|Actinium Announces New Data from Ongoing Phase 1/2 Trial of Actimab-A; NEMUS initiates anti-infective program|
|By William Kent|
|Wednesday, 18 March 2015 18:46|
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 18, 2015.
Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today the completion of the third cohort of the Company’s ongoing multi-center Phase 1/2 Study for Actimab-A for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) in elderly patients.
Cohort 3, which included 3 additional patients, demonstrated no dose limiting toxicities in patients older than 60 and up to 87 years of age who were not eligible for currently approved therapies. Two out of three Actimab-A treated patients achieved complete remission with different degrees of hematological recovery (CRi). These responses were documented in the settings of high pre-treatment leukemia burdens of up to 88% in the bone marrow. In the previous cohort treated at a lower dose level of Actimab-A, one patient achieved CRi.
"The positive results on both safety and anti-leukemic effect demonstrated in the completed third cohort represents a significant achievement for the Actimab-A program, and supports the advancement to a higher dose with the potential to further enhance the already strong results we have seen to date," stated Dragan Cicic, MD, Chief Medical Officer of Actinium. “We believe the responses observed for Actimab-A, with minimal toxicity being reported, are impressive in this disease setting. These findings build upon those presented and published over the past year which demonstrated a clear survival benefit in secondary AML patients. We remain steadfast in our belief that Actimab-A could play an important role in the treatment regimen for newly diagnosed elderly secondary AML patients who currently have limited treatment options, and have historically achieved overall survival of only 2 to 5 months, depending on treatment modality.”
The primary goals of the Phase 1 trial portion of the ongoing Phase 1/2 clinical trial are to establish the safety profile, determine the maximum tolerated dose (MTD) and assess the preliminary clinical activity of Actimab-A in newly diagnosed AML patients over 60. In the first cohort, patients were treated with two doses of Actimab-A at 0.5 μCi/kg activity level. In the second cohort, patients received two doses of Actimab-A at 1.0 μCi/kg activity level, and in the third cohort, patients received two doses at 1.5 μCi/kg activity. As the drug candidate continues to be well tolerated in in these high risk elderly AML patients, the trial will advance to a fourth cohort at two doses of Actimab-A at a μCi/kg activity level of 2.0. Upon reaching the MTD in the Phase 1 portion of the trial, the Phase 2 portion would begin at the established MTD level.
Actinium previously announced positive interim data from the ongoing Phase 1/2 trial of Actimab-A in older patients with newly diagnosed AML. Most notably, median overall survival (“OS”) of the seven secondary AML patients (with prior myelodysplastic syndrome, or MDS) in the study was 9.1 months, which compares favorably to historical norms of 2 to 5 months, depending on the treatment modality. Older AML patients are already higher risk, with secondary AML patients considered to have the more severe and less treatable form of AML, and as a consequence, have shorter expected survival. The clinical abstract was published and is available online in Blood, the official Journal of the American Society of Hematology.
NEMUS Bioscience, Inc. (OTCQB: NMUS) announced today that the company would begin studies concerning the medical utility of cannabinoids as anti-infective therapeutics. The initial studies will be performed at the University of Mississippi (UM), a NEMUS strategic collaborative partner and a global leader in the chemistry and science of cannabinoids and botanicals.
"While the company remains focused on bringing forward our leading candidate molecule, a pro-drug of THC, for the management of glaucoma, the anti-infective potential of botanicals, especially the cannabinoids, should not be ignored," stated John Hollister, NEMUS' CEO. "We are launching these initial studies to assess our target molecule portfolio against methicillin-resistant Staphylococcus aureus (MRSA)."
"MRSA has proven to be a major cause of morbidity and mortality throughout the world, with the incidence in the United States showing a rise in community-acquired versus healthcare-acquired disease," reports Brian Murphy, MD, MPH, NEMUS' CMO. "The NEMUS anti-infective program will explore the use of unique cannabinoid-based therapies to help treat bacterial, viral, and parasitic infections and conditions. To begin, we will focus solely on MRSA and the potential of these compounds to prevent systemic infection among patients colonized with the antibiotic-resistant form of this bacteria."
"Botanicals have been a significant source of therapeutic products and it is time to bring cannabis-derived medications forward that may have the potential to eliminate infective threats - especially those that have developed resistance to our current therapies," said Larry Walker, director of the National Center for Natural Products Research at the University of Mississippi.
"Ole Miss looks forward to the development process and partnering proprietary technologies with our development partner, NEMUS," said Mahmoud ElSohly, NCNPR research professor and a leading global expert on cannabinoid chemistry. "There are more than 100 compounds that can be derived from the cannabis plant, and we are excited to explore medical uses for these purified molecules."
"We look to complete in vitro testing early this year and progress to formulation and animal testing thereafter where applicable," stated Dr. Murphy. "There is an urgent medical need for newer agents to treat resistant organisms and NEMUS is looking to leverage the antimicrobial capacity of cannabinoids to meet these threats."
NEMUS Bioscience and the University of Mississippi entered into a research and in-licensing collaboration agreement in 2014.
Advaxis, Inc. (Nasdaq:ADXS), a cancer immunotherapy company, today announced that three abstracts revealing new data for Advaxis's proprietary Lm-LLO cancer immunotherapy platform have been selected for poster presentations at the 2015 American Association for Cancer Research (AACR) Annual Meeting, April 18 – 22, 2015, at the Pennsylvania Convention Center in Philadelphia, Pennsylvania.
Assembly Biosciences, Inc. (Nasdaq:ASMB) announced today that it is commencing an underwritten public offering of its common stock pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission. All of the shares in the offering are to be sold by Assembly.
Calithera Biosciences, Inc. (Nasdaq:CALA) a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, today announced the upcoming presentation of five preclinical abstracts, highlighting the potential of CB-839, the Company's novel, orally bioavailable glutaminase inhibitor, at the American Association for Cancer Research, taking place April 18-22, 2015 in Philadelphia, Pennsylvania.
Capricor Therapeutics, Inc. (Nasdaq:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today provided a business and financial update for the fourth quarter and full year ended December 31, 2014.
Dermira, Inc. (Nasdaq:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated dermatology products to dermatologists and their patients, today announced that it will report fourth quarter and full year 2014 financial results after the close of U.S. financial markets on March 25, 2015.
Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the development of programmed cellular therapeutics for the treatment of severe, life-threatening diseases, today announced that Christian Weyer, M.D., M.A.S., President and Chief Executive Officer, will present at the Alliance for Regenerative Medicine (ARM) 3rd Annual Regen Med Investor Day on Wednesday, March 25, 2015 at 11:35 am EDT in New York, NY.
Fibrocell Science, Inc. (Nasdaq:FCSC), an autologous cell therapy company primarily focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, announced the appointment of Keith A. Goldan as Senior Vice President and Chief Financial Officer (CFO), effective immediately.
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced the closing of its previously announced underwritten public offering of 24,358,974 shares of common stock, and warrants to purchase an aggregate of 12,179,487 shares of common stock at an exercise price of $2.08 per share.
Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today reported financial results for the year ended December 31, 2014.
Health Insurance Innovations, Inc. (Nasdaq:HIIQ) is a leading developer, distributor and virtual administrator of affordable, cloud-based individual health insurance plans and ancillary products. HealthPocket, Inc., a subsidiary of HII ("HealthPocket"), is the most comprehensive consumer comparison shopping website for health insurance plans.
Juno Therapeutics, Inc. (Nasdaq:JUNO), a biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer, today reported business highlights and financial results for the fourth quarter and year ended December 31, 2014.
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today reported financial results for the fourth quarter and fiscal year ended December 31, 2014.
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that fourteen abstracts describing the activity of selinexor (KPT-330), the company's lead drug candidate in development for hematological malignancies and solid tumors, have been selected for presentation at the 2015 Annual Meeting of the American Association for Cancer Research (AACR) taking place April 18-22 in Philadelphia.
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today reported financial results for the quarter and year ended December 31, 2014, and provided an update on its corporate activities and product pipeline.
The Spectranetics Corporation (Nasdaq:SPNC) reported today that Guy Childs, Chief Financial Officer, has announced his plan to transition from his current role.
Summit Therapeutics plc (Nasdaq:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection, today announced that the underwriters of its initial public offering have exercised in full their over-allotment option to purchase an additional 517,500 American Depositary Shares ("ADSs") at the initial public offering price of $9.90 per ADS, less underwriting discounts and commissions.
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR), an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), announced today that the Company is offering to sell 6,000,000 common shares in an underwritten public offering.