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CONRAD congratulates Global iPrEx study team for HIV prevention trial

CONRAD is pleased to join in congratulating the Global iPrEx study team for their successful trial of oral tenofovir (TDF) with emtricitabine (FTC) for HIV prevention.

24 Nov 2010

XenoPort receives grant from Michael J. Fox Foundation to support Parkinson's disease therapies

XenoPort, Inc. announced today that it has been awarded a grant from The Michael J. Fox Foundation for Parkinson's Research to support a preclinical study of the efficacy and safety of a novel, orally administered prodrug of acamprosate in reducing L-Dopa induced dyskinesias (LID) in a pre-clinical model of Parkinson's disease.

24 Nov 2010

ViiV Healthcare awards $20 million to Idenix for GSK2248761 clinical milestone

Idenix Pharmaceuticals, Inc, a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the Company will receive a payment of $20 million from the ViiV Healthcare Company for the achievement of a clinical milestone relating to GSK2248761.

23 Nov 2010

CEL-SCI holds clinical investigator meeting for Multikine Phase III clinical trial in head, neck cancer

CEL-SCI Corporation today announced that the Company held a clinical investigator meeting during the week of November 14th for its Phase III clinical trial of Multikine®, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer.

23 Nov 2010

DoD awards Regenicin and Lonza $18 million to develop PermaDerm for severe burns

The U.S. Department of Defense recently awarded more than $18 million in funding to a unit of Lonza Group, Ltd. for the development and commercialization of the therapeutic candidate, PermaDerm™ for the treatment of severe burns among U.S. troops and civilians. The funding was announced at a conference celebrating advancements in regenerative medicine on November 9th in Walkersville, MD.

23 Nov 2010

Compugen announces development of Protein Family Members Discovery Platform

Compugen Ltd. announced today the development of its Protein Family Members Discovery Platform, designed for the discovery of novel protein members belonging to various known and clinically important protein families.

23 Nov 2010

Preclinical trial shows Chimerix’s CMX001 inhibits HSV replication

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced that data demonstrating preclinical efficacy of Chimerix's lead antiviral compound CMX001 against herpes simplex virus (HSV) as well as its ability to penetrate the blood-brain barrier was published in the November 15, 2010 issue of The Journal of Infectious Diseases.

23 Nov 2010

Hemispherx announces publication of Ampligen Phase III data in Journal of Applied Research

Hemispherx Biopharma, Inc., announced the publication of a peer-reviewed article providing new data on Ampligen [rintatolimod; poly(I)·poly(C12,U)], an experimental therapeutic in Phase III clinical testing, in the current issue of The Journal of Applied Research.

23 Nov 2010

Apricus files protocol of PrevOnco Phase 3 clinical trial for FDA SPA program

Apricus Biosciences, Inc., today announced that it has filed the protocol for a proposed Phase 3 clinical trial of PrevOnco, its proprietary treatment for hepatocellular carcinoma (liver cancer), with the U.S. Food and Drug Administration (FDA).

23 Nov 2010

BioCancell raises $5.1 million by excess demand in public offering

Success for BioCancell Therapeutics Inc. Excess demand in BioCancell's public offering of shares and warrants generated immediate proceeds of $5.1 million, 18% above its stated minimal fundraising goal of $4.3 million.

23 Nov 2010

Winston announces Phase II study results of Dolorac for chronic migraine at Lazard Conference

Winston Pharmaceuticals, Inc. a specialty pharmaceutical company focused on developing and commercializing novel pain management therapies, announced the results of its Phase II study on its patented Dolorac Nasal Solution (doxepin 0.4%) for prophylaxis of chronic migraine at the Lazard Capital Markets 7th Annual Healthcare Conference in New York.

22 Nov 2010

Stem cell trial for eye disease receives FDA approval

The second clinical trial involving stem cells from human embryonic cells has received the go-ahead. The news came from Advanced Cell Technology Inc. this Monday. The company announced that the U.S. Food and Drug Administration has cleared the way for its Phase I/II trial of retinal cells for patients with Stargardt’s macular dystrophy, a childhood version of macular degeneration.

22 Nov 2010

Omthera reaches agreement with FDA on SPA for Epanova Phase III trial in patients with very high triglycerides

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of its planned Phase III registration clinical trial of Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega 3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

22 Nov 2010

Neurocrine announces results from elagolix Phase II Daisy PETAL study in endometriosis

Neurocrine Biosciences, Inc. today announced results from the open-label portion of the six month Phase II Daisy PETAL study (901 study) using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

22 Nov 2010

FDA grants ACT clearance for Phase I/II clinical trial of hESC derived retinal cells in patients with SMD

Advanced Cell Technology, Inc. announced today that the US Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to immediately initiate a Phase I/II multicenter clinical trial using retinal cells derived from human embryonic stem cells (hESCs) to treat patients with Stargardt's Macular Dystrophy (SMD), one of the most common forms of juvenile macular degeneration in the world. The decision removes the clinical hold that the FDA had placed on the trial.

22 Nov 2010

Mimetogen initiates MIM-D3 Phase II clinical trial for dry eye disease

Mimetogen Pharmaceuticals Inc., a clinical-stage biotechnology company focused on developing novel small molecule compounds that mimic the effects of neurotrophins, today announced that it has initiated the first human clinical trial evaluating MIM-D3, a mimetic of nerve growth factor (NGF), in a Phase II clinical trial in patients with moderate to severe dry eye disease. MIM-D3 is a small cyclic peptidomimetic of NGF, a naturally occurring protein in the eye that is responsible for the maintenance of corneal nerves and epithelium, mucin and tear production.

22 Nov 2010

$S*BIO begins SB1317 Phase 1 clinical trial in patients with advanced/refractory hematologic malignancies$

S*BIO begins SB1317 Phase 1 clinical trial in patients with advanced/refractory hematologic malignancies

S*BIO Pte Ltd today announced that a fourth novel, potential best-in-class compound discovered and developed by S*BIO has entered a Phase 1 clinical trial. The initiation of the study for S*BIO's oral multi-kinase inhibitor, SB1317 or TG02, in patients with advanced/refractory hematologic malignancies has triggered a payment from S*BIO's development and commercialization partner for the program, Tragara Pharmaceuticals.

22 Nov 2010

Interim results from H.P. Acthar Gel study in patients with advanced diabetic nephropathy

On November 20 at the American Society of Nephrology 43rd Annual Meeting, interim results presented from an ongoing, randomized prospective study conducted independently by James A. Tumlin, MD, at the University of Tennessee College of Medicine Chattanooga indicated that 9 of 15 patients (60%) with advanced diabetic nephropathy who are currently enrolled in the study and have completed or are still undergoing a six month course of treatment with H.P. Acthar ® Gel have exhibited a clinically significant decrease in proteinuria and achieved stabilized renal function.

22 Nov 2010

Acthar Gel may be a viable treatment option for resistant nephrotic syndrome

On November 20 at the American Society of Nephrology 43rd Annual Meeting, Columbia University Assistant Professor of Clinical Medicine Andrew Bomback, MD, presented results from a patient case series assessing the potential therapeutic value of H.P. Acthar Gel (repository corticotropin injection) as a treatment for patients with nephrotic syndrome, a kidney disorder characterized by excessive loss of urinary protein.

22 Nov 2010

Stealth Peptides introduces Bendavia clinical candidate at AHA Scientific Sessions

Stealth Peptides, a privately held biopharmaceutical company developing innovative mitochondrial therapies for diseases with significant unmet medical needs, introduced its lead clinical candidate, Bendavia, a novel compound that targets the mitochondrion, at the 2010 American Heart Association's (AHA) Scientific Sessions, Resuscitation Science Symposium.

22 Nov 2010

Drug Trial News

CONRAD congratulates Global iPrEx study team for HIV prevention trial

XenoPort receives grant from Michael J. Fox Foundation to support Parkinson's disease therapies

ViiV Healthcare awards $20 million to Idenix for GSK2248761 clinical milestone

CEL-SCI holds clinical investigator meeting for Multikine Phase III clinical trial in head, neck cancer

DoD awards Regenicin and Lonza $18 million to develop PermaDerm for severe burns

Compugen announces development of Protein Family Members Discovery Platform

Preclinical trial shows Chimerix’s CMX001 inhibits HSV replication

Hemispherx announces publication of Ampligen Phase III data in Journal of Applied Research

Apricus files protocol of PrevOnco Phase 3 clinical trial for FDA SPA program

BioCancell raises $5.1 million by excess demand in public offering

Winston announces Phase II study results of Dolorac for chronic migraine at Lazard Conference

Stem cell trial for eye disease receives FDA approval

Omthera reaches agreement with FDA on SPA for Epanova Phase III trial in patients with very high triglycerides

Neurocrine announces results from elagolix Phase II Daisy PETAL study in endometriosis

FDA grants ACT clearance for Phase I/II clinical trial of hESC derived retinal cells in patients with SMD

Mimetogen initiates MIM-D3 Phase II clinical trial for dry eye disease

S*BIO begins SB1317 Phase 1 clinical trial in patients with advanced/refractory hematologic malignancies

Interim results from H.P. Acthar Gel study in patients with advanced diabetic nephropathy

Acthar Gel may be a viable treatment option for resistant nephrotic syndrome

Stealth Peptides introduces Bendavia clinical candidate at AHA Scientific Sessions

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