Quanterix : to Collaborate With the Forsyth Institute and Beth Israel Deaconess Medical Center to Develop Tuberculosis Test

Feb. 9, 2012 - Partnership to Develop Innovative Pathogen Detection Test -

Quanterix Corporation, a company enabling a new generation of molecular diagnostic tests based on its revolutionary Single Molecule Array (SiMoA™) technology, announced that it will apply its cutting-edge technology towards the development of an improved test to aid in the diagnosis of active tuberculosis (TB). In collaboration with the Forsyth Institute and Beth Israel Deaconess Medical Center (BIDMC), Quanterix will validate novel low abundance protein biomarkers that may be useful for identifying individuals with active disease. Through this strategic partnership, Quanterix will continue to expand its infectious disease applications to include the development of a fast and simple test that will provide accurate diagnosis of active TB in high-burden countries.

"The Forsyth Institute has utilized a proteomics-based approach to identify a panel of novel M. tuberculosis markers present in the urine of human patients with active TB, but conventional protein detection platforms lack the analytical sensitivity to reliably detect these proteins in urine or blood. Using SiMoA, we are routinely able to improve the sensitivity of existing immunoassays by more than 1,000-fold, enabling accurate measurement of analytes that have previously been considered undetectable. Applying our technology to evaluate biomarkers that could not otherwise be detected will allow us to address a variety of important unmet medical needs, including the development of an improved test for the diagnosis of active tuberculosis," said David Duffy, Ph.D., Vice President of Research at Quanterix... Quanterix 's Press Release -

PhRMA : More Than 50 Medicines in Development for COPD, Third Leading Cause of Death in U.S.

February 2, 2012 — America’s biopharmaceutical research companies are working on 54 medicines to treat chronic obstructive pulmonary disease (COPD), according to a report released by the Pharmaceutical Research and Manufacturers of America (PhRMA). These exciting therapies are in late-stage development, meaning they are either in clinical trials or awaiting review by the Food and Drug Administration (FDA).

Today, more than 13 million American adults suffer from COPD, one of the most common lung diseases in the U.S. A chronic, progressive lower respiratory disease that encompasses two main conditions – chronic bronchitis and emphysema – COPD is characterized by obstructed airflow to the lungs that interferes with normal breathing. People with COPD may be limited in their ability to work, exercise and perform routine activities.

According to the National Institutes of Health (NIH), the number of patients with COPD is increasing. In addition to those who have been diagnosed with the disease, 12 million Americans likely have COPD without knowing it.

“Early detection of COPD is imperative, as effective treatment can change the course and progression of this devastating disease,” said PhRMA President and CEO John J. Castellani. “The promising new therapies highlighted in this report illustrate how emerging scientific approaches to treating respiratory diseases such as COPD offer great hope to improve and save the lives of future patients.”... PhRMA's Press Release -

Uptake Medical : Australian Therapeutic Goods Administration Approval of InterVapor for Patients With Severe Emphysema

Dec. 21, 2011 – Uptake Medical® announced that it received Australian Therapeutic Goods Administration (TGA) approval for its InterVapor™ System for endoscopic lung volume reduction for the treatment of severe emphysema. InterVapor is the first non-surgical, endoscopic lung volume reduction system for the treatment of severe emphysema that uses the body’s natural healing processes without leaving implants or foreign materials in the lung.

Clinical efficacy of InterVapor has been established by the multi-center VAPOR trial which showed a reduction in lung volume as well as statistical and clinical significance in lung function improvement (FEV1) and health-related quality of life (SGRQ) at six months.

“Our involvement with Uptake Medical and InterVapor goes back to the first usage in patients, and we are delighted to see the TGA approval,” commented Professor Gregory Snell, head of lung transplant services at the Alfred Hospital in Melbourne, Australia. “InterVapor has continued to demonstrate clinical efficacy and safety and we look forward to offering InterVapor to our patients.”... Uptake Medical's Press Release -

NovaBiotics : plans for cystic fibrosis drug after EU grants orphan status

20th December 2011 - NovaBiotics reveals plans for cystic fibrosis drug after EU grants orphan status -

Bolstered by the an EU orphan drug designation for its drug candidate for cystic fibrosis, Lynovex (cysteamine), UK-based NovaBiotics revealed to Scrip that it plans to begin a first-in-man, safety/tolerability and evidence of efficacy study of the product in 2012, followed by other trials in 2013.

The company announced that the Committee on Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has granted orphan status to the novel dual mucolytic-antibacterial drug for the treatment of cystic fibrosis and added that it is "currently in discussions with a number of interested parties with a view to licensing or co-developing the drug".

NovaBiotics stated it would "now progress with follow-on orphan applications for paediatric use and also applications for orphan drug designation in the US".

"This novel drug candidate is expected to be tested in patients in 2012," the biotech firm highlighted. It told Scrip that the study slated for next year would test Lynovex when used in conjunction with conventional inhaled ABX (antibiotic) therapies in the first instance. In 2013, NovaBiotics said it would initiate a second and third trial to further assess efficacy.

The company confirmed that it intends to partner the product, and "as per our core business model [this is] most likely after the second clinical study". With respect to its finances, it said: "NovaBiotics remains fully equity funded (still pre-revenue) and this is how development has been/will be funded in the short-term for Lynovex, but as the programme develops towards final clinical studies, revenue from Novexatin and Luminaderm commercialisation deals will be reinvested into the Lynovex programme."... NovaBiotics' Press Release -

GSK: Professor Rob Horne discusses the MyAsthma programme

Novartis : Becoming Christopher a fictional video trailer about living with Cycstic Fibrosis

Geron : Phase 2 Trial of GRN1005 in Brain Metastases From Lung Cancer

December 22, 2011 - Geron Corporation (Nasdaq: GERN) announced the initiation of GRABM-L (GRN1005 Against Brain Metastases - Lung cancer), a Phase 2 clinical trial to evaluate GRN1005 in patients with brain metastases arising from non-small cell lung cancer (NSCLC). GRN1005 is the company's lead LRP-directed peptide-drug conjugate (LRP-directed PDC) and consists of the cytotoxic drug paclitaxel linked to a peptide (Angiopep-2) that targets the LRP receptor to cross the blood-brain barrier (BBB) and to target tumors in the brain.

"With the treatment of the first patient in the GRABM-L study, we have initiated both of the planned Phase 2 clinical trials of GRN1005 in patients with cancer metastases in the brain, a significant unmet medical need for which there are currently no approved drug therapies," said Stephen M. Kelsey, M.D., Geron's Executive Vice President, Head of R&D and Chief Medical Officer. "We have been encouraged by the preliminary evidence of anti-tumor activity against brain metastases observed in the Phase 1 study of GRN1005, and we hope to confirm these results in our Phase 2 trials."

Phase 2 Clinical Trial Design (GRABM-L) 

The purpose of the Phase 2 study is to assess the efficacy, safety and tolerability of GRN1005 in patients with brain metastases from NSCLC. The trial plans to enroll 50 patients.

GRN1005 will be administered at a dose of 650 mg/m2 by intravenous (IV) infusion every three weeks. The primary efficacy endpoint for the trial is overall (intra-cranial and extra-cranial disease) objective response rate. Key secondary endpoints include duration of overall objective response, duration of overall progression-free survival and six month overall survival....Geron's Press Release -

Orchid Pharma : successful completion of Phase I study of its novel PDE4 inhibitor molecule, OCID 2987

January 02, 2012 - The Chennai-based global pharma major, Orchid Chemicals & Pharmaceuticals (Orchid) stated that it has successfully completed in Europe a Phase I trial of its orally administered PDE4 (phosphodiesterase 4 inhibitor) molecule OCID 2987 positioned for the treatment of inflammatory disorders including COPD (Chronic Obstructive Pulmonary Disease).

The Phase I study was conducted to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of OCID 2987 at escalating single or repeated doses on healthy male volunteers. OCID 2987 was well tolerated up to the highest doses administered in both single and repeat dose studies and did not demonstrate a potential for nausea/emesis, a common unacceptable side-effect with most PDE4 inhibitors. There were no serious adverse events or any cardiac safety concerns reported in the study... Orchid Pharma's Press Release -

Almirall and BioFocus : collaboration to find new hit compounds against key targets

November 15, 2011 - Targets are related to the treatment of respiratory and inflammatory conditions -

The pharmaceutical company Almirall S.A. and BioFocus, an integrated drug discovery partner, announced they have entered into a collaboration agreement to find new hit compounds against key targets of interest to Almirall. These compounds will be used to support projects aimed at the treatment of respiratory and inflammatory conditions.

Under the terms of the collaboration, BioFocus will apply its screening technologies and compound collections to an undisclosed number of Almirall projects.

“We have been impressed by the depth of the BioFocus technology platforms, the size, content and diversity of the available compound decks and the obvious strength and experience of the scientists that will be engaged on our projects working on respiratory and inflammatory conditions”, said Dr. Bertil Lindmark, CSO, Executive Director R&D of Almirall.

“We are delighted to form a drug discovery alliance with one of Europe’s leading research-based pharmaceutical companies,” added Dr. Kate Hilyard, VP Biological Sciences, BioFocus... BioFocus' Press Release - Almirall's Press Release -

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 -

Air Products : BIG Supports O2 Medical Grade to Help Patients in Flood Areas

October 25, 2011 - BIG Supports O2 Medical Grade to Help Patients in Flood Areas -

Management of Bangkok Industrial Gas Co., Ltd. or BIG led by Senior Executive Director Chaiwat Niyomkarn (5th from right), recently teamed up to Ayudhya province to present 70 cylinders of oxygen medical grade to the Center of Flood Relief in Ayudhya to help patients get stuck there.

The support will continue until the flood situation is eased.

This inundated is the worst of its kind as there are many victims waiting for helps. Stocks of oxygen are critical as the delivery was very difficult and some gas operations are closed. BIG has contacted the Public Health Ministry to offer the help... Bangkok Industrial Gas' Press Release - Air Products' Press Release -

ChemDiv Research Institute at ChemRar Hi-Tech Centre : Collaboration and License Option agreement with Novartis Institute for Tropical Diseases to battle Tuberculosis

October 6, 2011 - ChemDiv Research Institute (CDRI) at the ChemRar Hi-Tech Centre announced that it has signed collaboration and license option agreement with the Singapore based Novartis Institute for Tropical Diseases (NITD) to undertake discovery and development of patentable chemical compounds to find new, faster cures for Tuberculosis.

Tuberculosis (TB) is a major health problem in the world today, responsible for nearly 2 million deaths per year. One third of the world's population are infected with latent TB, and ~5-10% of infected individuals may develop active TB within their lifetime. Current treatment of TB takes more than half a year, much longer than treatment for other infectious diseases. Emergence of multi drug resistant tuberculosis and TB co-infection with HIV are escalating the need for finding new drugs for curing the TB.

CDRI has prepared and delivered to NITD a focused library consisting of thousands of compounds that will be screened in a cell-based assay to identify lead molecules that are active against the mycobacterium... ChemDiv's Press Release -