July's top stories: GBT's Phase II1 trial GBT440, Merck's Phase III trial ONCEMRK of Isentress

Global Blood Therapeutics (GBT) began the Phase IIa trial (GBT440-007) of GBT440 in adolescents with sickle cell disease (SCD), and Merck reported positive results from its ongoing Phase III pivotal trial ONCEMRK of Isentress (raltegravir) to treat adults with HIV-1 infection. Drugdevelopment-technology.com wraps up the key headlines from July 2016.


 

Global Blood Therapeutics began Phase IIa trial of GBT440 to treat sickle cell disease

US-based biopharmaceutical company Global Blood Therapeutics (GBT) began the Phase IIa trial (GBT440-007) of GBT440 in adolescents with sickle cell disease (SCD).

The GBT440 is an orally administered, once-daily therapy developed by the company.

The open-label, single and multiple dose Phase IIa trial is designed to assess the safety, tolerability, pharmacokinetics and exploratory treatment effect of GBT440 when administered to adolescents with SCD aged between 12 and 17.
 

Merck reported positive Phase III ONCEMRK trial of Isentress to treat HIV-1 infection

US-based pharmaceutical company Merck reported positive results from its ongoing Phase III pivotal trial ONCEMRK of Isentress (raltegravir) to treat adults with HIV-1 infection.

Isentress inhibits integrase for the treatment of HIV-1 infection in adult and pediatric patients aged four weeks and older and weighing at least 3kg as part of combination HIV therapy.

It blocks the integrase enzyme from inserting HIV-1DNA into human DNA, thereby demonstrating a rapid anti-viral activity.

The blockage of integrase limits the ability of the virus to replicate and infect new cells.
 

AbbVie and Bristol-Myers planned combination trial of Rova-T plus Opdivo and Opdivo + Yervoy regimen

AbbVie and Bristol-Myers Squibb planned to jointly conduct a Phase I/II clinical trial of Rova-T (rovalpituuzumab tesirine) in combination with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen to treat relapsed extensive-stage, small-cell lung cancer (SCLC).

Rova-T is AbbVie’s investigational antibody drug conjugate targeting the cancer-stem, cell-associated target, delta-like protein 3 that characterise SCLC tumours but do not occur in healthy tissues.

Bristol-Myers Squibb’s Opdivo is an PD-1 immune checkpoint inhibitor that fuses with the checkpoint receptor PD-1 expressed on activated T-cells and inhibits the binding of PD-L1 and PD-L2, thereby blocking the PD-1 pathway’s interfering signals to the immunity system.
 

PROMISE study presented drug therapy to eliminate HIV transmission from breastfeeding mothers to infants

The Promoting Maternal and Infant Survival Everywhere (PROMISE) study conducted in sub-Saharan Africa and India stated that administration of a three-drug, anti-retroviral regimen during breastfeeding of HIV-infected mothers who have a strong immunity system eliminates the risk of HIV transmission by breast milk to their infants.

Multi-component study PROMISE involved 2,431 pairs of HIV-infected mothers and their uninfected infants from South Africa, Malawi, Tanzania, Uganda, Zambia, Zimbabwe and India.

A component of this study was designed to determine ways to eliminate HIV transmission from HIV-infected women to their babies during pregnancy, delivery and after childbirth, while maintaining good health of both the mother and her baby.
 

Lilly and Boehringer evaluated combination drug in Phase Ib breast cancer trial

Eli Lilly and Company (LLY) and Boehringer Ingelheim planned to collaborate on the Phase Ib trial to evaluate the combination of abemaciclib (LY2835219) and BI 836845 to treat metastatic breast cancer.

Lilly's abemaciclib (LY2835219) is an investigational, orally administered product that inhibits cyclin-dependent kinases CDK 4 and CDK 6, thereby preventing the growth of cancer cells.

Boehringer's BI 836845 is an antibody that neutralises insulin-like growth factor (IGF)-1 / IGF-2 ligand.

Lilly oncology product development and medical affairs senior vice-president Richard Gaynor said: "We are pleased to join with Boehringer Ingelheim to study the potential of their molecule in combination with Lilly's abemaciclib, for which we have an active Phase III development programme underway.
 

Canada planned first clinical study of Zika vaccine

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Université Laval’s Infectious Disease Research Centre (IDRC) and Centre de recherche du CHU de Québec-Université Laval (CHU) planned to jointly conduct the first clinical study for a Zika vaccine in Canada.

The Zika virus is carried by Aedes mosquitoes, which cause symptoms such as mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise or headache that can last between two to seven days.

Infection of a pregnant woman can cause the fetus to develop microcephaly, an abnormal smallness of the head causing incomplete brain development.
 

Pfizer reported positive top-line result of Phase III S-TRAC Trial of Sutent to treat RCC

US-based pharmaceutical company Pfizer reported positive top-line results of the Phase III S-TRAC clinical trial of Sutent against placebo to treat patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery.

Sutent (sunitinib malate) is a multi-kinase inhibitor that is orally administered and indicated to be used for RCC, imatinib-resistant or imatinib-intolerant gastrointestinal stromal tumours (GIST) and advanced pancreatic neuroendocrine tumours (pNET).

The Phase III S-TRAC trial is a randomised, double-blind study of adjuvant Sutent against placebo.

More than 670 patients who were at high risk of recurrent RCC were involved in the trial and administered with Sutent or placebo for one year.
 

Boehringer began INMARK trial of OFEV to identify biomarkers for IPF

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German pharmaceutical company Boehringer Ingelheim enrolled the first patient in its new study, INMARK, to evaluate OFEV (nintedanib) on specific blood biomarkers in patients with idiopathic pulmonary fibrosis (IPF).

OFEV (nintedanib) is a small molecule tyrosine kinase inhibitor developed by Boehringer Ingelheim to treat IPF.

INMARK has been designed to evaluate the safety and tolerability of OFEV when administered in combination with other drugs and across different patient populations.
 

FluGen began Phase I trial of H3N2 RedeeFlu universal vaccine for influenza

US-based biopharmaceutical company FluGen began the first Phase I clinical trial of H3N2 RedeeFlu universal vaccine for influenza.

The RedeeFlu vaccines are new M2-deleted single replication (M2SR) viruses that rapidly issue antibody and cellular immune responses similar to that of wild type influenza, but without producing an infectious virus.

The randomised, blinded, dose-ranging Phase I trial has enrolled 96 healthy adult subjects between 18 and 49 years of age.

The trial has been designed to determine the safety of the vaccine, as well as evaluating both the antibody and T-cell responses generated by the vaccine.
 

Sanofi Genzyme initiated Phase II/III trial of olipudase alfa to treat ASMD

French-based pharmaceutical company Sanofi's specialist care global business unit Sanofi Genzyme dosed the first patient in the Ascend pivotal Phase II/III clinical trial of investigational therapy olipudase alfa to treat non-neurological manifestations of acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick disease type B (NPD B).

Olipudase alfa is a recombinant human acid sphingomyelinase (rhASM), enzyme replacement therapy.

The multi-national, multi-centre, double-blinded, placebo-controlled Phase II/III Ascend trial is designed to determine the efficacy, safety, pharmacodynamics and pharmacokinetics profile of olipudase alfa.