June's top stories: Bayer reported positive results of RESORCE trial, TapImmune initiated Phase II trial of TPIV 200
Bayer reported positive results from the Phase III RESORCE trial of Stivarga (regorafenib) tablets to treat unresectable hepatocellular carcinoma, and TapImmune initiated its Phase II trial of cancer vaccine TPIV 200. Drugdevelopment-technology.com wraps up the key headlines from June 2016.
German-based pharmaceutical company Bayer reported positive results from the Phase III RESORCE trial of Stivarga (regorafenib) tablets to treat unresectable hepatocellular carcinoma (HCC).
Stivarga is a prescription medicine indicated to be used for colon or rectal cancer that has spread to other parts of the anatomy and after the patient has been administered with chemotherapy medicines.
The Phase III RESORCE (REgorafenib after SORafenib in patients with hepatoCEllular carcinoma) clinical trial is a randomised, double-blind, placebo-controlled, multicentre study to evaluate Stivarga in treating patients with HCC who had a prior administration of sorafenib.
US-based immuno-oncology company TapImmune initiated its Phase II trial of cancer vaccine TPIV 200 to treat triple negative breast cancer by dosing the first patient.
Around 80 patients are to be included in the randomised, open label Phase II trial, which will be conducted across eight sites.
Tapimmune chairman and CEO Dr Glynn Wilson said: "The clinical strategy for TPIV 200 is designed to examine the potential for this exciting T-cell vaccine in as many clinical settings as possible, using the most cost-effective pathways.
"We are excited by the potential for this drug candidate and believe positive data from the Phase I study will be reflected in the results of our ongoing Phase II clinical investigations."
Bristol-Myers Squibb Company reported positive results from cohort B of a Phase II registration trial (CheckMate-205) of Opdivo (nivolumab) in patients with classical Hodgkin lymphoma (cHL).
Opdivo is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1, which is used by the cancer cells to take refuge from the immune system and block the tumour from being exposed to the immune system.
It prevents the binding of PD-L1 and PD-L2, blocking the PD-1 pathway's suppressive signalling on the immune system including the interference with an anti-tumour immune response.
Roche has reported positive results from the global, randomised, double-blind, placebo-controlled Phase III trial (GiACTA), which evaluated Actemra / RoActemra (tocilizumab) in people with giant cell arteritis (GCA).
During GiACTA, the patient afflicted with GCA exhibited sustained remission from the affliction when administered with Actemra / RoActemra in comparison to a six month steroid (glucocorticoid) regimen, while maintaining safety during the analysis.
Global product development head and chief medical officer Sandra Horning said: "These results are encouraging for patients with this rare disease, for which there have been no new treatments in more than 50 years.
"Long-term, high-dose steroids are currently the mainstay treatment for GCA but they can cause their own serious adverse effects.
Spanish-based biopharmaceutical company PharmaMar commenced the multicentre, prospective, pivotal study to assess the efficacy of anti-cancer agent plitidepsin in patients with relapsed and refractory angioimmunoblastic T-cell lymphoma.
The one study arm is designed to evaluate the efficacy of plitidepsin in terms of overall response rate, which will be assessed by an independent committee following the Lugano classification response criteria.
The study will also focus on the secondary endpoint in determining the other effective aspects of plitidepsin, which are duration of response, progression free survival and overall survival, the pharmacokinetic characteristics, the safety profile of plitidepsina and the identification of possible biomarkers.
US-based pharmaceutical company Merck reported positive results from the Phase II trial of its anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with advanced cancers characterised as deficient for DNA mismatch repair (MMR).
The Phase II trial evaluated the clinical activity of KEYTRUDA monotherapy administered in proportions 10mg/kg every two weeks, in patients with previously treated, progressive metastatic disease with or without MMR deficiency. It demonstrated a consistent safety of the drug.
The trial's key endpoints were overall response rate (ORR), duration of response (DOR), progression-free survival (PFS) measured by RECIST v1.1, and overall survival (OS).
Taiwan-based drug development company TWi Biotechnology (TWiB) completed enrolling patients in its Phase II clinical trial of AC-201CR for the treatment of gout.
AC-201CR is the controlled release oral formulation version of AC-201, an orally administered small molecule inhibiting URAT1, as well as the production and activity of caspase-1 and the cytokine interleukin-1Beta (IL-1Beta).
The Phase II clinical trial was launched in 2014 and is a multi-centre, double-blind, randomised, placebo-control study conducted in Taiwan, involving 127 patients with gout.
US-based biotechnology firm Advaxis started dosing in the first stage of its Phase II trial of fighting anal-cancer with a CTL-enhancing tumour therapy (FAWCETT) study, to evaluate axalimogene filolisbac (AXAL) for the treatment of persistent or recurrent metastatic anal cancer.
The first stage of this multi-centre, open-label, two-stage trial will enrol 31 anal cancer patients who have received a prior treatment regimen, after which they have experienced the recurrence of the disease.
The patients will be administered with AXAL 1x109 colony forming unit (CFU) doses every three weeks up to a duration of two years.
US-based biotechnology company GlycoMimetics started dosing in the Phase II portion of its Phase I/II clinical trial for new E-selectin antagonist, GMI-1271, combined with induction chemotherapy to treat patients with relapsed / refractory acute myeloid leukemia (AML).
It is reported that in this portion, patients will be administered to a simultaneous pre-determined dosage of GMI-1271, as well as the chemotherapy regimen to assess the safety and efficacy of GMI-1271.
Enrolment in this portion of the trial is limited to patients at least 18 years old with relapsed or refractory AML and who would be treated with mitoxantrone, etoposide, and cytarabine (MEC).
Slovakia-based biotech company Axon Neuroscience started the Adamant Phase II trial by administering the first patient with its active tau vaccine, AADvac1, to treat Alzheimer's disease.
The randomised, placebo-controlled, parallel group, double-blinded, multi-centre Adamant Phase II trial will be held for a period of 24 months.
It plans to enrol 185 patients and will be conducted across several countries in Europe.
The trial is primarily focused on assessing the safety and immunogenicity aspect of AADvac1 to treat mild Alzheimer's.