Weinmann : MEDUMAT Transport offers multi-faceted usage

05.13.09 - Non-invasive ventilation in emergency medical services – a good alternative -
Fulda – Non-invasive ventilation in emergency medicine is gaining ground in Germany. Recent studies have shown that non-invasive ventilation (NIV) for certain illnesses is a reasonable and reliable alternative to conventional ventilation. In its emergency and acute-care transport ventilator MEDUMAT Transport, the Hamburg-based firm Weinmann offers up to eight different pre-set ventilation modes and a non-invasive mode which can be activated in all ventilation modes.
In an observational study Dr. Clemens Kill (Marburg) showed that a simple CPAP system for non-invasive ventilation of emergency care patients with severe respiratory insufficiency is a reasonable and reliable alternative to conventional ventilation. He was able to prove that CPAP therapy can be used safely and successfully in pre-hospital situations in rescue vehicles. Observations were made of 142 patients with acute respiratory insufficiency and an average age of 77.2 years while they were being transported in an emergency physician's vehicle and were being treated with standard drugs and CPAP (Continuous Positive Airway Pressure) therapy. Despite an oxygen saturation of only 82% under very conservative therapy, only 10 (7%) of patients had to be intubated and treated with invasive ventilation. The results show that non-invasive ventilation in emergency medical services is a very good alternative to conventional ventilation for certain disorders... [PDF] Weinmann's Press Release -

CanBas and The Takeda Oncology Company (Millennium) : CBP501 Enters Phase II Trials for the Treatment of Non-Small Cell Lung Cancer

July 7, 2009 - CanBas Co., Ltd. (Numazu, Shizuoka, “CanBas”) and Takeda Pharmaceutical Company Limited (Osaka, “Takeda”) together with Takeda’s wholly-owned subsidiary Millennium: The Takeda Oncology Company (Cambridge, MA, “Millennium”) announced the advancement of CBP501 into Phase II clinical trials for the treatment of patients with non-small cell lung cancer (NSCLC). Current pre-clinical data suggest that CBP501 has the potential to induce cancer cell death through a mechanism of action that blocks the ability of cancer cells to transition through the cell cycle. Data from a previous Phase I study indicate that CBP501 may enhance anti-cancer cytotoxic activity when combined with selected chemotherapeutic drugs.



CanBas and Takeda signed a collaboration agreement in March 2007 for the development of investigational compounds to treat patients with cancer, including CBP501 and its backup compounds discovered by CanBas. Under the terms of this agreement, the worldwide exclusive rights for development, manufacturing and marketing have been granted to Takeda, while in the U.S. the development and promotion are jointly conducted by both companies. Millennium will work with CanBas to advance global development expeditiously. In November 2008, the companies initiated a Phase II trial of CBP501 in malignant pleural mesothelioma... CanBas' Press Release - Millennium's Press Release - Takeda's Press Release -

Allos Therapeutics Completes Enrollment in Randomized Phase 2b Trial of Pralatrexate in Patients with Advanced Non-Small Cell Lung Cancer

Jul. 7, 2009 - Allos Therapeutics, Inc. (Nasdaq: ALTH) announced the completion of patient enrollment in the Company's randomized Phase 2b clinical trial comparing pralatrexate to erlotinib (Tarceva®) in patients with Stage IIIB/IV non-small cell lung cancer (NSCLC) who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen.

“Advanced non-small cell lung cancer represents an area of high unmet medical need where we believe pralatrexate has the potential to offer a new treatment option,” said Pablo J. Cagnoni, M.D., chief medical officer of Allos Therapeutics. “We are pleased with the strong interest in this trial, having enrolled 201 patients in 18 months. The objective of this Phase 2b trial is to assess the treatment effect of pralatrexate in certain pre-specified subsets of patients with advanced non-small cell lung cancer where we believe the agent has the potential to provide clinical benefit.” ... Allos Therapeutics' Press Release -

Endocyte : data on EC145 at the IASLC 13th World Conference on Lung Cancer

July 14, 2009 – Endocyte, Inc., a cancer drug discovery and development company, announced that it would report results of a Phase II clinical study of EC145 in patients with advanced lung cancer. The data will be presented as part of the 13th World Conference on Lung Cancer to be held July 31 to August 4, 2009, in San Francisco... [PDF] Endocyte's Press Release -

Boehringer Ingelheim and DxS : agreement for a companion diagnostic to identify EGFR mutations in patients with lung cancer

29 May 2009 - DxS, a personalised medicine company, and Boehringer Ingelheim, a global group of pharmaceutical companies, headquartered in Germany, have entered into an agreement to provide a companion diagnostic test kit for Boehringer Ingelheim’s compound BIBW 2992 (Tovok™) to identify mutations of the EGFR (epidermal growth factor receptor) in patients with non small cell lung cancer. Financial terms of the agreement are not disclosed.

Clinical data published to date suggest that BIBW 2992 offers a marked increase in efficacy in comparison to standard treatments, for lung cancer patients carrying mutations in the EGFR gene. Under the terms of the agreement, DxS and Boehringer Ingelheim will work jointly to make a suitable companion diagnostic test kit globally available...

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About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.



About DxS
DxS is a personalised medicine company providing molecular diagnostics to aid doctors and drug companies in selecting therapies for patients. Working in partnership with pharmaceutical companies to support the development and sales of targeted cancer therapies by providing biomarkers and companion diagnostics... Boehringer Ingelheim's Press Release - DxS' Press Release -

Kai Sensors : FDA Clearance for its Wireless, Non-Contact Respiratory Device

June 10, 2009 – Hawaii-based Kai Sensors announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Kai Sensors Non- Contact Respiratory Rate Spot Check, also called the Kai RSpot. The 510(k) clearance allows Kai Sensors to market the Kai RSpot to physicians, hospitals, and clinics.
The Kai RSpot is a device that offers a practical and effective approach of measuring respiratory rate in hospital and clinical settings. The device is easy to use and works wirelessly, with no contact or attachment to the patient.
Due to difficulties with current approaches of measuring respiratory rate, this important vital sign is often measured infrequently, inaccurately, inconsistently, or not at all. The clinically tested Kai RSpot provides a solution that addresses many of the shortcomings of existing technologies, and will enable doctors and health care professionals to measure a patient’s respiration with greater ease and with increased regularity...

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About Kai Sensors, Inc.
Headquartered in Honolulu, Hawaii, Kai Sensors develops products designed to measure and monitor vital signs wirelessly, with no contact to the patient, and from a distance. Kai Sensors’ products are designed for use in the medical, homeland security, and other markets... [PDF] Kai Sensors' Press Release -

Osmetech : FDA clears its Cystic Fibrosis Genotyping Test

9 July 2009 - Osmetech plc (OMH.L), the fast growing international molecular diagnostics company announces that it has received US Food & Drug Administration (‘FDA’) 510(k) clearance for its eSensor® Cystic Fibrosis Genotyping Test for use on the eSensor® XT-8 System. This multiplex test is used for cystic fibrosis carrier screening for adults of reproductive age, as an aid in newborn screening for cystic fibrosis, and as a confirmatory diagnostic test for cystic fibrosis in newborns and children... Osmetech's Press Release -

Alnara Pharmaceuticals Licenses Worldwide Rights to Liprotamase from Cystic Fibrosis Foundation

March 25, 2009 - Novel, Oral, Pancreatic Enzyme Replacement Therapy with Phase 3 Data Offers Potential Advantages – Alnara Pharmaceuticals, a pharmaceutical company developing novel, non-systemic orally-delivered protein therapeutics for the treatment of metabolic diseases, announced a licensing agreement with the Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation, for the worldwide rights to liprotamase, a novel, oral, porcine-free pancreatic enzyme replacement therapy (PERT) that has already completed a Phase 3 efficacy trial. Under the terms of the agreement Alnara will obtain exclusive worldwide rights to develop and market liprotamase.
Liprotamase (formerly known as ALTU-135 and Trizytek) is designed to treat malabsorption that is the result of pancreatic insufficiency associated with conditions like cystic fibrosis (CF) and chronic pancreatitis (CP), in which patients require a significant amount of pancreatic enzyme supplements with each meal. Patients with pancreatic insufficiency cannot properly absorb and digest food due to their disease. Pancreatic enzyme replacement therapy is a lifesaving treatment involving the administration of pancreatic enzymes, and liprotamase, a novel, oral, porcine-free treatment, offers potential advantages over the existing standard of care. Currently, patients are treated with porcine-derived pancreatic enzymes, which vary in potency and stability and have a high pill burden. Alnara believes liprotamase has the potential to overcome these challenges by providing a first-in-class and best-in-class PERT...

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About Alnara
Alnara Pharmaceuticals, Inc. is dedicated to developing novel protein therapeutics for the treatment of metabolic diseases. The company's innovative approach focuses on designing effective protein therapies that can be orally delivered directly to the gastrointestinal tract without being absorbed into the bloodstream. The company is committed to bringing breakthrough new treatments to patients with unmet medical needs. Based in Cambridge, Massachusetts, Alnara is backed by top-tier venture investors, including Frazier Healthcare Ventures, Third Rock Ventures and Bessemer Venture Partners... [PDF] Alnara Pharmaceuticals' Press Release -

YM BioSciences : DAIICHI-SANKYO ENROLLS FIRST PATIENTS IN PHASE II, FIRST-LINE LUNG CANCER TRIAL WITH NIMOTUZUMAB

June 23, 2009 -- YM BioSciences Inc. , a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, reported that its licensee for nimotuzumab, Daiichi-Sankyo Co., Ltd. in Japan advises that it has commenced enrollment of a Phase II trial evaluating nimotuzumab in combination with radiation therapy/cisplatin/vinorelbine in first-line curative intent patients with Stage III non-small-cell lung cancer (NSCLC). The trial will evaluate the treatment completion rate and numerous secondary endpoints including response rate, progression-free survival, and the overall survival rate at 12 and 18 months as well as toxicity...

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About YM BioSciences

YM BioSciences Inc. is a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development. The Company is currently developing two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl. YM has proven regulatory and clinical trial expertise and a diversified business model designed to reduce risk while advancing clinical products toward international approval, marketing and commercialization... YM BioSciences' Press Release -

bitop AG and Activaero : collaboration on clinical study of inhalable Ectoin® solution

June 17, 2009 – bitop AG and Activaero GmbH announced the start of a clinical study on bitop AG’s medical device Ectoin® inhalation solution using Activaero’s leading controlled breathing technology, the AKITA²® inhalation system. Ectoin® inhalation solution is based on Ectoin®, an extremolyte, a natural substance developed by bitop AG and currently available in topical skin creams and nasal sprays for the treatment of dry and irritated tissue.
The present clinical study is a single-center dose-finding, safety and feasibility study involving patients with mild bronchial asthma in Germany. Ectoin® inhalation solution has already shown marked therapeutic efficacy in animal models of allergen induced asthma and the purpose of the study is to investigate the safety and tolerability of Ectoin® inhalation solution in the treatment of asthma.
The AKITA²® inhalation system allows for homogeneous drug deposition of aerosolized Ectoin® within the periphery of the lungs in a consistent and reproducible manner. The system also has a smart card technology meaning that data on compliance and dosing can be recorded automatically for each patient.

“We believe that Ectoin® inhalation solution shows tremendous potential as a treatment for mild to moderate bronchial asthma and may also be effective in other lung affecting diseases, e.g. COPD”...

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About bitop
bitop AG develops and markets its products on the basis of extremolytes, a group of natural substances, which is responsible for the stress resistance of extremophilic microorganisms. Based on the unique cell protective mechanisms, extremolytes build an innovative therapy approach. The aim is the development of highly effective, well tolerable and also preventively effective therapeutics. For the production of extremolytes bitop AG has developed proprietary biotechnological processes, allowing the worldwide exclusive production of ectoines and other extremolytes. The Company is privately held and located in Witten (Germany).



About Activaero
Activaero is the world leader in controlled breathing technologies for inhaled therapeutic agents. With stand alone inhalation products and inhalation systems available for clinical trials and marketing partnerships, Activaero’s technologies allow for the most precise and efficient patienttailored pulmonary delivery. Activaero currently has two products on the market, AKITA JET®, a patient-tailored controlled breathing system with a Smart Card that contains the patient dosing parameters and records the compliance, and Watchhaler™, a hand held delivery system tailored specifically to children. The company also has available a range of technologies ideal for the controlled delivery of inhaled therapeutics in the clinical trial setting (AKITA2®, LimiX) and tailored to specific partnerships. Activaero’s technological approach has been validated repeatedly in the clinical setting. The company is privately held and located in Gemünden (Wohra) and Munich in Germany and Dublin, Ohio in the USA... [PDF] Activaero's Press Release -