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Advaxis receives India’s DCGI approval for ADXS11-001 Phase II clinical trial for cervical cancer

Advaxis, Inc.,, the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, has received formal permission from the Drugs Controller General India (DCGI) to conduct a Phase II clinical trial of ADXS11-001, the Company's flagship drug construct, among 110 women with advanced, metastatic cervical cancer that has progressed subsequent to treatment with cytotoxic therapy. 55 women will receive ADXS11-001 alone, 55 will receive a combined regimen of both ADXS11-001 and cytotoxic therapy.

4 Aug 2010

ZymoGenetics second-quarter net loss declines to $3.8 million

ZymoGenetics, Inc. today reported substantially improved financial results for the quarter ended June 30, 2010. For the second quarter of 2010, the company's net loss declined to $3.8 million, or $0.04 per share, a $23.2 million improvement from the $27.0 million loss, or $0.39 per share, reported for the second quarter of 2009. The improvement resulted from higher revenues as well as reduced operating expenses.

4 Aug 2010

Boston Scientific initiates enrollment in EVOLVE clinical trial of SYNERGY Coronary Stent

Boston Scientific Corporation today announced the start of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of its fourth-generation SYNERGY™ Coronary Stent. The first patient was enrolled by Ian Meredith, M.B.B.S., Ph.D., Professor and Director of MonashHeart, at Monash Medical Centre in Melbourne, Australia.

4 Aug 2010

Arena reports lower net loss of $28.80M for second-quarter 2010

Arena Pharmaceuticals, Inc. today reported financial results for the second quarter ended June 30, 2010, and recent developments, including the successful Pre-Approval Inspection, or PAI, of the company's Swiss drug product manufacturing facility by the US Food and Drug Administration, or FDA.

4 Aug 2010

Excaliard reports positive results from EXC 001 Phase 2 clinical trial for reducing scar severity

Excaliard Pharmaceuticals, Inc., today announced positive results from its Phase 2 clinical trial of EXC 001, a new chemical entity for reducing fibrosis. Results showed that EXC 001 treatment significantly reduced scar severity in subjects undergoing an elective abdominoplasty compared to placebo.

4 Aug 2010

AGA Medical second-quarter 2010 net sales increase 7.6% to $53.8 million

AGA Medical Holdings, Inc., a leading developer of interventional medical devices for the minimally invasive treatment of structural heart defects and vascular abnormalities, today reported financial results for the second quarter ended June 30, 2010.

3 Aug 2010

Curis reports net loss of $2.1 million for second-quarter 2010

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today reported its financial results for the second quarter ended June 30, 2010.

3 Aug 2010

Celsion reports net loss of $2.6M for second-quarter 2010

Celsion Corporation, a biotechnology drug development company, today announced financial results for the second quarter and six months ended June 30, 2010 and addressed the progression of the clinical trials of ThermoDox, Celsion's heat activated liposomal encapsulation of doxorubicin. ThermoDox is currently being evaluated in the Phase III HEAT trial for the treatment of hepatocellular carcinoma and in a Phase I/II trial for patients with recurrent chest wall breast cancer.

3 Aug 2010

First patient treated in Phase Ib expansion study of CUDC-101

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the first patient has been treated in a Phase Ib expansion study for CUDC-101 in patients with advanced head and neck, gastric, breast and liver cancers.

3 Aug 2010

Particles of iron oxide enhance tumor visibility through MRI

Tiny particles of iron oxide could become tools for simultaneous tumor imaging and treatment, because of their magnetic properties and toxic effects against brain cancer cells. In mice, researchers from Emory University School of Medicine have demonstrated how these particles can deliver antibodies to implanted brain tumors, while enhancing tumor visibility via magnetic resonance imaging (MRI).

3 Aug 2010

ArQule, Daiichi Sankyo announce decision to advance ARQ 197 into Phase 3 clinical trial for NSCLC

ArQule, Inc. and Daiichi Sankyo Co., Ltd. today announced that they will move forward with a Phase 3 clinical trial of ARQ 197, a small molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with non-small cell lung cancer (NSCLC). In connection with this decision, the sponsor company, Daiichi Sankyo, will file a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for a trial comparing ARQ 197 plus erlotinib against erlotinib plus placebo.

3 Aug 2010

Methods to boost neutralizing antibody may prevent HIV-1 transmission

Monkeys repeatedly immunized with a particular form the HIV-1 envelope glycoprotein generated antibodies capable of neutralizing diverse strains of HIV-1, according to a paper published online in the Journal of Experimental Medicine on August 2.

3 Aug 2010

Researchers discover manipulation of microRNA-29a shows potential of novel IBS treatment

A possible cause of irritable bowel syndrome has been traced to a small piece of RNA that blocks a substance protecting the colon membrane, leading to hostile conditions that can produce diarrhea, bloating and chronic abdominal pain.New research shows that this RNA segment sends signals that stop the activity of the gene that produces glutamine, an amino acid. Previous research has linked a shortage of glutamine in the gut with the seepage of toxins and bacteria through the intestinal wall, irritating nerves and creating disease symptoms.

3 Aug 2010

BioMarin provides update on PEG-PAL Phase 2 clinical study for phenylketonuria

BioMarin Pharmaceutical Inc. announced today an update in the Phase 2 clinical study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of phenylketonuria (PKU). Data reported in this announcement reflect preliminary results as of July 23, 2010. Complete top-line results are expected in the fourth quarter of 2010.

3 Aug 2010

BioMarin reports $0.5 million GAAP net loss for second-quarter 2010

BioMarin Pharmaceutical Inc. today announced financial results for the second quarter of 2010. GAAP net loss was $0.5 million ($0.01 per diluted share) for the second quarter of 2010, compared to GAAP net income of $1.3 million ($0.01 per diluted share) for the second quarter of 2009. Non-GAAP net income was $8.6 million ($0.08 per diluted share) for the second quarter of 2010, compared to non-GAAP net income of $9.0 million ($0.09 per diluted share) for the second quarter of 2009.

3 Aug 2010

BioMarin completes BMN 195 Phase 1 clinical trial for Duchenne muscular dystrophy

BioMarin Pharmaceutical Inc. announced today that it has completed the Phase 1 clinical study of BMN 195, a small molecule utrophin up-regulator, for the treatment of Duchenne muscular dystrophy (DMD). The Phase 1 clinical trial was a single-center, double-blind, placebo-controlled, single-dose escalation study followed by a multiple-dose escalation study in healthy volunteers.

3 Aug 2010

VertiFlex enrolls 150 patients in Superion Interspinous Spacer IDE clinical trial

VertiFlex, Inc., a leading innovator of minimally invasive and motion preserving spinal surgery technologies, today announced that 150 patients have been enrolled in its pivotal IDE clinical trial of the Superion Interspinous Spacer (ISS).

3 Aug 2010

Patrys secures funding of up to A$15 million to support advancement of clinical products

Patrys Limited (ASX: PAB), a company focused on the development of natural human antibodies for the treatment of cancer, announced today that it has secured up to A$15 million in funding.

3 Aug 2010

Study: hGH linked to PROLOR's CTP technology increases half-life, bioactivity

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today reported publication of a preclinical study in the current on-line edition of the journal Endocrinology showing that human growth hormone (hGH) linked to PROLOR's carboxyl terminal peptide (CTP) technology has significantly increased half-life and bioactivity compared to commercially available hGH. The publication, which is authored by PROLOR researchers, will also be included in the September print edition of Endocrinology.

2 Aug 2010

Lexicon acquires equity shares of Symphony Icon Holdings

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today announced that it has exercised a restructured purchase option under its drug development financing collaboration with Symphony Icon Holdings LLC and acquired all the equity of Symphony Icon, Inc., thereby reacquiring all rights to LX1031, LX1032, LX1033 and the other drug programs subject to the collaboration.

2 Aug 2010

Clinical Trial News and Research

Advaxis receives India’s DCGI approval for ADXS11-001 Phase II clinical trial for cervical cancer

ZymoGenetics second-quarter net loss declines to $3.8 million

Boston Scientific initiates enrollment in EVOLVE clinical trial of SYNERGY Coronary Stent

Arena reports lower net loss of $28.80M for second-quarter 2010

Excaliard reports positive results from EXC 001 Phase 2 clinical trial for reducing scar severity

AGA Medical second-quarter 2010 net sales increase 7.6% to $53.8 million

Curis reports net loss of $2.1 million for second-quarter 2010

Celsion reports net loss of $2.6M for second-quarter 2010

First patient treated in Phase Ib expansion study of CUDC-101

Particles of iron oxide enhance tumor visibility through MRI

ArQule, Daiichi Sankyo announce decision to advance ARQ 197 into Phase 3 clinical trial for NSCLC

Methods to boost neutralizing antibody may prevent HIV-1 transmission

Researchers discover manipulation of microRNA-29a shows potential of novel IBS treatment

BioMarin provides update on PEG-PAL Phase 2 clinical study for phenylketonuria

BioMarin reports $0.5 million GAAP net loss for second-quarter 2010

BioMarin completes BMN 195 Phase 1 clinical trial for Duchenne muscular dystrophy

VertiFlex enrolls 150 patients in Superion Interspinous Spacer IDE clinical trial

Patrys secures funding of up to A$15 million to support advancement of clinical products

Study: hGH linked to PROLOR's CTP technology increases half-life, bioactivity

Lexicon acquires equity shares of Symphony Icon Holdings

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

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