Exact Sciences Publish Results of DeeP-C Study in NEJM; Navidea Offers Update on EMA Application For Lymphoseek Print E-mail
By Staff and Wire Reports   
Wednesday, 19 March 2014 18:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 19, 2014.

Exact Sciences Corp. (Nasdaq: EXAS)
announced results from its DeeP-C pivotal clinical study have been published online in the New England Journal of Medicine. The peer-reviewed study, “Multi-target Stool DNA Testing for Colorectal-Cancer Screening” will also appear in the journal's April 3, 2014 print issue.

The 10,000-patient DeeP-C study was designed to determine the performance characteristics of Exact Sciences' multi-target stool DNA-based screening test, Cologuard ®, for colorectal cancer and to compare that performance to the fecal immunochemical test (FIT), a commonly used non-invasive colorectal cancer screening test. The DeeP-C study took place at 90 centers throughout the U.S. and Canada.

The DeeP-C data published in the NEJM elaborate on top-line data Exact Sciences announced in April of 2013. Data published today include:

* Sensitivity of Cologuard in detecting patients with colorectal cancer was 92% versus 74% for FIT; * Sensitivity in detecting patients with colorectal cancers in Stages I-III —those determined by the American Joint Committee on Cancer to be associated with an increased rate of being cured—was 93% for Cologuard versus 73 % for FIT; * Sensitivity for patients with advanced pre-cancerous lesions was 42% for Cologuard versus 24% for FIT; * Cologuard detected 69% of patients with polyps with high-grade dysplasia versus 46% for FIT; * Cologuard achieved a specificity of 87% versus FIT specificity of 95%.

Colorectal cancer is often considered the most preventable, yet least prevented cancer. One out of 3 adults age 50 and older has not been screened as recommended and, as a result, colorectal cancer remains the second-leading cancer killer in the United States. Colorectal cancer is highly treatable if found early, making the detection of pre-cancerous polyps paramount.

“We know that colorectal cancer can be prevented and can be highly treatable if found early through screening,” said lead author Thomas F. Imperiale M.D., of the Indiana University School of Medicine, Regenstrief Institute Inc., the IU Simon Cancer Center, and the Roudebush VA Medical Center in Indianapolis. “Sensitivity is the most important characteristic for screening tests because the primary role of such testing is to rule out diseases such as cancer. In our clinical study, the data show that Cologuard, the multi-target stool-based DNA test, is highly sensitive in detecting colorectal cancer and higher risk pre-cancerous polyps in a large, diverse average-risk patient population and has the potential to be an important screening tool.”

“We are very pleased with the data published today in the New England Journal of Medicine,” said Kevin T. Conroy, president and chief executive of Exact Sciences. “We believe Cologuard could be an important tool in the early detection of colorectal cancer. This is an important milestone for Exact Sciences and Cologuard.”

The Exact Sciences Cologuard screening test is an investigational device currently under review by the U.S. Food and Drug Administration (FDA) and is not available for sale in the United States. The FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to review Exact Science's PMA application for Cologuard on March 27, 2014.


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Navidea Biopharmaceuticals, Inc. (NYSE: NAVB)
, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced it held an update meeting with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the pending Marketing Authorization Application (MAA) of Lymphoseek^® (technetium Tc 99m tilmanocept) Injection. Lymphoseek is a lymphatic mapping agent designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. As part of the MAA review process, Navidea presented Oral Explanations to the CHMP relating to open questions in the Lymphoseek MAA. At the conclusion of the meeting, the CHMP informed Navidea that the Committee will continue with its review of the MAA. Navidea believes the course of the review continues to be supportive of its market development plans and outlook for material revenue generation in Europe beginning in 2015, as previously disclosed.

Based on feedback received at the meeting, Navidea believes that the CHMP has found the safety and efficacy data submitted in the MAA for breast cancer and melanoma to be acceptable. The CHMP will now focus its review on the remaining areas of product specifications unique to the European application and on data from the Phase 3 study in head and neck cancer. During this process, the MAA remains active but the review clock will continue to be stopped while Navidea works with the CHMP to address these remaining areas.

"The European review of Lymphoseek continues to progress. The Oral Explanation meeting was productive and provided an opportunity for both Navidea and our technical experts to discuss the Lymphoseek application with the CHMP. We achieved our goals in this meeting of getting positive feedback on the breast cancer and melanoma aspects of the filing and clarifying the remaining areas of focus so the review can proceed in a timely manner. We appreciate the CHMP's constructive input and guidance,” stated Mark Pykett, VMD, PhD, Navidea CEO. “We will continue our ongoing dialogue with the EMA to address remaining areas and plan to provide further updates on this process in the coming weeks.”

The Lymphoseek MAA is supported by a comprehensive, multi-trial clinical program including two Phase 3 studies of Lymphoseek (NEO3-05 and NEO3-09) performed in patients with either breast cancer or melanoma and a third Phase 3 study (NEO3-06), in patients with head and neck cancer, contributing to a safety database of more than 550 patients. The MAA is based on the same pivotal efficacy and safety data package provided in the U.S. New Drug Application (NDA) and two supplemental NDA (sNDA) submissions. The U.S. Food and Drug Administration (FDA) approved Lymphoseek in the United States in 2013 for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. Lymphoseek was also granted Fast Track designation and Priority Review for one of its sNDAs focused on sentinel lymph node detection in patients with head and neck cancer, with an upcoming Prescription Drug User Fee Act (PDUFA) target date of June 16, 2014. The second sNDA has a PDUFA target date of October 16, 2014.


Also Wednesday:



Aastrom Biosciences, Inc. (Nasdaq:ASTM)
, the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today announced that Nick Colangelo, President and CEO of Aastrom, will present at the 2014 Regen Med Investor Day on Wednesday, March 26 at 3:15 p.m. EDT at the Metropolitan Club in New York City.

Abengoa (MCE: ABG.B/P SM /NASDAQ: ABGB), the company that applies innovative technology solutions for sustainability in the energy and environment sectors, has been awarded a positive credit outlook by the credit rating agency Standard & Poor's (S&P).

Anavex Life Sciences Corp. (OTCQB:AVXL)
, a clinical stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's, diseases of the central nervous system (CNS) and various types of cancer, announced today that it has closed, as previously announced on March 13, 2014, the private placement of $10 million in principal amount of convertible debentures with several institutional and accredited investors, including U.S. and international healthcare funds.

Argos Therapeutics Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced that the company will be presenting at the Second Annual Regen Med Investor Day hosted by the Alliance for Regenerative Medicine on March 26, and the 4th Annual Cancer Immunotherapy: A Long Awaited Reality Conference presented by Maidstone Life Sciences on March 27.

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR)
today announced the appointment of Dr. Mark Corrigan to the company's board of directors.

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX),
a specialty pharmaceutical company focused on developing safe and effective approved medicines targeting orphan neuromuscular and neurological diseases today reported financial results for the fourth quarter and year-ended December 31, 2013.

Cellectar Biosciences, Inc. (OTCQX:CLRB)
, a biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced that management will host a conference call and live webcast to discuss full year 2013 financial results, provide an update on each of its development programs and discuss expectations for fiscal 2014 on Tuesday, March 25 at 5:00 PM ET.

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
today announced that Chief Executive Officer Bob Palay will present at the 2nd Annual Regen Med Investor Day to be held Wednesday, March 26, 2014, in New York City.

Global supercomputer leader Cray Inc. (NASDAQ: CRAY) today announced the Company has been awarded a contract to provide the Hong Kong Sanatorium & Hospital (HKSH) with a Cray® XC30™ supercomputer -- the first XC30 system in China.

Foundation Healthcare Inc. (OTCQB:FDNH),
an owner and operator of surgery focused hospitals that facilitate and enhance the surgical experience for surgeons and their patients, announced today it will host an earnings call to discuss the Company's 4th Quarter and full year 2013 financial results at 4 p.m. EDT (3 p.m. CDT) on Thursday, March 27, 2014.

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
will participate in the 11th Biennial International Research and Clinical Conference to be held in San Francisco, California, USA, March 20-23, 2014.

Intelligent Living Inc. (OTCQB: ILIV)
announced that it would be holding a shareholder conference call on Friday, April 11, 2014 from 11 AM to 12 PM EDT.

Medical Marijuana Inc. (OTC Pink:MJNA)
is pleased to announce that it has fully funded operations of subsidiary Wellness Managed Services' new company, MPS International (MPSI). Since MPSI operations began on January 1, 2014, the Company has expanded the business from one to four states and is already planning expansion into seven additional states.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today that the Company will present at three sessions at the Alliance for Regenerative Medicine (ARM) 2nd Annual Regen Med Investor Day, to be held on March 26, 2014.

Omeros Corporation (NASDAQ: OMER)
today announced that it has closed the underwritten public offering that was priced and allocated to investors prior to the opening of the market on March 14, 2014, relating to the sale of 3,500,000 shares of its common stock at a price of $11.50 per share for gross proceeds of approximately $40.25 million.

O'Reilly Automotive, Inc. (Nasdaq:ORLY),
a leading retailer in the automotive aftermarket industry, announces that it is extending coverage under its fully self-funded health plans to same-sex spouses of otherwise eligible Team Members whose marriages are legally recognized under state law at the time and location of their marriage.

Parametric Sound Corporation (NASDAQ: PAMT)
today announced that it plans to file an amendment to its Current Report on Form 8-K filed on January 16, 2014 after the market close on Thursday, March 27, 2014 to include unaudited pro forma financial information of the combined companies as of and for the year ended December 31, 2013 along with audited financial statements for VTB Holdings, Inc. and its subsidiaries.

Portola Pharmaceuticals (Nasdaq:PTLA)
today announced that it has initiated a Phase 3 study of andexanet alfa, the company's investigational Factor Xa inhibitor reversal agent.

Sangamo BioSciences, Inc. (Nasdaq: SGMO)
announced today that it has commenced a $100 million underwritten public offering of shares of its common stock.

SK3 Group (OTC Pink: SKTO) (PINKSHEETS: SKTO)
and PharmaJanes.com (OTCQB: AEGY) are pleased to announce that they have signed a definitive agreement with Video Podcast Network, LLC to sponsor multiple episodes of the industry leading YouTube based video talk show "Getting Doug with High," broadcast live weekly each Wednesday at 4:15pm.

Cutting edge and industry leading YouTube based talk show "Getting Doug with High" will feature the products and services of title sponsors SK3 Group (OTC Pink: SKTO) (PINKSHEETS: SKTO) and Pharmajanes.com (OTCQB: AEGY) (PINKSHEETS: AEGY) ( later today at 6:15pm Pacific Time.

StemCells, Inc. (Nasdaq:STEM)
announced today that management will present at the 13th Annual Needham Healthcare Conference, on Wednesday, April 9, at 8:40 AM EDT at the Westin Grand Central Hotel, 212 East 42nd Street, in New York City.

Wellness Center USA, Inc. (OTCQB:WCUI)
, a healthcare and medical solutions provider, today announced that Dr. Jay Joshi, MD, WCUI's Chief Medical Officer, was recently featured in one of CNN's key debates on medical marijuana for chronic pain.

Xencor Inc. (NASDAQ: XNCR)
, a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases, and cancer, today reported financial results for the fourth quarter and full year ended December 31, 2013 and provided a review of business highlights.



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