Clinical Intelligence

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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Ovid Therapeutics initiates phase I trial of OV101 for Angelman or Fragile X syndrome

Wednesday, April 12, 2017

Ovid Therapeutics, a privately held biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, has initiated a phase I clinical trial to evaluate the pharmacokinetics (PK), safety and tolerability of OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome. OV101 (gaboxadol), a delta (δ)-selective GABAA receptor agonist, is believed to be the first investigational drug to target the disruption of tonic inhibition, a key mechanism that allows a healthy human brain to decipher excitatory and inhibitory neurological signals correctly without being overloaded. Tonic inhibition is believed to play a significant role in the neurodevelopmental symptoms characteristic of disorders such as Angelman syndrome and Fragile X syndrome.

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Castleman Disease Collaborative Network, Janssen partner on study

Wednesday, April 12, 2017

The Castleman Disease Collaborative Network (CDCN), a global nonprofit organization dedicated to accelerating research and treatments for Castleman disease (CD), a rare immunological disease, announced a collaboration with Janssen Research & Development to conduct a proteomics study of idiopathic multicentric Castleman disease (iMCD), a deadly subtype of CD. This collaborative study has the potential to improve diagnosis and treatment for iMCD patients. The collaboration combines CDCN’s strong expertise in iMCD research and its world-wide network of physician researchers with Janssen’s industry leading iMCD research resources.

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ArQule Receives FDA IND clearance for BTK inhibitor ARQ 531

Wednesday, April 12, 2017

ArQule has received clearance from the FDA for the Investigational New Drug (IND) application to conduct a phase I clinical trial with ARQ 531 in patients with B-cell malignancies who are refractory to other therapeutic options. ARQ 531 is an investigational, orally bioavailable, potent and reversible inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK).

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AbbVie announces IIb data of elagolix for heavy menstrual bleeding

Tuesday, April 11, 2017

AbbVie, a global biopharmaceutical company in cooperation with Neurocrine Biosciences, announced detailed results from a phase IIb clinical trial evaluating the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) compared to placebo. The data demonstrated that elagolix, with and without add-back therapy, met the primary efficacy endpoint of reduced heavy menstrual bleeding as compared to placebo (p<0.001). These results were shared for the first time in an oral presentation at the third Congress of the Society of Endometriosis and Uterine Disorders (SEUD) in Singapore.

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