Clinical Trial News and Research

RSS

American Medical News examines clinical trials outsourcing

American Medical News examines the ethical considerations of outsourcing pharmaceutical clinical trials to developing countries. The article highlights how it is less expensive for a drug company to conduct a trial in India, where it runs about $2,000 to track a patient through a trial, compared to the cost in the U.S., which is "10 times more."

9 Sep 2009

University of California receives $3.5 million grant from NIDA for AIDS vaccine research

The National Institute on Drug Abuse (NIDA) has awarded a $3.5 million grant for AIDS vaccine research to Phillip Berman, professor and chair of biomolecular engineering at the Jack Baskin School of Engineering at the University of California, Santa Cruz.

9 Sep 2009

INSPIRE Phase I/IIa study data to be presented at ICAAC

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that data from an interim analysis of its INSPIRE Phase I/IIa study of HIV-infected patients with low CD4 T cell counts treated with a three injection cycle of the Company’s investigative immune-modulator, recombinant human Interleukin-7 (CYT107), will be presented during an oral late breaker session at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), to be held September 12-15, 2009, in San Francisco, CA.

9 Sep 2009

Synexus on track to double its clinical trial capacity in South Africa, opens two new research centres in Pretoria

Manchester-based Synexus, the world’s largest multi-national company dedicated to the recruitment and running of clinical trials, celebrated the first phase of its South African expansion programme in Pretoria today.

From AES - Accelerated Enrollment Solutions 9 Sep 2009

Patient enrollment completed in Phase II clinical trial of bavituximab

Peregrine Pharmaceuticals, Inc. today reported completion of patient enrollment in its Phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel in advanced breast cancer patients.

9 Sep 2009

Gabapentin improves sleep quality in menopausal women

Gabapentin, a drug initially used to treat seizures, improves sleep quality in menopausal women with hot flashes, University of Rochester Medical Center researchers report online and in the September issue of the Journal of Women's Health.

9 Sep 2009

BioElectronics to file for FDA pre-marketing clearance of its ActiPatch Therapy product

BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announces its schedule for filing with the U.S. government's Food and Drug Administration for 510(K) pre-marketing clearance for its ActiPatch® Therapy and RecoveryRx™ products. In these applications BioElectronics will seek over-the-counter clearance of its ActiPatch Therapy product for indications for the treatment of heel and foot pain, and for pain relief relative to general musculoskeletal complaints.

9 Sep 2009

Amarillo Biosciences is midway in Phase 2 clinical study of interferon against H1N1

Amarillo Biosciences, Inc. (OTCBB: AMAR) today announced that a Phase 2 study of orally administered interferon-alpha for the prevention of influenza and winter colds has reached the midway point. The study in Perth, Australia achieved full target enrollment of 200 subjects and 98% of the subjects remain on study drug. Subjects in the study are receiving a lozenge containing interferon-alpha or a matching placebo once a day for 16 weeks.

9 Sep 2009

Helix Biopharma announces the closure of private placement of 6,625,000 units

Helix BioPharma Corp. (TSX, FSE: "HBP"; OTCQX: "HXBPF") today announced that it has closed its previously announced private placement of 6,625,000 units at $2.05 per unit.

9 Sep 2009

PKCiota oncogene essential for lung cancer stem cell proliferation

Scientists at the Mayo Clinic campus in Florida have found that the lung cancer oncogene PKCiota is necessary for the proliferation of lung cancer stem cells. These stem cells are rare and powerful master cells that manufacture the other cells that make up lung tumors and are resistant to chemotherapy treatment.

9 Sep 2009

New procedure for transapical valve replacement minimizes trauma and blood loss

Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced today the first successful clinical use of its new lower-profile Ascendra 2 transapical delivery system, designed to benefit both patients and physicians by minimizing trauma and blood loss, and facilitating transcatheter heart valve delivery and deployment.

9 Sep 2009

Cytrx to submit revised protocol for arimoclomol Phase IIb clinical trial

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced its intention during the 2009 fourth quarter to submit a revised protocol for its planned Phase IIb clinical trial for arimoclomol as a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The decision follows receipt of an anticipated written letter from the U.S.

8 Sep 2009

Protalix receives orphan drug designation for prGCD

Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that the FDA’s Office of Orphan Products Development has granted orphan drug designation to prGCD, the Company’s proprietary plant cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.

8 Sep 2009

Fourth-quarter and fiscal year end 2009 results announced by Palatin Technologies

Palatin Technologies, Inc. (NYSE Amex: PTN) today announced results for its fourth quarter and fiscal year ended June 30, 2009. For the year ended June 30, 2009, total revenues were $11.4 million, compared to $11.5 million for year ended June 30, 2008. Palatin's net loss for the year ended June 30, 2009 was $4.8 million, or $(0.06) per basic and diluted share, compared to a net loss of $14.4 million, or $(0.17) per basic and diluted share, for the year ended June 30, 2008.

8 Sep 2009

DOR's Phase 1/2 clinical trial for prevention of radiation enteritis receives NIH grant

DOR BioPharma, Inc. (OTC Bulletin Board: DORB) (DOR or the Company), a late-stage biotechnology company, announced today that the National Institutes of Health (NIH) has awarded DOR a Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 1/2 clinical trial evaluating DOR201, a time-release formulation of oral beclomethasone dipropionate (oral BDP), for the prevention of acute radiation enteritis.

8 Sep 2009

Patient enrollment for Phase 2b study of PRX302 completed by Protox Therapeutics

Protox Therapeutics Inc. (TSX: PRX), a leader in the development of receptor targeted fusion proteins, today announced that it has completed patient enrollment in its multi-centre, double-blinded, placebo controlled Phase 2b study of PRX302 (study name: TRIUMPH) in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide.

8 Sep 2009

Third human clinical trial of LigoCyte's norovirus vaccine started

LigoCyte Pharmaceuticals, Inc. announced today that it has initiated its third human clinical trial of its norovirus vaccine. The Phase I/II study will assess safety and immunogenicity associated with LigoCyte's investigational, nasally-delivered, dry powder vaccine in healthy adults. The study will also assess potential protection against clinical symptoms of norovirus infection by including a live virus challenge of subjects that have received either the vaccine or placebo.

8 Sep 2009

Lupus Foundation of America takes steps to address shortage of participants for clinical trial

It has been more than 50 years since the U.S. Food and Drug Administration (FDA) last approved a new medicine specifically for lupus – when Dwight D. Eisenhower was president. Existing treatments have been "borrowed" from other disorders and the risk/benefit ratio of these treatments is far from optimal. However, hope is on the horizon.

8 Sep 2009

Recruitment for the Phase IIa clinical trial to assess CNS 7056 sedative completed by PAION

The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today announces the successful completion of the Recruitment for the Phase IIa clinical trial assessing the new short-acting intravenous anesthetic/sedative CNS 7056 in patients undergoing endoscopy of the upper gastrointestinal tract.

8 Sep 2009

$geneX combined with Mesenchymal stem cells for treating fracture$

geneX combined with Mesenchymal stem cells for treating fracture

Professor James B. Richardson of the Robert Jones and Agnes Hunt Orthopaedic Hospital, Oswestry, UK has been carrying out pioneering work combining geneX with selected and culture expanded Mesenchymal stem cells to treat fracture non-unions.

7 Sep 2009

Clinical Trial News and Research

American Medical News examines clinical trials outsourcing

University of California receives $3.5 million grant from NIDA for AIDS vaccine research

INSPIRE Phase I/IIa study data to be presented at ICAAC

Synexus on track to double its clinical trial capacity in South Africa, opens two new research centres in Pretoria

Patient enrollment completed in Phase II clinical trial of bavituximab

Gabapentin improves sleep quality in menopausal women

BioElectronics to file for FDA pre-marketing clearance of its ActiPatch Therapy product

Amarillo Biosciences is midway in Phase 2 clinical study of interferon against H1N1

Helix Biopharma announces the closure of private placement of 6,625,000 units

PKCiota oncogene essential for lung cancer stem cell proliferation

New procedure for transapical valve replacement minimizes trauma and blood loss

Cytrx to submit revised protocol for arimoclomol Phase IIb clinical trial

Protalix receives orphan drug designation for prGCD

Fourth-quarter and fiscal year end 2009 results announced by Palatin Technologies

DOR's Phase 1/2 clinical trial for prevention of radiation enteritis receives NIH grant

Patient enrollment for Phase 2b study of PRX302 completed by Protox Therapeutics

Third human clinical trial of LigoCyte's norovirus vaccine started

Lupus Foundation of America takes steps to address shortage of participants for clinical trial

Recruitment for the Phase IIa clinical trial to assess CNS 7056 sedative completed by PAION

geneX combined with Mesenchymal stem cells for treating fracture

eBook: Using iPSCs models for human disease research and drug discovery eBook

Latest eBooks

Industry Focus eBook - Microbiome (1st edition)

Industry Focus eBook - Cell biology (5th edition)

Advancing degrader and proximity-based drug development

Driving innovation in Korean drug development

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

Applications Engineer