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Malignant in Medical Technology

CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors

... as monotherapy, and for patients with malignant gliomas, such as GBM or anaplastic astrocytoma ... effective treatment for patients in Europe with malignant gliomas, but is only available orally. Upon ... (EU) in 1999 for the treatment of patients with malignant glioma, such as GBM or AA, showing recurrence or ...

Late-Breaking Data Highlighting Research Advances in Several Blood Disorders to Be Presented At the American Society of Hematology Annual Meeting

... MP L defects cause the overproduction of mature malignant blood cells, but multiple lines of evidence ... of patients (85 percent) had an overproduction of malignant cells mainly dependent on the late stages of ... percent) had an early expansion of very immature malignant progenitor cells, close to the stem cell. ...

FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)

... patients with persistent or recurrent CTCL whose malignant cells express the CD25 component of the ... patients with persistent or recurrent CTCL whose malignant cells express the CD25 component of the ... and efficacy of ONTAK in patients with CTCL whose malignant cells do not express the CD25 component of the ...

Micromet's BiTE Antibody Blinatumomab (MT103/MEDI-538) Demonstrates Durable Responses in Patients with Relapsed Non-Hodgkin's Lymphoma

... 1 Data Presented at International Conference on malignant Lymphomas Shows Dose Dependent Single ... at the 10th International Conference on malignant Lymphomas (ICML) in Lugano, Switzerland. The new ... advancements and insights in the treatment of malignant lymphomas," said Dr. Michael J. Keating, ...

Anti-TGF-Beta Antisense AP 12009 Shows Very Good Safety and Tolerability in Systemic Treatment of Pancreatic Carcinoma, Malignant Melanoma and Colorectal Carcinoma

... with advanced stage pancreatic carcinoma, malignant melanoma or colorectal carcinoma were included. ... One patient, diagnosed with stage IV malignant melanoma, survived more than 60 weeks after the ... of AP 12009 is safe in patients suffering from malignant tumors, such as pancreatic carcinoma or melanoma. ...

Alfacell Corporation Announces Preliminary Results From ONCONASE(R) Phase IIIb Clinical Trial

... the primary endpoint of survival in unresectable malignant mesothelioma (UMM). However, a statistically ... and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE ... multiple molecular mechanisms of action. About malignant Mesothelioma ...

Vermillion's Biomarkers Prove Beneficial in Identifying Women With Ovarian Cancer and Detecting Early-Stage Disease

... our biomarkers to distinguish between benign and malignant tumors and diagnose early-stage disease," said ... independent validation that it can distinguish malignant tumors from benign pelvic masses. Results of the ... A and B, two proteins commonly found in malignant ovarian cysts, may be useful in helping diagnose ...

AmpliMed Corporation Announces Promising 1-year Survival Data from Phase I/II Study of Amplimexon(R) in Metastatic Malignant Melanoma

... Amplimexon/dacarbazine combination in metastatic malignant melanoma, in addition to safety. The criteria ... this product candidate may offer to patients with malignant melanoma the most serious form of skin cancer." ... studies of dacarbazine as a single agent to treat malignant melanoma, median overall survival has ranged from ...

Alfacell Reports Financial Results for First Quarter of Fiscal 2008

... in patients suffering from unresectable malignant mesothelioma. A total of 428 patients were ... and orphan-drug designation for treatment of malignant mesothelioma. The rolling NDA submission for ... In addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell is conducting a Phase I/II ...

Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer

... cisplatin, for the treatment of patients with malignant pleural mesothelioma (MPM) whose disease is ... of chemotherapy naive patients with unresectable malignant pleural mesothelioma. ALIMTA is indicated as ... in the use of cytotoxic anti-cancer therapy. malignant pleural mesothelioma: Pemetrexed in combination ...

Encouraging First Data on New Targeted Treatment for Patients With Melanoma - the Deadliest Form of Skin Cancer

... to result in a treatment that is both effective and well tolerated. malignant melanoma is the most serious type of skin cancer, with about 160,000 new ... not only represent an important step forward in understanding and treating malignant melanoma, but also represent a significant advance in the use of ...

FDA Advisory Panel Makes Favorable Recommendation for GlaxoSmithKline and Genmab's ARZERRA(TM) (ofatumumab)

... CLL CLL is the most common adult leukemia and one of the most common malignant lymphoid diseases. In the United States, about 90,000 people are living ... than 330,000 new cases and more than 245,000 deaths. CLL cells are malignant B-cells that have a low concentration of CD20 molecules on their surface. ...

RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder

... treatment of patients with dementia-related psychosis. Neuroleptic malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with ... treatment of patients with dementia-related psychosis. Neuroleptic malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been ...

Discovery of Marker for Colon Stem Cells Could Shed Light on What Drives Tumor Growth

... of Delaware , have discovered an enzyme common to both normal and malignant colon stem cells that will assist scientists searching for a cure for ... a marker, that enables doctors to identify, locate, and isolate normal and malignant colon stem cells, has been elusive. But the discovery by Dr. Boman and ...

ExonHit Reports Proof-of-Concept in Breast Cancer Diagnostic Using its SpliceArray(TM) Platform

... [1]. Study data demonstrate that exons are differently expressed in malignant and benign lesions, and alternative transcripts determine the molecular ... large dataset of 165 breast tumor samples that compares gene expression of malignant versus benign breast tumors. The signature was tested on 71 tumor samples, ...

Vermillion Presents Critical Data From Its OVA1 Clinical Trial

... 196). The study entitled "A biomarker panel for distinguishing between malignant and benign ovarian tumors" was co-authored by Fred Ueland, MD, Associate ... in the attached link "A biomarker panel for distinguishing between malignant and benign ovarian tumors." The primary aim of the study was to ...

Medarex Announces Enhanced Activity Data with Second Generation Anti-CD30 Antibody for Malignant Lymphoma

... targets CD30, a marker for activated lymphocytes that is present on the malignant cells of Hodgkin's lymphoma (HL) as well as other CD30-expressing cancers. ... a human anti-CD30 antibody with enhanced effector function, for therapy of malignant lymphoma" (abstract #1580) at the 50th Annual Meeting of the American ...

Alfacell Provides ONCONASE(R) NDA Submission Update

... rolling New Drug Application (NDA) for the treatment of unresectable malignant mesothelioma (UMM) patients. The pre-NDA meeting is an important step to ... granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted ...

Vermillion Renews Strategic Alliance Agreement With Quest Diagnostics, Inc.

... The oral presentation, "A Biomarker Panel for Distinguishing Between malignant and Benign Ovarian Tumors" was co-authored by scientists at Vermillion, ... to developing a diagnostic test designed to distinguish between benign and malignant pelvic masses, Vermillion has a broad program of ovarian cancer diagnostic ...

Paper in Molecular Cancer Therapeutics Reports that a Novel Combination of Alfacell's ONCONASE(R) and Rosiglitazone Induces a Synergistic Apoptotic Effect in Several Cancer Cell Lines

... granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted ... has completed Phase III clinical trials of ONCONASE in unresectable malignant mesothelioma and, in addition to ongoing efforts to complete the related ...

Alfacell Announces ONCONASE(R) Distribution and Marketing Agreement with Megapharm for Israel

... granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted ... has completed Phase III clinical trials of ONCONASE in unresectable malignant mesothelioma and, in addition to ongoing efforts to complete the related ...

Preliminary Phase 2 Results of R788 in Lymphoma Show Benefit in Diffuse Large B-Cell and SLL/CLL

... and follow-up, will be presented at the 10th International Conference on malignant Lymphoma in Lugano, Switzerland later this week. Rigel will host a ... and build up in the lymphatic system and bone marrow giving rise to malignant tumors. The uncontrolled growth is, in part, mediated by the Syk enzyme, ...

Genasense(R) Chemotherapy Program Yields High Response Rate in Patients with Stage 4 Melanoma

... are progression-free survival and overall survival. About Melanoma malignant melanoma is the most deadly form of skin cancer. The incidence of this ... In 2004, the American Cancer Society estimates more than 55,000 cases of malignant melanoma will have been diagnosed. Melanoma is the number one cause of ...

Strativa Pharmaceuticals Announces Preliminary Results from ONCONASE(R) Phase IIIb Clinical Trial

... about the potential of ONCONASE for patients living with unresectable malignant mesothelioma. We are committed to collaborating with Alfacell as they ... granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted ...

Micromet to Present Clinical Update for BiTE Antibody MT103/MEDI-538 at the International Conference on Malignant Lymphomas

... BiTE(R) antibody MT103/MEDI-538 at the 10th International Conference on malignant Lymphomas, taking place June 4-7 in Lugano, Switzerland. The ... during the week of the conference. The 10th International Conference on malignant Lymphoma gathers 3,000 leading physicians from all over the world: ...

Eisai's Commitment to Oncology Demonstrated by Clinical Data to be Presented at ASCO Annual Meeting

... implant) Wafer is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. Gliadel is also indicated ... or any of the components of Gliadel. Patients undergoing craniotomy for malignant glioma and implantation of Gliadel should be monitored closely for ...

Vermillion Receives Award From the Society of Gynecologic Oncologists

... independent validation of a marker panel for distinguishing benign from malignant pelvic masses." The abstract, which demonstrated that the Company's ... -- Validation of a Marker Panel for Distinguishing between Benign and malignant Pelvic Masses Collaborators: The Danish Cancer Society, Copenhagen; ...

Thalidomide Pharmion(R) Receives Positive Opinion for Treatment of First-line Multiple Myeloma from European Medicines Agency

... 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 ... (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells ...

Nexavar First FDA-Approved Drug Therapy for Liver Cancer

... form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults.(1,2) Liver cancer is the sixth most common cancer ... (2) Penn State Milton S. Hershey Medical Center College of Medicine. malignant Hepatoma. Available at: ...

Cellectar Expands Clinical Management Team

... of action is based on their selective accumulation and retention in malignant tumors and not normal cells. The company's operations are based in ... studies have shown that this compound is selectively retained in malignant cells. In pre-clinical studies, CLR1404 was taken up and retained in 100% ...

BioMosaics' Glypican-3 Blood & Tissue Tests Receive CE Marking in Europe

... antibody (MAb; clone 1G12) has also been used to assess GPC3 expression in malignant and non-malignant liver tissue samples and for ELISA detection of GPC3 in ... or Hepatocellular Carcinoma, is one of the most common and aggressive malignant tumors worldwide, causing an estimated one million deaths annually. Over ...

Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology

... median 12.3 mos. 9.9 mos. 0.64 0.0009 About Melanoma malignant melanoma is the most deadly form of skin cancer. The incidence of this ... In 2004, the American Cancer Society estimates more than 55,000 cases of malignant melanoma will have been diagnosed. Melanoma is the number one cause of ...

Nexavar Significantly Improved Overall Survival in Phase 3 Asia-Pacific Liver Cancer Trial

... form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults.(1,2) Liver cancer is the sixth most common cancer ... 2. Penn State Milton S. Hershey Medical Center College of Medicine. malignant Hepatoma. Available at: ...

Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma

... 12.3 mos. 9.9 mos. 0.64 0.0009 About Melanoma malignant melanoma is the most deadly form of skin cancer. The incidence of this ... In 2004, the American Cancer Society estimates more than 55,000 cases of malignant melanoma will have been diagnosed. Melanoma is the number one cause of ...

Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS)

... treatment options for higher-risk MDS," said Dr. Alan F. List, Chief, malignant Hematology Division and Deputy Physician in Chief, H. Lee Moffitt Cancer ... known hypersensitivity to Vidaza or mannitol and in patients with advanced malignant hepatic tumors. In clinical studies, the most commonly occurring adverse ...

Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer

... to cancer progression. Anti-EGFR antibody therapies work by blocking the activation of EGFR, thereby inhibiting downstream events that lead to malignant signaling. However, it is hypothesized that in patients whose tumors harbor a mutated KRAS gene, the KRAS protein is always turned "on," ...

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

... INVEGA ((R)) SUSTENNA(TM) in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death. Neuroleptic malignant Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with INVEGA((R)) SUSTENNA(TM) and similar medicines. Call ...

Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing

... that enrich the quality of life for patients around the world. A central focus of Daiichi Sankyo research and development are thrombotic disorders, malignant neoplasm, diabetes mellitus, and autoimmune disorders. Equally important to the company are hypertension, hyperlipidemia or atherosclerosis and ...

Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center

... in imaging equipment and treatments have resulted in an overall decline in mortality and increased survival, approximately half of all children with malignant solid tumors will experience relapse and, of these children, less than 10% will achieve long-term survival after standard multimodal therapy. ...

Alfacell Provides Shareholder Update

... As you are aware, we did not meet our primary endpoint of overall survival in our Phase IIIb clinical trial in patients suffering from unresectable malignant mesothelioma (UMM). We did however; achieve statistical significance with a subgroup of patients who failed a prior chemo therapy. Overall survival ...
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