June's top stories: AbbVie's cancer drug, GSK and Genmab's leukaemia drug trial
AbbVie started a Phase III clinical trial of veliparib, in combination with carboplatin and paclitaxel, in patients with advanced breast cancer, while GSK and Genmab's Phase III trial of leukaemia drug ofatumumab fails to meet primary endpoint. Drugdevelopment-technology.com wraps-up the key headlines from June 2014.
US-based biopharmaceutical firm AbbVie started a Phase III clinical trial assessing the safety and efficacy of its investigational compound, veliparib (ABT-888), in combination with carboplatin and paclitaxel, two chemotherapeutic medicines, in patients with advanced breast cancer.
Veliparib is an investigational oral poly (adenosine diphosphate [ADP]-ribose) polymerases (PARP) inhibitor currently being assessed in multiple tumour types.
In the trial, the combination of veliparib, carboplatin and paclitaxel will be compared with treatment with carboplatin, paclitaxel and placebo in these patients with human epidermal growth factor receptor 2-(HER2) negative metastatic or locally-advanced breast cancer, containing BRCA1 and/or BRCA2 gene mutations.
GlaxoSmithKline (GSK) and Genmab reported results from the Phase III trial of ofatumumab (Arzerra) versus physicians' choice in patients with bulky fludarabine-refractory chronic lymphocytic leukaemia (CLL).
In the trial, a total of 122 patients with bulky fludarabine-refractory CLL were randomised to one of two treatment arms either ofatumumab or physicians' choice (2:1).
The open-label Phase III trial failed to meet its primary endpoint of progression free survival (PFS), as the median PFS was 5.36 months for ofatumumab and 3.61 months for physicians' choice. The trial was carried out to meet requirements from the EU Commission for the conditional approval of ofatumumab to treat CLL in patients who are refractory to fludarabine and alemtuzumab.
US-based clinical-stage pharmaceutical firm Karyopharm Therapeutics started a Phase II trial of its novel, oral Selective Inhibitor of Nuclear Export (SINE) compound Selinexor (KPT-330) for treatment of patients with metastatic hormone-refractory prostate cancer (HRPC).
The company is focused on the discovery and development of new first-in-class drugs directed against nuclear transport targets for treatment of cancer and other major diseases.
Referred to as the SHIP (Selinexor in Hormone Refractory Indications in Prostate Cancer) study, the trial is led by doctors Christopher Logothetis and John Araujo of the MD Anderson Cancer Center at the University of Texas in Houston and is being funded in part by a grant from the Prostate Cancer Foundation.
Irish firm Alkermes started the second Phase II trial of a new, oral, broad-spectrum anti-psychotic medicine 'ALKS 3831' developed for treatment of schizophrenia.
Around 450 patients will be enrolled in the randomised, double-blind, active-controlled trial, which will evaluate the efficacy, safety and tolerability of ALKS 3831 in treating schizophrenia in patients with co-occurring alcohol use disorder, compared with olanzapine over a treatment period of up to 15 months.
Olanzapine is an approved and widely used atypical anti-psychotic medicine. The objective of the trial is to compare symptom exacerbation between the two treatment groups.
French drug maker Sanofi and US-based Regeneron Pharmaceuticals released positive results from a Phase III trial of investigational drug sarilumab in rheumatoid arthritis (RA) patients who were inadequate responders to methotrexate (MTX) therapy.
The data showed that sarilumab increased major clinical response rates defined as achieving an ACR70 for at least 24 consecutive weeks, as well as showed sustained improvement in signs and symptoms of RA after 52 weeks, which were secondary endpoints of the trial.
The company said that in the SARIL-RA-MOBILITY Phase III trial, sarilumab met all three co-primary endpoints, showing improvement in disease signs and symptoms at 24 weeks, physical function at 16 weeks and inhibition of joint damage progression at 52 weeks.
Israel-based biopharmaceutical firm BioLineRx received approval from the Israeli Ministry of Health to start a Phase I trial for BL-8040, a new treatment for the mobilisation of stem cells from the bone marrow to the peripheral blood circulation.
The trial is scheduled to start during the third quarter of 2014 at Hadassah Medical Center in Jerusalem.
BioLineRx chief executive officer Kinneret Savitsky said: "Current treatment regimens involve daily injections for four to six days of G-CSF, with or without the addition of a mobilising agent such as Plerixafor (Mozobil).
US-based Eli Lilly and Company reported results from REVEL, a global Phase III trial of Cyramza (ramucirumab) in combination with chemotherapy designed to treat patients with second-line non-small cell lung cancer (NSCLC).
The company said that REVEL is the first positive Phase III trial of a biologic in combination with chemotherapy to show improved overall survival compared to chemotherapy alone in second-line NSCLC.
In the US and most other countries, lung cancer is the leading cause of cancer death, while NSCLC accounts for 85% of all lung cancer cases.
US-based Advanced Cancer Therapeutics (ACT) initiated a Phase I dose escalation trial of PFK-158, an anti-cancer drug candidate, which inactivates a new cancer metabolism target never examined before in human clinical trials.
The US Food and Drug Administration (FDA) approved trial is designed to assess the safety, tolerability and anti-tumour activity of PFK-158 in cancer patients with solid tumours such as melanoma, lung, colon, breast and pancreatic cancer.
The small molecule therapeutic candidate PFK-158 is the first 6-phosphofructo-2-kinase/fructose-2,6-biphosphatase 3 (PFKFB3) inhibitor to undergo clinical trial testing in cancer patients.