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FDA approves CSC’s Phase II clinical trial for cancer immunotherapy in women with ovarian cancer

California Stem Cell, Inc. (CSC) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's application to begin a Phase II clinical trial exploring the potential of a patient-specific cancer immunotherapy in women with Stage III or IV ovarian, fallopian tube or primary peritoneal cancer.

19 Feb 2014

CytoDyn submits PRO 140 Phase 2b trial protocol to FDA for treatment substitution in HIV patients

CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today that the Company has submitted a Phase 2b clinical trial protocol, for its lead product candidate, PRO 140, to the U.S. Food and Drug Administration for treatment substitution in patients with Human Immunodeficiency Virus (HIV).

19 Feb 2014

Viamet announces positive interim results from VT-1161 Phase 2 study in patients with AVVC

Viamet Pharmaceuticals Inc. today reported positive interim results from an ongoing Phase 2 study of VT-1161, the Company's novel oral antifungal compound, in patients with moderate to severe acute vulvovaginal candidiasis (AVVC). This study is intended as a precursor to a Phase 2b study in patients with recurrent vulvovaginal candidiasis (RVVC).

18 Feb 2014

Commonly-used HIV drug kills HPV that leads to cervical cancer

A commonly-used HIV drug has been shown to kill-off the human papilloma virus (HPV) that leads to cervical cancer in a world-first clinical trial led by The University of Manchester with Kenyatta National Hospital in Nairobi.

17 Feb 2014

Altrient C improves skin firmness and elasticity by 32.7%

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17 Feb 2014

NIAID awards Soligenix SBIR grant to further develop SGX943 for treatment of melioidosis

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that the National Institute of Allergy and Infectious Diseases has awarded Soligenix a Small Business Innovation Research grant to support further preclinical development of SGX943 as a treatment for melioidosis.

14 Feb 2014

FAST-MAG clinical trial finds that magnesium does not improve stroke-related disability

In the first study of its kind, a consortium led by UCLA physicians found that giving stroke patients intravenous magnesium within an hour of symptom onset does not improve stroke outcomes, according to research presented today at the American Stroke Association's International Stroke Conference.

14 Feb 2014

Aerpio Therapeutics doses first patient in AKB-9778 Phase 2 trial for diabetic macular edema treatment

Aerpio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on advancing innovative therapies for vascular diseases, today announced that it has dosed the first patient in a Phase 2 trial evaluating AKB-9778, a Tie2 activator, alone and in combination with ranibizumab (Lucentis) for the treatment of diabetic macular edema (DME). AKB-9778 is a first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPβ) that activates the Tie2 pathway to promote vascular stability, preventing abnormal blood vessel growth and vascular leak.

13 Feb 2014

Ario Pharma begins XEN-0501 Phase IIa study for treatment persistent cough in COPD patients

Ario Pharma Ltd, the Cambridge biopharmaceutical company developing innovative new approaches to treat respiratory disease, announced today that it has commenced a Phase IIa study of its TRPV1 antagonist, XEN-0501, for the treatment and prevention of cough in patients with chronic obstructive pulmonary disease (COPD). Persistent cough in COPD and other respiratory conditions present as a huge unmet medical need, with novel therapies urgently needed to improve the quality of life of patients.

11 Feb 2014

Alba Therapeutics reports positive results from Phase IIb trial of larazotide acetate for CeD treatment

Alba Therapeutics Corporation announced today the positive results of their Phase IIb trial evaluating its investigational product, larazotide acetate, a first-in-class tight junction regulator, intended for the treatment of patients with celiac disease (CeD).

11 Feb 2014

Omeros announces additional positive data from OMS824 Phase 1 program

Omeros Corporation today announced additional positive data from its Phase 1 program for OMS824, the lead compound in Omeros' phosphodiesterase 10 (PDE10) program. This clinical trial evaluated the extent to which OMS824 binds to PDE10, an enzyme expressed in the region of the brain that has been linked to a wide range of diseases that affect cognition. In the latest cohort enrolled in this trial, OMS824 achieved a high of approximately 70‑percent engagement at PDE10 without evidence of extrapyramidal symptoms (EPS).

11 Feb 2014

Targacept completes patient recruitment in TC-5214 Phase 2b study for treatment of overactive bladder

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced that it has completed recruitment of patients in its Phase 2b clinical study of TC-5214 as a treatment for overactive bladder (OAB).

10 Feb 2014

Sarepta Therapeutics reports positive safety results from AVI-7288 Phase I study

Sarepta Therapeutics, Inc., a developer of innovative RNA-based therapeutics, today announced positive safety results from a Phase I multiple ascending dose study of AVI-7288 in healthy volunteers.

10 Feb 2014

e-Therapeutics initiates Phase I clinical trial with oral formulation of ETS2101 anti-cancer compound

e-Therapeutics plc (AIM:ETX) announced today that it has dosed the first healthy volunteer in a newly initiated Phase I clinical trial with an oral formulation of its anti-cancer compound, ETS2101.

10 Feb 2014

Ipsen’s phase III clinical trial evaluating Decapeptyl in patients with prostate cancer meets primary endpoints

Ipsen today announced that the phase III clinical trial evaluating Decapeptyl (triptorelin pamoate) 11.25 mg administered subcutaneously in patients with locally advanced or metastatic prostate cancer has met its primary endpoints.

10 Feb 2014

Spinifex announces results of Phase 2 clinical trial of EMA401 in postherpetic neuralgia

Spinifex Pharmaceuticals, an Australian pain drug development company, today announces that The Lancet has published the results of its Phase 2 clinical trial of its lead candidate, EMA401, in postherpetic neuralgia (PHN).

5 Feb 2014

Fraunhofer USA receives FDA clearance for IND malaria TBV that targets Pfs25 antigen

Fraunhofer USA Center for Molecular Biotechnology (FhCMB) announced today that clearance was obtained from the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND), Fraunhofer's plant-derived malaria transmission-blocking vaccine (TBV), which targets the Pfs25 antigen, to proceed into the clinic in a Phase 1 safety and immunogenicity study.

5 Feb 2014

Randomized trial shows injecting anesthetic near nerve bundle reduces troublesome hot flashes

Injecting a little anesthetic near a nerve bundle in the neck cut troublesome hot flashes significantly, shows a new randomized, controlled trial published online today in Menopause, the journal of The North American Menopause Society (NAMS).

5 Feb 2014

Furiex announces top-line results of Phase III clinical trials of eluxadoline in treatment of IBS-d

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced top-line results indicating the company's two pivotal Phase III clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d) met both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) formally agreed-upon primary endpoints of composite response based on simultaneous improvements in stool consistency and abdominal pain.

4 Feb 2014

Pfizer’s palbociclib Phase 2 trial achieves primary endpoint in patients with advanced breast cancer

Pfizer Inc. today announced that the randomized Phase 2 trial [PALOMA-1] of palbociclib achieved its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the combination of palbociclib and letrozole compared with letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or newly diagnosed metastatic breast cancer.

4 Feb 2014

Drug Trial News

FDA approves CSC’s Phase II clinical trial for cancer immunotherapy in women with ovarian cancer

CytoDyn submits PRO 140 Phase 2b trial protocol to FDA for treatment substitution in HIV patients

Viamet announces positive interim results from VT-1161 Phase 2 study in patients with AVVC

Commonly-used HIV drug kills HPV that leads to cervical cancer

Altrient C improves skin firmness and elasticity by 32.7%

NIAID awards Soligenix SBIR grant to further develop SGX943 for treatment of melioidosis

FAST-MAG clinical trial finds that magnesium does not improve stroke-related disability

Aerpio Therapeutics doses first patient in AKB-9778 Phase 2 trial for diabetic macular edema treatment

Ario Pharma begins XEN-0501 Phase IIa study for treatment persistent cough in COPD patients

Alba Therapeutics reports positive results from Phase IIb trial of larazotide acetate for CeD treatment

Omeros announces additional positive data from OMS824 Phase 1 program

Targacept completes patient recruitment in TC-5214 Phase 2b study for treatment of overactive bladder

Sarepta Therapeutics reports positive safety results from AVI-7288 Phase I study

e-Therapeutics initiates Phase I clinical trial with oral formulation of ETS2101 anti-cancer compound

Ipsen’s phase III clinical trial evaluating Decapeptyl in patients with prostate cancer meets primary endpoints

Spinifex announces results of Phase 2 clinical trial of EMA401 in postherpetic neuralgia

Fraunhofer USA receives FDA clearance for IND malaria TBV that targets Pfs25 antigen

Randomized trial shows injecting anesthetic near nerve bundle reduces troublesome hot flashes

Furiex announces top-line results of Phase III clinical trials of eluxadoline in treatment of IBS-d

Pfizer’s palbociclib Phase 2 trial achieves primary endpoint in patients with advanced breast cancer

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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