Efficacy News and Research

RSS

Global phase IV study confirms efficacy of erlotinib in treatment of non-small cell lung cancer

Featured in the October edition of the Journal of Thoracic Oncology (JTO), data from The Tarceva Lung Cancer Survival Treatment (TRUST) confirms the safety and efficacy profile of erlotinib, a highly potent oral active, reversible inhibitor of epidermal growth factor receptor (EGFR) tyrosine-kinase (TK) activity in a large heterogeneous non-small cell lung cancer (NSCLC) population.

1 Oct 2010

FDA takes action against unapproved single-ingredient oral colchicine

The U.S. Food and Drug Administration took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

1 Oct 2010

DMC recommends continuation of enrollment in Celsion's Phase III ThermoDox HEAT study for primary liver cancer

Celsion Corporation, a leading oncology drug development company, announced that after reviewing data from 401 patients enrolled in its pivotal Phase III ThermoDox ® clinical study (the HEAT study) for primary liver cancer, the Data Monitoring Committee (DMC) has unanimously recommended that the trial continue to enroll patients with the goal of reaching the 600 patients required to complete the study.

1 Oct 2010

Study demonstrates rufinamide therapy is effective in reducing partial seizure frequency

Researchers from the Arkansas Epilepsy Program found treatment with rufinamide results in a significant reduction in seizure frequency compared with placebo, for patients with uncontrolled partial-onset seizures (POS).

1 Oct 2010

NIH awards Polymedix $986,000 to develop defensin mimetic antimicrobial compounds for oral candidiasis

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has received a Phase 2 grant in the amount of $986,000 from the National Institute of Health (NIH) to support the development of defensin mimetic antimicrobial compounds for the treatment of oral candidiasis. This grant will fund this research project through August 31, 2012. This award represents the 14th grant or research contract received to date by PolyMedix.

30 Sep 2010

Erchonia launches Zerona body-contouring laser in South East Asia

Erchonia, the global leader in low level laser healthcare applications, today announces the launch of the Zerona® body-contouring laser in South East Asia's SAARC. Erchonia Asia will exclusively market and sell the Zerona throughout the region. This new expansion coincides with the recent U.S. FDA-approval of the Zerona Laser, a non-invasive, painless treatment that guarantees the removal of fat.

30 Sep 2010

Repligen Corporation completes patient enrollment in RG2417 Phase 2b clinical trial

Repligen Corporation reported today that it has completed enrollment of patients in its Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression.

30 Sep 2010

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to note that its partner, sanofi-aventis, has today announced positive top-line results of the Phase III GETGOAL-L-ASIA trial which assessed the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist discovered by Zealand Pharma, in combination with basal insulin.

30 Sep 2010

AVEO regains global rights for development, commercialization of AV-299 anti-HGF antibody candidate

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that AVEO has regained worldwide rights from Merck (through its subsidiary, Schering Corporation) to develop and commercialize AV-299 (also known as SCH 900105), its anti-hepatocyte growth factor (HGF) antibody candidate.

30 Sep 2010

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

Repros Therapeutics Inc. today announced that the Company has been granted a Type B meeting to be held on November 8, 2010 with the Division of Reproductive and Urologic Products to review the Company's Phase III pivotal efficacy protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

30 Sep 2010

Best P.A.D. Research Awards honor investigators for research on peripheral arterial disease

The Peripheral Arterial Disease (P.A.D.) Coalition presented the Coalition's second annual Best P.A.D. Research Awards to the top three research papers on P.A.D. published in 2009 at the organization's Seventh Annual Meeting in Alexandria, VA last week. The Best P.A.D. Research Awards honor the work of investigators and acknowledge the creation of new clinical research relevant to the understanding and/or treatment of peripheral arterial disease.

30 Sep 2010

AccuPSA test for detecting prostate cancer recurrence

A new test could reliably detect early increases in prostate specific antigen (PSA) levels a biomarker commonly used to measure the recurrence of prostate cancer in men who have undergone prostate cancer treating surgery. Earlier detection of these rising levels would allow men with cancer recurrence to undergo earlier, more effective treatment for potentially better outcomes.

30 Sep 2010

Mount Sinai receives contract to develop nanotechnology tools for diagnosing diseases

Mount Sinai School of Medicine received a contract for almost $16.5 million from The National Institutes of Health (NIH) and the National Heart and Lung Institute (NHLBI) through the Program of Excellence in Nanotechnology (PEN). The contract is one of four issued nationally to develop multidisciplinary research Centers with the goal of developing nanotechnology tools for diagnosing and treating heart, lung and blood diseases.

30 Sep 2010

Zyclara 3.75% more effective than cryotherapy alone in treatment of Actinic Keratoses: Study

Results from a randomized, double-blinded, placebo-controlled, multicentred study just published in the Journal of Drugs in Dermatology shows that treating Actinic Keratoses (AK) with imiquimod 3.75% (Zyclara®) following cryotherapy was more effective than cryotherapy alone in reducing total AK lesion count and achieving complete clearance of AK.

30 Sep 2010

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

Santarus, Inc. and Cosmo Pharmaceuticals S.p.A. today announced positive top-line results from the Phase III clinical study conducted in the U.S. and India to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo.

30 Sep 2010

Austrian AGES approves Baxter's PREFLUCEL vaccine for seasonal influenza

Baxter International Inc. today announced the first approval of PREFLUCEL by the Austrian Agency for Health and Food Safety (AGES). The vaccine was shown to be effective in preventing seasonal influenza and is indicated for prophylaxis of influenza in adults and the elderly. PREFLUCEL is manufactured using Baxter's proprietary advanced Vero cell technology.

From Baxter International Inc. 30 Sep 2010

UNC scientists receive grant to develop targeted delivery system for pancreatic cancer

A team of UNC scientists has received a five-year $2,308,800 grant from the National Cancer Institute's Cancer Nanotechnology Platform Partnerships to address the critical need for early diagnosis of and more effective treatments for pancreatic cancer.

30 Sep 2010

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Alnylam Pharmaceuticals, Inc. a leading RNAi therapeutics company announced today that it has published results in the American Journal of Respiratory and Critical Care Medicine from its double-blind, placebo-controlled, randomized Phase IIa study of ALN-RSV01 in lung transplant patients naturally infected with respiratory syncytial virus (RSV).

30 Sep 2010

Unique genetic markers point to patient response to SCV-07 treatment

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that researchers have identified two unique gene clusters that differentiated subjects who responded to treatment in the Company’s phase 2a proof of concept study of SCV-07 for the prevention of severe oral mucositis (OM; WHO grades 3-4) in patients with advanced head and neck cancer.

29 Sep 2010

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

Keryx Biopharmaceuticals, Inc. announced today the initiation of the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.

29 Sep 2010

Efficacy News and Research

Global phase IV study confirms efficacy of erlotinib in treatment of non-small cell lung cancer

FDA takes action against unapproved single-ingredient oral colchicine

DMC recommends continuation of enrollment in Celsion's Phase III ThermoDox HEAT study for primary liver cancer

Study demonstrates rufinamide therapy is effective in reducing partial seizure frequency

NIH awards Polymedix $986,000 to develop defensin mimetic antimicrobial compounds for oral candidiasis

Erchonia launches Zerona body-contouring laser in South East Asia

Repligen Corporation completes patient enrollment in RG2417 Phase 2b clinical trial

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

AVEO regains global rights for development, commercialization of AV-299 anti-HGF antibody candidate

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

Best P.A.D. Research Awards honor investigators for research on peripheral arterial disease

AccuPSA test for detecting prostate cancer recurrence

Mount Sinai receives contract to develop nanotechnology tools for diagnosing diseases

Zyclara 3.75% more effective than cryotherapy alone in treatment of Actinic Keratoses: Study

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

Austrian AGES approves Baxter's PREFLUCEL vaccine for seasonal influenza

UNC scientists receive grant to develop targeted delivery system for pancreatic cancer

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Unique genetic markers point to patient response to SCV-07 treatment

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

Latest News