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International study to test effectiveness of celecoxib in preventing growth of precancerous polyps

Rush University Medical Center is testing whether celecoxib, known by its brand name Celebrex, can help prevent the growth of precancerous polyps that form in the colon, rectum and small intestine of children with an inheritable genetic disease called familial adenomatous polyposis.

14 May 2010

DMC recommends Celsion to continue enrollment in ThermoDox clinical study for primary liver cancer

Celsion Corporation announced today that after reviewing data from 294 patients including data from 12 Japanese patients enrolled in the pivotal Phase III ThermoDox® clinical study (HEAT Study) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

14 May 2010

Jennerex to present key data on JX-594 Phase 1 dose escalation clinical study at ASGCT Annual Meeting

Jennerex, Inc., a clinical-stage cancer biotherapeutics company, today announced that key data from its JX-594 intravenous administration Phase 1 dose escalation clinical study will be presented at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting taking place May 19-22, 2010, in Washington DC.

14 May 2010

Phase IIb trail results of epratuzumab in lupus patients to be presented at EULAR 2010

Immunomedics, Inc., a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that clinical trial results on epratuzumab, the anti-CD22 humanized monoclonal antibody licensed to UCB SA, Brussels, for autoimmune disease indications, from the Phase IIb study in patients with lupus, will be presented in four posters sessions and one published abstract.

14 May 2010

Transdel Pharmaceuticals reports lower net loss of $0.9 million for first-quarter 2010

Transdel Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced financial results for the quarter ended March 31, 2010. The Company also highlighted recent achievements.

14 May 2010

RegeneRx Biopharmaceuticals awarded $3M federal grant to develop heart attack drug

RegeneRx Biopharmaceuticals, Inc. announced today that it has been awarded a $3 million grant from the National Institutes of Health's National Heart, Lung and Blood Institute to support and accelerate the clinical development of its novel product candidate RGN-352, an injectable formulation of the novel therapeutic peptide Thymosin beta 4, or Tβ4, for patients who have suffered an acute myocardial infarction, or AMI, commonly known as a heart attack.

14 May 2010

Derma Sciences first-quarter net sales up 23% to $12,844,382

Derma Sciences, Inc., a specialty medical device/pharmaceutical company focused on advanced wound care, reported financial and operating results today for the three months ended March 31, 2010.

14 May 2010

Chimerix commences first-in-human study of CMX157 for HIV

Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced the commencement of a first-in-human study of CMX157, a novel lipid conjugate of the nucleotide tenofovir with in vitro activity against both tenofovir-sensitive and tenofovir-resistant human immunodeficiency virus (HIV). CMX157 has the potential to increase efficacy and decrease toxicity as compared to tenofovir, and may enable the creation of new 'one pill, once-a-day', fixed-dose combination regimens for the treatment of HIV infection.

14 May 2010

Rexahn Pharmaceuticals announces Phase IIb clinical trial of Zoraxel for ED

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it will initiate a Phase IIb clinical trial for ZoraxelTM in the treatment of erectile dysfunction (ED).

13 May 2010

ARYx Therapeutics decreases first-quarter net loss to $6.4 million

ARYx Therapeutics, Inc. today reported results of operations and provided an update on its business activities for the first quarter ended March 31, 2010.

13 May 2010

Repligen files IND for Phase 1 study of RG2833 selective HDAC-3 inhibitor for Friedreich's ataxia

Repligen Corporation announced today that it has filed an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) for a Phase 1 study of RG2833, a selective histone deacetylase 3 (HDAC-3) inhibitor. This is a double-blind, single ascending dose, Phase 1 study in healthy volunteers to evaluate the pharmacokinetic and safety profile of RG2833 in up to 40 subjects.

13 May 2010

Genta first-quarter net loss increases to $166.6 million

Genta Incorporated today announced financial results for the quarter ended March 31, 2010.

13 May 2010

Aeterna Zentaris posts net loss of $5.9 million for first-quarter 2010

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrinology, today reported financial and operating results as at and for the three months ended March 31, 2010.

13 May 2010

Trubion Pharmaceuticals to present promising data from Phase 1 studies of SBI-087, SBI-087

Trubion Pharmaceuticals, Inc. today announced the acceptance of two Phase 1 data presentations on SBI-087 (PF-05230895) at the 2010 annual congress of the European League Against Rheumatism (EULAR) in Rome, Italy. Presentations will include promising data from a Phase 1 study of SBI-087 for the treatment of rheumatoid arthritis (RA) and a Phase 1 study of SBI-087 for the treatment of systemic lupus erythematosus (SLE). Copies of both abstracts are available at http://www.eular.org. SBI-087 is Trubion's next-generation CD20-directed small modular immunopharmaceutical (SMIP™) product candidate and is being developed in collaboration with Pfizer.

13 May 2010

Amarin reports cash balance of $44 million for first-quarter 2010

Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported selected financial results for the fiscal quarter ended March 31, 2010 and provided a progress update of the Company's ANCHOR and MARINE trials, the two pivotal Phase 3 clinical trials of its lead product candidate AMR101 for treating elevated triglyceride levels.

13 May 2010

Regeneron Pharmaceuticals provides update on REGN727, REGN475 antibody product candidates

Regeneron Pharmaceuticals, Inc. (REGN) provided an update on two antibody product candidates in its pipeline and scheduled its first Investor Day to be held in New York City on July 15, 2010. Both product candidates, REGN727 (SAR236553) and, REGN475 (SAR164877) are being developed with sanofi-aventis under a global, strategic collaboration to discover, develop, and commercialize fully human antibodies.

13 May 2010

CTI to conduct phase II study of pixantrone in patients with HER2-negative breast cancer

Cell Therapeutics, Inc. (CTI) today announced an agreement with the North Central Cancer Treatment Group (NCCTG) to conduct a phase II study of pixantrone in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens.

13 May 2010

Resverlogix' Phase 2 ASSERT trial dosing complete ahead of schedule

Resverlogix is pleased to announce that the Phase 2 ASSERT clinical trial for its lead drug, RVX-208, a small molecule therapy for the treatment of atherosclerosis has now completed dosing. "The completion of dosing for our Phase 2 ASSERT trial, five months ahead of schedule and without any alterations to the dose levels of the three drug receiving cohorts, is another major step forward in the development of this important cardiovascular drug.

13 May 2010

Avexa halts HIV drug trials

Melbourne-based biotech Avexa has announced the closure of its lead HIV program for apricitabine after failing to attract a licensing partner for the Phase III drug.

12 May 2010

GTC Biotherapeutics reports lower total net loss of $7.7M for first-quarter 2010

GTC Biotherapeutics, Inc. today reported its financial results for the first fiscal quarter ended April 4, 2010. The total net loss for the first quarter was $7.7 million, or $0.26 per share, compared to $10.4 million, or $0.99 per share, for the first quarter of 2009.

12 May 2010

Drug Trial News

International study to test effectiveness of celecoxib in preventing growth of precancerous polyps

DMC recommends Celsion to continue enrollment in ThermoDox clinical study for primary liver cancer

Jennerex to present key data on JX-594 Phase 1 dose escalation clinical study at ASGCT Annual Meeting

Phase IIb trail results of epratuzumab in lupus patients to be presented at EULAR 2010

Transdel Pharmaceuticals reports lower net loss of $0.9 million for first-quarter 2010

RegeneRx Biopharmaceuticals awarded $3M federal grant to develop heart attack drug

Derma Sciences first-quarter net sales up 23% to $12,844,382

Chimerix commences first-in-human study of CMX157 for HIV

Rexahn Pharmaceuticals announces Phase IIb clinical trial of Zoraxel for ED

ARYx Therapeutics decreases first-quarter net loss to $6.4 million

Repligen files IND for Phase 1 study of RG2833 selective HDAC-3 inhibitor for Friedreich's ataxia

Genta first-quarter net loss increases to $166.6 million

Aeterna Zentaris posts net loss of $5.9 million for first-quarter 2010

Trubion Pharmaceuticals to present promising data from Phase 1 studies of SBI-087, SBI-087

Amarin reports cash balance of $44 million for first-quarter 2010

Regeneron Pharmaceuticals provides update on REGN727, REGN475 antibody product candidates

CTI to conduct phase II study of pixantrone in patients with HER2-negative breast cancer

Resverlogix' Phase 2 ASSERT trial dosing complete ahead of schedule

Avexa halts HIV drug trials

GTC Biotherapeutics reports lower total net loss of $7.7M for first-quarter 2010

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