CEL-SCI's Phase III Head and Neck Cancer Clinical Trial to Enroll and Treat Detroit Patients; ImmunoGen's Initial Research Shows IMGN853 Achieves Objective Print
By Staff and Wire Reports   
Tuesday, 08 April 2014 18:45

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 8, 2014.
CEL-SCI Corporation (NYSE MKT: CVM) announced the Henry Ford Health System in Detroit, Michigan is the latest U.S. clinical center to join the Company's Phase III head and neck cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). CEL-SCI is currently expanding and accelerating patient enrollment in its trial. The Company expects to rapidly expand the number of clinical sites active in the U.S. As the world's largest Phase III trial for head and neck cancer, CEL-SCI's study is already active in dozens of clinical centers in 12 countries and is expected to expand to a total of 20 countries by the end of 2015.

CEL-SCI's Multikine investigational cancer immunotherapy is intended to create an anti-tumor immune response to reduce local/regional tumor recurrence and thereby increase the survival rate of patients. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors.

According to a report published by the Metropolitan Detroit Cancer Surveillance System in 2010, there were 24,651 new invasive and in situ cancers diagnosed in residents of the metropolitan Detroit area of Wayne, Oakland, and Macomb Counties. In a national study researchers estimated that more than 52,000 men and women would be diagnosed in the U.S. with head and neck cancers in 2012, according to the National Cancer Institute.

Founded in 1915 by auto pioneer Henry Ford and now one of the nation's leading health care providers, Detroit's Henry Ford Health System is comprised of hospitals, medical centers and one of the nation's largest group practices, which includes more than 1,200 physicians practicing in over 40 specialties.

The Josephine Ford Cancer Institute at Henry Ford is a leader in groundbreaking techniques, offering the most advanced diagnostic testing, and multiple treatment approaches including surgery and radiation therapy. Dr. Haythem Ali, a medical oncologist, is the Principal Investigator for CEL-SCI's study at Henry Ford. His specialties include head and neck cancer and he has published several articles in peer reviewed journals.

"This is our first U.S. clinical center to open in the Midwest. Our intention is to rapidly add more clinical research centers located across North America so that patients seeking to enroll in our immunotherapy trial may have the opportunity to access a site. We are pleased that Dr. Haythem and one of the leading healthcare providers in the country, Henry Ford Health System, have chosen to participate in our groundbreaking study," stated CEL-SCI Chief Executive Officer Geert Kersten.


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ImmunoGen, Inc. (NASDAQ: IMGN)
, a biotechnology company that develops novel anticancer therapeutics using its antibody-drug conjugate (ADC) technology, today announced the first findings from Company research aimed at optimizing the dosing of its IMGN853 product candidate. The data were presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA.

Based on findings in the first patients to receive IMGN853, ImmunoGen identified that clinical activity is seen with the compound starting at doses of 3.3 mg/kg and its dose-limiting toxicity is the reversible ocular side effects (blurred vision and keratitis) reported with ADCs in development by several companies. These side effects occurred at IMGN853 doses of 5 mg/kg and above, with dose based on patient total body weight (TBW).

As presented today, modeling research conducted by ImmunoGen predicted that dosing IMGN853 using adjusted ideal body weight (ADJ) rather than TBW should reduce the variability among patients in the concentration of IMGN853 in their blood, as ADJ would better match the dose administered to patient blood volume. Reducing this variability should enable IMGN853 to be well tolerated in more patients at dose levels greater than 3.3 mg/kg. Based on these insights, dosing in the ongoing IMGN853 Phase 1 trial was changed to ADJ several months ago, and the first findings were reported today.

The clinical findings to date validate the prediction: none (0 of 6) of the patients treated with IMGN853 at 5 mg/kg ADJ have had ocular side effects of any grade. This compares with 4 of 10 patients treated at 5 mg/kg TBW. IMGN853 dose escalation above 5 mg/kg ADJ is ongoing.

“ImmunoGen is committed to successfully developing novel drugs that make a difference for people with cancer,” said Dr. Charles Morris, ImmunoGen Executive Vice President and Chief Development Officer. “Key to drug development is establishing the dosing strategy that provides the greatest efficacy with the least toxicity for each compound, and we believe the findings reported today reflect a strong path forward for IMGN853. We look forward to sharing additional IMGN853 clinical data in the months ahead.”

ImmunoGen also identified that dosing IMGN853 with a modified weekly schedule – weekly for three weeks every four weeks – should maximize tumor exposure to the compound while keeping IMGN853 blood levels in well-tolerated ranges. This dosing schedule, also using ADJ, has been added to the IMGN853 Phase 1 trial, but patient enrollment started too recently for findings to be available by AACR.

IMGN853 is in Phase I clinical testing for the treatment of folate receptor α (FRα)-positive cancers. The Company is currently establishing the maximum tolerated dose (MTD) of IMGN853 when administered once every three weeks using ADJ. Once this MTD is established, IMGN853 will be evaluated at that dose specifically in patients with platinum-resistant ovarian cancer and in patients with relapsed endometrial cancer. The Company is now also establishing its MTD with the modified weekly schedule.


Also Tuesday:



Abiomed, Inc. (Nasdaq:ABMD),
a leading provider of break-through heart support technologies, today announced it has received CE Marking approval in the European Union to market the Impella® RP device, a new percutaneous Impella heart pump that provides temporary ventricular support for patients with right ventricular failure.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to cell cycle dysregulation, endoplasmic reticulum stress, neurodegeneration and apoptosis, today announced the appointment of Charlotte Keywood, MD, as Chief Medical Officer of the Company's therapeutics division.

AtheroNova Inc. (OTCBB:AHRO)
, a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced that Randolph M. Johnson, Ph.D. has joined the Company as Chief Operating Officer.

Authentidate Holding Corp. (Nasdaq:ADAT)
, a provider of secure web-based software applications and telehealth products and services for healthcare organizations, today announced that Canton-Potsdam Hospital of Potsdam, New York (CPH) has selected Authentidate's InscrybeMD® Telehealth solution to support their remote patient monitoring needs for its growing community care network.

Capstone Therapeutics (OTCQB:CAPS)
and its joint venture affiliate, LipimetiX Development, LLC ("JV"), announced today the initiation of dosing for its AEM-28 (Apo E mimetic peptide) Phase 1 human clinical trial in LDL/non-HDL cholesterol reduction.

Hemispherx Biopharma, Inc. (NYSE:HEB)
announced today the peer-reviewed publication titled "Discordant Biological and Toxicological Species Responses to TLR-3 Activation" in the current issue of the American Journal of Pathology Vol. 184 (pages 1062-1072), 2014.

Hemp, Inc. (OTC:HEMP)
today reported 2013 fourth quarter sales of $722,486, showing quarter-on-quarter increase for the year of 2013. Sales by quarter for the year were $426,321 for the 1st quarter; $534,871 in sales for the 2nd quarter; and, $673,588 sales in for the 3rd quarter.

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported results from preclinical studies on the Company's two investigational SN-38-containing antibody drug conjugates (ADCs), IMMU-130 and IMMU-132, that demonstrated a high therapeutic index for both agents.

Intuitive Surgical, Inc. (Nasdaq:ISRG)
, the industry leader in robotic-assisted surgery, today issued the following announcement in advance of the April 22, 2014 release of its first quarter 2014 financial results.

MediciNova, Inc. a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the appointment of Mr. Yoshio Ishizaka to its Board of Directors.

Medical Marijuana, Inc. (OTC Pink:MJNA)
is pleased to inform shareholders and the general public that HempWire, LLC ("HempWire") – the Company's joint venture with LiveWire Ergogenics, Inc. (OTCQB:LVVV) ("LiveWire") – received its initial purchase order for the world's first CBD-rich hemp oil-infused functional food products.

Medical Marijuana Sciences, Inc.,
a subsidiary of Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, reported today that Dr. Mark L. Rabe's presentation at the National Medical Cannabis Unity Conference, held this past weekend in Washington DC, prompted numerous questions and a lively discussion on Nuvilex's proprietary Cell-in-a-Box® platform and how Medical Marijuana Sciences is working to combine it with the cancer-fighting properties of cannabinoids.

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced data from an oral presentation and eight poster presentations at the American Association of Cancer Research (AACR) Annual Meeting in San Diego, CA April 5-9, 2014.

Prosensa Holding N.V. (NASDAQ: RNA)
, the Dutch biopharmaceutical company focusing on rare diseases with a high unmet medical need, today announced that Michael S. Wyzga has been nominated for appointment to its Supervisory Board at the next shareholders' meeting, scheduled for June 17, 2014.

Protea Biosciences Group, Inc. (OTCBB:PRGB)
, announced today that Greg Kilby, Ph.D. has joined the Company as its Chief Bioanalytics Officer (CBO) and Director of Biomolecular Information Services.

Prothena Corporation plc (Nasdaq:PRTA)
, a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion, announced today the successful start of a Phase 1 clinical trial of its therapeutic monoclonal antibody candidate, PRX002, for the treatment of Parkinson's disease.

Relypsa, Inc. (Nasdaq:RLYP)
, a biopharmaceutical company, today announced it has commenced an underwritten public offering of shares of its common stock to raise aggregate proceeds of $80 million.

Rich Pharmaceuticals, Inc. (OTCQB:RCHA)
is pleased to announce the appointment of Renping Zhou, Ph.D., to the Company's Medical Advisory Board.

Stemline Therapeutics, Inc. (Nasdaq:STML)
announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for SL-701, which enables the company to advance SL-701 into a Phase 2 trial of adults with glioblastoma multiforme (GBM) in first recurrence.

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS)
today announced the presentation of results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it will host a live webcast of its first quarter conference call on Tuesday, April 22nd at 3:30pm CDT. Vascular Solutions' Chief Executive Officer, Howard Root, Chief Financial Officer, James Hennen and VP of Corporate Development, Phil Nalbone, will discuss the company's first quarter results.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
, a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today the presentation of data from a study demonstrating the anti-tumor effects and tolerability of Ad-RTS-mIL-12 in a glioblastoma (brain cancer) murine model.




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