Provectus' Novel Synthesis Patent Application Allowed by Chinese Patent Office; Actinium Submits Pre-IND Meeting Request to the U.S. FDA for its Iomab-B Drug Candidate Print
By William Kent   
Monday, 26 January 2015 20:32
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 26, 2015.
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT), a development-stage oncology and dermatology biopharmaceutical company (“Provectus”), announced today that it has received notification of allowance from the Chinese Patent Office for its patent application protecting the synthetic process used to produce the small molecule Rose Bengal, the active pharmaceutical ingredient (API) in PV-10, the Company's lead oncology drug candidate.

The pending Chinese patent covers the same process as the one granted by the US Patent Office in September 2013, as U.S. Patent 8,530,675, "Process for the Synthesis of 4,5,6,7-tetrachloro-3',6'-dihydroxy-2',4',5',7'-tetraiodo-3H-spiro[isobenzofuran-1,9-xanthen]-3-one (Rose Bengal) and Related Xanthenes.”  The application details a new process for the manufacture of Rose Bengal and related iodinated xanthenes in high purity. The allowed claims cover the process under which pharmaceutical grade Rose Bengal and related xanthenes are produced, reducing the formation of certain previously unknown transhalogenated impurities that currently exist in commercial grade Rose Bengal in uncontrolled amounts.

The requirement to identify and control related substances is in accordance with International Conference on Harmonisation (ICH) guidelines for manufacture of API suitable for phase 3 clinical trial material and commercial pharmaceutical use. Once issued later this year, the patent is expected to provide protection for Rose Bengal API to 2031and covers any hypothetical process that controls the amount of transhalogenated impurities in Rose Bengal through the awarded Jepson style claims.

Eric  Wachter, CTO of Provectus, stated, "The issuance of this patent will enhance the protection of our novel synthesis process for the manufacture of Rose Bengal covering the entire Chinese market. As we prepare to begin our phase 3 clinical trial for intralesional PV-10 as a treatment for melanoma and as we discuss with Chinese interests licensing PV-10 for other indications, it is important that we defend our intellectual property in this way. We are pleased that the Chinese authorities have been so helpful in this, and we will continue to protect our stockholders’ interests in this way as we seek out partners globally to further develop our product line.”


 

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Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM)
, a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that it has submitted a request for a pre-IND (Investigational New Drug) meeting to the U.S. Food and Drug Administration (FDA) for the company's Iomab-B drug candidate currently undergoing final preparations to start the pivotal Phase 3 trial in mid-2015.  The goal of the pre-IND meeting is to finalize preparations for the final stages of its Iomab-B drug candidate development. The initial indication for Iomab-B is conditioning for bone marrow transplant in older relapsed and
refractory acute myeloid leukemia (AML) patients, for which there are no FDA approved therapies.  

"The pre-IND meeting request marks an important step in Actinium’s development program to obtain US FDA approval for Iomab-B.” stated Kaushik J. Dave, President and

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Chief Executive Officer of Actinium Pharmaceuticals, Inc. “We believe that our planned Phase 3 trial will provide patients and
physicians an important treatment option given the strength of Iomab-B’s Phase 2 clinical trial results.  The prior trial enabled previously ineligible patients to receive the procedure, yielded superior outcomes in terms of initial and durable complete responses compared to current treatments using drug combinations that are unapproved for this indication and also provided a potentially curative long term survival in 19% of patients.

“We are highly focused on moving this product into a pivotal Phase 3 trial in mid-2015.” said Dr. Dragan Cicic, Chief Medical Officer of Actinium Pharmaceuticals, Inc.  “We look forward to the FDA's response and we are preparing ourselves for our final IND submission and commencement of the pivotal Phase 3.  Given the dire medical need in this patient population, we remain committed to moving this program forward as quickly as possible."

The upcoming Phase 3 trial is a randomized controlled two armed multicenter trial with the planned enrollment of 150 patients (75 patients per arm).  The trial will be conducted in the US with the primary endpoint of durable complete response, which is a complete response lasting at least 6 months.  The secondary endpoint is landmark overall survival at 1 year.  Of all the hematological drugs approved in the US to date, about 75% have been approved based on the response rate, with the balance having been approved on disease progression and symptoms control related endpoints. Most recently, complete response was the basis for the December 2014 FDA approval of Blincyto (blinatumomab), an infusion therapy for the treatment of certain patients with acute lymphoblastic leukemia (ALL).

About Iomab-B  --  Iomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fastest growing hospital procedure in the U.S. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission could include a single, pivotal Phase 3 clinical study if it is successful. The trial population in this two arm, randomized, controlled, multicenter trial will be refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55. The trial size was set at 150 patients with 75 patients per arm. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year. There are currently no effective treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab-B has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to HSCT in various blood cancers including the Phase 1/2 study in relapsed and/or refractory AML patients. The results of these studies in over 300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.

Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.


 

Also Monday:

 

In response to the state of emergency declared in Massachusetts due to the impending winter storm tomorrow, Abiomed, Inc. (Nasdaq:ABMD) is announcing that it will reschedule its third quarter fiscal 2015 earnings release and conference call.

ACETO Corporation (Nasdaq:ACET)
, a global leader in the marketing, sale and distribution of products for Human Health, Pharmaceutical Ingredients and Performance Chemicals, will issue its financial results of operations for the second quarter of fiscal 2015 ended December 31, 2014 after the stock market close on Thursday, February 5, 2015.

Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L)
, a leading designer and manufacturer of rapid diagnostic screening and testing products, announces that the European Patent Office has issued a patent surrounding the Company's novel blood separator technology and method of separating a fluid fraction from whole blood.

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer and Mr. Stephen Tulipano, Chief Financial Officer of Aldeyra, will participate in the Canaccord Genuity Rare Disease, BioPharma One-on-One Day, being held on Tuesday, February 3, 2015 in New York, NY.

American CareSource Holdings, Inc. (Nasdaq:ANCI)
, operator of urgent care centers and a national network of ancillary health care providers, announced Friday the hiring of a new Chief Financial Officer, Anthony Levinson.

BioCryst Pharmaceuticals, Inc., (Nasdaq:BCRX)
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BCX4161, a novel, orally administered, selective inhibitor of plasma kallikrein in advanced clinical development for the treatment of hereditary angioedema.

Cutera, Inc. (Nasdaq:CUTR)
, a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, will announce results for the fourth quarter ended December 31, 2014 on Tuesday, February 3, 2015, after market close.

Enlivex Therapeutics (Enlivex), a Hadasit Bio-Holdings ("HBL") (TASE:HDST) (OTCQB:HADSY) portfolio company, today announced that the European Medicines Agency ("EMA") has granted orphan drug status to the Company's lead product candidate, ApoCell, for the prevention of Graft-versus-Host Disease (GvHD).

Erba Diagnostics, Inc. (NYSE MKT:ERB)
, strengthened its U.S. distribution network by having entered into a new agreement with Government Scientific Source and having strengthened and expanded the scope of an agreement with an existing, nationally, prominent channel partner.

Heat Biologics, Inc. (Nasdaq:HTBX)
, a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced positive data demonstrating substantially increased tumor infiltrating lymphocytes following treatment in its Phase 1 clinical trial of HS-410 in non-muscle invasive bladder cancer (NMIBC).

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
, announced today that in a new publication in the journal mBio, scientists at the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID), Harvard University, and Massachusetts Institute of Technology (MIT) studied genetic changes in the Ebola virus (EBOV) circulating in West Africa and concluded that genomic drift of the EBOV over time may be sufficient to block the action of otherwise potential therapies that target EBOV genetic sequences.

ICU Medical, Inc., (Nasdaq:ICUI)
, a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced the time of its fourth quarter 2014 earnings release conference call.

ImmuDyne, Inc. (OTCQB:IMMD)
announced today that It has chosen HellaWella as a media partner. The first published content can be accessed here: http://www.hellawella.com/how-get-immune-coldflu-season-featured-partner.

Nanosphere, Inc. (Nasdaq:NSPH),
a company enhancing medicine through targeted molecular diagnostics, today announced that it will report preliminary results for the fourth quarter and fiscal year ended December 31, 2014, as well as a business update after the market close on Wednesday, January 28, 2015.

Natus Medical Incorporated (Nasdaq:BABY)
today announced that it has entered the neurodiagnostic services market through the acquisition of Global Neuro-Diagnostics ("GND"). 

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel cancer therapeutics, announced that David Chaplin, Ph.D., president and chief executive officer, will provide a corporate overview at the 17th Annual BIO CEO & Investor conference on February 10, 2015.

Pazoo, Inc. (OTCQB:PZOO) (German WKN#: A1J3DK)
is pleased to announce its seventh Pazoo Radio episode is now available for download at www.pazoo.com by clicking on the Pazoo Radio tab on the upper right hand side of the home page.

PharmaCyte Biotech, Inc. (OTCQB:PMCB),
a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live cell encapsulation technology, Cell-in-a-Box®, today reported that preparations for an expanded, follow-up study of the effectiveness of its pancreatic cancer treatment (a combination of low doses of the cancer prodrug ifosfamide and Cell-in-a- Box® capsules containing live cells capable of converting ifosfamide into its cancer-killing form) on the accumulation of malignant ascites fluid are in their final stages.

Rockwell Medical, Inc. (Nasdaq:RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that the U.S. Food & Drug Administration (FDA) has approved its drug Triferic for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.

Steiner Leisure Limited (Nasdaq:STNR)
, announced today that it will release its Fourth Quarter 2014 earnings on Wednesday, February 18, 2015 after market close.

StemCells, Inc. (Nasdaq:STEM)
, a leading stem cell company developing novel cell-based therapeutics for disorders of the central nervous system, posted today the following Letter to Shareholders from its President and CEO, Martin McGlynn.



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