Vaccine Demonstrated Tolerable Safety Profile, Induced Measurable Immunogenic Response in 100 Percent of Study Participants in Higher Dose Cohort Trial Provides Immunovaccine's First Clinical Immunogenicity Demonstration in Infectious Disease Applications

 

HALIFAX, NOVA SCOTIA--(Jul 6, 2016) - Immunovaccine Inc. ("Immunovaccine" or the "company") (IMV.TO)(IMMVF), a clinical stage vaccine and immunotherapy company, today announced that a team of investigators has completed an interim analysis of the safety and immunogenicity of its DepoVax™ prophylactic respiratory syncytial virus (RSV) vaccine candidate (DPX-RSV) in a Phase 1 clinical trial in healthy older adult volunteers. The safety analysis indicates that the DPX-RSV was well tolerated among all study participants, with no serious adverse events (SAEs) recorded. Furthermore, immunogenicity data supported DPX-RSV's ability to generate a relevant immune response; the vaccine candidate obtained antigen-specific antibody responses in 75 percent of subjects vaccinated with the lower dose, and 100 percent of those vaccinated with the higher dose.

PHOENIX, July 05, 2016 -- Insys Therapeutics, Inc. (“Insys” or “the Company”) (INSY) today announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, SyndrosTM, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC").  Syndros is approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.  Syndros is currently awaiting scheduling by the U.S. Drug Enforcement Administration.

 

"We are very pleased to announce FDA approval of Syndros. We believe that Syndros will be an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with weight loss in AIDS,” said the Company’s Chairman, CEO and President, Dr. John N. Kapoor.  

NEW YORK, NY--(June 29, 2016) - Iomab-B Uniquely Positioned as the Only Investigational Therapy Intended to be an Induction and Conditioning Agent Prior to a Bone Marrow Transplant in its Target Patient Population

 

SIERRA Phase 3 Trial to Study Iomab-B as an Induction and Conditioning Agent Prior to a Bone Marrow Transplant in Patients with Relapsed or Refractory Acute Myeloid Lukemia (AML) over the Age of 55

Iomab-B Proof of Concept Study Demonstrated Significant Survival Benefit at Two Years Versus Current Therapy and has been Studied in Almost 300 Patients to Date in Multiple Phase 1 and Phase 2 Studies in Numerous Blood Cancers

 

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or the "Company"), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the pivotal Phase 3 clinical trial for Iomab-B has been initiated. Iomab-B, the Company's lead asset, upon approval, is intended to be an induction and conditioning agent used to prepare patients with relapsed or refractory AML who are over the age of 55 for a hematopoietic stem cell transplant (HSCT), commonly referred to as bone marrow transplant (BMT). Iomab-B is a radioimmunotherapy comprised of the monoclonal antibody BC8 coupled with the radioisotope Iodine-131 that is designed to deliver targeted payloads to cells that express CD45, a pan-leukemic antigen expressed on white blood cells and stem cells.

myChoice HRD Increases Eligible Patients by Approximately Twofold

 

SALT LAKE CITY, June 29, 2016  -- Myriad Genetics, Inc. (MYGN), a leader in molecular diagnostics and personalized medicine, today announced that its myChoice® HRD test successfully identified an increased number of patients with ovarian cancer who may benefit from treatment with niraparib.  Niraparib is an investigational oral PARP inhibitor being developed by TESARO (TSRO).

 

Today’s announcement follows results of the NOVA study (NCT01847274), which evaluated the safety and efficacy of niraparib as a maintenance therapy in more than 500 patients with recurrent ovarian cancer.