Clinical Intelligence

Kalytera identifies sites for planned GvHD clinical trials

Wednesday, April 26, 2017

Kalytera Therapeutics, a clinical-stage biopharmaceutical company developing next-generation cannabinoid- derived therapeutics, has developed the multicenter location component of the plan for the proposed clinical trials to evaluate cannabidiol (CBD) for the prevention and treatment of Graft versus Host Disease (GvHD). Kalytera is developing this clinical trial plan with the intent of obtaining FDA and EMEA approval for commercialization.

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Sunovion touts positive results from ADHD pivotal study evaluating dasotraline

Monday, April 24, 2017

Sunovion Pharmaceuticals announced positive results of a pivotal phase III study (SEP360-305) evaluating the efficacy and safety of novel drug candidate dasotraline, a dopamine and norepinephrine reuptake inhibitor (DNRI) being evaluated in children 6 to 12 years of age with attention deficit hyperactivity disorder (ADHD). In a laboratory classroom setting, dasotraline showed persistent, statistically significant improvement in ADHD symptoms compared to placebo throughout the day (12 to 24 hours post-dose), demonstrating a duration of effect of up to 24 hours, and was generally well-tolerated.

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CytoDyn’s PRO 140 for HIV rejected by FDA for Orphan Drug Designation

Thursday, April 20, 2017

CytoDyn, a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that its application for Orphan Drug Designation (ODD) was not granted by the Office of Orphan Products Development of the FDA because PRO 140 appears to have the potential to treat more than just the subset of multi-drug resistant HIV patients for which the designation was requested.

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Novartis’s CTL019 receives FDA Breakthrough Therapy designation

Thursday, April 20, 2017

Novartis announced that the FDA has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies. This is the second indication for which CTL019 has received this designation; the first being for the treatment of r/r B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients.

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Bavarian Nordic initiates phase II PROSTVAC combo prostate cancer trial

Wednesday, April 19, 2017

Bavarian Nordic initiated a phase II clinical trial of its prostate cancer immunotherapy candidate, PROSTVAC (rilimogene), in combination treatment with YERVOY (ipilimumab) and/or OPDIVO (nivolumab), both of which are immune checkpoint inhibitors from Bristol-Myers Squibb, as neoadjuvant therapy in patients with localized prostate cancer.

A lead-in stage will evaluate the safety of the combination of all three drugs in 10 patients with castration-resistant prostate cancer, followed by enrollment of up to 55 patients with localized prostate cancer in three cohorts, who will receive PROSTVAC in combination with either ipilimumab or nivolumab, or a combination of all three drugs prior to undergoing radical prostatectomy. The primary endpoint of the study is to evaluate and compare changes in T cell infiltration in the tumor after neoadjuvant treatment across the three different cohorts.

The principal investigator of the study is James L. Gulley, MD, Senior Investigator, Center for Cancer Research, part of the National Cancer Institute (NCI), and the sponsor of the study.  

“There are now 11 ongoing studies of PROSTVAC across various stages of prostate cancer. In recent years, there has been a growing interest in the evaluation of the immunotherapy candidate in earlier disease stages, where the cancer has not yet spread beyond the prostate. We are excited to learn more about the potential of PROSTVAC for treating this population, and to evaluate the potential synergistic effects of combining the vaccine with checkpoint inhibitors, as we believe PROSTVAC may enhance the clinical activity of these drugs,” said Paul Chaplin, president & chief executive officer of Bavarian Nordic.

This is the second trial conducted in collaboration with Bristol-Myers Squibb. The first trial was initiated in October 2016, and is investigating the combination treatment of PROSTVAC and ipilimumab at the University of California, San Francisco (UCSF), also in a neoadjuvant setting.

CASI halts enrollment of ENMD-2076 triple-negative breast cancer study

Tuesday, April 18, 2017

CASI Pharmaceuticals, a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported that, along with the investigators, a decision has been reached to stop further patient enrollment in its phase II, open-label study of ENMD-2076 in previously treated locally advanced or metastatic triple-negative breast cancer (TNBC) conducted at the University of Colorado, Denver, and the Indiana University Melvin and Bren Simon Cancer Center.

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