Pharmion Corporation Provides EU Registration Strategy Update For Thalidomide
BOULDER, Colo., Jan. 10 /PRNewswire-FirstCall/ -- Pharmion Corporation announced today that, pending further data review and communication with the European regulatory authorities, it expects that the results of the pivotal Phase III multiple myeloma trial announced yesterday by Celgene Corporation will form the basis of Pharmion's Marketing Authorization Application (MAA) for thalidomide in the treatment of first-line multiple myeloma in Europe.
Yesterday, Celgene announced that the study met the pre-specified interim endpoint for efficacy and the trial would be stopped. Pharmion, which jointly funded this study with Celgene, intends to submit an MAA with the European Medicines Agency (EMEA) for thalidomide in the treatment of first-line multiple myeloma by early 2007.
An external Independent Data Monitoring Committee analysis of the multi-centered, randomized, placebo-controlled phase III study (MM-003) of combination thalidomide plus dexamethasone versus dexamethasone alone as induction therapy for previously untreated multiple myeloma met the pre-specified p<0.0015 value for stopping the trial. The IDMC found time to disease progression -- the primary endpoint of this Phase III trial -- of 75.7 weeks versus 27.9 weeks (p=0.000065), plus progression-free survival of 55.7 weeks versus 24.3 weeks (p=0.0003) in patients receiving THALOMID(R) plus dexamethasone compared to patients receiving dexamethasone alone.
Treatment assignments for patients currently on the trials will be unblinded and those currently not on THALOMID will have the opportunity to add THALOMID to their dexamethasone regimen.
The thalidomide phase III special protocol assessment trial included patients with previously untreated (first-line) multiple myeloma. Patients were randomized to receive thalidomide plus dexamethasone or placebo plus dexamethasone alone. A total of 270 patients were randomized to receive thalidomide plus dexamethasone, or placebo plus dexamethasone, in this multi-centered clinical trial. The trial design included a primary endpoint of time to disease progression calculated as the time from randomization to the first documentation of progressive disease based on Blade myeloma response criteria.
Patients treated with thalidomide and dexamethasone had an increase in side effects as compared to those patients only treated with placebo plus dexamethasone alone. These adverse drug events included insomnia, tremors, dizziness, peripheral neuropathy and constipation. Grade 3 or 4 adverse events reported included deep vein thrombosis (DVT) occurred in 10.3% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone, and pulmonary embolism (PE) occurred in 5.6% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone.
"We believe that this data demonstrates the significant benefit that thalidomide provides to patients with newly-diagnosed multiple myeloma and we will work closely with the EMEA and other constituency groups in Europe to get this drug approved," said Patrick J. Mahaffy, president and chief executive officer of Pharmion Corporation.
Safety Notice
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide Pharmion 50mg hard capsules will only be available under a special restricted distribution program. This program is called the Pharmion Risk Management Programme (PRMP).
Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of PRMP.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. The most commonly observed adverse reactions associated with the use of thalidomide are constipation, somnolence and asthenia.
The other clinically most important adverse reactions associated with the use of thalidomide include orthostatic hypotension, decreased white blood cell counts including neutropenia, severe skin reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis, headache, rash, eosinophilia, peripheral oedema, dyspnoea, dizziness, hypotension, bradycardia, symptomatic hypothyroidism, increase or decrease in platelet count, anaemia and, in HIV patients, an increase in HIV viral load.
Seizures, including grand mal convulsions, have been reported very rarely during the use of thalidomide in clinical practice. It has been suggested that thalidomide's anti-angiogenic properties may interfere with wound healing. Patients should be advised about associated adverse events and routinely monitored by a physician during treatment with thalidomide.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease is unknown.
About Pharmion Corporation
Pharmion is a pharmaceutical company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. For additional information about Pharmion, please visit the company's website at www.pharmion.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Pharmion's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements.
Pharmion CorporationCONTACT: Breanna Burkart, or Anna Sussman, Directors, Investor Relationsand Corporate Communications, both of Pharmion Corporation,+1-720-564-9150, ir@pharmion.com
Web site: http://www.pharmion.com/