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Cedars-Sinai's ICT-107 doubles median survival of patients with malignant brain tumor

An experimental immune-based therapy more than doubled median survival of patients diagnosed with the most aggressive malignant brain tumor, Cedars-Sinai Medical Center researchers reported in Cancer Immunology, Immunotherapy, published online Aug. 3.

16 Aug 2012

Genocea commences GEN-003 Phase 1/2a study in moderate-to-severe HSV-2 infection

Genocea Biosciences announced today that it has initiated a Phase 1/2a clinical study with its lead candidate, GEN-003. GEN-003 is an investigational vaccine designed to stimulate T cell and B cell immune responses to potentially reduce the frequency and severity of clinical outbreaks associated with moderate-to-severe Herpes Simplex Virus type 2 (HSV-2) infection.

16 Aug 2012

3SBio files APX001 IND application with SFDA in China

Apexigen, Inc., an emerging biopharmaceutical company focused on the discovery and development of monoclonal antibody therapeutics, announced today that its partner, 3SBio [SSRX] of Shenyang, China, filed an Investigational New Drug (IND) application for APX001, also known as SSS07, with the State Food and Drug Administration (SFDA) in China.

16 Aug 2012

Recognizing the role of international partnerships in global health

"When you're dealing with a global public health crisis, having an international presence isn't just advisable -- it is imperative," Margaret McGlynn, president and CEO of the International AIDS Vaccine Initiative (IAVI), writes in this post in USAID's "Impact" blog, adding, "That's why the [IAVI], in partnership with USAID, has worked diligently over the past several years to establish itself as a truly global non-profit partner."

15 Aug 2012

Proteonomix receives FDA approval to commence UMK-121 Phase 1 trial in end-stage liver disease

Proteonomix, Inc., a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, today announced that the U.S. Food and Drug Administration (FDA) has granted permission to the Company to initiate a Phase 1 clinical trial with its mobilization technology UMK-121.

15 Aug 2012

FDA requests Biovest to conduct second Phase III trial of BV301 for NHL

Biovest International, Inc., a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., today announced that it conducted a formal clinical guidance meeting with the U.S. FDA to determine the most expeditious U.S. registration pathway for BiovaxID, its personalized cancer vaccine for the consolidation treatment of follicular non-Hodgkin's lymphoma.

15 Aug 2012

Spectrum Pharmaceuticals initiates enrollment in Phase 2b ozarelix study for prostate cancer

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced initiation of patient enrollment in the second part of the Company's randomized Phase 2 clinical program of ozarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, in men with prostate cancer for whom hormonal treatment is indicated.

15 Aug 2012

Compounds in cocoa may help decrease blood pressure

Compounds in cocoa may help to reduce blood pressure, according to a new systematic review in The Cochrane Library. The researchers reviewed evidence from short-term trials in which participants were given dark chocolate or cocoa powder daily and found that their blood pressure dropped slightly compared to a control group.

15 Aug 2012

Latrepiridine reduces level of at least two neurodegeneration-related proteins in mice

The second of two studies on latrepirdine, recently published in Molecular Psychiatry, demonstrates new potential for the compound in the treatment of Alzheimer's disease, Parkinson's disease, sleep disorders, and other neurodegenerative conditions.

14 Aug 2012

CBIS initiates CS-TATI-1 GMP development plan

Cannabis Science (CBIS), a pioneering U.S. Biotech Company developing pharmaceutical to meet global public health challenges is pleased to announce the initiation of GMP development plan for CS-TATI-1 with the initial production of CS-TATI-1 to be performed in Colorado under C-GMP conditions evaluated by the FDA for initial human studies to treat HIV associated Kaposi Sarcoma.

13 Aug 2012

Meritage commences OBS Phase 2 clinical trial for eosinophilic esophagitis

Meritage Pharma, Inc. announced that it has initiated a Phase 2 clinical trial to evaluate oral budesonide suspension (OBS) for the treatment of adolescents and young adults with eosinophilic esophagitis (EoE), an allergic inflammatory condition of the esophagus. EoE is a chronic disease characterized by symptoms related to esophageal dysfunction and eosinophil-predominant inflammation.

13 Aug 2012

Positive results from Acorda post-marketing commitment study of dalfampridine-ER for MS

Acorda Therapeutics, Inc. today announced top line results from a post-marketing commitment study evaluating a 5mg dose of dalfampridine-ER to improve walking in people with multiple sclerosis. The study failed to confirm efficacy of the 5mg dose.

13 Aug 2012

NIH awards ADi Phase II SBIR grant to scan Plasmodium falciparum proteome for protective antigens

Antigen Discovery, Inc. today announced that it has received a Phase II Small Business Innovation and Research award from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. The three-year award, totaling approximately $ 2.5 million, is a continuation of a Phase I SBIR grant to scan the Plasmodium falciparum proteome for protective antigens.

13 Aug 2012

Orally effective FluCide anti-influenza drug candidate

NanoViricides, Inc. announced today that an anti-influenza drug candidate under its FluCide program is effective when given orally. The Company has received information that a FluCide drug candidate designed for oral administration has shown very strong efficacy in corresponding animal studies.

13 Aug 2012

Study assesses gender differences in the efficacy of antiretroviral treatment

Women comprise nearly half of the HIV-infected population worldwide, but these 15.5 million women tend to be under-represented in clinical trials of anti-HIV drug therapies. The U.S. Food and Drug Administration (FDA) has created a database from 40 clinical studies to assess gender differences in the efficacy of antiretroviral treatments.

12 Aug 2012

Combination of novel drug therapy and PSA test can effectively detect prostate cancer

Researchers have successfully developed and tested a new prostate cancer screening method that uses the combined power of a novel drug therapy and changes in PSA levels over time to identify men with a high PSA who are more likely to have aggressive prostate cancer despite negative biopsies.

12 Aug 2012

Daily aspirin use may reduce overall cancer mortality

Daily aspirin usage is associated with lower overall cancer mortality, but the association may be smaller than what was previously believed, according to a study published August 10 in the Journal of the National Cancer Institute.

12 Aug 2012

Combination therapy does not change safety and efficacy relationship of TORISEL for advanced RCC

Pfizer Inc. announced that the Phase 3 INTORACT trial (B1771006), evaluating the combination of bevacizumab plus TORISEL (temsirolimus) compared with bevacizumab plus interferon-alfa-2a (IFN-α-2a) in the first-line treatment of patients with advanced renal cell carcinoma (RCC) across risk groups, did not meet its primary endpoint of superiority in extending progression free survival (PFS) in the study population.

12 Aug 2012

PharmAthene receives clinical hold order from FDA for SparVax rPA anthrax vaccine program

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today it has received notification from the U.S. Food and Drug Administration (FDA) that its SparVax rPA anthrax vaccine program has been placed on clinical hold.

12 Aug 2012

Herceptin® could potentially be delivered via a standard injection

A new method of delivering a commonly used breast cancer drug could result in considerably less time spent in hospital for some women undergoing breast cancer treatment, according to the results of a Phase 3 trial published Online First in The Lancet Oncology.

9 Aug 2012

Drug Trial News

Cedars-Sinai's ICT-107 doubles median survival of patients with malignant brain tumor

Genocea commences GEN-003 Phase 1/2a study in moderate-to-severe HSV-2 infection

3SBio files APX001 IND application with SFDA in China

Recognizing the role of international partnerships in global health

Proteonomix receives FDA approval to commence UMK-121 Phase 1 trial in end-stage liver disease

FDA requests Biovest to conduct second Phase III trial of BV301 for NHL

Spectrum Pharmaceuticals initiates enrollment in Phase 2b ozarelix study for prostate cancer

Compounds in cocoa may help decrease blood pressure

Latrepiridine reduces level of at least two neurodegeneration-related proteins in mice

CBIS initiates CS-TATI-1 GMP development plan

Meritage commences OBS Phase 2 clinical trial for eosinophilic esophagitis

Positive results from Acorda post-marketing commitment study of dalfampridine-ER for MS

NIH awards ADi Phase II SBIR grant to scan Plasmodium falciparum proteome for protective antigens

Orally effective FluCide anti-influenza drug candidate

Study assesses gender differences in the efficacy of antiretroviral treatment

Combination of novel drug therapy and PSA test can effectively detect prostate cancer

Daily aspirin use may reduce overall cancer mortality

Combination therapy does not change safety and efficacy relationship of TORISEL for advanced RCC

PharmAthene receives clinical hold order from FDA for SparVax rPA anthrax vaccine program

Herceptin® could potentially be delivered via a standard injection

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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