Provectus Announces Abstract Available on PV-10; Baxalta Reports Continued Progress on Phase 1/2 Clinical Trial of BAX335 Print E-mail
By David Fowler   
Wednesday, 24 June 2015 18:39
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 24, 2015.
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT), announced that the abstract titled, "Phase 1 Study of PV-10 for Chemoablation of Hepatocellular Cancer and Cancer Metastatic to the Liver" to be presented at the ESMO 17th World Congress on Gastrointestinal Cancer is now available online at:
The abstract concludes "Preliminary efficacy in treatment of liver tumors with PV-10 was observed. Toxicity was transient, and treatment had acceptable tolerability. The study is continuing at three study centers with two expansion cohorts to assess response in hepatocellular carcinoma and other cancers metastatic to the liver."
Eric Wachter, PhD, Chief Technology Officer of Provectus, will be the presenter, and is scheduled to make the presentation twice during the Congress. Both presentations are scheduled for Thursday, July 2, 2015; the first is from 10:30 to 11:00 a.m. and the second from 4:55 to 5:25 p.m. local time.
Baxalta Incorporated, a wholly-owned subsidiary of Baxter International Inc. (NYSE: BAX), reported continued progress on the Phase 1/2 open-label clinical trial assessing the safety and optimal dosing level of BAX 335, an investigational factor IX (FIX) gene therapy treatment for hemophilia B, during an oral presentation at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress in Toronto, Canada.
Individuals with hemophilia B lack the ability to produce clotting factor IX and are today treated with infusions of plasma-derived or recombinant factor IX. BAX 335 is designed to provide a mechanism for a hemophilia B patient's own liver to begin producing FIX over an extended period following a single dose of treatment.
The technology Baxalta has investigated since 2012 is the Biological Nano Particle (BNP™) platform — an advanced rAAV8-based gene therapy technology obtained through the collaboration and subsequent acquisition of Chatham Therapeutics. The BNP platform is designed to enable patients to achieve stable factor IX activity on their own when infused in the body. To achieve a therapeutic effect while keeping vector doses as low as possible, BAX 335 uses FIX-Padua, a naturally occurring, highly active variant of FIX.
A total of seven patients in three sequentially-ascending dosing cohorts have been treated in the trial with evidence of a dose-related response. No patients have developed FIX inhibitors to date. Some FIX expression was observed in the lowest dosing cohort (2x1011 vector genomes [vg] per kilogram of body weight: vg/kg). In the second dosing cohort (1x1012 vg/kg), two patients have experienced no bleeds without regular infusions of FIX and one of these patients has had sustained FIX expression levels of 20-25 percent for 12 months.
In the highest dose cohort (3x1012 vg/kg), expression levels have peaked above 50 percent, though the two patients in this cohort experienced an immune response which has led to decreased FIX expression, with one patient resuming regular FIX infusions. Immune responses have been reported and managed in previous studies with gene therapy technology. Baxalta continues to address the immune responses observed while working to maintain target trough levels.
''Gene therapy has the potential to achieve a long term therapeutic solution for people with hemophilia and will continue to be a key focus for Baxalta,'' said John Orloff, MD, vice president and global head of research and development at Baxalta. ''We continue to advance this program as we learn more about this new concept and its value for those living with hemophilia, with an opportunity to truly transform the treatment paradigm.''
The clinical trial is assessing the safety of ascending doses of BAX 335 to determine the optimal single dose in up to 16 adult subjects with hemophilia B at treatment centers in the United States. The primary endpoint is the safety of a single dose of BAX 335 administered intravenously. Secondary endpoints include evaluation of the optimal dose to achieve stable therapeutic plasma FIX activity, as well as pharmacokinetics and immune response to treatment. Additional patients are being screened and more information on the trial is available at, by using Identifier #01687608.
In April 2014, Baxter acquired Chatham Therapeutics, LLC, an affiliate of Asklepios BioPharmaceutical, Inc. (AskBio), and its developmental gene therapy programs. Chatham's Biological Nano Particles (BNP), an advanced recombinant adeno-associated virus- (rAAV-) based gene therapy technology, has shown potential therapeutic activity in early studies. In addition to the research in hemophilia B, Baxalta is also advancing plans to evaluate the gene therapy technology in the treatment of hemophilia A.
Also Wednesday:
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. will present at the Cantor Fitzgerald Inaugural Healthcare Conference in New York on Wednesday, July 8, 2015 at 1:00 PM Eastern Time.
Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced dose administration for the first patient in a Phase 1, open-label, dose-escalation and expansion study of single agent AG-881, a small molecule that has shown in preclinical studies to fully penetrate the blood-brain barrier and inhibit isocitrate dehydrogenase-1 (IDH1) and IDH2 mutations in cancer models.
Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR), a clinical-stage biopharmaceutical company, announced today that it intends to offer and sell, subject to market and other conditions, $200.0 million of its common stock in an underwritten public offering.
Bacterin International Holdings, Inc. (OTCQX:BONE) has been awarded a new group purchasing agreement for the Bone Tissue Synthetic Implantable Products Category with Premier, Inc. Effective July 1st, 2015, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for its members.
Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that previously disclosed results from its Phase 2b clinical trial evaluating EVK-001, its patented intranasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women, have been published in the July issue of Clinical Gastroenterology and Hepatology, a leading peer‑reviewed journal published by the American Gastroenterological Association (AGA).
FutureWorld Corp. (OTC: FWDG), a cannabis technology accelerator and a leading provider of advanced technologies and solutions to the global cannabis industry, announced today that it has concluded the incubation of Bioceutical Sciences™ after months of vetting and numerous development processes.  Bioceutical Sciences™ will become the newest addition to its family of companies as a wholly owned subsidiary. 
iKang Healthcare Group, Inc. (Nasdaq:KANG), China's largest private preventive healthcare services provider, has acquired 100% equity interest in Yantai Hongkang Tijian Co. Ltd. and Yantai Hongkang Jiankang Tijian Co. Ltd. 
Inovalon (Nasdaq:INOV), a leading technology company providing advanced, cloud-based data analytics and data-driven intervention platforms to the healthcare industry, today announced that it has expanded its current relationship with FamilyCare Health, a leader in Oregon healthcare, in a multi-year agreement to provide solutions that improve patient disease insight, risk score accuracy, financial performance and regulatory data compliance for their Medicare Advantage population.
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider organization, announced today that it has acquired Geriatric Associates of America (GAA), one of the largest private practice post-acute groups in Texas. 
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative therapies to market for people with renal disease, today announced that two national insurance providers have added Auryxia™ to their Medicare Part D formularies.
Lion Biotechnologies, Inc. (Nasdaq:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today announced that it will join the Russell Global Index on June 26, according to a list of final additions posted June 19 on the FTSE Russell website.
MediciNova, Inc., (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that principal investigator Lara Ray, Ph.D., Associate Professor, Department of Psychology, Brain Research Institute at University of California Los Angeles, gave a RSA 2014 Young Investigator Awardee presentation today at the 38th Annual RSA (Research Society on Alcoholism) Scientific Meeting in San Antonio, TX entitled "A RESEARCH AGENDA ON THE CLINICAL NEUROSCIENCE OF ALCOHOLISM." 
Medigus Ltd. (Nasdaq:MDGS) (TASE:MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, announced that BNY Mellon's Depositary Receipts Division is offering free issuances for conversions of Medigus' ordinary shares into Medigus' American Depositary Receipts (ADRs) (Nasdaq:MDGS) and will waive the issuance fee for the period 1 June 2015 to the 31 August 2015 inclusive. 
Portola Pharmaceuticals (Nasdaq:PTLA) today announced results of a study demonstrating that andexanet alfa significantly reduced bleeding in a validated animal model of bleeding using the Factor Xa inhibitor rivaroxaban as the anticoagulant.
Premier, Inc. (Nasdaq:PINC) selected a range of unique medical devices and products for its 7th annual Innovation Celebration, an event honoring the industry's leading healthcare advancements and supplier commitment to innovation.
Representatives of Materialise (Nasdaq:MTLS) and Fuwai Hospital signed an agreement that will result in the opening of a multidisciplinary 3D printing center within a reputable Chinese cardiovascular hospital. 
Sabra Health Care REIT, Inc. (Nasdaq:SBRA) announced today that it plans to offer 5,000,000 shares of its common stock in an underwritten public offering.
Sonoco ThermoSafe, a unit of Sonoco (NYSE:SON) and a leading supplier of temperature assurance packaging, has launched a revolutionary new product for the transport and temporary storage of red blood cells and platelets.  
The Spectranetics Corporation (Nasdaq:SPNC) today announced it has received U.S. Food and Drug Administration 510(k) clearance for the AngioSculpt® PTA Scoring Balloon Catheter in 7 and 8 millimeter (mm) diameter balloon sizes. 
XBiotech Inc., (Nasdaq:XBIT), the developer of True HumanTM therapeutic antibodies, announced today that the Company has been added to the Russell 2000 Index, Russell 3000 Index, Russell Global Index, and Russell Microcap Index as part of Russell Investments' annual index rebalance on June 29, 2015.

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