All Blog Posts Tagged 'trial' (80)

U.S. FDA Gives Orphan Drug Designation to SL-401 for the Treatment of Acute Myeloid Leukemia

Earlier today SL-401, Stemline Therapeutics' lead compound, received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). The new drug candidate has completed a multi-center Phase I/II clinical trial in AML where it has demonstrated single agent efficacy, including two durable complete responses (CRs), multiple blast reductions and disease stabilizations, and…

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Added by Peter Hofland, PhD on March 9, 2011 at 5:30am — No Comments

Preclinical Data Show TRX518, a Novel, First-in-Class, Anti-GITR Antibody Immunotherapeutic, Prolongs Survival and is Well Tolerated and Safe at High Doses

TRX518, a novel, first-in-class immunomodulatory agent demonstrates anti-tumor activity in data presented at the Keystone Symposia ‘Antibodies as Drugs’ meeting held from February 6 - 11, 2011 in Keystone, Colorado.



TRX518 is an investigational monoclonal antibody reactive withthe glucocorticoid-induced tumor necrosis factor receptor (GITR) and is designed…

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Added by Peter Hofland, PhD on February 9, 2011 at 4:30am — No Comments

Results from Phase I Trial with ENMD-2076 Demonstrates Activity in Refractory Cancer Patients

Data on the clinical and preclinical development of ENMD-2076, published in the December 3, 2010 on-line issue of the American Association for Cancer Research (AACR) journal, Clinical Cancer Research, is expected appear in an upcoming edition of the publication.



ENMD-2076, which is being developed by EntreMed Inc. , a clinical-stage pharmaceutical company, is an orally-active, Aurora A/angiogenic kinase…

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Added by Peter Hofland, PhD on February 4, 2011 at 4:00am — No Comments

New Cancer-Targeting Investigational Nanoparticle Receives FDA IND Approval for First-In-Human Trial

Researchers at Memorial Sloan-Kettering Cancer Center's Nanotechnology Center, along with collaborators at Cornell University and Hybrid Silica Technologies, have received approval for their first Investigational New Drug Application (IND) from the US Food and Drug Administration (FDA) for an ultrasmall silica inorganic nanoparticle platform for targeted molecular imaging of cancer, which may be useful for…

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Added by Peter Hofland, PhD on January 31, 2011 at 12:30pm — No Comments

Promising Clinical Trial of DCVax® for Brain Cancer Resumes Enrollment of New Patients

A Phase II trial with an investigational therapy called DCVax® (Northwest Biotherapeutics), a personalized vaccine that takes a patient’s immune cells and the biomarkers from that patient’s tumor tissue to mobilize the full immune system response to recognize and kill the tumor cells, resumes enrollment.



The purpose of the ongoing 240-patient, double blind, randomized, placebo controlled Phase II clinical…

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Added by Peter Hofland, PhD on January 24, 2011 at 4:30am — No Comments

Clinical Trial to Evaluate Intravenous JX-594 in Patients With Refractory Metastatic Colorectal Cancer Starts in Korea

San Francisco based Jennerex, Inc., a private clinical-stage biotherapeutics company and Transgene , a member of the Institut Merieux Group initiated the enrollment and treatment of patients in a Phase 1b clinical trial to evaluate JX-594 (Vaccinia GM-CSF/thymidine kinase-deactivated virus…

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Added by Peter Hofland, PhD on December 15, 2010 at 11:30pm — No Comments

Denosumab Significantly Improves Bone Metastasis-Free Survival in Men With Prostate Cancer

Top-line results from the pivotal phase III '147 study evaluating denosumab (Xgeva™, Amgen) versus placebo in 1,432 men with castrate-resistant prostate cancer demonstrated that the new drug significantly improved median bone metastasis-free survival by 4.2 months (HR=0.85, 95 percent CI 0.73-0.98, p=0.03) compared to placebo (primary endpoint), and significantly improved time to first occurrence of bone metastases (secondary…

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Added by Peter Hofland, PhD on December 13, 2010 at 3:00pm — No Comments

Adding Pertuzumab to Trastuzumab and Docetaxel Improved Efficacy for Women With HER2-positive Breast Cancer

The combination of pertuzumab (Omnitarg, Genentech) and trastuzumab (Herceptin, Genentech) had superior antitumor activity in women with early HER2-positive breast cancer, according to Phase II study results of the NeoSphere neoadjuvant trial.Details of these study results were presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held Dec. 8-12, 2010.



Pertuzumab is a monoclonal antibody. It is the first of its class in a line of…

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Added by Peter Hofland, PhD on December 10, 2010 at 5:30pm — No Comments

Sunscreen Helps Reduce the Risk of Developing Melanoma

A randomized, prospective study, published online December 6, 2010, in the Journal of Clinical Oncology found that regular use of sunscreen reduced the risk of developing melanoma – the deadliest form of skin cancer – by half, including a 73% drop in risk for invasive melanoma The study included more than 1,600 adults participates in Australia.



“Our…

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Added by Peter Hofland, PhD on December 6, 2010 at 12:30pm — No Comments

Lung Cancer Patients Centerpiece For Northwestern Medicine Quality Of Care Study

Chicago's Northwestern Memorial Hospital, an 854-bed academic medical center and one of the country's premier academic medical centers, is the primary teaching hospital of the Northwestern University Feinberg School of Medicine. The hospital is one of six national participants in a pilot study that will test whether operable lung cancer patients and their families have a smoother care experience and better outcomes by hardwiring data… Continue

Added by Peter Hofland, PhD on November 18, 2010 at 10:00am — No Comments

Statement of the American College of Radiology (ACR) on the National Lung Cancer Screening Trial (NLST)

Lung cancer, most frequently caused by cigarette smoking, is the leading cause of cancer-related deaths in the United States – claiming nearly 160,000 lives each year. The most effective way to avoid lung cancer death is not to start smoking, and if you already smoke, to quit immediately and permanently.



As a medical association representing nearly 34,000 health care providers dedicated to… Continue

Added by Peter Hofland, PhD on November 4, 2010 at 11:30am — No Comments

US National Lung Cancer Partnership Welcomes Results of Lung Cancer Screening Trial and Urges People at Risk to Discuss Screening Options with Their Doctors

The National Lung Cancer Partnership heralded the results of the National Lung Screening Trial (NLST), released today by the National Cancer Institute (NCI), sponsor of the trial. The research, which compared low-dose spiral CT to standard chest X-ray in the early detection of lung cancer, found 20 percent fewer lung cancer deaths among those screened with CT compared to those screened with chest… Continue

Added by Peter Hofland, PhD on November 4, 2010 at 11:00am — No Comments

Watchdog Does Not Recommend Ofatumumab, Temsirolimus, and Bendamustine For Use In The UK

The United Kingdom's health watchdog, the National Institute for Health and Clinical Excellence (NICE) earlier today published three separate pieces of guidance for the NHS on the use of the cancer drugs ofatumumab (Arzerra®, GlaxoSmithKline), temsirolimus (… Continue

Added by Peter Hofland, PhD on October 27, 2010 at 10:00am — No Comments

Phase II Clinical Trial of SG2000 in Ovarian Cancer Starts Recruiting Patients

A Phase II clinical trial of SG2000 in ovarian cancer, being sponsored by the National Cancer Institute (NCI), is now actively recruiting patients for treatment for the treatmet of various forms of ovarian cancer

Ovarian cancer is the sixth most commonly diagnosed cancer in women and the eighth leading cause of cancer death among women worldwide, according to the American Cancer Society. Annually, an estimated 230,000 women are diagnosed with ovarian cancer around the world…

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Added by Peter Hofland, PhD on October 15, 2010 at 5:00pm — No Comments

Early Tumor Shrinkage With 1st Line Cetuximab Therapy Leads To Longest-Ever Median Survival In KRAS Wild-Type mCRC

An analysis from the Phase III CRYSTAL study with cetuximab (Erbitux®, Merck Serono/ Merck KgaA) in metastatic colorectal cancer (MCRC) presented during 35th ESMO Congress Poster Presentation II, on October 10 2010, by Professor H Piessevaux shows that patients with KRAS… Continue

Added by Peter Hofland, PhD on October 10, 2010 at 7:00am — No Comments

Some Patients With Advanced Lung Cancer Benefit From New Targeted Therapy

A subset of lung cancer patients seem to live longer and experience delays in disease progression when a new drug that targets a cancer-associated molecule called MET is added to treatment with erlotinib (Tarceva®, OSI Pharmaceuticals, Inc., and Genentech, Inc), the results of a double-blind Phase-II… Continue

Added by Peter Hofland, PhD on October 9, 2010 at 10:30am — No Comments

Erlotinib Nearly Triples Progression-free Survival as First-line Therapy in Advanced Lung Cancer

For patients with advanced lung cancer whose tumors carry EGFR activating mutations, first-line treatment with erlotinib (Tarceva®, OSI Pharmaceuticals, Inc., and Genentech, Inc.) nearly tripled progression-free survival compared to a standard chemotherapy combination, show results from the first… Continue

Added by Peter Hofland, PhD on October 9, 2010 at 10:30am — No Comments

Antibody-drug Conjugate Shows Promise As First-line Therapy in HER2-positive Metastatic Breast Cancer

A new type of breast cancer treatment has shown encouraging activity as a first-line therapy in HER2-positive metastatic disease, researchers reported at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy.



Principal investigator Edith Perez, MD, Mayo Clinic in Florida, presented the results of the first ever randomized trial of trastuzumab-DM1 (T-DM1) as a first-line treatment for metastatic breast cancer.



T-DM1 is… Continue

Added by Peter Hofland, PhD on October 8, 2010 at 12:00pm — No Comments

Evidence Links Cancer and Diabetes - Experts Join Forces

A growing number of medical studies suggest that diabetes might contribute to the development of certain cancers. The exact mechanism linking the two diseases are yet unknown. During the annual meeting of the European Association for the Study of Diabetes (EASD) in Stockholm, Sweden (Seeptember 22 – 24, 2010), Dr Hsin-Chieh Yeh, Johns Hopkins University, Baltimore, Maryland, USA, discussed the growing evidence base and called for experts across both specialties to ‘wage war’… Continue

Added by Peter Hofland, PhD on September 23, 2010 at 9:30am — No Comments

First Pivotal Phase III Trial Of Afatinib (BIBW 2992; Tomtovok™), In Metastatic HER2 Positive Breast Cancer Beyond Lung Cancer

Boehringer Ingelheim initiated a new phase III clinical trial to investigate one of its most advanced oncology pipeline compounds, afatinib (BIBW 2992, planned brand name Tomtovok™), for the treatment of patients with advanced (metastatic) breast cancer.



Afatinib is a next generation, orally administered oral compound (taken as a tablet), targeted therapy, that irreversibly inhibits both, the… Continue

Added by Peter Hofland, PhD on September 17, 2010 at 9:30am — No Comments

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