Oxagen : Completion of Recruitment in Phase IIb Dose Range-Finding Clinical Trial in New Oral Treatment for Asthma

9th December 2009 – Oxagen Limited, a drug discovery and development company specializing in inflammation, announced that the recruitment for its double blind, randomised, placebo controlled Phase IIb clinical trial in asthma with OC000459, its lead oral CRTH2 (DP2) antagonist, has now been completed.

The study, which was initiated in mid May 2009, is expected to complete by the end of Q2 2010. It involves 440 asthmatic patients with moderate persistent asthma who will be randomised to one of three possible dose levels of OC000459 or placebo by oral tablet for a 12 week dosing period, with lung function (improvement in clinic FEV1) being the primary end point.

The purpose of the study is to determine the magnitude of further improvement in lung function and asthma symptoms on longer term therapy and to define the optimal once daily oral dose of OC000459... Oxagen's Press Release -

Genta : to Support Initiation of New Clinical Trial using Ganite® as Treatment for Life-Threatening Infections in Patients with Cystic Fibrosis

December 2, 2009 - Genta Incorporated (OTCBB: GETA) announced that the Company will supply Ganite® (gallium nitrate injection) for a new clinical trial that will be initiated in patients with cystic fibrosis (CF) who may develop serious infections.

Infection is the most common cause of death in CF patients. Frequently, these infections are due to bacteria known as Pseudomonas aeruginosa, and patients are commonly treated with years of antibiotic therapy to control such infections. However, prolonged antibiotic use has greatly increased resistance due to genetic mutations. In addition, Pseudomonas has evolved protective mechanisms known as "biofilms" that encase colonies of bacteria and prevent antibiotics from reaching infection sites. Bacteria in biofilms are far more resistant to being killed. Recent information has suggested that gallium may be used as an anti-bacterial agent against Pseudomonas, in part due to its ability to disrupt biofilms... Genta's Press Release -

Eurand : ZENPEP(TM) (Pancrelipase) Delayed-Release Capsules

Nov 30, 2009 - First and Only FDA-Approved Pancreatic Enzyme Product Clinically Proven in Patients as Young as One Year Old - Eurand N.V. (NASDAQ: EURX), a global specialty pharmaceutical company, announced the commercial availability of ZENPEP(TM) (pancrelipase) Delayed-Release Capsules, a pancreatic enzyme product (PEP) indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. The U.S. Food and Drug Administration (FDA) approved ZENPEP on August 27, 2009.

Eurand has also completed the hiring, training and deployment of its sales organization to promote ZENPEP, including a specialty CF sales force composed of 16 Eurand sales people targeting the 120 accredited cystic fibrosis centers, satellites and other specialists who treat CF. In addition, the Company has contracted with Innovex, a Quintiles company, to promote ZENPEP to PEP prescribers who commonly treat patients with EPI associated with other conditions such as chronic pancreatitis, pancreatic cancer and gastric surgery. These 49 Innovex sales professionals will call on key gastroenterologists, internal medicine specialists, family-practice physicians and oncologists... Eurand's Press Release -

Chart's CAIRE : Acquisition of Covidien's Oxygen Therapy Business

Nov. 30, 2009 - Chart Industries, Inc. (Nasdaq:GTLS) announced that CAIRE, which operates under Chart's BioMedical segment, has completed the previously announced acquisition of Covidien's (NYSE:COV) oxygen therapy business, including the design, manufacturing, and sales and service functions worldwide. The acquisition includes products sold under the leading Companion(TM) and HELiOS(TM) brands. Financial terms of the transaction were not disclosed... Chart Industries' Press Release - Covidien's Press Release -

ZaBeCor Pharmaceuticals : Phase II Clinical Trial In Asthma Patients Following Positive Phase I Results

September 14, 2009 - ZaBeCor Pharmaceuticals announced the initiation of a Phase II clinical trial for its asthma drug candidate ExcellairTM, following the successful results of the Company’s Phase I clinical trials. ZaBeCor is one of the first companies to deliver siRNA to the lung and one of the first to target asthma with siRNA.

“The advancement of ExcellairTM into a Phase II clinical trial for asthma is a significant milestone for our company... ZaBeCor Pharmaceuticals' Press Release -

SuperGen : MP-470 Demonstrates Clinical Benefit in Small Cell Lung Cancer and Neuroendocrine Tumor Patients

Aug. 3, 2009 - SuperGen Inc., (NASDAQ: SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that preliminary results from Phase Ib data of MP-470, its multi-targeted, tyrosine kinase inhibitor and RAD51 suppressor, demonstrated an overall clinical benefit rate of 54 percent when the drug is given in combination with standard of care (SOC) carboplatin containing doublet chemotherapy in patients with small cell lung cancer (SCLC) and neuroendocrine malignancies (NE). The data was presented on August 2, at the International Association for the Study of Lung Cancer (IASLC), 13th World Conference on Lung Cancer in San Francisco, CA.

The Phase I dose titration study enrolled four patients with SCLC and nine patients with NE as of February 28, 2009. As measured by the Response Evaluation Criteria in Solid Tumors (RECIST), five of thirteen patients achieved a confirmed partial response and two additional patients demonstrated stable disease greater than twelve weeks for an overall clinical benefit rate of 7/13 patients or 54% (95% CI, 25% - 81%). There were no clinically significant adverse events attributable to the addition of MP-470 to SOC. "We continue to be encouraged by the clinical data resulting from our MP-470 trials and the potential benefit of its addition to standard of care treatment regimens... SuperGen's Press Release -

Entest BioMedical : Treatment of Chronic Obstructive Pulmonary Disease

Nov. 5, 2009 – David Koos, Chairman and CEO of Entest BioMedical, Inc. (OTCBB: ENTB), stated that the Company's unique treatments for Chronic Obstructive Pulmonary Disease (COPD), currently in development, can lead to substantial revenue opportunities. According to Koos, "Current treatment for COPD is aimed at improving quality of life, not curing the illness. It is Entest's goal to reverse the damage from COPD. If successful, Entest stands to profit substantially from the money currently spent on maintenance treatments that are not cures."

The Company stated that over the next 5 years over $170 billion will be spent on treating COPD in the United States. Currently COPD is the 4th leading cause of death in the United States and is projected to become the 3rd leading cause of death in the US by 2020. It is estimated that COPD medical related costs will be in excess of $800 billion during the next 20 years... Entest BioMedical's Press Release -

NovaRx : FDA Approval of Protocol Amendment to Special Protocol Assessment (SPA) for Phase III Lucanix® Study

Nov. 4 - 2009 -- NovaRx Corporation announced that the Company has successfully negotiated and received FDA approval for a Special Protocol Assessment (SPA) Protocol Amendment to the pivotal Lucanix® Phase III clinical trial in patients with Non-Small Cell Lung Cancer (NSCLC). The amendment will expand patient eligibility and enable study investigators to treat patients with stable brain metastases. As many as one in three NSCLC patients have such metastases, thus the amendment will make significantly more patients eligible for the trial. Other approved protocol changes include expanded stratification criteria and the ability for investigators to treat patients with decreased serum albumin levels... NovaRx's Press Releases -

Sagent Pharmaceuticals launches VINORELBINE INJECTION, USP

30 September 2009 - Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, announced that it has launched vinorelbine injection, USP, an anti-mitotic chemotherapy drug. According to IMS, 2008 sales of vinorelbine injection, USP in the United States approximated $17 million. Sagent will begin marketing and shipping vinorelbine injection immediately.

“Sagent has launched six products in the third quarter of 2009, including vinorelbine, our third oncolytic product. Our innovative business model enables us to provide our customers with a broad range of products and delivery systems with features designed to help enhance safety and convenience,” said Michael Logerfo, corporate vice president of Sagent. “We continue to receive positive feedback from our customers who often consider the enhanced features of our products to be important factors when making their purchasing decisions.”

Sagent’s vinorelbine injection is offered in 10 mg per 1 mL and 50 mg per 5 mL, latex-free and preservative-free, single-dose vials that incorporate easy-to-read product and dosage information.

About Vinorelbine Injection, USP

Vinorelbine injection is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced non-small cell lung cancer (NSCLC). In patients with Stage IV NSCLC, vinorelbine is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, vinorelbine is indicated in combination with cisplatin... Sagent Pharmaceuticals' Press Release -

Almac and Lilly Partner on Companion Diagnostic Development

15-SEP-09 - Almac and Lilly UK have entered into a partnership to develop a companion diagnostic for ALIMTA, with cisplatin, as a combination therapy for non-squamous non-small cell lung cancer.


The study focuses on evaluating Thymidylate Synthase (TS) as a predictive marker of response to Alimta in combination with cisplatin. A number of parallel exploratory analyses will be performed as alternative strategies to identify further potentially novel predictive biomarkers of response to the combination therapy. These include global gene expression profiling from FFPE tumour samples using the Almac Diagnostics Lung Cancer DSA™ research tool... Almac's Press Release -

Aerocrine and Panasonic Shikoku Electronics : asthma partnership

4 November 2009 – Aerocrine AB (OMX Nordic Exchange: AERO) announced that Aerocrine and Panasonic Shikoku Electronics, CO., LTD (PSEC) have entered into a long-term agreement to develop, manufacture and market new generation products for airway inflammation monitoring using exhaled nitric oxide.

PSEC, a wholly owned subsidiary of Panasonic Corporation, is a world class electronic development, manufacturing and marketing corporation with extensive experience in designing and manufacturing consumer and professional medical devices. Aerocrine is a clinically based medical technology corporation that discovered exhaled nitric oxide monitoring for clinical use in asthma care and leads the market with proprietary technology and products for airway inflammation measurement.



Under the agreement, Aerocrine and PSEC will collaborate to develop future generations of products for airway inflammation monitoring for both clinical and personal use. PSEC will be responsible for the worldwide manufacture and supply of the products and Aerocrine will be responsible for regulatory approvals, method development and global commercialization... Aerocrine's Press Release -

Pulmatrix : Company Developing Novel Therapies to Treat and Prevent Respiratory Diseases

November 2, 2009 – Pulmatrix, a clinical stage biotechnology company discovering and developing a new class of therapies for the treatment and prevention of infectious and progressive respiratory diseases, announced that it has secured $30.2 million in Series B financing. ARCH Venture Partners and Novartis Bioventures Fund co-led the round with participation from existing investors Polaris Venture Partners and 5AM Ventures.
Proceeds from the financing will be used to enhance Pulmatrix’s R&D capabilities in advancing a new class of host-targeted therapies that treat and prevent a full range of respiratory diseases by harnessing the airway and lungs own natural biophysical properties and host defense mechanisms. In particular, the financing will accelerate the development of Pulmatrix’s product pipeline, including multiple clinical trials in a number of respiratory diseases that will initiate in 2010 and 2011. Currently, Pulmatrix has a drug compound, PUR003, which is being evaluated in Phase 1B/2A trials in influenza, with results from this initial clinical study expected by the end of the year. The new and ongoing clinical trials build upon previous preclinical studies that have demonstrated the efficacy of the Pulmatrix approach in the treatment, prevention, and transmission control of both viral and bacterial diseases in multiple animal species... [PDF] Pulmatrix's Press Release -

Ingen Technologies Brings Aboard Leading OEM Partner for Australia

Oct 23, 2009 - Ingen Technologies, Inc., a leading global Medical Device Manufacturer focused on the $4B Respiratory market with their Oxyview products for the growing aging population and emerging markets for Home (DME), Hospital and Aviation industries announced that Medical Industries Australia has signed an OEM contract with Ingen.

Medical Industries Australia is a leading provider of sterile and non-sterile medical products, training and maintenance services, and provides high quality products and services to the Australian healthcare sector and has been supplying distributors and resellers, public and private hospitals, government departments, private clinics, aged care facilities and medical surgeries for more than 20 years.

In Australia, under the national Medicare health scheme, all interstitial lung disease and COPD patients who require oxygen therapy, are provided with a 5 liter/min oxygen concentrator at no cost, this includes a free Oxygen tubing & nasal cannula each month. State Government funded, the concentrators and consumables suppliers are selected by tender, usually on a 3+1 year arrangement.

In the case of new or innovative devices, such as Ingen's Oxyview Nasal Cannula, they fall outside the state tender and can be offered to public government-funded hospitals for trial and evaluation and if accepted, purchased by the various respiratory departments to be used by their patients. Approximately 1,000 COPD patients, each day, occupy a public hospital bed in Australia (at a cost of $580 per day). In many cases it's due to an exacerbation requiring a respiratory investigative review with new titration and oxygen therapy needs established. Approximately 30,000 patients use Oxygen concentrators on a daily basis... Ingen Technologies' Press Release -

Sequenom : Launch of SensiGene Cystic Fibrosis Carrier Screening Test

Sept. 17, 2009 - SEQUENOM, Inc. (Nasdaq: SQNM) announced that the company's first laboratory developed test, the SensiGene(TM) Cystic Fibrosis (CF) Carrier Screening test, has been launched. This test is available exclusively through the Sequenom Center for Molecular Medicine, a next-generation CLIA (Clinical Laboratory Improvement Amendments, 1988) molecular diagnostic laboratory and a wholly-owned subsidiary of Sequenom, Inc... Sequenom's Press Release -

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...

...

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...

...

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...

...

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”...

...


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 -

Biosystems International : Development of a Diagnostic Blood Test for Lung Cancer

PARIS-may 14, 2009 -Biosystems International a biotechnology company focused on the development of novel monoclonal antibody-based cancer diagnostics has initiated the development of an in vitro diagnostic blood test for lung cancer. This decision is based on the successful validation of a panel of monoclonal antibodies on multiple cohorts of lung cancer patients and control subjects.
The antibodies of the test under development were discovered using BSI’s patented monoclonal antibody proteomics platform which has delivered a panel of lung cancer specific antibodies that has been tested on 4 patient cohorts totaling 367 patients and 304 controls and demonstrates > 80% sensitivity and > 80% specificity (for comparison, the PSA test for prostate cancer screening has a sensitivity of 35% and specificity of 63%). Importantly, similar values were obtained on a subpopulation of 128 patients with stage I cancer, demonstrating the strong potential to develop the first blood test to detect early stage lung cancer when it is treatable by surgery resulting in a dramatic increase in the chance for survival. Furthermore, a subset of
antibodies discriminates between different histological subtypes, a finding which can aid in accurate diagnosis assuring appropriate treatment.
To confirm the specificity of the antibody panel to lung cancer, it has also been tested on control cohorts including subjects with non-malignant lung pathologies such as COPD, bronchial pneumonia, and fibrosis, as well as lung tumors of non-pulmonary origin. In all cases the antibodies were insensitive to these conditions as well as gender, treatment and smoking status... [PDF] Biosystems International's Press Release -

Clarient : New Gene Mutation Test to Help Select Therapy for Non-Small Cell Lung Cancer

June 16, 2009 - Clarient, Inc. (Nasdaq: CLRT), a premier anatomic pathology and molecular testing services resource for pathologists, oncologists, and the pharmaceutical industry, announced the launch of a new gene mutation test that can help physicians select the proper therapy for patients with non-small cell lung cancer (NSCLC). The test, called epidermal growth factor receptor (EGFR) mutation, has been validated as a laboratory-developed test and is now available to physicians and their patients... Clarient's Press Release -