January's top stories: Pfizer's lung cancer drug fails two trials and first patients dosed with ADXS-HPV

Pfizer's lung cancer drug dacomitinib fails in two Phase III trials, while Advaxis doses first patient with ADXS-HPV in Phase I/II head and neck cancer trial. Drugdevelopment-technology.com wraps-up the key headlines from January 2014.


HPV

Pfizer's lung cancer drug dacomitinib fails in two Phase III trials

lung

Pfizer released top-line results from two randomised Phase III trials of the irreversible pan-HER kinase inhibitor 'dacomitinib' for the treatment of patients with advanced non-small cell lung cancer (NSCLC).

Both trials, ARCHER 1009 and NCIC CTG BR.26, evaluated dacomitinib in populations of previously treated patients with advanced NSCLC.

The ARCHER 1009 trial included patients previously treated with second/third line chemotherapy. It did not meet its objective of showing improvement in progression-free survival (PFS) when compared with the EGFR inhibitor erlotinib.

Advaxis doses first patient with ADXS-HPV in Phase I/II head and neck cancer trial

HPV

US-based clinical-stage biotechnology firm Advaxis dosed the first patient with ADXS-HPV immunotherapy in a Phase I/II 'window of opportunity' trial for the treatment of patients diagnosed with HPV-associated head and neck cancer.

Icahn School of Medicine at Mount Sinai is carrying out the trial, under which patients will be given ADXS-HPV immunotherapy during the 'window' of time between initial diagnosis and minimally invasive transoral robotic surgery (TORS) to remove their tumours.

ADXS-HPV is the company's lead immunotherapy product candidate for the treatment of HPV-associated cancers and is currently under investigation in three HPV-associated cancers: cervical cancer, head and neck cancer, and anal cancer.

Intellect Neurosciences reports positive data from preclinical studies of TauC3 monoclonal antibody

antibody

US-based biopharmaceutical firm Intellect Neurosciences (ILNS) achieved proof of concept in a pre-clinical Alzheimer's model for its TauC3 monoclonal antibody, indicating its potential to be disease modifying.

The pre-clinical study was carried out in collaboration with the University of California Chancellor's professor and chair, Neurobiology and Behavior School of Biological Sciences and director, Institute for Memory Impairments and Neurological Disorders Dr. Frank LaFerla, as well as Dr. Kim Green and his team.

Data secured from the pre-clinical study demonstrated that the TauC3 antibody effectively engaged the target and reduced certain phosphorylated pathological forms of Tau, indicating that the treatment with the peripherally administered antibody had an effect on the brain and is able to be disease modifying.

Cell Therapeutics announces completion of patient enrolment in Phase III ovarian cancer study

ovarian cancer

Cell Therapeutics has announced the completion of patient enrolment in the GOG-0212 Phase III clinical trial of investigational agent paclitaxel poliglumex (Opaxio) as maintenance therapy in ovarian cancer.

The trial is being managed and carried out by Gynecologic Oncology Group (GOG), which is one of the National Cancer Institute's (NCI) funded cooperative cancer research groups focused on the study of gynaecologic malignancies.

Opaxio (paclitaxel poliglumex, CT-2103), is an investigational, biologically improved chemotherapeutic that links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer, which results in a new chemical entity.

Cubist files clinical trial application in Netherlands to start human studies of new antibiotic

antibiotic

US-based biopharmaceutical firm Cubist Pharmaceuticals filed a clinical trial application (CTA) with the Dutch Competent Authority and Ethics Committee to start a first-in-human trial of CB-618 in the Netherlands.

CB-618 is a novel, broad-spectrum beta-lactamase inhibitor (BLI) investigational compound, discovered by Cubist.

The company said that based on in vitro studies, the BLI compound has been shown to increase the spectrum of activity of certain beta-lactam antibiotics.

OncoMed starts Phase Ib study of combination therapy in pancreatic cancer patients

pancreatic

OncoMed Pharmaceuticals initiated a multi-centre Phase Ib clinical trial of its first-in-class Wnt-pathway-targeting decoy receptor OMP-54F28 (Fzd8-Fc) with nab-paclitaxel (Abraxane) and gemcitabine in pancreatic cancer.

The trial is the first of three Phase Ib trials for OMP-54F28 scheduled to commence patient enrolment in the next few months as part of the company's deal with Bayer Pharma.

The Phase Ib trial is a dose escalation study of OMP-54F28 in combination with nab-paclitaxel and gemcitabine to treat patients with first-line Stage IV pancreatic cancer.

TauRx Therapeutics adds 35 new centres for Alzheimer's drug clinical trials

Alzheimer

TauRx Therapeutics announced the addition of 35 new clinical research centres across the US for its Alzheimer's disease drug clinical trials.

The company is currently evaluating LMTX in Phase III clinical trials for Alzheimer's disease. With the addition of new clinical research centres, more patients suffering from mild or moderate Alzheimer's will have an opportunity to see if they qualify for participation in the company's clinical trials.

With the expansion of study centres across the US, patients from Bennington, Vermont; Farmington Hills, Michigan; Waukesha, Wisconsin; and Creve Coeur, Missouri can also participate in the studies.

Eisai announces availability of Fycompa for adjunctive treatment of epilepsy in US

Eisai

The US subsidiary of Tokyo-based Eisai announced that its epilepsy drug Fycompa (perampanel) will be available to eligible patients by prescription in the US, beginning 6 January.

Fycompa, an oral medication, is the first and only FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist.

It is offered as an adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy age 12 years and older.

Scientists discover solution for preventing human stem cell rejection


Scientists from the University of California San Diego found an effective way to prevent the rejection of grafts derived from human embryonic stem cells by the human immune system.

The immune rejection of human embryonic stem cells is a major problem, limiting the development of human stem cell therapies.

Using a new humanised laboratory mouse, the scientists have now found that one combination of two immune suppressing molecules worked perfectly to protect cells derived from human embryonic stem cells from immune rejection.

Cytodyn gets FDA approval to begin patient screening in Phase IIB study of HIV drug

HIV

US-based biotechnology firm CytoDyn received approval from the US Food and Drug Administration (FDA) to start patient screening for a Phase IIb study of PRO 140, a monoclonal CCR5 antibody, to treat patients with human immunodeficiency virus type 1 (HIV-1).

Drexel University College of Medicine is conducting the multicentre, randomised, double-blind, placebo-controlled Phase IIb clinical trial, which is being funded by grants from the National Institutes of Health (NIH).

The Phase IIb study design involves observed systemic, long-acting, anti-HIV treatment with PRO 140 as an adjunct to an optimised oral antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented poor adherence to the previous antiretroviral regimen.