May's top stories: Amgen’s skin cancer trial, Novartis COPD Phase III study

Amgen’s Talimogene Laherparepvec's (T-VEC) Phase III OPTiM study demonstrated durable treatment response in patients of skin cancer trial and Novartis has presented positive results from two pivotal COPD Phase III clinical trial programmes. Drugdevelopment-technology.com wraps-up key headlines from May 2015.


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Amgen's T-VEC demonstrates durable treatment response in patients of skin cancer trial

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Researchers from a clinical trial revealed that a genetically engineered herpes virus can block the progression of skin cancer by killing cancer cells and enhance the activity of the immune system against tumours.

Amgen has announced the primary results of the Talimogene Laherparepvec's (T-VEC) Phase III OPTiM study, which was carried out at The Institute of Cancer Research (ICR) of London and The Royal Marsden NHS Foundation Trust in the UK.

T-VEC is a modified form of herpes simplex virus type-1 that multiplies inside cancer cells and bursts them from within and is genetically engineered to produce a molecule called GM-CSF that stimulates the immune system to attack and destroy the tumour.

GSK, Emergent and Oxford University commence trial of Ebola vaccine candidates

glaxo ebola

British drugmaker GlaxoSmithKline (GSK), Emergent BioSolutions and the University of Oxford started a new Phase I study of Ebola vaccine candidates.

The trial will study the use of a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ) as a prime-boost to GSK's Chimp Adenovirus type 3 (ChAd3) Ebola vaccine candidate.

The trial obtained regulatory approval from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA), and is being carried out by clinical research group of professor Adrian Hill of the Jenner Institute at Oxford.

Novartis presents data of two US COPD Phase III programmes

novartis copd

Swiss drugmaker Novartis presented positive results from two pivotal Phase III clinical trial programmes for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

According to the company, the Expedition, including Flight I, II and III studies and Gem programmes reached their primary and secondary endpoints.

Novartis Pharmaceuticals development global head Vasant Narasimhan said: "These data confirm that QVA149 significantly improves lung function, breathlessness, and most importantly, overall quality of life."

Outside of the US, QVA149 is marketed as Ultibro Breezhaler 110/50mcg and NVA237 is marketed as Seebri Breezhaler 50mcg.

In the Gem I and II, NVA237 when administered twice-daily showed better improvements in lung function (FEV1 AUC0-12h) at week 12 in moderate-to-severe COPD patients compared to placebo.

New skin cancer drug trial commences at The Royal Marsden in UK

The trial of new skin cancer drug, BAL3833/CCT3833, started at The Royal Marsden NHS Foundation Trust in the UK.

The first patient has been treated with a new panRAF inhibitor, which is a new type of drug under development to solve the problem of drug resistance in advanced skin cancer and multiple other cancer types.

PanRAF inhibitors are said to block several key cancer-causing proteins at once including BRAF, which are responsible for about half of all melanomas.

ViiV Healthcare commences Phase III programme of dual HIV maintenance therapy

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GlaxoSmithKline and Pfizer joint venture firm ViiV Healthcare began a Phase III trial programme to assess the safety and efficacy of dolutegravir (Tivicay) and rilpivirine (Edurant) as maintenance therapy for adult patients with HIV.

The Phase III programme includes two replicate studies, SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797).

The studies will assess 48 week viral suppression with a two drug regimen combining an integrase inhibitor (dolutegravir) and a non-nucleoside reverse transcriptase inhibitor (rilpivirine) in patients with HIV who have already achieved viral suppression with a three drug regimen.

Theravance reports positive Phase II trial data of velusetrag for gastroparesis

Theravance Biopharma presented the positive data from a Phase II trial of velusetrag (TD-5108), an investigational drug being developed to treat patients with gastroparesis and other gastrointestinal motility disorders.

According to the company, the trial (study 0093) data demonstrated that all three doses of velusetrag, including 5mg, 15mg and 30mg, decreased gastric emptying time (GE t1/2) compared to placebo in patients with either diabetic or idiopathic gastroparesis.

In March this year, the company started a Phase IIb study of velusetrag to treat gastroparesis, based on the positive results from the Phase II trial.

GW Pharmaceuticals commences Phase III trial of LGS treatment Epidiolex

UK-based GW Pharmaceuticals started a Phase III clinical trial of Epidiolex (cannabidiol or CBD) to treat Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy.

The company obtained orphan drug designation from the US Food and Drug Administration (FDA) for Epidiolex to treat LGS in 2014.

The study is a randomised, double-blind and 14-week comparison of Epidiolex against placebo in a total of 150 patients to evaluate the dose-ranging safety and efficacy of the Epidiolex as an adjunctive antiepileptic treatment.

GlobeImmune reports top line results of GS-4774 Phase II trial

US-based biopharmaceutical firm GlobeImmune presented top line results from its GS-4774 Phase II trial in patients with chronic hepatitis B on long term viral suppression with an oral antiviral treatment.

Exclusively licenced to Gilead Sciences, GS-4774 is a therapeutic vaccine engineered to activate an HBV-specific T cell immune response to eliminate or clear virus from cells containing HBV.

According to the firm, the patients in the 0101 Phase II trial treated with the highest dose of GS-4774 plus ongoing oral antiviral therapy (OAV) did not show a reduction in hepatitis B surface antigen (HBsAg) at week 24, the primary endpoint of the study.