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Biotech / Medical : CLTR COULTER PHARMACEUTICAL -- Ignore unavailable to you. Want to Upgrade?


To: Vector1 who wrote (657)12/5/2000 10:56:03 AM
From: Micawber  Read Replies (1) | Respond to of 666
 
IMO blows Zev away which was under 50% ORR with zero CR.

And IDPH goes up 6% today while CLTR and CRXA barely budge. What am I missing?



To: Vector1 who wrote (657)12/5/2000 12:17:17 PM
From: nigel bates  Respond to of 666
 
Dec. 5, 2000-- IDEC Pharmaceuticals Corporation (Nasdaq:IDPH - news) announced the final results of two pivotal trials of ZEVALIN(TM) (Ibritumomab Tiuxetan), an investigational radioimmunotherapy, during oral presentations at the 42nd Annual Meeting of the American Society of Hematology (ASH).
Thomas E. Witzig, M.D. of the Mayo Clinic, Rochester, MN, today delivered an oral presentation of a Phase III randomized, controlled study of 143 patients with relapsed or refractory low grade, follicular, or CD20-positive transformed B-cell non-Hodgkins lymphoma (NHL). He noted that the ZEVALIN combined with Rituxan arm of the study showed an overall response rate (ORR) of 80 percent, compared to the Rituxan® (Rituxumab) alone control arm, which showed an overall response rate of 56 percent. A treatment course for ZEVALIN includes a Rituxan infusion (250 mg/m.2) on day one, followed by infusions of Rituxan (250 mg/m2) and ZEVALIN (at a standard radiation dose of 0.4 mCi/kg of patient body weight) on day eight. A treatment course of the Rituxan control consisted of four weekly doses of 375 mg/m2 of Rituxan.
Dr. Witzig said that 30 percent of the ZEVALIN patients achieved complete responses to therapy. Sixteen percent of Rituxan patients achieved complete responses. To date duration of response estimates between ZEVALIN plus Rituxan and Rituxan alone are not statistically different but further analysis will be conducted as the data mature.
ZEVALIN associated toxicity was primarily hematologic, transient and reversible. Thirty-two percent of patients in the ZEVALIN arm of the study experienced Grade 4 neutropenia (neutrophil count below 500/mm3) and five percent experienced Grade 4 thrombocytopenia (platelet count below 10,000/mm3). Patients who had Grade 3 or greater neutropenia or thrombocytopenia recovered in a median of 14 and 13 days, respectively. Only five patients in the ZEVALIN arm required hospitalization due to infection. The most common adverse events associated with Rituxan were infusion related, consisting mainly of mild to moderate flu-like symptoms, for example fever, chills and rigors that occur in the majority of patients during the first infusion.
Second Pivotal Trial -- ZEVALIN in Rituxan-Refractory Follicular NHL Patients
On the previous day Dr. Witzig delivered an oral presentation of the final results of an open-label Phase III pivotal trial of ZEVALIN in 54 follicular NHL patients who are refractory to Rituxan (i.e., non-responders or patients with time-to-progression of less than six months after Rituxan treatment.) He said the ZEVALIN study showed an overall response rate (ORR) of 74 percent.
Dr. Witzig noted that 15 percent of patients achieved complete responses to therapy. ZEVALIN associated toxicity was primarily hematologic, transient and reversible. Thirty-five percent of patients in the study experienced Grade 4 neutropenia (neutrophil count below 500/mm3) and nine percent experienced Grade 4 thrombocytopenia (platelet count below 10,000/mm3). Patients who experienced Grade 3 or greater neutropenia or thrombocytopenia recovered in a median of 8 and 13 days, respectively.
ZEVALIN for Relapsed or Refractory NHL Patients with Mild Thrombocytopenia
On Dec. 4 Dr. Witzig also gave a poster presentation of the final results of a Phase II trial evaluating the safety and efficacy of treating relapsed or refractory, low grade, follicular or transformed NHL patients with mild thrombocytopenia (platelet count between 100,000 and 149,000/mm3) with ZEVALIN at a reduced radiation dose (0.3 mCi/kg). The overall response rate in 30 patients was 67 percent with 10 patients (33 percent) achieving complete responses. Responses were seen even in patients with adverse prognostic factors, such as large tumors or chemoresistant disease.
In the study, 33 percent of patients experienced Grade 4 neutropenia and 13 percent of patients experienced Grade 4 thrombocytopenia. Again, the toxicity of ZEVALIN was primarily hematologic, transient and reversible with patients recovering in a median of 14 days.
ZEVALIN Is Safe and Well-Tolerated in Relapsed or Refractory NHL Patients
In a second poster presentation on Dec. 4, Dr. Witzig summarized the safety results of four clinical trials which showed that ZEVALIN is very well tolerated, even in a refractory population at risk for toxicity. Two hundred and eleven patients with relapsed or refractory, low grade, follicular, transformed or intermediate NHL were treated with ZEVALIN in the following trials: 1) a Phase I/II dose-finding trial, 2) a Phase II trial of reduced doze ZEVALIN (0.3 mCi/kg) in patients with mild thrombocytopenia, 3) a Phase III randomized trial of 0.4 mCi/kg, and 4) a Phase III non-randomized trial of 0.4 mCi/kg in patients with Rituxan-refractory follicular NHL.
Dr. Witzig noted that toxicity in all four trials was primarily hematologic, transient and reversible. Overall, thirty-two percent of patients in the four studies experienced Grade 4 neutropenia and 8.5 percent of patients experienced Grade 4 thrombocytopenia. Only 17 percent of patients used one or more hematopoietic growth factors. There were no excessive infection risks, with only 7.6 percent of patients hospitalized with infections.
Studies of ZEVALIN Show Improved Quality of Life in NHL Patients
On Dec. 4 Gregory A. Wiseman, M.D. of the Mayo Clinic, Rochester, MN, gave a poster presentation that showed that ZEVALIN treatment results in a statistically significant improvement in the NHL patient's self-assessment of quality of life.
ZEVALIN is a monoclonal antibody that targets the CD20 antigen and is stably linked to the radioisotope yttrium-90. This investigational agent is in late stages of development for the treatment of certain NHLs. On Nov. 1, 2000, IDEC submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval of ZEVALIN.
Schering AG has marketing rights to ZEVALIN outside the U.S. ....



To: Vector1 who wrote (657)12/5/2000 8:02:19 PM
From: Gary L. Kepler  Respond to of 666
 
Perhaps there will be a delayed market reaction to CLTR news?

CLTR did not respond to todays news. Maybe it will tomorrow. In contrast IDEC soared today. Check the following release and you tell me which is the better drug. Bexxar by Coulter has higher total remissions in trials with fewer side effects. So why did IDEC soar and CLTR lanquish. Perhaps a more appropriate action will show tomorrow.

Tuesday December 5, 6:45 pm Eastern Time

CORRECTED - Radioactive antibodies effective
against lymphoma-studies

In LOS ANGELES story ``Radioactive antibodies effective against lymphoma-studies,''
please read in 22nd paragraph ``patients who achieved remission with Bexxar...'' instead of
``patients who achieved remission with Zevalin..'' (corrects name of drug)

A corrected version follows:

By Deena Beasley

LOS ANGELES, Dec 5 (Reuters) - Experimental drugs that use cloned antibodies to deliver radiation directly to cancerous
lymphoma tumors are effective in most patients who do not respond to standard therapies, researchers said on Tuesday.

Results from clinical trials of non-Hodgkin's lymphoma drugs Zevalin and Bexxar were presented at a meeting of the American
Society of Hematology in San Francisco.

The research showed that Zevalin, made by IDEC Pharmaceuticals Corp. (NasdaqNM:IDPH - news), was effective in 74
percent of patients, 15 percent of whom went into complete remission.

Potential competitor, Bexxar, which is being developed by Coulter Pharmaceutical Inc. (NasdaqNM:CLTR - news) and
SmithKline Beecham Plc(NYSE:SBH - news), was effective in 70 percent of patients, with 40 percent entering remission, according to researchers.

Both studies tested the drugs' effectiveness in around 50 patients with low-grade non-Hodgkin's lymphoma who had previously
been treated with Rituxan, a cloned antibody that targets and destroys B cells, a type of white blood cell affected by cancer in
lymphoma patients.

Non-Hodgkin's lymphomas are a group of related cancers that originate in the lymphatic system, which carries white blood
cells called lymphocytes throughout the body. An estimated 50,000 new cases are diagnosed in the United States each year,
with the elderly, organ transfer recipients and those infected with HIV at highest risk.

Shares of San Diego-based IDEC were up 13-1/8, or 8 percent, at 186-1/2 early on Nasdaq, while shares of Coulter, based in South San Francisco, Calif., were up 1/8 at $31-1/16.

Both Zevalin and Bexxar use cloned antibodies similar to Rituxan in combination with microradiation to deliver a greater, and
more closely targeted dose of radiation to tumor cells, while minimizing the amount of radiation affecting normal tissues.

Bexxar combines the immune system targeting agent with radiation therapy in the form of iodine-131. Zevalin is armed with a
different radioactive isotope, yttrium-90.

Side effects associated with both drugs include low white blood cell counts, which make a patient more susceptible to infection,
and low platelet counts, which can cause increased bleeding.

DRUGS HAVE SIDE EFFECTS

Zevalin, however, is particularly toxic to delicate bone marrow tissue, according to IDEC.

``Almost any type of radiation has the potential to damage bone marrow. We don't treat patients with Zevalin that have had
more than 25 percent of their bone marrow compromised,'' said Connie Matsui, senior vice president of planning and resource
development at IDEC.

Kari Nadeau, director of medical research at Coulter, said Bexxar is less toxic than Zevalin because yttrium is absorbed by
bone marrow where it interferes with the generation of new cells.

``Bexxar uses iodine that gets taken up by the kidneys,'' and is passed as urine she said.

Matsui at IDEC said, ``Our philosophy is that patients should receive Rituxan or chemotherapy plus Rituxan as first-line
therapy.''

IDEC currently co-markets Rituxan with Genentech Inc. (NYSE:DNA - news) as a treatment for patients with the low-grade
form of the disease who have failed to benefit from standard care like chemotherapy.

In a late-stage trial of Zevalin in 54 patients who had not responded to Rituxan, 74 percent of the patients experienced at a
least a 50-percent reduction in tumor size, while 15 percent went into remission, according to the study's leader Dr. Thomas
Witzig, of the Mayo Clinic in Rochester, Minnesota.

But 35 percent of patients in this study experienced decreased white blood cell counts and 9 percent had decreased blood
platelets, he said.

``The complete response rate is high...but there are some toxicity concerns,'' said Gwen Fyfe, senior director of oncology at
Genentech. Drugs like Zevalin are most important for patients with relapsed disease, she said.

In a late-stage study of 40 patients previously treated with Rituxan, Bexxar reduced tumor size by more than half in 70 percent
of patients and 40 percent had no signs of the cancer, according to investigators.

``These patients can go into the hospital for two hours and receive a single dose of Bexxar. The duration of the response has been remarkable,'' said Coulter's Nadeau. Trial patients who achieved remission with Bexxar were disease-free for an average of 15 months and are still being monitored, she said.

IDEC filed last month with the U.S. Food and Drug Administration (FDA) for approval to sell Zevalin as a treatment for certain
types of non-Hodgkin's lymphoma.

After asking last year for additional data, the FDA agreed in September to a prioritized review of Bexxar as a treatment for
certain types of low-grade non-Hodgkin's lymphoma.

If approved, Bexxar would be Coulter's first commercial drug.