|iCad gets 510k clearence. XOMA jumps on Orphan designation|
|By BioMedReports.com Staff|
|Wednesday, 04 August 2010 18:19|
iCad Inc. (Nasdaq: ICAD) Announced today that The U.S. Food and Drug Administration has given clearance to VeraLook, iCAD’s computer-aided detection product used in the interpretation of virtual colonoscopy exams. iCAD is an industry-leading provider of advanced image analysis solutions for the early detection of cancer.
"This breakthrough technology will aid radiologists in detecting and highlighting suspicious areas that could be missed during an initial review of a virtual colonoscopy exam," said Dr. Abraham Dachman, Professor of Radiology and Director of Fellowship Programs at the University of Chicago. "As with breast and prostate cancer detection, computer-aided detection for virtual colonoscopy will help us find more cancers at an earlier stage."
VeraLook from iCAD uses sophisticated interpretive technology to automatically identify polyps in images produced from a virtual colonoscopy, also known as CT colonography (CTC). A typical exam may contain between 1,200-1,500 images per patient. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Shares of iCad soared 17.71% or 34 cents to $2.26.
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that the U.S. Food and Drug Administration has designated XOMA 052, an antibody to interleukin-1 beta, an orphan drug for the treatment of Behcet's disease. As previously announced, the Committee for Orphan Medical Products of the European Medicines Agency has recommended the granting of orphan medicinal product designation for XOMA 052 for the same indication in the European Union.
Shares of XOMA jumped as much as 40% in early trading before paring back some of its gains and closing the day at 32 cents, up 15.48%.
NeoStem, Inc. (NYSE Amex: NBS) today announced that it has appointed Thomas Einhorn, M.D., Chairman of Orthopaedic Surgery at Boston University to its Medical Advisory Board. Thomas A. Einhorn, M.D. is Chairman of the Department of Orthopaedic Surgery and Professor of Orthopaedic Surgery, Biochemistry and Biomedical Engineering at Boston University. A graduate of Rutgers University and Cornell Medical College, he completed his internship at the Hospital of the University of Pennsylvania, orthopaedic residency at St. Luke's – Roosevelt Hospital in New York City, and a fellowship at the Hospital for Special Surgery. His professional focus is on the repair and regeneration of bone and cartilage using autologous adult stem cells, reconstructive surgery of the hip and knee, and the treatment of metabolic bone disease. He has authored over 200 peer-reviewed articles during his career to date.
Shares of NeoStem, which have been on a steady incline over the past couple of weeks, were up another 7.5% on the day.
NewCardio, Inc., (OTC Bulletin Board:NWCI.ob) announced today that, in collaboration with a leading global biopharmaceutical services provider that signed a Master Services Agreement (MSA) for the use of NewCardio's QTinno software solution earlier this year, the first revenue generating study has been completed.
NewCardio successfully installed QTinno at one of their Phase 1 units, enabling the sponsor to complete a small initial study. The data will provide an initial cardiac safety profile which can then be used to determine the next steps for the compound which could include further QT analysis or potential out-licensing of the compound. NewCardio expects to recognize the modest revenue from this study during the third quarter.
"The successful completion of this study, which satisfied all NewCardio's expectations for accuracy and timeliness, will facilitate the ongoing transition to more automated studies in the future," said Vincent Renz, NewCardio's President and Chief Operating Officer. "QTinno was implemented to help perform a small Phase 1 study rapidly and at low cost for their sponsor, providing useful data indicating the cardiac safety profile of the drug. We are excited to have achieved this milestone, and look forward to this leading to additional business with the biopharmaceutical services provider as well as this sponsor in the future."
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the second quarter and six months ended June 30, 2010 and provided an update on corporate developments.
"We made excellent progress during the second quarter on the ridaforolimus transition to our partner, Merck, which we expect to complete before the end of this year, and with preparations to initiate a global registration trial of AP24534, our investigational pan-BCR-ABL inhibitor, this fall," stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "We are on track to achieve these goals and to drive and retain important shareholder value for our pipeline products."
CEL-SCI Corporation (NYSE AMEX: CVM) announced today that it has successfully produced and filled its first lot of Multikine® in preparation for the upcoming pivotal Phase III trial targeting advanced primary head and neck cancer.
The drug was filled in CEL-SCI’s state-of-the-art "Cold-Fill" manufacturing facility. The Company completed this test in order to ensure that it is able to produce significant quantities of Multikine to support the 880 patient clinical trial which is expected to commence prior to the end of the year. CEL-SCI's manufacturing facility, located outside of Baltimore, has been designed to fill biologics such as Multikine in true cold conditions (4 degrees Centigrade) which prevents/minimizes the loss of biological activity.
"Over the past few months, we have been highly focused on staffing and testing the facility in order to ensure that we have the equipment, resources and personnel to deliver Multikine to patients in the Phase III trial," said Geert Kersten, CEL-SCI's Chief Executive Officer. "We recognize that in a trial of this scale involving a biologic there are many precautions that we need to take, and we have made excellent progress in completing these tasks so we can begin the trial later this year. With a strong balance sheet, the new manufacturing facility, a global CRO in place and having Phase III partners Teva Pharmaceuticals and Orient Europharma, we are well positioned to take Multikine through this pivotal trial. We believe that Multikine represents a paradigm shift in the way cancer patients are treated."
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced it has filed for a Special Protocol Assessment with the U.S. Food and Drug Administration for the design of its new phase III trial of pixantrone for patients with relapsed or refractory aggressive B-Cell non-Hodgkin's lymphoma ("NHL").
In the filing, CTI proposed to the FDA that the randomized study will compare pixantrone plus rituximab against the current standard regimens used to treat this patient group. This trial is planned to enroll relapsed or refractory aggressive B-Cell NHL patients who failed first-line to third-line treatment with standard chemotherapy and are not transplant eligible.
Cypress Bioscience, Inc. (NASDAQ:CYPB) today announced that it is discontinuing its rights under its agreement with Forest Laboratories to co-promote Savella®, its drug for fibromyalgia. Forest has agreed to pay Cypress a one-time payment of $2.0 million to help facilitate with this transition. Cypress will retain all other rights under its agreement with Forest including its royalty on Savella sales and may pursue the opportunity to re-activate the co-promotion right through discussions with Forest in the future. Forest will maintain promotional levels behind Savella.
In an effort to further reduce its cost structure, Cypress will also either discontinue or sell its personalized medicine services business by the end of Q3'2010. Cypress estimates that these actions will decrease its operating costs by approximately $10 million on an annualized basis. Operating results for the remainder of 2010 will be adversely affected by charges related to severance payments and termination of contractual obligations, which the company currently estimates will be approximately $3.5 million and up to approximately $1.0 million in impairment charges.
Additionally, Cypress will be decreasing its workforce by approximately 86% affecting 123 of its employees. Concurrent with this announcement, all affected employees will receive appropriate notice of the lay off to be effective October 6, 2010.
Penwest Pharmaceuticals Co. (Nasdaq:PPCO) surged more than 10% today after the company reported record financial results for the three and six months ended June 30, 2010. For the second quarter of 2010, revenues increased 159% year-over-year and total operating expenses decreased 28% year-over-year, leading to record net income of $8.4 million, or $0.26 per share.
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, announced that it has been added to the Russell Microcap® Index, following the Russell Investment Group’s annual reconstitution of its indices.
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) a late-stage drug development company specialized in oncology and endocrinology, will announce its second quarter 2010 financial and operating results before market open on Thursday, August 12, 2010.
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