Clinical Trial News and Research

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Vtesse receives FDA's Breakthrough Therapy designation for VTS-270

Vtesse, Inc. announced today that the U.S. Food and Drug Administration has granted its drug candidate, VTS-270 for treatment of Niemann-Pick Type C1 Disease (NPC), Breakthrough Therapy designation status. Both the FDA and the European Medicines Agency (EMA) had previously granted Orphan Drug status to VTS-270, which is currently in a pivotal Phase 2b/3 clinical trial.

6 Jan 2016

Sohn Conference Foundation awards $50,000 grant to support cutting-edge pediatric clinical trial in New York

The Sohn Conference Foundation today announced a $50,000 grant to support funding of a Phase 2 cutting-edge pediatric clinical trial from the Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC) now extending to New York City.

6 Jan 2016

Millendo signs license agreement, secures funding to test new drugs for treatment of endocrine disorders

Millendo Therapeutics, a University of Michigan startup company, announced an exclusive license agreement with AstraZeneca for the worldwide development and commercialization rights to test a new compound, MLE4901, for the treatment of polycystic ovary syndrome.

6 Jan 2016

SillaJen reports initiation of multinational randomized Phase 3 study of Pexa-Vec in HCC patients

SillaJen, Inc., a private, clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, has announced the initiation of a multinational randomized Phase 3 open-label study of its lead product candidate, Pexa-Vec (formerly JX-594), in patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC).

5 Jan 2016

Xcovery to present data from X-396 Phase l/ll trial in patients with ALK+ NSCLC at AACR-IASLC conference

Xcovery, a developer of targeted therapeutics for ALK+ non-small cell lung cancer (NSCLC) is scheduled to present January 6th, 2016 at the fourth annual AACR-IASLC International Joint Conference: Lung Cancer Translational Science from the Bench to the Clinic, at the Hard Rock Hotel, in San Diego, CA.

5 Jan 2016

FDA permits Sound Pharmaceuticals to start SPI-1005 clinical trial for treatment of Meniere's Disease

Sound Pharmaceuticals is pleased to announce that it began enrolling a clinical trial to test SPI-1005 in the treatment of Meniere's Disease (MD). MD or idiopathic endolymphatic hydrops is an inner ear disease that involves episodic vertigo, sensorineural hearing loss, and tinnitus.

5 Jan 2016

FDA grants Orphan Drug Designation to Ionis Pharmaceuticals' IONIS-HTT Rx for treatment of HD patients

Ionis Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to IONIS-HTTRx for the treatment of patients with Huntington's disease (HD).

5 Jan 2016

Ardelyx announces positive results from RDX022 clinical study for treatment of hyperkalemia

Ardelyx, Inc., a clinical-stage biopharmaceutical company focused on gastrointestinal and cardio-renal diseases, today announced positive results of an open label clinical study evaluating the pharmacodynamic (PD) activity of RDX022 in healthy adult volunteers.

5 Jan 2016

New phase III trial takes intravaginal DHEA a step closer to approval

A new phase III trial with positive results is taking intravaginal DHEA a step closer to governmental approval. The formulation could provide women who cannot or do not wish to use intravaginal estrogen with an effective vaginal alternative for easing vaginal symptoms and pain with sex after menopause.

5 Jan 2016

Researchers to undertake long-term clinical trial of artificial pancreas system for type 1 diabetes patients

Researchers will soon undertake one of the largest-ever long-term clinical trials of a system designed to help regulate blood sugar levels of individuals with type 1 diabetes mellitus. If the so-called artificial pancreas system performs in patients as hoped, it could lead to commercial trials and eventual regulatory approval in the United States and abroad.

5 Jan 2016

Bayer to present new research findings on Xofigo (radium Ra 223 dichloride) injection at ASCO GU 2016

Bayer announced today that new research findings on Xofigo (radium Ra 223 dichloride) injection will be presented at the 2016 Genitourinary Cancers Symposium of the American Society of Clinical Oncology (ASCO GU) taking place January 7 – 9 in San Francisco.

4 Jan 2016

NCCLC patients with KRAS-related gene mutations may benefit from triple therapy

Although the most common type of lung cancer - non-small cell lung cancer (NSCLC) - has recently seen major treatment advances in some genetic subtypes, other subtypes continue to evade effective treatment. (New therapies exist for NCCLC patients whose cancers harbor mutations in the ALK or EGFR genes, for example.)

4 Jan 2016

DATATRAK announces top ranking content in Clinical Leader Top 10 of 2015

DATATRAK International, Inc., the leader in developing cloud-based, unified dClinical technologies and delivering related services for the clinical trials industry, today announced top ranking content in the Clinical Leader Top 10 of 2015.

31 Dec 2015

Novel imaging-based method as accurate as current standard-of-care for breast cancer treatment

A new study shows that a novel imaging-based method for defining appropriateness of breast cancer treatment is as accurate as the current standard-of-care and could reduce the need for invasive tissue sampling. The results suggest that the method might lead to more optimal treatment of individual patients.

31 Dec 2015

Natural dietary supplement Arthrem significantly reduces pain and stiffness in osteoarthritis patients

New Zealand company Promisia Integrative Limited, announced today significant positive results from a clinical trial on their natural dietary supplement Arthrem. The results have been published in the December 2015 issue of Clinical Rheumatology, a prestigious international peer reviewed medical journal.

31 Dec 2015

NeoGenomics acquires Clarient and Clarient Diagnostic Services

NeoGenomics, Inc., a leading provider of cancer-focused genetic testing services, announced today that it has completed the acquisition of Clarient, Inc. and its wholly-owned subsidiary Clarient Diagnostic Services, Inc. Clarient, a provider of comprehensive cancer diagnostic testing to hospitals, physicians and the pharmaceutical industry, was a unit of GE Healthcare's Life Sciences business.

30 Dec 2015

Discovery Laboratories initiates AEROSURF phase 2b clinical trial in premature infants with RDS

Discovery Laboratories, Inc., a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that it has initiated its AEROSURF phase 2b clinical trial in premature infants 26 to 32 weeks gestational age (GA) receiving non-invasive nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS).

29 Dec 2015

Infusing small dose of cytokine can prevent or reverse diabetes-related kidney failure

Diabetes is the leading cause of kidney failure, and scientists have found that infusing just a small dose of a cytokine, thought to help cause that failure, can instead prevent or reverse it.

29 Dec 2015

Northwest Biotherapeutics closes registered direct placement of $12.6M

Northwest Biotherapeutics, a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced the closing of its previously-announced registered direct placement with healthcare focused institutional investors, for gross proceeds of $12.6 million on the terms previously announced.

26 Dec 2015

Azithromycin remains effective in treatment of urogenital chlamydia, confirms UAB study

In one of the most tightly controlled trials ever conducted of drugs used to treat sexually transmitted infections, researchers at the University of Alabama at Birmingham have confirmed that azithromycin remains effective in the treatment of urogenital chlamydia.

24 Dec 2015

Clinical Trial News and Research

Vtesse receives FDA's Breakthrough Therapy designation for VTS-270

Sohn Conference Foundation awards $50,000 grant to support cutting-edge pediatric clinical trial in New York

Millendo signs license agreement, secures funding to test new drugs for treatment of endocrine disorders

SillaJen reports initiation of multinational randomized Phase 3 study of Pexa-Vec in HCC patients

Xcovery to present data from X-396 Phase l/ll trial in patients with ALK+ NSCLC at AACR-IASLC conference

FDA permits Sound Pharmaceuticals to start SPI-1005 clinical trial for treatment of Meniere's Disease

FDA grants Orphan Drug Designation to Ionis Pharmaceuticals' IONIS-HTT Rx for treatment of HD patients

Ardelyx announces positive results from RDX022 clinical study for treatment of hyperkalemia

New phase III trial takes intravaginal DHEA a step closer to approval

Researchers to undertake long-term clinical trial of artificial pancreas system for type 1 diabetes patients

Bayer to present new research findings on Xofigo (radium Ra 223 dichloride) injection at ASCO GU 2016

NCCLC patients with KRAS-related gene mutations may benefit from triple therapy

DATATRAK announces top ranking content in Clinical Leader Top 10 of 2015

Novel imaging-based method as accurate as current standard-of-care for breast cancer treatment

Natural dietary supplement Arthrem significantly reduces pain and stiffness in osteoarthritis patients

NeoGenomics acquires Clarient and Clarient Diagnostic Services

Discovery Laboratories initiates AEROSURF phase 2b clinical trial in premature infants with RDS

Infusing small dose of cytokine can prevent or reverse diabetes-related kidney failure

Northwest Biotherapeutics closes registered direct placement of $12.6M

Azithromycin remains effective in treatment of urogenital chlamydia, confirms UAB study

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