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Twelve DOXIL(R) Clinical Studies to be Presented at American Society of Hematology Annual Meeting

ATLANTA, Dec. 7 /PRNewswire/ -- Ortho Biotech today announced that 12 clinical studies of DOXIL(R) (doxorubicin HCl pegylated liposome injection) will be presented at the 49th annual meeting of the American Society of Hematology (ASH) at the Georgia World Congress Center on December 8-11, 2007.

"We are very pleased that ASH accepted these 12 studies for presentation," said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/Nephrology, Ortho Biotech Products, L.P. "These presentations are further evidence of Ortho Biotech's ongoing commitment to developing oncology therapeutics and to helping patients with cancer."
The 12 presentations include:

-- Phase I/II Study of Rituxan in Combination with DOXIL in Patients with

Relapsing or Refractory B-Cell Lymphoma: Clinical Efficacy without

Cardiac Toxicity - Myron S. Czuczman, Roswell Park Cancer Institute,

Buffalo, NY (Abstract 1369)

-- Saturday, December 8, 2007, 5:30 p.m.-7:30 p.m., Hall B3 and B4

(Poster Board #: 523-I)

-- Gene Expression Profiles (GEP) to Predict at Least Very Good Partial

Response to VELCADE, DOXIL, and Dexamethasone in Newly Diagnosed

Patients with Multiple Myeloma - Malathi Hari, University of Michigan,

Ann Arbor (Abstract 1489)

-- Sunday, December 9, 2007, 5:30 p.m.-7:30 p.m., Hall B3 and B4

(Poster Board #:643-I)

-- Pegylated Liposomal Doxorubicin in Combination with Bortezomib May

Provide Therapeutic Advantage for High-Risk Multiple Myeloma Patients

Relapsing within 12 Months of Stem Cell Transplant - Shaji Kumar, Mayo

Clinic, Rochester, MN (Abstract 2730)

-- Sunday, December 9, 2007, 6:00 p.m.-8:00 p.m., Hall B3 and B4

(Poster Board #:920-II)

-- Effect of Disease Stage and Time Since Diagnosis on Time to Progression

for Pegylated Liposomal Doxorubicin + Bortezomib vs. Bortezomib Alone

in Relapsed or Refractory Multiple Myeloma - Heather J. Sutherland,

University of British Columbia (Abstract 2740)

-- Sunday, December 9, 2007, 6:00 p.m.-8:00 p.m., Hall B3 and B4

(Poster Board #:930-II)

-- Early Normalization of Serum Free Light Chain Is Associated with

Prolonged Time to Progression Following Bortezomib Pegylated

Liposomal Doxorubicin Treatment of Relapsed/Refractory Multiple Myeloma

- Robert Orlowski, University of North Carolina, Chapel Hill (Abstract


-- Sunday, December 9, 2007, 6:00 p.m.-8:00 p.m., Hall B3 and B4

(Poster Board #: 925-II)

-- Serum Free Light Chain Analysis Improves Monitoring of Multiple Myeloma

Patients Receiving First-Line Therapy with the Combination of VELCADE,

DOXIL, and Dexamethasone (VDD) - Daniel Lebovic, University of

Michigan, Ann Arbor (Abstract 2736)

-- Sunday, December 9, 2007, 6:00 p.m.-8:00 p.m., Hall B3 and B4

(Poster Board #:926-II)

-- Bortezomib in Combination with Pegylated Liposomal Doxorubicin and

Thalidomide (VDT) for the Treatment of Previously Untreated Multiple

Myeloma - Asher A. Chanan-Khan, Roswell Park Cancer Institute, Buffalo,

NY (Abstract 3614)

-- Monday, December 10, 2007, 10:30 a.m. - 7:00 p.m., Hall B3 and B4

(Poster Board #: 2768)

-- The Prolonged Time to Progression with Pegylated Liposomal Doxorubicin

+ Bortezomib Versus Bortezomib Alone in Relapsed or Refractory Multiple

Myeloma Is Unaffected by Extent of Prior Therapy or Previous

Anthracycline Exposure - Joan Blade, Hospital Clinic i Provincial,

Barcelona, Spain (Abstract 410)

-- Monday, December 10, 2007, 11:15 a.m., Rooms C303-C305 (simultaneous

oral session)

-- Bortezomib (VELCADE), Pegylated Liposomal Doxorubicin (DOXIL/CAELYX)

and Dexamethasone in the Treatment of Previously Untreated Multiple

Myeloma Patients: Impact on Quality-of-Life - Andrew Belch, Cross

Cancer Institute, Edmonton, Alberta, Canada (Abstract 3618)

-- Monday, December 10, 2007, 5:00 p.m.-7:00 p.m., Hall B3 and B4

(Poster Board #:837-III)

-- Pegylated Liposomal Doxorubicin (PLD), Dexamethasone and Low Dose

Thalidomide (DDt): An Active Regimen in the Frontline Therapy for

Multiple Myeloma (MM) - Delva Deauna-Limayo, University of Kansas

Medical Center, Kansas City, KS (Abstract 3619)

-- Monday, December 10, 2007, 5:00 p.m.-7:00 p.m., Hall B3 and B4

(Poster Board #:838-III)

-- Preliminary Results of a Phase II Study of HCVID DOXIL Alternated with

Methotrexate-Cytarabine in Patients with Newly Diagnosed T-Cell

Lymphoma - Barbara Pro, M.D. Anderson Cancer Center, Houston, TX

(Abstract 3456)

-- Monday, December 10, 2007, 5:00 p.m.-7:00 p.m., Hall B3 and B4

(Poster Board #: 675-III)

-- Phase II study of RCHOP with Pegylated Liposomal Doxorubicin (DRCOP)

for Patients > 60 Years Old with Untreated Diffuse Large B Cell

Lymphoma (DLBCL) - Maria Alma Rodriguez, University of Texas M.D.

Anderson Cancer Center, Houston, TX (Abstract 4468 [accepted as

abstract only])


DOXIL in combination with VELCADE(R) (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma who have not previously received VELCADE and have received at least one prior therapy.



Cardiotoxicity, infusion reaction, myelosuppression, liver impairment, Substitution
-- The use of DOXIL may lead to cardiac toxicity. Myocardial damage may

lead to congestive heart failure and may occur as the total cumulative

dose of doxorubicin HCl approaches 550 mg/m2

-- Prior use of other anthracyclines or anthracenediones should be

included in calculations of total cumulative dose

-- Cardiac toxicity may also occur at lower cumulative doses (400

mg/m2) in patients with prior mediastinal irradiation or who are

receiving concurrent cyclophosphamide therapy

-- Acute infusion-related reactions including, but not limited to,

flushing, shortness of breath, facial swelling, headache, chills, back

pain, tightness in the chest or throat, and/or hypotension have

occurred in up to 10% of patients treated with DOXIL. In most patients,

these reactions have resolved within several hours to a day once the

infusion is terminated. In some patients, reactions resolved with

slowing of the infusion rate

-- Serious and sometimes life-threatening or fatal

allergic/anaphylactoidlike infusion reactions have occurred.

Medications to treat such reactions, as well as emergency equipment,

should be available for immediate use

-- The initial rate of infusion should be 1 mg/min to minimize the risk

of infusion reactions

-- Severe myelosuppression may occur

-- DOXIL dosage should be reduced in patients with impaired hepatic


-- Accidental substitution has resulted in severe side effects. Do not

substitute for doxorubicin HCl on a mg per mg basis


-- Patients with a history of hypersensitivity reactions to a conventional

doxorubicin formulation or the components of DOXIL

-- Nursing mothers

Additional Safety Information

-- Cardiac function should be carefully monitored

-- Congestive heart failure or cardiomyopathy may occur after

discontinuation of anthracycline therapy

-- For patients with a history of cardiovascular disease, or if the

results of cardiac monitoring indicate possible cardiac injury, the

benefit of therapy must be weighed against the risk of myocardial


-- In the randomized multiple myeloma study, 25 patients (8%) in the

VELCADE for Injection arm and 42 patients (13%) in the VELCADE plus

DOXIL arm experienced left ventricular ejection fraction decrease

(defined as absolute decrease greater than or equal to 15% over

baseline or a greater than or equal to 5% decrease below

institutional lower limit of normal)

-- Myelosuppression may occur; frequently monitor complete blood count

(including platelet count), at least prior to each dose of DOXIL

-- In patients with multiple myeloma, hematologic toxicity (based on

platelet count, absolute neutrophil count, hemoglobin level, or

neutropenia with fever) may require dose reduction, delay in

administration, or suspension of DOXIL and/or VELCADE

-- Persistent severe myelosuppression may result in superinfection,

neutropenic fever, or hemorrhage

-- Sepsis occurring during neutropenia has resulted in discontinuation

of treatment and in rare cases of death

-- DOXIL may potentiate the toxicity of other anticancer therapies,

especially hematologic toxicities, when used in combination with other

therapies that suppress bone marrow

-- Hand-foot syndrome (HFS) may occur during therapy with DOXIL

-- Based on HFS toxicity grade, dose reduction, delay in

administration, or discontinuation of DOXIL may be required

-- HFS was generally observed after 2 to 3 cycles of treatment, but may

occur earlier

-- The reaction was mild in most patients, resolving in 1 to 2 weeks

-- The reaction can be severe and debilitating in some patients,

resulting in discontinuation of therapy

-- DOXIL is an irritant, not a vesicant; use precautions to avoid


-- DOXIL can cause fetal harm when used during pregnancy

-- Recall reaction has occurred with DOXIL administration after


-- DOXIL may interact with drugs known to interact with the conventional

formulation of doxorubicin HCl

-- In patients with multiple myeloma, the most common all-grade ARs

greater than or equal to 20%

(VELCADE plus DOXIL vs VELCADE, respectively) included: neutropenia

(36% vs 22%), thrombocytopenia (33% vs 28%), anemia (25% vs 21%),

fatigue (36% vs 28%), pyrexia (31% vs 22%), asthenia (22% vs 18%),

nausea (48% vs 40%), diarrhea (46% vs 39%), vomiting (32% vs 22%),

constipation (31% vs 31%), mucositis/stomatitis (20% vs 5%), peripheral

neuropathy (42% vs 45%), neuralgia (17% vs 20%), and rash (22% vs 18%)

-- In addition, 19% vs <1% reported HFS Please see full Prescribing Information, including Boxed WARNINGS.

DOXIL is marketed in the United States by Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough Corporation, under a licensing agreement, has exclusive rights to market the medication as CAELYX(R) throughout the rest of the world, excluding Japan and Israel. For more information about DOXIL, please visit


VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. will co-promote VELCADE in the U.S. VELCADE is approved in more than 80 countries worldwide. To access the full U.S. prescribing information for VELCADE, go to:

In the U.S., VELCADE is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. In the European Union and many other countries worldwide, VELCADE is approved for patients with multiple myeloma after first relapse.

Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension observed throughout therapy, cardiac and pulmonary disorders, gastrointestinal adverse events, thrombocytopenia, neutropenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE. Cases of severe sensory and motor peripheral neuropathy have been reported. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with few or no risk factors for decreased left ventricular ejection fraction. There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of these events have been fatal. A higher proportion of these events have been reported in Japan. There have been rare reports of RPLS in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. VELCADE is associated with thrombocytopenia and neutropenia. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. Complete blood counts (CBC) should be frequently monitored during treatment with VELCADE. Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.

Safety Data of VELCADE as a Single-Agent: In 1163 patients in multiple myeloma and mantle cell lymphoma studies, the most commonly reported adverse events were asthenic conditions (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy (39%), thrombocytopenia (36%), appetite decrease, including reports of anorexia (36%), pyrexia (34%), vomiting (33%) and anemia (29%). Twenty percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (5%) and neutropenia (3%). Fifty percent of patients reported serious adverse events. The most commonly reported serious adverse events were pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).

For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).

About Ortho Biotech Products, L.P.

Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech also markets treatments for anemia, recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit

SOURCE Ortho Biotech
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