Hologic, Inc. recently announced that its 3D mammography technology showed a significant reduction in recall rates and a sizeable increase in cancer detection, particularly invasive cancer, across all breast tissue densities when compared to conventional 2D mammography alone.

The study, “Implementation of Breast Tomosynthesis in a Routine Screening Practice: An Observational Study” was the first large-scale observational study in the US to compare these technologies. The study evaluating recall, biopsy, cancer detection and invasive cancer detection rates in a community-based breast imaging practice was published in the June issue of the American Journal of Roentgenology (AJR).

The study, led by Stephen L. Rose, MD, President and Founder of Rose Imaging, Medical Director of TOPS Comprehensive Breast Cancer, and Breast Radiologist affiliated with Memorial Hermann Health System in Houston, Texas compared the outcomes of 2D mammography screening exams that were interpreted prior to the introduction of Hologic’s 3D mammography, with screening exams after introduction.

Results showed that the use of Hologic’s 3D mammography resulted in a 38 percent reduction in recall rates and an 11 percent decrease in biopsy rates. Additionally, there was a 35 percent increase in cancer detection rates and a 53 percent increase in invasive cancer detection rates.

The study consisted of 13,856 women who had received the conventional 2D mammography screening exams and 9,499 women who received Hologic’s 3D version.

“The findings in the Rose paper demonstrate that Hologic 3D mammograms overcome many of the limitations of conventional mammography, namely missed cancers and unnecessary recalls,” Peter Soltani, Hologic Senior Vice President and General Manager, Breast Health stated. “The use of this groundbreaking technology when performing a screening exam allows radiologists to see distortions of the breast tissue in greater detail than with 2D mammography alone. This results in earlier detection of cancers when they are easier to treat and a reduction in false positive that may look worrisome on conventional digital mammography.”

Source: Hologic, Inc.

Last Updated: 5/23/13; 2:25PM EST

Bayer HealthCare recently announced data from its interim analysis of an extension of a late-stage trial with riociguat showing long-term safety and sustained clinical benefits in patients with pulmonary arterial hypertension (PAH).

The ongoing PATENT-2 trial is the open-label long-term extension of the pivotal Phase III study PATENT-1. An interim analysis was presented at the American Thoracic Society International Conference in Philadelphia, PA. The results support the safety and clinical benefits from the PATENT-1 trial.

“Despite the availability and advantages of several approved PAH therapies, the prognosis for patients remains poor and mortality remains high. The interim results of PATENT-2 support the benefits of riociguat that were seen in the PATENT-1 trial. We are confident that, together, these results reinforce the role of riociguat, if approved, as a new treatment in the armamentarium against PAH,” Kemal Malik, member of the Bayer HealthCare Executive Committee and Head of Global Development stated.

Data from the first interim analysis of PATENT-2 showed that riociguat was well tolerated with a good long-term safety profile for both treatment-naïve and pre-treated PAH patients. According to the company, headache, dizziness, dyspepsia, and hypotension were the most frequent drug-related adverse events. For patients who continued riociguat treatment, further improvemeds were seen in the six minute walking distance (6MWD).  In PATENT-2, after an additional 12 weeks of treatment the 6MWD had increased further in former riociguat patients compared with baseline of pivotal PATENT-1 trial.

The presentation of the interim analysis follows the priority review that was recently granted to riociguat by the US Food and Drug Administration (FDA).

Source: Bayer HealthCare

Last Updated: 5/21/13; 3:30PM EST

Today, Baxter International Inc. and Halozyme Therapeutics, Inc. announced that the European Commission has granted Baxter marketing authorization for HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies.

“HyQvia offers patients with primary and secondary immunodeficiencies the ability to administer their treatment in a single subcutaneous site every three to four weeks. This represents an important advance for patients who are managing chronic disease as HyQvia combines key benefits of intravenous and subcutaneous administration into one product,” Ludwig Hantson, PhD, President of Baxter’s BioScience Business stated. “We look forward to introducing HyQvia in the coming weeks to support physicians and adult immunodeficient patients in Europe.”

According to the company, the European Commission has granted Baxter marketing authorization in all European Union (EU) Member States. Baxter will introduce the drug in select countries during 2013 and will expand launch to other EU countries in 2014.

HyQvia is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which assists in the dispersion and absorption of the IGSC, increasing the bioavailability. Hyaluronidase is a licensed product from Halozyme Therapeutics.

The approval was based on results from a Phase III clinical trial, which evaluated the safety and effectiveness of the drug in preventing acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously.  The study’s objective was to infuse a three or four-week dose of the treatment in a single subcutaneous site.

“We are delighted that these patients who depend on immunoglobulin replacement treatment will have access to HyQvia,” Gregory I. Frost, PhD, President and Chief Executive Officer at Halozyme Therapeutics said in a statement.

Source: Baxter International Inc.

Last Updated: 5/21/13; 9:35AM EST

Synageva BioPharma Corp., a biopharmaceutical company focused on development of therapeutic products for rare diseases, announced that its sebelipase alfa was granted Breakthrough Therapy designation from the US Food and Drug Administration (FDA).

Sebelipase alfa was granted Breakthrough Therapy designation for treatment of early onset lysosomal acid lipase deficiency (LAL Deficiency), which is a rare autosomal recessive lysosomal storage disorder. LAL Deficiency is commonly known as Wolman disease.

According to the company, late onset of LAL Deficiency is an underappreciated cause of cirrhosis and accelerated atherosclerosis in children and adults. These are a result of the buildup of fatty material in the liver and blood vessel walls, which is a result of decreased LAL enzyme activity. Early onset LAL Deficiency, Wolman disease, is the most rapidly progressive form of LAL Deficiency. It is usually fatal within the first six months of life. Currently, there are no treatments for this disease.

“We are pleased that the FDA designated sebelipase alfa as Breakthrough Therapy for patients with early onset LAL Deficiency, or Wolman disease,” Anthony Quinn, MBChB, PhD, FRCP, Senior Vice President and Chief Medical Officer of Synageva said in a statement. “We are deeply aware of the devastating impact this disease has on infants who often die within the first six months of life because of this disease. Our ongoing Phase 2/3 trial delivers hope for these infants and their families. We continue to progress site activation and patient enrollment in both this trial and the global Phase 3 ARISE trial in children and adults, and look forward to working closely with the FDA to support approval of the drug in an efficient manner.”

Source:  Synageva BioPharma Corp.

Last Updated: 5/20/13; 4:30PM EST