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Oramed Pharmaceuticals submits study protocol to FDA for Phase IIb trial of ORMD-0801

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has submitted the study protocol for the company's Phase IIb trial of ORMD-0801, its oral insulin capsule, to the U.S. Food and Drug Administration.

30 Jun 2015

BiondVax’s universal influenza vaccine meets safety and immunogenicity endpoints

BiondVax Pharmaceuticals Ltd. today announced positive preliminary results from its BVX-006 Phase II clinical trial of M-001, BiondVax's candidate for a universal influenza vaccine.

30 Jun 2015

Aeterna Zentaris recruits patients for ZoptEC Phase 3 study in women with advanced endometrial cancer

Aeterna Zentaris Inc. today announced it has reached its goal of recruiting 500 patients for its pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) clinical study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer.

30 Jun 2015

Axovant Sciences accepts two presentations at Alzheimer's Association International Conference 2015

Axovant Sciences Ltd., a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced the acceptance of two presentations at the Alzheimer's Association International Conference 2015 (AAIC) being held in Washington, D.C. from July 18-23, 2015.

30 Jun 2015

$FDA accepts TxCell’s IND application for Ovasave for treatment of refractory Crohn’s disease$

FDA accepts TxCell’s IND application for Ovasave for treatment of refractory Crohn’s disease

TxCell SA, a biotechnology company developing innovative, personalized T cell immunotherapies using antigen specific regulatory T-cells for severe chronic inflammatory and autoimmune diseases, announces today that the United States Food and Drug Administration has accepted TxCell’s Investigational New Drug application for the company’s lead product, Ovasave(R), currently in a phase 2b clinical trial for the treatment of patients with refractory Crohn’s disease.

30 Jun 2015

PharmaMar begins PM1183 phase III study in patients with platinum-resistant ovarian cancer

PharmaMar announced today the start of a phase III study for the anticancer agent PM1183 in patients with platinum-resistant ovarian cancer (PROC). Once study objectives are met, the CORAIL trial (NCT02421588) will be used to support the regulatory filing of PM1183 as treatment for this indication.

30 Jun 2015

Clinical data demonstrates safe administration of Pexa-Vec in patients with metastatic colorectal cancer

SillaJen, Inc., a private clinical-stage biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, today announced a publication of data demonstrating that in a Phase Ib trial of Pexa-Vec, patients received multiple bi-weekly doses of its lead product Pexa-Vec, representing the first report of multiple intravenous administrations of an oncolytic vaccinia.

29 Jun 2015

Synthetic Biologics announces initiation of SYN-010 Phase 2 clinical trial for treatment of IBS-C

Synthetic Biologics, Inc., a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, reported the initiation of a Phase 2 clinical trial of its proprietary SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C).

29 Jun 2015

Neuralstem's HK532-IGF-1 neural stem cells therapy for Alzheimer's disease presented at ISSCR Annual Meeting

Neuralstem, Inc., a biopharmaceutical company using neural stem cell technology to develop small molecule and cell therapy treatments for central nervous system diseases, announced that the poster "Human Neural Stem Cells Expressing IGF-1: A Novel Cellular Therapy for Alzheimer's Disease" was presented yesterday at the International Society for Stem Cell Research (ISSCR) Annual Meeting in Stockholm, Sweden.

27 Jun 2015

CTCA at Western begins Phase Ib/II trial of new immunotherapy treatment for cancer patients

Cancer Treatment Centers of America at Western Regional Medical Center in Goodyear, Arizona, has begun a new Phase Ib/II clinical trial using a new immunotherapy treatment for patients with advanced kidney, non-small cell lung cancer, pancreatic cancer and colorectal carcinoma.

27 Jun 2015

Human intervention trial results show that Comvita’s Olive Leaf Extract improves cardiovascular function

Comvita, the global natural health products company, today announces the results of a human intervention trial demonstrating for the first time a positive effect between the intake of Comvita’s fresh Olive Leaf Extract and positive short-term changes in measures associated with cardiovascular disease.

27 Jun 2015

Weight loss, combined with vitamin D supplements, reduces chronic inflammation

For the first time, researchers at Fred Hutchinson Cancer Research Center have found that weight loss, in combination with vitamin D supplementation, has a greater effect on reducing chronic inflammation than weight loss alone. Chronic inflammation is known to contribute to the development and progression of several diseases, including some cancers.

26 Jun 2015

Aeterna Zentaris selects Ergomed to manage Phase 3 clinical study of Macrilen

Aeterna Zentaris Inc. announced today that it has executed a definitive agreement with Ergomed PLC, pursuant to which Ergomed will manage the new, confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency ("AGHD").

25 Jun 2015

Immune Pharmaceuticals begins bertilimumab Phase II clinical trials in Bullous Pemphigoid, Ulcerative Colitis

Immune Pharmaceuticals Inc. announced today that it has initiated its Phase II Ulcerative Colitis clinical trial and is scheduled to initiate its Phase II Bullous Pemphigoid clinical trial on July 1, 2015. Study Initiation is the training of hospital staff to allow for patient screening and immediate patient enrollment into the clinical trial upon selection.

25 Jun 2015

CSL Behring presents Phase I/III rVIII-SingleChain hemophilia A data at 2015 ISTH Congress

CSL Behring today presented data from a Phase I/III study on the efficacy and safety of its novel investigational recombinant factor VIII single chain in adolescents and adults with hemophilia A during a late breaking abstract session at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress.

25 Jun 2015

TxCell’s pilot manufacturing facility activities put on temporary partial hold

TxCell SA, a biotechnology company developing innovative, personalized T cell immunotherapies using antigen specific regulatory T-cells for severe chronic inflammatory and autoimmune diseases, announces today that it has temporarily put its pilot manufacturing facility activities at Besançon, France on partial hold.

24 Jun 2015

Novogen’s chemotherapy drug Anisina proves as effective anti-cancer agent in animals

US-Australian drug discovery company, Novogen Limited announced today that its candidate cytotoxic chemotherapy drug, Anisina, has proved an effective anti-cancer agent in animals, the result of which it now has been fast-tracked by the Company to come into the clinic.

24 Jun 2015

Alnylam presents positive Phase 1 ALN-AT3 trial results in hemophilia at ISTH 2015 Congress

Additional study results from 12 hemophilia A and B subjects demonstrated that subcutaneous administration of ALN-AT3 achieved potent and dose-dependent knockdown of AT of up to 86%. AT knockdown was highly durable, with effects lasting over two months after the last dose, supporting further evaluation of a once-monthly subcutaneous dose regimen.

24 Jun 2015

Understanding of tumor biology opens new opportunities to conduct clinical trial for thoracic tumors

Our understanding of tumor biology has improved and continues to expand at a rapid pace, and this has opened new opportunities for cancer clinical trials, particularly for thoracic tumors. The identification and molecular alterations in the cancer and the possibility to specifically and selectively target them, has dramatically improved the treatment efficacy in patients with lung cancer.

24 Jun 2015

Perle Bioscience announces enrollment for Phase 3 trial of combination therapy in type 1 diabetics

Perle Bioscience, Inc. announces enrollment for the Insulin Independence Trial (IIT). This trial is the first and only Phase 3 trial to test a combination therapy in type 1 diabetics.

24 Jun 2015

Drug Trial News

Oramed Pharmaceuticals submits study protocol to FDA for Phase IIb trial of ORMD-0801

BiondVax’s universal influenza vaccine meets safety and immunogenicity endpoints

Aeterna Zentaris recruits patients for ZoptEC Phase 3 study in women with advanced endometrial cancer

Axovant Sciences accepts two presentations at Alzheimer's Association International Conference 2015

FDA accepts TxCell’s IND application for Ovasave for treatment of refractory Crohn’s disease

PharmaMar begins PM1183 phase III study in patients with platinum-resistant ovarian cancer

Clinical data demonstrates safe administration of Pexa-Vec in patients with metastatic colorectal cancer

Synthetic Biologics announces initiation of SYN-010 Phase 2 clinical trial for treatment of IBS-C

Neuralstem's HK532-IGF-1 neural stem cells therapy for Alzheimer's disease presented at ISSCR Annual Meeting

CTCA at Western begins Phase Ib/II trial of new immunotherapy treatment for cancer patients

Human intervention trial results show that Comvita’s Olive Leaf Extract improves cardiovascular function

Weight loss, combined with vitamin D supplements, reduces chronic inflammation

Aeterna Zentaris selects Ergomed to manage Phase 3 clinical study of Macrilen

Immune Pharmaceuticals begins bertilimumab Phase II clinical trials in Bullous Pemphigoid, Ulcerative Colitis

CSL Behring presents Phase I/III rVIII-SingleChain hemophilia A data at 2015 ISTH Congress

TxCell’s pilot manufacturing facility activities put on temporary partial hold

Novogen’s chemotherapy drug Anisina proves as effective anti-cancer agent in animals

Alnylam presents positive Phase 1 ALN-AT3 trial results in hemophilia at ISTH 2015 Congress

Understanding of tumor biology opens new opportunities to conduct clinical trial for thoracic tumors

Perle Bioscience announces enrollment for Phase 3 trial of combination therapy in type 1 diabetics

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