Actinium Engages A Leading CRO To Support Phase 3 Trial of IOMAB-B; Lilly Announces Detailed Results from Two Phase III Studies Print E-mail
By Staff and Wire Reports   
Monday, 16 June 2014 19:22

Below is a look at some of the headlines for companies that made news in the healthcare sector on June 16, 2014. Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced that it has executed an agreement with ACT Oncology, a full-service clinical research organization (CRO) specializing in providing oncology drug development support for biotech, pharmaceutical and non-profit oncology organizations, to utilize their services for a number of clinical development-related projects. This agreement includes the preparations for the Phase 3 clinical trial of Iomab-B, a myeloconditioning drug for bone marrow transplant preparation.


Actinium remains on track to submit all the regulatory documentation for the Phase 3 clinical trial by the end of 2014. ACT Oncology has a full North American coverage and the ability to support global programs.

"We are extremely pleased to have an organization with the skills and experience of ACT Oncology to support the initiation and execution of the Phase 3 trial of Iomab-B. They have been responsible for managing nearly 30 studies in hematological oncology, so their experience in this highly specialized field of medicine will be invaluable to us. Based on our team’s previous experience working with ACT Oncology, we have been consistently impressed with their communication and project management systems which will be critical to the successful execution of our pivotal trial," said Kaushik J. Dave, Ph.D., MBA, Actinium’s President and CEO.

Dr. Dave added, “We have been working closely with leading US transplant experts and the U.S. Food and Drug Administration (FDA) to develop our Phase 3 trial. Feedback from the FDA on our trial design lead to a very manageable trial size of 150 patients. We are now finalizing our manufacturing scale-up and upgrade and preparation of all regulatory materials with the help of ACT Oncology and anticipate initiating this clinical trial by the end of 2104 or early 2105.”

“ACT Oncology is thrilled to have the opportunity to support Actinium’s Phase 3 Iomab-B program for the treatment of patients with relapsed/refractory AML”, stated Patricia Devitt, Pharm. D., President, ACT Oncology LLC. “This study holds great promise for the AML patient population and we look forward to leveraging ACT Oncology’s deep pool of talented clinical research professionals to make our collaboration with Actinium a success.”  

The Phase 3 trial will be conducted in relapsed and refractory acute myeloid leukemia (AML) patients over the age of 55.  The primary endpoint of this Phase 3 trial is durable complete remission (dCR) rate, where durable complete remission is defined as a complete remission lasting at least 180 days.


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Eli Lilly and Company (NYSE: LLY)
today released detailed results from two AWARD trials that showed treatment with once-weekly dulaglutide 1.5 mg resulted in superior reductions in HbA1c from baseline compared to insulin glargine, with a lower risk for hypoglycemia.1,2 Dulaglutide is an investigational glucagon-like peptide-1 (GLP-1) receptor agonist being studied for the treatment of type 2 diabetes. Results were presented at the 74th American Diabetes Association Scientific Sessions in San Francisco.

"Many patients with type 2 diabetes reach a point when oral medicines alone may no longer be effective enough. In these cases, many healthcare professionals choose to intensify treatment with an injectable medicine," said Francesco Giorgino, MD, professor of endocrinology and metabolism, University of Bari, Italy. "Data from these two studies comparing once-weekly dulaglutide with insulin glargine, in combination with other diabetes treatments, provide important information about a GLP-1 receptor agonist that, if approved, may be appropriate for patients with type 2 diabetes."

Study Results Overview - Results from the AWARD-2 trial, which evaluated the safety and efficacy of two doses of once-weekly dulaglutide compared to insulin glargine as add on to combination therapy with sulfonylurea and metformin, showed that once-weekly dulaglutide 1.5 mg provided superior blood sugar control at 52 and 78 weeks. Significantly more dulaglutide 1.5 mg-treated patients reached target HbA1c levels of less than 7 percent. Further, once-weekly dulaglutide 0.75 mg was non-inferior to insulin glargine in reducing HbA1c levels. Both doses of dulaglutide were associated with sustained weight loss, while insulin glargine showed weight gain.

Results from the AWARD-4 trial – the first Phase III study to evaluate a GLP-1 receptor agonist in combination with a mealtime insulin – showed that once-weekly dulaglutide 1.5 mg and 0.75 mg combined with mealtime insulin lispro provided superior blood sugar control at 26 and 52 weeks compared to the traditional basal/bolus combination of insulin glargine and mealtime insulin lispro. Further, at the 26-week primary endpoint, significantly more dulaglutide-treated patients reached target HbA1c levels of less than 7 percent, and patients treated with the dulaglutide-mealtime insulin lispro combination had 30 percent less total insulin dose. Both doses of dulaglutide, in combination with mealtime insulin lispro, were associated with relative weight benefit compared to the basal/bolus therapy of insulin glargine and mealtime insulin lispro.



Also Monday:



Aastrom Biosciences, Inc. (Nasdaq:ASTM)
, the leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced its strategic plan to maximize the profitability and growth potential of the cell therapy and regenerative medicine business that it recently acquired from Sanofi.

Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO)
, an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces the resignation of Xavier Harland as Chief Financial Officer of Acasti with immediate effect.

Advaxis, Inc.  (Nasdaq:ADXS)
, a clinical-stage biotechnology company developing cancer immunotherapies, announced that the Georgia Regents University (GRU) Cancer Center has received Institutional Review Board (IRB) approval to initiate a Phase 1/2 trial evaluating higher doses and repeat cycles of ADXS-HPV in patients with recurrent cervical cancer.

Baxano Surgical, Inc. (Nasdaq:BAXS)
announced today that the Company's CEO, Ken Reali, will present at the JMP Securities Healthcare Conference in New York on June 24, 2014.

Cellular Biomedicine Group Inc. (OTCQB:CBMG)
, a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, announced today that its common stock has been approved for listing on the Nasdaq Capital Market and is expected to commence trading on Nasdaq under the ticker symbol "CBMG" on June 18, 2014.

CNS Response, Inc. (OTCBB:CNSO)
CNS Response will be showcasing PEER, technology to guide psychiatric treatment, at the June 18 AdvaMed Veterans & Medical Technology event on Capitol Hill.

Dehaier Medical Systems Ltd. (Nasdaq:DHRM)
, an emerging leader in the development, assembly, marketing and sale of medical devices and sleep respiratory products in China, today announced that it has obtained a software copyright certificate for its Tele-Consultation Management System V1.0 from China's State Copyright Bureau and has received the software product register and test report from the Software Testing Center of China's State Information Center.

Hemispherx Biopharma (NYSE:HEB)
announced that a new publication (June 2, 2014) in the Formulary Journal suggests that the high pathogenicity of MERS may be due, in part, to an innate immune deficiency state that results secondary to inhibition of a first responder to viral infection, interferon (IFN), at an early step in MERS infection.

Intuitive Surgical, Inc. (Nasdaq:ISRG)
, the leader in operative surgical robotics, will hold its quarterly conference call to discuss Second Quarter 2014 results, Tuesday, July 22nd, at 4:30 p.m. Eastern Time.

LDR Holding Corporation (Nasdaq:LDRH)
, a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today announced that Robert McNamara, the Company's Executive Vice President and Chief Financial Officer, will be presenting at the 9th Annual JMP Securities Healthcare Conference to be held on June 24 and 25, 2014 in New York, NY. 

LifeVantage Corporation (Nasdaq:LFVN)
, a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, today announced that it has appointed Jeffery Bean as its new Managing Director in Japan.

Medgenics, Inc. (NYSE MKT:MDGN)
, the developer of a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that members of the senior management team will be participating in the following upcoming healthcare investor conferences.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, today announced the presentation of the results of an open-label dose escalation Phase 1 clinical study of autologous T regulatory cell (Treg) immunotherapy for type 1 diabetes mellitus (T1DM) indicating safety and tolerability following administration.

Premier, Inc. (Nasdaq:PINC)
has recognized 250 hospitals, health systems and suppliers for their outstanding work to improve community health and reduce costs.

RadNet, Inc. (Nasdaq:RDNT)
, a national leader in providing high-quality, cost-effective diagnostic imaging services through a network of 250 owned and operated outpatient imaging centers, announced today it is set to join the U.S. broad-market Russell 3000® Index when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 27, according to a preliminary list of additions posted June 13 on www.russell.com/indexes.

Response Genetics, Inc. (Nasdaq:RGDX)
, a company focused on the development and sale of molecular diagnostic tests that help guide cancer therapy selection, today announced the availability of new testing capabilities to advance cancer immunotherapy clinical development.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
today announced a proposed underwritten public offering of 3,000,000 shares of its common stock pursuant to a registration statement filed with the Securities and Exchange Commission (SEC). Revance expects to grant the underwriters a 30-day option to acquire an additional 450,000 shares.

SCYNEXIS, Inc. (Nasdaq:SCYX)
, a clinical-stage company focused on developing novel anti-infectives to address drug-resistant infections, today provided a corporate progress update and reported financial results for the quarter ended March 31, 2014.

Stereotaxis, Inc. (Nasdaq:STXS)
today announced that it will participate in Cardiostim 2014, the biennial scientific congress of the European Heart Rhythm Association (EHRA), to be held June 18-21, 2014 in Nice, France.

TG Therapeutics, Inc. (Nasdaq:TGTX)
, an innovative, clinical-stage biopharmaceutical company today announced that Michael Weiss, the Company's Interim Chief Executive Officer, will be presenting at the 2014 Wells Fargo Healthcare Conference being held at the Intercontinental Hotel in Boston, Massachusetts.




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