Amgen Cancer Drug Fails in Phase 3 Study
Thousand Oaks, Calif — Amgen, Cambridge, Mass-based Millennium: The Takeda Oncology Company, and Takeda Pharmaceutical Co, Osaka, Japan, announced the top-line results from the pivotal phase 3 trial evaluating motesanib administered in combination with paclitaxel and carboplatin in 1,090 patients with advanced non-squamous non-small cell lung cancer (NSCLC). The trial did not meet its primary objective of demonstrating an improvement in overall survival.
“We are disappointed with the results from this trial, but look forward to further analysis of the data which may ultimately help inform future research in this area,” said Roger M. Perlmutter, MD, PhD, executive vice president of research and development at Amgen.
“We thank the patients, caregivers, and investigators for their participation and engagement in the clinical evaluation of motesanib worldwide,” said Nancy Simonian, MD, chief medical officer, Millennium. “These disappointing results support the need for new treatments to address the unmet need in advanced non-squamous NSCLC.”
Overall, the adverse event profile for motesanib was consistent with that seen in previous motesanib studies in NSCLC. Notable adverse events reported included hypertension, GI events (abdominal pain, diarrhea, nausea, and vomiting), gallbladder events (cholecystitis, gallbladder enlargement), fatigue, and hematological events (neutropenia, thrombocytopenia). Serious adverse events were more frequently reported in the motesanib arm.
Detailed results will be submitted for presentation at an upcoming medical congress.
Dilon Diagnostics Hailed as Top National Innovator
Newport News, Va — The US Department of Energy (DoE) has acclaimed Dilon Diagnostics as a success story in the field of medical technology and innovation for commercializing the technologies of the national laboratories. According to the government agency, Dilon and similar entrepreneurs “build the new industries of the 21st century, and help solve some of our toughest global challenges.”
The Dilon 6800 digital gamma camera is based on gamma-imaging technology developed at the DoE’s Thomas Jefferson National Accelerator Facility in Newport News, Va. The medical procedure that this advanced imaging technology enables is known as Breast-Specific Gamma Imaging/Molecular Breast Imaging (BSGI/MBI), and reveals cancerous lesions even at very early stages. BSGI/MBI is a proven technology that can find cancers missed by mammography and ultrasound.
“We are honored to be acknowledged by the Department of Energy as one the country’s successful innovators in the medical technology field,” said Bob Moussa, president and CEO of Dilon. “We have been able to make a significant impact by utilizing our licensing agreement with Jefferson Lab to help save lives.”
Pathwork Diagnostics Lab Awarded CAP Accreditation
Redwood City, Calif — Pathwork Diagnostics Inc, a privately held molecular diagnostics company focused on oncology, announced that its laboratory has been awarded accreditation by the College of American Pathologists (CAP). The company’s gene expression-based Pathwork Tissue of Origin Test, offered by the Pathwork Diagnostics Laboratory, helps identify the origin of metastatic and poorly differentiated tumors and increases pathologists’ and oncologists’ confidence in the cancer diagnosis.
“The CAP Laboratory Accreditation Program is the gold standard for laboratory accreditation with standards exceeding those set by the federal government,” explained pathologist Samuel Caughron, MD, director of molecular pathology, MAWD Pathology Group, North Kansas City, Mo. “CAP accreditation of the Pathwork Diagnostics Laboratory assures patients and physicians that specimens sent for the Tissue of Origin Test are processed with meticulous quality control and in accord with best established practices for laboratory medicine.”
In addition, the Centers for Medicare & Medicaid Services has certified the Pathwork Diagnostics Laboratory through its Clinical Laboratory Improvement Amendments program. In 2010, the Pathwork Diagnostics Laboratory received a clinical laboratory permit from the New York State Department of Health, establishing the Tissue of Origin Test as the only FDA-cleared tissue of origin testing service available in New York State. The Pathwork Tissue of Origin Test was also recently endorsed by the Florida Society of Clinical Oncology.
PathXchange Surpasses 12,000 Members
Tucson, Ariz — PathXchange.org, a global online pathology Web site, announced that its community has exceeded 12,000 registered members from more than 160 countries, making PathXchange services one of the most widely used professional networking, collaboration, and e-learning tools enabled by digital pathology.
Since its launch in June 2009, PathXchange has experienced unprecedented growth. Pathology professionals from clinical, research, and educational institutions widely utilize PathXchange for an increasing array of use cases including tumor boards, peer consultations, case conferencing, research studies, residency training, and continuing medical education.
Mahul B. Amin, MD, chairman and professor, Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, and an active supporter of PathXchange services since its beginnings, noted the power and global reach of this Web 2.0 tool. “PathXchange was instrumental in allowing us to read a second opinion case with less than 24-hour turnaround time,” Amin said, “with the ability for pathologists in India and California to simultaneously review case slides.”
PathXchange.org is available to individual users free of charge. Dedicated and secure microsites are available at a reasonable fee to institutions seeking to leverage PathXchange networking technologies for their own pathology applications.
Thermo Spectrometer Named Scientists’ Choice Winner
Madison, Wis — Thermo Fisher Scientific announced that its Thermo Scientific Nicolet iS5 FT-IR spectrometer received a 2011 Scientists’ Choice Award for Best New Spectroscopy Product of 2010. The award, voted on by scientists, recognizes the rugged instrument’s FT-IR spectroscopy capabilities.
The Nicolet iS5 combines flexible sample handling with Thermo Scientific OMNIC software to deliver the ideal FT-IR solution for manufacturers, forensic laboratories, and chemistry classrooms. The instrument, which provides performance comparable to larger-sized spectrometers, is used for product assurance testing, basic troubleshooting, and chemistry teaching.
This year, more than 35,000 members of the SelectScience.net Web community were invited to nominate their favorite general lab, separations, and spectroscopy products. The most popular nominated products were then voted on by scientists. The Thermo Scientific Nicolet iS5 received approximately one quarter of the votes and was selected as the winner from among eight final nominations. The award ceremony took place at Pittcon 2011 in Atlanta.
“It is a great honor for our Nicolet iS5 to be nominated by its users, and I congratulate the FT-IR and IR microscopy teams in Madison, Wisconsin, for delivering such a reliable, robust, and high-performance spectrometer,” said Brian Davies, vice president and general manager of molecular spectroscopy and microanalysis, Thermo Fisher Scientific. “The spectrometer’s reasonable price, compact size, and superior ease of use make this technology more accessible, even to non FT-IR specialists.”
Study of Pain Therapy Device Announced
Fairfield, Conn — Competitive Technologies Inc has announced that researchers at the University of Wisconsin’s (UW) Carbone Cancer Center have begun accepting patients into a new phase 2 clinical study to evaluate the efficacy of the company’s Calmare Pain Therapy medical device utilizing Scrambler Technology versus a sham procedure in treating painful chemotherapy-induced peripheral neuropathy.
The principal investigator for this study is Toby C. Campbell, MD, who is a research physician specializing in medical oncology and palliative care at the UW Carbone Cancer Center.
The study designed by Campbell is a randomized double-blind, sham-controlled clinical trial with a target enrollment of 40 patients that will measure the effectiveness of the devices by recording the change in participants’ pain as measured by a Visual Analog Scale before and after treatment with the Calmare Scrambler MC-5A device or the sham device.
The UW Carbone Cancer Center is recognized throughout the Midwest and the nation as one of the leading innovators in cancer research, quality patient care, and active community involvement. The Carbone Cancer Center is the only comprehensive cancer center, as designated by the National Cancer Institute, in Wisconsin.
FDA Grants OraSure, Roche Clearance for Four Oral Fluid Assays
Bethlehem, Pa — OraSure Technologies Inc and Roche announced that the FDA has granted the Companies 510(k) clearance on four homogeneous fully automated oral fluid drugs-of-abuse assays developed to be used exclusively as part of OraSure’s Intercept Oral Fluid Drug Testing System. The cleared oral fluid assays include Phencyclidine, Cocaine, Opiates and Methamphetamine.
The oral fluid assays use Roche’s kinetic interaction of micro-particles in solution (KIMS) technology and were jointly developed under an agreement previously signed by the parties. These assays are designed to run on various clinical chemistry automated analyzers, which are intended to allow oral fluid samples to be processed with the same efficiency as current fully automated urine-based drug tests.
“We are very pleased to announce this significant milestone in our joint effort with Roche to develop and market these important drugs-of-abuse assays,” said Douglas A. Michels, president and CEO of OraSure Technologies. “The combination of Roche’s industry leadership in lab instrumentation and reagent chemistry, and our leadership in oral fluid technology and sample collection devices, has enabled us to bring to market a breakthrough system that will have an immediate and positive impact on laboratory efficiency for drugs-of-abuse testing.”
The companies anticipate the first four assays to be available for sale later this year. Several additional assays are also in development and are currently in varying stages of submission with the FDA.
Avinger Completes CONNECT Trial Enrollment
Redwood City, Calif — Avinger Inc, medical device manufacturer of multifunctional catheters for treating patients with peripheral artery disease (PAD), announced that it has successfully completed enrollment in its Chronic TOtal OcclusioN CrossiNg with thE WildCat CatheTer (CONNECT) clinical trial, a prospective, multicenter, nonrandomized study to evaluate its Wildcat Catheter’s ability to cross chronic total occlusions in femoropopliteal lesions, which is the leading cause of amputations associated with PAD in the United States.
Avinger’s Wildcat Catheter received FDA 510(k) clearance in February 2009 for use as a guidewire support device to access discreet areas of the vasculature. Avinger conducted this study to secure FDA clearance for an indication specific to crossing CTOs. Patients with PAD may have chronic total occlusions that are sometimes difficult to treat with endovascular therapy, resulting in either bypass surgery or amputation.
“This is a great day for Avinger and a huge accomplishment for our entire team,” said Avinger founder and CEO, John B. Simpson, PhD, MD. “We have a lot of work to do, but this is a giant step forward for our organization. A lot of people put in a lot of long hours to complete this trial, and we can’t thank them enough. We’d like to thank our investigating physicians and their phenomenal staffs and the patients that participated in CONNECT.”
The CONNECT study evaluated 88 patients with femoropopliteal CTO lesions at 15 centers in the United States. Patients were followed for 30 days postprocedure, and an independent group of physicians is currently reviewing the angiographic results to determine crossing efficacy and safety end points.
Ariad, MolecularMD to Develop Diagnostic Test for CML Patients
Cambridge, Mass — Ariad Pharmaceuticals Inc and Portland, Ore-based MolecularMD Corp have announced an exclusive collaboration agreement in which MolecularMD will develop and commercialize a companion diagnostic test to identify the T315I mutation of the BCR-ABL gene in patients with chronic myeloid leukemia (CML) and Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL).
Ariad is advancing its investigational, pan-BCR-ABL inhibitor, ponatinib, in the pivotal PACE trial of patients with resistant or intolerant CML and Ph+ ALL, or those with the T315I mutation. MolecularMD has performed BCR-ABL mutation testing with its standardized and validated sequencing test in patients enrolled in Ariad’s earlier phase 1 trial of ponatinib, and now is conducting similar testing prior to patient treatment in the PACE trial.
“We believe that MolecularMD has more experience with T315I mutation assays than any other laboratory in the world,” stated Timothy P. Clackson, PhD, president of research and development and chief scientific officer at ARIAD. “We are pleased to extend our highly productive collaboration with MolecularMD and look forward to working together on the development of a commercial test for the detection of the T315I mutation.”
Oxford Medical, V&F Join Mass Spectrometry Forces
Oxford, United Kingdom — Oxford Medical Diagnostics (OMD), the developer of breath-based, medical diagnostic technology for the rapid, noninvasive, accurate, and low-cost diagnosis and monitoring of metabolic and infectious diseases, and Absam, Austria-based V&F Analyse- und Messtechnik GmbH (V&F), a provider of analytical instruments to a wide range of industries, today announced a strategic alliance focusing on the area of mass spectrometry.
Under the terms of the new agreement with V&F, OMD will offer and support V&F’s high-performance mass spectrometry analyzers in the UK and Ireland. Also, OMD will establish a contract batch sample analysis service in its Oxford laboratories to provide analytical services to third-party customers using V&F’s mass spectrometers.
OMD will bring to bear its expertise in spectrometry and is itself developing the Acetone Breath Analyzer, based on its proprietary infrared absorption spectroscopy. The device will be used to screen and diagnose type 1 and type 2 diabetes, as well as monitor weight loss in healthy individuals.
In addition to this collaboration, the two companies are looking into other opportunities for joint research. These include bacterial headspace analysis—analyzing the space above bacteriological samples such as MRSA and Clostridium difficile—as well as sports performance monitoring and healthy weight-loss management.
“We project an exciting future working with OMD,” said Werner Federer, MSc, PhD, president of V&F. “Diabetes and lifestyle-weight loss represent significant opportunities for both our companies.”
BioTek to Establish South Korean Office
Winooski, Vt — Continuing its global expansion in the microplate-based technology market, BioTek Industries has announced the establishment of BioTek Korea. Managed by Yunki Kyung, the new direct sales and service organization will focus on growing BioTek’s brand and expanding direct service and application support for its growing customer base in South Korea.
BioTek Korea will be fully functional by July 1, according to the company. BioTek’s longtime partner and distributor, DI Biotech, will work closely with BioTek Korea to ensure a seamless transition for the company’s existing and expanding customer base.
“The establishment of BioTek Korea will allow BioTek to increase our investment of resources in this very important marketplace,” said Briar Alpert, BioTek president and CEO. “In addition to providing incremental local service and application support, our customers in South Korea will have direct access to the company’s global scientific and applications resources. Ultimately, this will lead to enhanced customer satisfaction for our Korean customers.”
DiagnoCure Announces First-Quarter Results
Quebec City, Canada — DiagnoCure Inc, a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, recently reported financial and operation results for the first quarter of fiscal 2011. The company announced a net loss of $1,608,543, or $0.04 per share, for the quarter ended January 31, 2011. These results reflect activities undertaken during this quarter and the company’s ongoing commitment to develop high-value diagnostic tests for the detection and management of cancer. At the end of the quarter, cash, short-term investments, and long-term investments stood at $6,291,784.
In January 2011, the results of the first phase of a new clinical study on DiagnoCure’s Previstage GCC Colorectal Cancer Staging Test, called Validating Indicators To Associate Recurrence Risk (VITAR), were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium by the study’s principal investigator, Daniel Sargent, PhD, professor of Biostatistics and Oncology at Mayo Clinic. The study included 241 stage II colon cancer patients from six North American clinical sites and was aimed at further classifying the risk of recurrence of these patients. Stage II colon cancer patients are considered as low risk by traditional methods yet with an average recurrence rate of 20%. In this population, the study demonstrated that Previstage GCC can stratify patients into high and low risk of recurrence groups, thereby providing relevant and more accurate clinical information for physicians to make more personalized treatment decisions.
Total revenues for the first quarter of 2011 were $362,101, compared with $362,401 for the first quarter of 2010. In the first quarter of 2011, royalty revenues amounted to $161,790 compared with $161,421 for the corresponding period of 2010.
Partnership Offers Breakthrough Diagnostic Assay
Richmond, Va — Health Diagnostic Laboratory Inc (HDL) has announced a partnership to develop a novel laboratory developed test with Gamma Therapeutics Inc, an Oregon-based biotechnology venture developing diagnostic test and surgical therapy solutions for the cardiovascular disease industry.
Cardiovascular disease (CVD), coronary heart disease, and stroke are responsible for 16.7 million, or 29.9%, of total global deaths associated with some type of disease, according to the World Health Organization. In 2010, CVD became the leading cause of death in developing countries.
Gamma Therapeutics, launched in November 2010, is bringing to market in a joint product development effort with HDL a novel CVD Risk Assay to enhance cardiologists’ ability to assess heart attack and stroke risk by providing a new predictive and prognostic tool. The laboratory-developed CVD Risk Assay is based upon a naturally occurring clotting protein in human blood called Gamma Prime Fibrinogen, a biomarker strongly associated with cardiovascular disease. The laboratory-developed test version of the Gamma Therapeutics’ CVD Assay will be offered exclusively by HDL, which also will take the lead in BETA testing of the assay for FDA approval.
“Thanks to advanced testing, it’s now possible to reveal risk factors and biomarkers for cardiovascular and related diseases,” said Tonya Mallory, HDL CEO and co-founder. “The partnership with Gamma Therapeutics demonstrates HDL’s ongoing goal to provide best-of-breed biomarkers, such as this new assay.” Using a systematic approach to identify factors contributing to disease allows HDL to provide its physicians with a better basis for effective treatment plans.
Paper Outlines Benefits of Umbilical, Menstrual Blood Stem Cells
Oldsmar, Fla — Cryo-Cell International, Inc, one of the world’s largest and most established family cord blood banks, announced the publication of a collective paper outlining the potential benefits of transplanting stem cells derived from umbilical cord and menstrual blood cells. The paper, titled “The Treatment of Neurodegenerative Disorders Using Umbilical Cord Blood and Menstrual Blood-Derived Stem Cells,” was a collaborative effort between Cryo-Cell, the University of South Florida’s Department of Neurosurgery and Brain Repair, and two private-sector research groups, Saneron CCEL Therapeutics Inc and Cell PRAXIS Bioengenharia, and is published in Cell Transplantation (20:1).
“Umbilical cord blood cells and stem cells derived from menstrual blood are relatively easy to obtain, appear to be able to differentiate into many kinds of cells, and are immunologically immature, offering them the potential to promote cell survival rather than play a cell-replacement role when transplanted,” said Paul Sanberg, PhD, DSc, distinguished university professor and executive director of the Center of Excellence on Aging and Brain Repair at the University of South Florida.
According to Mercedes Walton, chair & CEO of Cryo-Cell International Inc, stem cell science and stem cell therapies have been emerging with amazing speed in the last several years. “Our breakthrough discovery that menstrual blood cells contain proliferative stem cells that can differentiate into many different types of cells, including cardiac and neural cells, has opened new therapy possibilities,” she said.
Lithera Appoints Wiggans to Board
San Diego — Lithera Inc, a clinical stage company developing pharmaceutical and biomedical products addressing both medical and lifestyle indications in ophthalmology and aesthetic medicine, has announced the appointment of Thomas G. Wiggans to its Board of Directors.
“Lithera is making substantial progress with LIPO-102 by generating positive results with selective, nonablative localized fat reduction,” said George Mahaffey, president and CEO of Lithera. “These encouraging developments will allow us to enter the next stages of corporate development. I have worked closely with Tom before, and believe that his experience in successfully building and leading dermatology companies will be of great value as we advance our programs.”
“I am impressed with the significant milestones Lithera has achieved in such a short period of time,” Wiggans said. “I look forward to working with this proven team to further advance the company and its very exciting programs.”
Wiggans most recently served as chairman of the Board of Directors and CEO of Peplin Inc, a dermatology company acquired in 2009 by LEO Pharma A/S. Wiggans holds a BS in pharmacy from the University of Kansas and an MBA from Southern Methodist University.