.55M     +10.58%
----------  ------------  ------------  ----------  ------------  ----------
EPS:             ($1.59)       ($4.67)     +65.95%       ($1.95)     +18.46%
----------  ------------  ------------  ----------  ------------  ----------

&

Cell Therapeutics, Inc. (CTI) Reports 2005 Fourth Quarter and Year End Results
Thursday , March 09, 2006 07:01 ET

SEATTLE, March 9, 2006 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) reported financial results for the quarter and year ended December 31, 2005. Total revenues for the quarter were $1.2 million compared to $8.1 million in the fourth quarter of 2004. CTI reported a net loss for the quarter of $18.7 million ($0.27 per share) compared to a net loss of $43.5 million ($0.72 per share) for the same period in 2004. This included a $40.7 million gain in the quarter on the divestiture of TRISENOX(R) and a $23.6 million charge for the conversion of $38.4 million related to the Company's 4% and 5.75% convertible senior subordinated notes.

Total revenues for the year ended December 31, 2005, were $16.1 million compared to $29.6 million in 2004. For the year, CTI posted a net loss of $102.5 million ($1.59 per share), including a $71.2 million gain for the year on the divestiture of TRISENOX, compared to a net loss of $252.3 million ($4.67 per share) in 2004, which included an $87.4 million charge related to in-process research and development resulting from the acquisition of Novuspharma S.p.A..

Revenues for the quarter and year ended December 31, 2005 were lower as compared to the same periods in 2004 due to a reduction in product sales revenues as a result of the divestiture of TRISENOX to Cephalon in July 2005. The Company ended the year with cash, cash equivalents, securities available-for-sale and interest receivable of approximately $69 million. This amount excludes proceeds of $24.6 million held in escrow until April 30, 2006 to fund potential redemptions of 30% of the 6.75% convertible senior notes.

As of February 28, 2006, $56.1 million of the 6.75% convertible senior notes had converted into approximately 21.3 million shares. As a result of the conversions we paid make whole interest of $18.9 million.

"Our efforts to reduce expenses and raise additional capital over the last several months have placed us in the position this year to focus on advancing XYOTAX(TM) toward marketing applications in the United States and Europe and on reporting the interim analysis for the pixantrone phase III trial in non-Hodgkin's lymphoma," stated James A. Bianco, M.D., President and CEO of CTI.

2005 Highlights

     --  Completed an $82 million convertible senior notes offering and
         conversion of $38.4 million of outstanding 5.75% and 4% convertible
         senior subordinated notes

     --  Announced that pixantrone achieved the primary endpoint of a
         randomized trial, significantly prolonging time to progression when
         added to rituximab compared to rituximab alone, in indolent
         non-Hodgkin's lymphoma

     --  Reported gender specific survival benefit observed in STELLAR 3 and
         4 trials among women on XYOTAX, linking survival benefit to estrogen
         status and metabolism of polymer

     --  Reported prospective analysis of phase II trial (PGT202)
         demonstrating estrogen-linked survival benefit for women with
         non-small cell lung cancer on XYOTAX

     --  Initiated first gender specific approval trial (PIONEER trial) in
         non-small cell lung cancer

     --  Significantly reduced operating costs compared to 2004 and refocused
         resources on near term XYOTAX and pixantrone milestones

     --  Completed the divestiture of TRISENOX to Cephalon, and recorded a
         $71.2 million gain for the year, with the potential to earn an
         additional $100 million in milestones

     --  Appointed Stonefield Josephson, Inc. as independent registered public
         accounting firm

     --  Appointed John Bauer, former Nintendo of America, Inc. Executive Vice
         President of Finance, as new board member and Chair of the Company's
         Audit Committee and appointed Phil Nudelman as Chairman of the Board

     --  Announced initiation by the Gynecologic Oncology Group (GOG) of a
         large phase III clinical trial examining the ability of XYOTAX to
         maintain remission and prolong the survival of ovarian
         cancer patients

     --  Announced XYOTAX patent allowance in Japan, which will provide
         exclusivity until 2018; announced that the European Patent Office
         issued an allowance for a patent directed to XYOTAX, which when
         issued, will have the same term as existing U.S. patents that provide
         patent protection for XYOTAX until 2017

[sir_joke]

Here's another reason to be buying CTIC for long term huge profit gains


Press Release   Source: Cell Therapeutics, Inc.

Pixantrone Combination Regimen Produces High Rates of Complete Remission for Patients With Aggressive NHL Who Fail CHOP Therapy
Wednesday March 22, 7:00 am ET
Preliminary Results of Phase II Trial Reported at Invest Northwest Conference

SEATTLE, March 22 /PRNewswire-FirstCall/ -- At the 2006 Invest Northwest conference, Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC - News) presented preliminary results of a phase I/II clinical trial of pixantrone in 64 patients with relapsed aggressive non-Hodgkin's lymphoma who had previously failed one or two prior chemotherapy regimens, including the CHOP regimen. The two-part study was designed to determine the maximum tolerated dose and evaluate the drug's effectiveness in a combination known as CPOP, in which pixantrone replaces doxorubicin in the standard CHOP regimen. All patients on the study had received prior doxorubicin therapy and as such were at risk for developing severe cardiac toxicity with additional anthracycline therapy.

ADVERTISEMENT
The CPOP regimen was highly effective, with complete response/unconfirmed complete response rates of 41 percent (14 of 34 patients) and 43 percent (13 of 30 patients) and overall response rates of 71 percent (24 of 34 patients) and 77 percent (23 of 30 patients) in the phase 1 and 2 component of the study, respectively. Predominant side effects were blood-related and included 60 to 75 percent grade 4 neutropenia and 23 percent febrile neutropenia. Grade 3 infections were observed at the 150 mg/m2 dose level (10 percent), but no grade 3 infections have been reported to date at the 180 mg/m2 dose level. There was one case of congestive heart failure reported, which was felt by the investigator to be related to the patient's underlying cardiac disease.

"These data suggest that in the relapsed setting, substituting pixantrone for doxorubicin can offer patients a high probability of achieving a complete remission not available with standard chemotherapy regimens and underscores the rationale for studying the CPOP regimen versus the CHOP regimen in first-line treatment of aggressive NHL," stated James A. Bianco, M.D., President and CEO of CTI. "Complete responses are the reference standard in treating non-Hodgkin's lymphoma, since it not only correlates with longer survival, but among patients who are at high risk for disease recurrence, a CR is required in order for them to undergo potentially curative bone marrow transplants."

About the CHOP Regimen

The CHOP chemotherapy regimen (a combination of cyclophosphamide, vincristine, prednisone and doxorubicin) is the standard-of-care treatment for newly diagnosed (first-line) aggressive NHL. Response rates following CHOP in first-line aggressive NHL can reach 70 percent and the regimen is potentially curative in up to 40 percent of patients. The prognosis is poor for patients who have a recurrence of the disease (relapsed patients). Despite its impressive anti-tumor activity, CHOP cannot be used to retreat the 60 to 65 percent of patients who will relapse following CHOP, due to the cumulative cardiotoxicity associated with one of its constituent agents, doxorubicin; a chemotherapy agent which belongs to the anthracycline family. The maximum lifetime recommended dose of doxorubicin ranges from 450 mg to 550 mg and this level is often reached during first-line treatment with CHOP.

About Pixantrone and the CPOP Regimen

Pixantrone is an investigational drug designed to potentially increase anti-tumor activity and decrease the potential for cardiac toxicity associated with the currently marketed anthracyclines. This trial examines the safety and potential efficacy of pixantrone when substituted for doxorubicin in the CHOP regimen among patients who have failed prior doxorubicin-containing CHOP therapy for aggressive NHL. The CPOP regimen includes pixantrone, cyclosphosphamide, vincristine, and prednisone. Patients were treated with escalating doses of pixantrone, starting at a dose of 80 mg up to 180 mg/m2.

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 www.cticseattle.com. 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, without limitation, the potential failure of pixantrone to prove safe and effective for treatment of aggressive NHL, determinations by regulatory, patent and administrative governmental authorities, 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. CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.


Source: Cell Therapeutics, Inc.

[beleggerjan]

HI,

Are you up to date with the newest cancer drugs for BREAST CANCER?

JAN.

[Melf Elf]

The 4.79 target MADE on Monday.  On Friday, we came within eight cents of the 4.43 target still IN PLAY.  DNDN is in full-blown bearish "knife catching" mode at this point.  It's been in a waterfall decline since the last pattern break.  Longs are capitulating, so we could be nearing some sort of bottom here. 

Yesterday, DNDN made the UBS downside target of 4.00, issued on July 22, 2005.  It closed at 3.91, making a 3-year low.

DNDN still is in full-blown bearish "knife catching" mode, and no sign of capitulation on volume, however yesterday's break below the down-sloping channel looks "Wolfe Wave-ish." 

May 7 is six months since fast track status for Provenge, which produced a top in DNDN at 6.22.   May 9 is earnings.

[stockpicker]

This is my "baby"... I follow it for over a year, averaging down (OK, doesn't sound attractive thus far) ... I am 25%, in average, in the red (sounds worse)... but the story is amazing:

1. Dendreon is a biotech company that develops a vaccine for prostate cancer which is based on the person's white blood cells. As some may know, today's only therapy for PC (prostate cancer) is Taxotere, which is a chemo (that many patients prefer not to take due to horrible side effects) - whereas Provenge, DNDN's vaccine, has NO side effects.

2. DNDN has COMPLETED and announced 2 phase-3 clinical trials. The results were mixed - they missed (slight miss) the primary end point (TTP = Time To Progression), but they have showed great increase in survival (34% were alive after 3 years vs. 11% from the placebo arm of the trial).

3. The market potential is 30-50,000 pts/year in the US. A typical novel cancer treatment costs around $45,000, so being a first line treatment can easily make Provenge a blockbuster (drug that sells over $1 billion/year)

4. Biotechs typically trade at 8-12 times revenues, so IF Provenge is approved, the mkt of DNDN will be in the range of $6-12 Billion. Moreover, DNDN has more promision vaccines, based on the same technology, in its pipeline... and there is the ROW market ...

5. The FDA has never rejected a cancer drug that showed increased survival. Will it reject DNDN because it failed in showing TTP, which is only surrogate to survival?

6. DNDN is about to file its BLA (biological equivalent of the NDA) to the FDA within the coming months. The FDA will likely to decide by the middle of next year, and DNDN, with over $140MM (I might be slightly wrong here) HAS ENOUGH CASH until the decision is made, so no dilution is expected in the very short term.

7. There is HEAVY HEAVY short activity in DNDN, most likely by SAC, orchestrated by manipulative, half-truth reports by analysts (UBS, in praticular), and biased (and WRONG) media (Cramer, twice). This manipulation has led the company to be traded at a market cap of ... $270MM ...


DNDN is not for a short term trade. It is also not for a margin account. This is a "buy and hold" stock. Assuming approval, DNDN can be traded at anywhere between $30-$100 - check what happened to IMCL (Martha Stewart, remember?) after Erbitux has been approved. 10-fold (and more) moves happen in biotech. The downside is around 50% - but who cares, give the downside a 50% probability with zero value, the upside is still overwhelming. Did I mention that DNDN is now at $3.90 or so...

There is a LOT to learn about DNDN. There is a risk to lose all the investment, but many believe that the approval chances are VERY high, so the risk/reward here is simply amazing and worth a small portion of one's portfolio (assuming he is not a trader).

Some interesting links can be found here: http://finance.messages.yahoo.com/bbs?.mm=FN&board=1600905258&tid=dndn&sid=1600905258&action=m&mid=200000. DNDN's MB in Yahoo is cluttered with 100's of daily posts - and one can see the huge efforts that the shorts are putting to bash the company. OTOH, there are a bunch of doctors, statisticians and other well-educated posters that post great stuff about the science, market potential and analyze the market manipulation.

The shorts have created an unbelievable imbalance here, IMHO - and I encourage you guys to check it. I will love to hear other's comments, I hope to being able to handle most of your Q's.