Clinical Intelligence

Bionovo initiates enrollment for phase III Menerba trial

Thursday, October 27, 2011 11:34 AM

Bionovo has started enrollment for the phase III pivotal clinical trial evaluating the safety and efficacy of two doses of Menerba (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes.

More... »

FDA, ADVENTRX reach agreement for ANX-514 trial

Thursday, October 27, 2011 11:03 AM

ADVENTRX Pharmaceuticals met with the FDA to discuss a single clinical study to support approval of ANX-514 (docetaxel for injectable emulsion), a detergent-free reformulation of Taxotere.

More... »

FDA approves generic olanzapine injection

Thursday, October 27, 2011 10:40 AM

The FDA has approved INNOPHARMA’s Abbreviated New Drug Application (ANDA) for olanzapine injection (the generic equivalent of ZyprexaR injection).

More... »

Nerualstem completes phase Ia MDD trial

Thursday, October 27, 2011 10:29 AM

Neuralstem has completed phase Ia in the ongoing safety trial to test its neuroregenerative small molecule drug, NSI-189, in the treatment of major depressive disorder (MDD).  Phase Ia tested the drug in healthy volunteers for safety and tolerability. Phase Ib, which the company expects to commence later this year, will test the safety and tolerability of NSI-189 in depressed patients.

More... »

S*BIO to initiate phase III myelofibrosis trial

Tuesday, October 25, 2011 11:32 AM

S*BIO plans to initiate a global phase III clinical program of its novel JAK2 inhibitor pacritinib (SB1518), in the first half of 2012 to further demonstrate its activity and tolerability for the treatment of myelofibrosis (MF). The company is actively exploring partnering opportunities for the advancement of its leading JAK2 program.

More... »

APEPTICO successfully completes phase I AP301 trial

Tuesday, October 25, 2011 11:19 AM

APEPTICO has completed a phase I clinical trial for its pulmonary sodium ion channel activator AP301. The orally inhaled drug candidate was safe and well-tolerated by all study participants. AP301 is being developed for the prevention and treatment of oedematous respiratory failure in patients suffering from lung infection, lung injury and lung transplantation.

More... »

Oncothyreon advances to phase II of PX-866 trial

Thursday, October 20, 2011 11:19 AM

Oncothyreon it has initiated the phase II portion of  its ongoing phase I/II trial of PX-866 in combination with the chemotherapeutic agent  docetaxel (Taxotere) following successful completion of the phase I dose escalation portion  of the study. PX-866 is a small molecule compound designed to inhibit  the activity of phosphatidylinositol-3-kinase (PI-3K), a component of  an important cell survival signaling pathway.

More... »

Genticel completes patient recruitment for ProCervix trial

Wednesday, October 19, 2011 11:31 AM

Genticel has completed the recruitment of all patients participating in its phase one clinical trial with a liquid formulation of ProCervix, its candidate therapeutic HPV vaccine designed for adult women already infected with human papillomavirus (HPV) genotype 16 or 18.

More... »

Roche’s Herceptin phase III trial shows positive results

Tuesday, October 18, 2011 09:45 AM

Halozyme Therapeutics has reported that the phase III HannaH trial, conducted by Roche, showed that women with HER2-positive early breast cancer who received a new, investigational subcutaneous (SC) injection of Herceptin (trastuzumab), experienced comparable results to Herceptin given as an intravenous (IV) infusion. The SC administration takes around 5 minutes to administer whereas the IV formulation (the current standard) takes around 30 minutes to infuse. Since the subcutaneous administration is an injection under the skin it may allow patients to spend less time in hospital receiving their treatment versus the intravenous method. The ready to use formulation may also significantly reduce pharmacy time as no medicine preparation time is required.

More... »

ChemoCentryx initiates phase II CCX168 trial

Monday, October 17, 2011 11:49 AM

ChemoCentryx has initiated a phase II clinical trial for CCX168, an orally-administered small molecule for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), a disease which can lead to renal and pulmonary failure.  CCX168 specifically targets the C5a receptor (C5aR), a potent pro-inflammatory mediator that is involved in AAV as well as several other autoimmune diseases.  This randomized, double-blind, placebo-controlled trial will evaluate the safety and tolerability of CCX168 in patients with ANCA-associated renal vasculitis while assessing the potential for reducing or eliminating the use of corticosteroids in these patients.

More... »