Selecta Biosciences : Phase 1 Clinical Study of SEL-068, a First-in-Class Synthetic Nicotine Vaccine for Smoking Cessation and Relapse Prevention

November 21, 2011 - First Clinical Program for Selecta's Synthetic Vaccine Particle Platform with Broad Potential for a Range of Therapeutic Applications Including Infections, Cancer, Allergies, and Autoimmune Diseases –

Selecta Biosciences, Inc., a biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, announced that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SEL-068, a nicotine vaccine candidate for smoking cessation and relapse prevention. SEL-068 is the first product candidate to enter clinical evaluation from Selecta's proprietary Synthetic Vaccine Particle (SVP™) Platform, and has the potential to become the first nanoparticle vaccine that is synthetically engineered, distinct from conventional biological vaccine manufacturing processes.

"This is the first time ever that a fully integrated synthetic, nanoparticle vaccine is being tested in human clinical trials and is a very important milestone in the translation of Selecta's SVP technology," said Ulrich von Andrian, Ph.D., M.D., Edward Mallinckrodt Jr. Professor of Immunopathology at Harvard Medical School and Selecta co-founder. "Selecta has demonstrated its ability to rationally design immunotherapeutics and induce a robust targeted immune response. SVP technology will revolutionize the way vaccines will be designed, produced and applied."

The Phase 1 clinical study of SEL-068 is a double-blind, placebo-controlled, ascending dose study in healthy, non-smoking and smoking volunteers. In addition to safety, the study will evaluate the vaccine's potency through the measurement of concentrations of nicotine-specific antibodies. Selecta expects to report initial results from this Phase 1 study in the first half of 2012.

Because SEL-068 is fully synthetic, the immune response is entirely focused on nicotine and avoids off-target responses to biological carriers typically used with other vaccine technologies. The resulting high antibody concentrations induced by SEL-068 have the potential to absorb inhaled nicotine, preventing it from reaching the brain and triggering the addictive response... Selecta Biosciences' Press Release -

Quest Diagnostics : Launch of Simplexa(TM) Direct Test for Influenza and Respiratory Viruses in Europe

Nov. 1, 2011 - Focus Diagnostics product eliminates nucleic-acid sample extraction with proprietary technology, for faster testing -

Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, announced the CE mark and European availability of the Simplexa Flu A/B & RSV Direct test on the 3M(TM) Integrated Cycler. The new test, from the company's Focus Diagnostics business, uses a proprietary technique to eliminate nucleic-acid sample extraction, a time-consuming process required by other molecular test products, for faster results reporting.

"Simplexa Direct chemistry employs a novel technology that overcomes a critical limitation found in most molecular test kits on the market: the need for extraction of nucleic acids," said Maurice Exner, Ph.D., vice president of research and development, Focus Diagnostics. "With this advance, molecular testing will be far easier and faster for labs to perform than before. We believe the Simplexa Direct method is an important step toward enabling a greater range of healthcare professionals to access quality molecular testing. We look forward to introducing our first Simplexa Direct product, for influenza and respiratory syncytial virus testing, to laboratories in Europe."

Nucleic-acid extraction is a process requiring specialized molecular equipment and trained personnel. It involves extracting DNA or RNA from a blood, plasma or other specimen type for testing. The nucleic-acid extraction process, used in most commercial molecular test kits, can add approximately 60 to 90 minutes to total testing time. Focus Diagnostics has replaced the process with a proprietary reaction-mix technique. The company expects to use the proprietary technology in future Simplexa products.

Simplexa Flu A/B & RSV Direct is an addition to the influenza and respiratory franchise of award-winning FDA-cleared and CE-marked assays available through Focus Diagnostics... Quest Diagnostics' Press Release - Focus Diagnostics' Press Release -

VentriPoint : Clinical Studies of Pulmonary Arterial Hypertension Application of Right Heart Analysis System

Nov. 1, 2011 - The University of Chicago Completes First Patient -

VentriPoint Diagnostics (TSX VENTURE:VPT)(PINK SHEETS:VPTDF) announces the University of Chicago has secured a VentriPoint Medical System (VMS™) and has begun the clinical evaluation of the database for patients with Pulmonary Arterial Hypertension (PAH).

The study will be led by four highly regarded cardiac specialists from the University of Chicago; Dr. Roberto Lang, former President of the American Society of Echocardiography and Director of the Echo Lab; Dr. Mardi Gomberg, expert clinician and researcher in the field of pulmonary hypertension; Dr. Amit Patel, Director of Cardiac MRI; and Dr. Benjamin Freed, Lead Cardiologist.

"I expect that an assessment of RV volume and function using the VMS™ will become part of the routine clinical ultrasound evaluation for patients at risk for PAH," stated Dr. Roberto Lang. "A simple way to detect and monitor PAH is gravely needed and this methodology will be extremely useful to quantify interventions (therapeutic and surgical) performed on the right ventricle," Dr. Lang added.

It is anticipated this first clinical study will take four to six weeks and will verify the accuracy of the system in patients known to have PAH. If successful, a multicenter clinical trial will be initiated to compare VMS™ with MRI as part of a submission to the FDA as part of a 510K submission.

Dr. George Adams, VentriPoint President and CEO stated, "The Company will leverage the success of the VentriPoint technology with congenital heart disease to address the needs of a significantly larger population of patients at risk for pulmonary hypertension."

The VMS™ is for investigational use only in the United States and approved for clinical use in Canada and Europe... [PDF] VentriPoint Diagnostics' Press Release -