MEDICAL NEWS: If a trial is adequately powered for two clinically important endpoints, A and B, each of which can fully characterize a treatment benefit to support a regulatory claim by itself, then both endpoints are usually labeled primary, and the trial is deemed positive if either endpoint is statistically significant after a multiplicity [...]
Sep
1
An efficient method for accommodating potentially underpowered primary endpoints
≡ Category: Cancer, Cancer Lawsuits, Doctors, Drugs & RX, Hospitals, Medical News, Mesothelioma Info, Uncategorized, Vioxx Lawsuit | ≅ Leave a Comment
Aug
29
A robust classifier of high predictive value to identify good prognosis patients in ER negative breast cancer.
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CANCER NEWS: IntroductionPatients with primary operable estrogen receptor negative (ER-) breast (women’s) cancer account for approximately 30% of all cases and generally have worse prognosis (outlook) than ER+ patients. Nevertheless, a significant proportion of ER- cases have favourable outcome and could potentially benefit from a less aggressive course of therapy. Identification of such good [...]
Aug
29
Genmab Announces Upcoming Ofatumumab Studies: Front Line CLL, NHL And CLL Retreatment Planned
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CANCER NEWS: COPENHAGEN, Denmark — Genmab has announced plans to begin four studies of ofatumumab in chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. Genmab A/S announced today plans to begin four studies of ofatumumab in chronic lymphocytic leukemia (CLL) and follicular non-Hodgkin’s lymphoma (NHL) this year. “Genmab and GSK have worked diligently to expand the [...]
Aug
29
The Multiple Myeloma Research Consortium Partners With Celgene Corporation On Phase I/II Trial Of Pomalidomide In Relapsed And Refractory Multiple Myeloma Patients
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CANCER NEWS: NORWALK, Conn. — The Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a clinical trial with the oral immunomodulatory agent pomalidomide (CC-4047) in patients who have received at least two prior therapies including treatments with REVLIMID(R) (lenalidomide) and VELCADE(R) (bortezomib) for Injection. Paul Richardson, MD, Clinical Director of the Jerome [...]
Aug
29
Telik’s Proteasome Inhibitor Program Meets A Preclinical Development Milestone
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CANCER NEWS: PALO ALTO, Calif. — Telik, Inc. announced today that its novel small molecule proteasome inhibitor program met a preclinical development milestone by demonstrating anticancer activity in preclinical models of human leukemia. The proteasome is an important cellular structure necessary for the growth and function of cancer cells and inhibition of the proteasome [...]
Aug
29
Clinical Data Published In ‘Science’ Show Tumor Regressions In Relapsed Lymphoma Patients Treated With T Cell Engaging Bite Antibody Blinatumomab
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CANCER NEWS: Micromet, Inc., a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, announced publication of a Phase 1 clinical study(1) on its BiTE(R) antibody blinatumomab (MT103/MEDI-538) in this week’s issue of Science. The article is available at www.sciencemag.org. Blinatumomab is being co-developed with MedImmune. Blinatumomab is [...]
Aug
29
Scientists Unveil Cancer Diagnosis Breakthrough
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CANCER NEWS: Stem cell scientists in the region have helped to develop a more accurate way of identifying aggressive forms of bowel cancer, which should eventually lead to better treatment and improved survival rates. The UK-led team, headed by scientists from Durham University and the North-East England Stem Cell Institute, (NESCI), studied tissue samples [...]
Aug
28
Human Genome Sciences Completes Enrollment In Randomized Phase 2 Trial Of HGS-ETR1 In Non-small Cell Lung Cancer
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(Mesothelioma News) ROCKVILLE, Md. — Human Genome Sciences, Inc. today announced that it has completed the enrollment and initial dosing of patients in a randomized Phase 2 trial of HGS-ETR1 (mapatumumab) in combination with the chemotherapy (serious, serious drugs) agents paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer (NSCLC). “There is [...]
Aug
28
FDA Grants Fast Track Designation For Oncogenex Pharmaceuticals’ Lead Product Candidate OGX-011
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(Mesothelioma News) BOTHELL, WA and VANCOUVER — OncoGenex Pharmaceuticals announced today that OGX-011, also known as custirsen sodium, received Fast Track designation from the U.S. Food & Drug Administration (FDA) in combination with docetaxel for progressive metastatic prostate cancer. OGX-011 is currently completing five Phase 2 clinical studies in prostate, lung and breast cancer, and [...]
Aug
28
Vaccine Strong In Tests: Treatment For Lung Cancer In Third Round Of Trials
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(Mesothelioma News) The biotech company that Justin Murdock, the son of Dole Food Co. owner David Murdock, leads has begun stage-III clinical trials for a lung cancer vaccine. NovaRx, based in San Diego, is testing its Lucanix vaccine in about 700 patients with lung cancer — a disease which the American Cancer Society says is [...]
Aug
27
FDA Approves First Drug for Treatment of Chorea in Huntington’s Disease
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DRUGS & RX: The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington’s disease. Chorea is the jerky, involuntary movement that occurs in people with this disease.
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FDA Approves First Drug for Treatment of Chorea in Huntington’s Disease was another wonderful and [...]
Aug
27
Curis Announces Nature Publication Elucidating a Paracrine Mechanism of Action in Hedgehog-Expressing Tumors
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DRUGS & RX: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug 27, 2008 - Curis, Inc. (NASDAQ: CRIS), a drug development company focused on developing next generation proprietary targeted medicines for cancer treatment, today announced the publication of preclinical data…
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Curis Announces Nature Publication Elucidating a Paracrine Mechanism of Action in Hedgehog-Expressing Tumors was another wonderful [...]