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 -