Novartis : Early data show potential for imatinib to treat life-threatening form of pulmonary artery disease

October 8, 2008 - An early proof-of-concept study presented shows promising results for imatinib in the treatment of pulmonary arterial hypertension (PAH), a severe, incurable blood vessel disorder.

Preliminary findings from a 59-patient, multi-center Phase II clinical trial suggest imatinib provides a treatment benefit, as demonstrated by a significant improvement in pulmonary vascular resistance and a numerical increase in cardiac output, key hemodynamic measures used to monitor the progression of the disease. Improvements in the six-minute walk test, the primary endpoint of the study, approached, but did not reach, statistical significance... Novartis' Press Release -

Alfacell's ONCONASE(R) Targets siRNA : Paper in Cell Cycle

Oct. 9, 2008- Alfacell Corporation (Nasdaq: ACEL) announced that a paper published in Cell Cycle (2008; Vol. 7, Issue 20) reports that ONCONASE (ranpirnase) targets small interfering RNA (siRNA), likely within the RNA-induced silencing complex (RISC) of the RNA interference (RNAi) mechanism.

The paper is the result of research conducted by collaborators at the Brander Cancer Research Institute and Department of Pathology at New York Medical College and Alfacell. The study demonstrated that silencing the glyceraldehyde 3-phosphate dehydrogenase (GAPDH) gene (an abundant and ubiquitously expressed housekeeping gene) in human lung adenocarcinoma A549 cells by siRNA was effectively prevented by ONCONASE. While transfection of cells with GAPDH siRNA reduced expression of this protein by nearly 70 percent, the expression was restored in the cells exposed to ONCONASE for 48 or 72 hours. The data thus provide evidence that one of the targets of ONCONASE (ranpirnase) is siRNA... Alfacell's Press Release -

Neotropix : Expansion of On-going Clinical Trial for Adult Neuroendocrine Cancers

October 8, 2008 - Neotropix®, Inc., a clinical-stage development company focused on neuroendocrine cancer treatments, announced that it has begun enrolling neuroendocrine cancer patients into an expanded clinical trial of its lead candidate, NTX-010 (SVV-001), a tumor-selective naturally-occurring oncolytic virus. Neotropix® also announced that it has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) of NTX-010 for the treatment of neuroendocrine tumors.

After reviewing safety data from the current Phase I dose escalation study, conducted in neuroendocrine cancer patients, and as previously defined in the on-going protocol, the study is open to recruit more patients at the highest dose planned for long-term drug development. The expansion phase of the study allows the clinical sites to enroll additional patients meeting the enrollment criteria to evaluate safety and efficacy across a range of related cancers. To date, the Company has tested this clinical candidate, primarily in patients with carcinoid cancers of multiple origins, small cell cancer, including lung cancer, pancreatic islet cancer, and neuroendocrine cancers of unknown origin... Neotropix' Press Release -

Health Hero Network : Recertification from National Committee for Quality Assurance (NCQA) for Chronic Care Programs

October 23, 2008 - Health Hero Network, a leading innovator of technology solutions for chronic care management, announced today that it has received recertification in Disease Management from the National Committee for Quality Assurance (NCQA) for 10 of its Health Buddy® health management programs. NCQA certification indicates that Health Buddy® Programs have passed rigorous reviews for their quality in implementing evidence-based practice guidelines for patient education and care management. These programs are delivered via the Health Buddy System, which serves as the interface between patients at home and care providers, facilitating patient education and monitoring of chronic conditions. “We appreciate NCQA’s continued recognition and validation that our Health Management programs meet the highest level of quality,” says Leslie Honor, RN, Clinical Director for Health Hero Network. “This recertification assures our customers that these Health Buddy Programs indeed offer quality care management for their patients with chronic illnesses.”

Health Buddy® System

NCQA DM certification standards are intended to help organizations achieve the highest level of performance possible, reduce patient risk, and create an environment of continuous improvement. Health Hero Network received recertification in all ten previously recognized areas of care. The Health Buddy Programs recertified by NCQA include asthma, cancer, cardiovascular disease, chronic pain, depression, pediatric asthma, chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes, and hypertension programs... Health Hero Network's Press Release -

Teva Pharmaceutical : Proair® HFA, the Market Leading Albuterol Inhaler, Receives New Pediatric Indication

September 24, 2008 - Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved ProAir® HFA (albuterol sulfate) Inhalation Aerosol for use in patients as young as 4 years of age. Previously, ProAir HFA had been indicated for use in patients aged 12 and older.
In clinical studies, ProAir HFA, the market leading albuterol sulfate inhaler, exhibited significant bronchodilator efficacy in pediatric asthmatics aged 4 to 11 years. ProAir HFA provides physicians with a treatment option to help relieve children's asthma symptoms as they occur wherever they occur, which is especially important as children return to school. With asthma affecting more than one child in every 20 in the United States, studies show that asthma emergency room and hospitalization rates spike in September... Teva Pharmaceutical's Press Release -

Gemin X : Key U.S. Patent Issued for Obatoclax

September 23, 2008 -Novel Pan Bcl-2 Inhibitor is a Potential Treatment for Broad Range of Cancers - Gemin X, a clinical stage biopharmaceutical company developing novel, targeted cancer therapeutics, announced that the United States Patent & Trademark Office issued to Gemin X a patent protecting the composition of matter of obatoclax through 2025 - U.S. Patent No. 7,425,553. One of Gemin X's lead pipeline programs, obatoclax is an oncology treatment based on programmed cell death, or apoptosis, and has the potential to be a first-in-class pan Bcl-2 inhibitor. Obatoclax is currently in Phase 2 clinical trials for the treatment of elderly acute myeloid leukemia and the treatment of small cell lung cancer... Gemin X's Press Release -

Kuros Biosurgery and Aeris Therapeutics : Exclusive License Agreement in the Field of Lung Volume Reduction

September 23, 2008 - Kuros Biosurgery AG and Aeris Therapeutics, Inc., both privately held biotech companies, announced today that Kuros has granted Aeris an exclusive license in the field of lung volume reduction to certain patent rights Kuros exclusively licensed from the American Red Cross that cover the delivery of certain drugs in a fibrin sealant. In return for the license, Kuros will receive upfronts, milestones and royalties on the sale of Aeris’ lead product, the AeriSeal™ Biologic Lung Volume Reduction (BLVR) System, a novel investigational emphysema treatment. Aeris is currently preparing for the initiation of Phase 3 clinical trials for the AeriSeal BLVR system... [PDF] Kuros Biosurgery's Press Release - Aeris Therapeutics' Press Release -

REGENERX : RGN-457 for Cystic Fibrosis

October 01, 2008 - REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) announced that it is seeking a strategic partner to assist in the development of RGN-457 for the treatment of cystic fibrosis (CF). RGN-457 is based on thymosin beta 4 (TB4) peptide formulated as an inhaled therapeutic agent to address this patient population. CF is a life-threatening, hereditary disease that impairs the patient's ability to breathe due to the accumulation of thick and sticky mucus secretions in the airways of the lungs. There are estimated to be 30,000 and 40,000 CF patients in the U.S. and Europe, respectively. It is, therefore, considered an "orphan" disease in both territories. In 2006, the predicted median age of survival for patients with cystic fibrosis was 37 years... REGENERX BIOPHARMACEUTICALS' Press Release -

Gilead Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for CF

Sept. 16, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) announced that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for aztreonam lysine for inhalation, an investigational therapy in development for people with cystic fibrosis who have Pseudomonas aeruginosa (P. aeruginosa).

In this letter, the FDA informed Gilead that the review of the company's NDA has been completed. The agency stated that they cannot approve the application in its current form and an additional clinical study will be required. Gilead will continue its dialogue with the FDA to determine whether further analyses of existing data could lead to approval, or whether the company will need to conduct the additional study as stated in the letter... Gilead Sciences' Press Release -

MD Biosciences : Preclinical Disease Models at the 15th International Inflammation Research Association Conference

September 15, 2008 – MD Biosciences, a global biotechnology company focused in inflammations & neurology research will showcase its inflammations related pre-clinical services and research products at the Inflammation Research Association (IRA) International Conference, September 21-24, Chantilly, VA. Capabilities featured will be pre-clinical efficacy disease models and research products for drug discovery and research.

MD Biosciences will be hosting a lunch and learn session titled “Discovery of novel therapies for asthma requires suitable and relevant disease models”. Conference attendees are invited to register for this free session upon arrival of the conference. This session will focus on the OVA-induced Asthma model and airway hyperresponsiveness (AHR) as well as the OVA-IgE specific ELISA for measuring OVA specific IgE levels in murine serum samples... MD Biosciences' Press Release -

Medical Acoustics : Results on Efficacy of Medical Acoustics’ Lung Flute® to be Presented at European Respiratory Society Congress

September 22, 2008 — Medical Acoustics LLC, a commercial-stage medical device company which employs acoustic technologies for diagnostic and therapeutic medical applications, announced that the tuberculosis (TB) study of its innovative and easy to use pulmonary device, the Lung Flute^®, conducted by Dr. Akira Fujita, and Dr. Kengo Murata at Tokyo Metropolitan Fuchu Hospital, Tokyo, Japan, has been accepted for a presentation at the European Respiratory Society’s Annual Congress on October 6^th 2008, in Berlin, Germany. The results of the study, entitled “A Novel Method for Sputum Induction by the Lung Flute^® in Patients Suspected of Pulmonary Tuberculosis” were previously presented at the APSR Congress in Australia in December 2007 and at the Japanese Respiratory Society Conference in Kyoto, Japan in June 2008... Medical Acoustics' Press Release -

Arriva Pharmaceuticals : Protein Production Patent

1 October 2008 - Arriva Pharmaceuticals, a biopharmaceutical company focused on developing anti-inflammatory therapies, announced that it had been granted a patent in the U.S. for methods to produce certain proteins in yeast. Among the proteins whose production is covered by the patent (United States Patent 7,419,801) is recombinant alpha 1-antitrypsin (rAAT), the protein used in Respriva™, the company’s lead product.

“This patent extends our patent portfolio and strengthens our intellectual property estate for Respriva™,” said Sue Preston, chief executive officer of Arriva. “As we move forward with the development of Respriva™, we have multiple competitive advantages that leave us well positioned in the global market.”

Respriva™ is an inhaled rAAT. Arriva is currently conducting clinical trials with Respriva™ as replacement therapy in hereditary emphysema (HE). Patients with HE have a congenital deficiency in naturally occurring alpha 1-antitrypsin (AAT). Respriva™ also has the potential to ameliorate lung disease in other indications, such as chronic obstructive pulmonary disease (COPD), asthma and cystic fibrosis... [PDF] Arriva Pharmaceuticals' Press Release -

Dynavax Technologies : Milestone from AstraZeneca

Sep 22, 2008 - Novel Asthma/COPD Drug Candidate Nominated for Clinical Development - Dynavax Technologies, Inc. (NASDAQ:DVAX) announced receipt of a $4.5 million milestone payment from its partner AstraZeneca AB for the nomination of candidate drug AZD1419 for the treatment of asthma and chronic obstructive pulmonary disease (COPD). As part of this potential $136 million development and commercialization collaboration, AstraZeneca and Dynavax have initiated Investigational New Drug (IND) enabling studies with AZD1419 and plan to begin phase 1 clinical development in 2009.


AZD1419 represents a new strategy for the treatment of allergic respiratory diseases such as asthma. AZD1419 is designed to modify the course of these diseases by reprogramming the immune response to multiple allergens. AZD1419 is based on Dynavax's proprietary second-generation immunostimulatory sequences (ISS), which are short DNA sequences that specifically target Toll-Like Receptor 9 (TLR9) to stimulate the innate immune response... Dynavax Technologies' Press Release -

Advanced Life Sciences : NDA Submission for Cethromycin in Community Acquired Pneumonia

Oct. 1, 2008 - Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), announced the submission of a new drug application (NDA) for cethromycin in mild-to-moderate community acquired pneumonia (CAP). Advanced Life Sciences also entered into debt and equity financing agreements to strengthen its balance sheet and help fund commitments associated with the NDA submission and pre-commercialization activities.

CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. CAP affects 5.6 million patients in the United States each year, with 10 million physician visits and 2 million hospitalizations occurring annually.

Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CAP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance... Advanced Life Sciences' Press Release -