|CytRx Offers Initial Results from Aldoxorubicin Trial; Abbott Announces CE Mark for World's Longest Coronary Drug Eluting Stent|
|By Staff and Wire Reports|
|Tuesday, 21 May 2013 18:30|
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced initial data from a Phase 1b clinical trial evaluating the pharmacokinetics and safety of aldoxorubicin, its novel conjugate of the widely used chemotherapeutic agent doxorubicin, in patients with metastatic solid tumors who have either relapsed or not responded to treatment with standard therapies. The data indicate that aldoxorubicin has a distribution half-life of 20-24 hours following infusion, which is significantly longer than doxorubicin's initial half-life of five minutes. The data also demonstrate that aldoxorubicin demonstrated a distribution to healthy tissues that was 250-fold lower than that of doxorubicin.
“The initial trial results provide positive insights about how aldoxorubicin acts within the body, which is an important component of regulatory submissions and could point to its safety and effectiveness,” said Steven A. Kriegsman, CytRx President and CEO. “A longer half-life and narrow drug distribution to healthy tissues are potentially beneficial characteristics, because the drug remains active for increased time periods with decreased potential for toxicity.
“In the clinical trial, aldoxorubicin has shown prolonged clinical activity in two trial patients with small cell lung cancer who had failed other therapies, including a partial tumor response,” he added. “This was observed even at the lower, well-tolerated dose. We may consider further investigating aldoxorubicin in this indication among several others in the future. In fact, aldoxorubicin could be active against a variety of cancers, having shown to be superior to widely used doxorubicin in multiple animal models of cancer.”
The open-label, single-center Phase 1b clinical trial is being conducted under the direction of Dr. Monica Mita at Cedars-Sinai Medical Center in Los Angeles. Aldoxorubicin is being administered at doses of 230 mg/m2 and 350 mg/m2 every 21 days for up to 8 consecutive cycles.
Abbott (NYSE: ABT ) announced CE Mark in Europe for the XIENCE Xpedition™ 48 Everolimus Eluting Coronary Stent System, the first-of-its-kind treatment for very long blockages in the vessels that supply blood to the heart due to coronary artery disease (CAD). XIENCE Xpedition 48 leverages the proven design and clinical outcomes of the XIENCE family of drug eluting stents in a unique 48 mm length. Abbott continues to offer physicians more options for the treatment of patients with complex coronary artery disease and is the only major manufacturer to offer a coronary drug eluting stent greater than 38 mm in length. XIENCE Xpedition 48 is the latest in a long history of stent innovations pioneered by Abbott, which was the first company to offer physicians size-specific metallic stents for use in small and large vessels of the heart.
Studies indicate that physicians choose to use multiple shorter length stents to meet the challenges of treating long blockages – or lesions – in as many as 30 percent of interventional heart procedures, as conventional stent sizes may not always fully cover the lesion. It has been shown, however, that the use of a single stent instead of multiple stents may result in several procedural benefits, including the use of fewer devices, less exposure to X-ray during the procedure, and reduced procedure time, which could lead to economic benefits.
In patients with coronary artery disease, lesions are caused by the buildup of fat and cholesterol inside blood vessels; long lesions are most often seen in patients with diabetes, a significant and growing portion of the population due to changing diet and lifestyle habits. When the blood vessels feeding the heart are blocked or partially blocked due to CAD, patients can experience symptoms such as chest pain and shortness of breath, and in some cases, a heart attack.
"With global economic pressures impacting hospitals and health care systems around the world, products like XIENCE Xpedition 48 may provide important cost savings to the system," said Peter Smits, M.D., Maasstad Ziekenhuis, Rotterdam, the Netherlands. "I believe that this new treatment option, backed by the robust clinical outcomes of the XIENCE family of drug eluting stents, will help physicians in the treatment of long lesions."
XIENCE Xpedition 48 is supported by strong clinical evidence from the XIENCE family of drug eluting stents, including data from more than 53,000 patients across more than 100 studies with long-term outcomes out to five years. The safety of the XIENCE family of drug eluting stents has been consistently demonstrated in a number of clinical trials representative of routine clinical practice. The XIENCE family has one of the broadest ranges of CE Mark indications for drug eluting stents on the market in Europe, including indications to treat patients with complex disease such as diabetes.
"One of the hallmarks of Abbott's vascular product development is our ability to identify new ways to help physicians address the needs of their patients," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. "XIENCE Xpedition 48 provides a new, unique solution for treating patients with very long lesions, affirming Abbott's commitment to continued innovation."
XIENCE Xpedition is available in one of the broadest size matrices on the European market, with diameters ranging from 2.25 mm to 4 mm, including a unique 3.25 mm diameter, and now with lengths ranging from 8 mm to 48 mm.
Acorda Therapeutics (NASDAQ: ACOR) today announced new research findings that show a loss of mobility due to multiple sclerosis (MS) has a negative impact on work productivity and patient-reported perceptions of health.
Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, is sponsoring two screenings of the new film Decoding Annie Parkerat the Seattle International Film Festival on June 6 and 8, 2013.
Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc., (NASDAQ:HALO) today announced that the European Commission has granted Baxter marketing authorization in all European Union (EU) Member States for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies.
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, announced today that its Board of Directors has declared a one-half percent stock dividend payable on June 28, 2013, to stockholders of record on June 14, 2013.
BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today provided an update on the company's current and upcoming clinical trial and scientific conference activities.
Cancer Genetics, Inc. (OTCQB: CGIX) ("CGI" or the "Company"), a leader in oncology-focused personalized medicine, has entered into an agreement with MultiPlan, Inc. (“MultiPlan”), the industry’s most comprehensive provider of healthcare cost management solutions.
ChromaDex Corporation (OTCQB: CDXC) Director Michael Brauser purchased 25,000 shares of common stock on the open market on May 13th, according to a Form 4 filing made with the SEC.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that one-year data from its European post-approval study of the Edwards SAPIEN XT transcatheter aortic heart valve continued to demonstrate positive patient outcomes, including all-cause mortality and complication rates.
eHealth, Inc. (NASDAQ: EHTH), parent company of eHealthInsurance.com, the nation's first and largest private online health insurance exchange, published the first step in its six step guide to help consumers prepare for health care reform and this year's new open enrollment period, which begins Oct. 1, 2013.
Grifols, S.A. (MCE:GRF, MCE:GRF.P and NASDAQ:GRFS) (“Grifols”) and Aradigm Corporation (OTC BB:ARDM.OB) (“Aradigm”) today announced the signing of an exclusive, worldwide license for Aradigm’s proprietary formulations of inhaled ciprofloxacin (Pulmaquin and Lipoquin™) for the treatment of severe respiratory diseases, including non-cystic fibrosis bronchiectasis (BE).
IsoRay, Inc. (AMEX: ISR), announced today that it has entered into an exclusive international distribution agreement with IASIS Medical for the sale of IsoRay's complete product line in Greece.
Masimo (NASDAQ: MASI) announced today that a new clinical study posted online in Respiratory Care confirms the clinical utility of Masimo's noninvasive carboxyhemoglobin (SpCO®) from rainbow® Pulse CO-Oximetry™ as a first-line assessment tool in helping clinicians rapidly detect carbon monoxide (CO) poisoning.1
Medistem, Inc. (PINKSHEETS: MEDS), today announced that it has appointed Herm Rosenman to its Board of Directors and Chairman of the Audit Committee.
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced the upcoming presentation of data highlighting Kyprolis® (carfilzomib) for Injection, a second-generation proteasome inhibitor, and oprozomib, an oral proteasome inhibitor in early development, at the 18th Congress of the European Hematology Association (EHA) Annual Meeting, June 13-16, 2013 in Stockholm, Sweden.
Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio technology and solutions, today announced results from the first round of clinical testing of its HyperSound audio system.
Revolutions Medical Corporation (OTCQB: RMCP) has received a 12 million unit contract of its RevVac™ auto-retractable vacuum safety syringe from AGN Tech International, LLC, ("AGN Tech") the exclusive distributor of all RevVac™ safety syringe product lines in Brazil.
Royal Philips Electronics (NYSE: PHG, AEX: PHIA) today announced that CX50 xMATRIX, the world's first portable ultrasound with Philips' industry leading Live 3D TEE, now offers 2-D Intracardiac Echo (ICE) capability.
Safeguard Scientifics, Inc. (NYSE:SFE), a holding company that builds value in growth-stage healthcare and technology companies, today announced that its annual meeting of shareholders will be held on Thursday, May 23, 2013 at 8:00 a.m. EDT at the Courtyard Philadelphia Valley Forge / King of Prussia.
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH) announced today that Frank Oaks, President & CEO and Darrell Brookstein, Executive VP, will present at the Second Annual Marcum LLP MicroCap Conference on Thursday, May 30, 2013 in New York City at the Grand Hyatt Hotel.
Stevia Corp. (OTCQB: STEV) ("Stevia Corp" or the "Company"), a farm management company focused on the economic development of stevia, the fastest growing product in the alternative sweetener sector, is pleased to announce that it achieved its revenue projection for the current harvest and that its Vietnam project will be used as a case study by the Vietnam Ministry of Finance.
Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focused on the prevention and treatment of serious infectious diseases, announced today that Jeffrey Riley, CEO, will present at the 2nd Annual Marcum LLP MicroCap Conference on Thursday, May 30, 2013 in New York City at the Grand Hyatt Hotel.