Lamellar Biomedical : First Orphan Drug Licence

June 16, 2011 - Provides 10-year Market Exclusivity for the treatment of Cystic Fibrosis - Glasgow biopharmaceutical firm, Lamellar Biomedical Ltd, launched four years ago to develop a new class of therapies for the prevention, treatment and control of severe respiratory disease, announced that their lead clinical candidate LMS-611 for the treatment of patients with cystic fibrosis has received Orphan Drug Designation from the European Commission. The designation follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) earlier this month.

“The designation of LMS-611 as an orphan drug by the European Medicines Agency underscores the importance of developing effective treatments for patients with cystic fibrosis,” said Dr Iain McDougall, Chief Business Officer of Lamellar Biomedical Ltd. “To date we have been extremely encouraged by LMS-611’s preclinical results, and we continue to believe we are developing a therapy which will prove to be both safe and effective with the potential to offer a brand new way of treating the disease when we enter clinical trials early next year.”

Drugs for rare diseases are called “orphans” because the small number of patients they would treat means they are often not developed by the pharmaceutical industry. Today’s designation will make it easier for Lamellar Biomedical Ltd to attract both investment and development partners and facilitate LMS-611’s entry into clinical use. Lamellar Biomedical Ltd and its partners will also have ten years to exclusively market the Drug in the European Union.

LMS-611 is developed from Lamellar’s proprietary inhaled LamellasomeTM delivery platform. The LamellasomeTM is based on the biological and biophysical resemblance to the natural lamellar bodies found in healthy lungs, and found to be absent in cystic fibrosis patients. By mimicking this missing body responsible for normal lung function, Lamellar Biomedical Ltd have already established an impressive package of preclinical data demonstrating significant potential as a mucus-altering treatment with the ability to fight and prevent infection... Lamellar Biomedical's Press Release -

Philips introduces HomeLox : only system that generates and stores liquid oxygen at home

June 21, 2011 - Philips introduces only system that generates and stores liquid oxygen at home; HomeLox helps increase freedom for patients and reduces costs for providers — Royal Philips Electronics (NYSE: PHG, AEX: PHI) introduced the HomeLox portable liquid oxygen system. The innovative system enables oxygen users to generate and store the liquid form of oxygen in the home setting. The HomeLox system offers users the long-lasting and lightweight characteristics of traditional liquid systems, while freeing them from difficulties of filling and dependence on deliveries associated with conventional systems.

Home oxygen is a critical, life-sustaining medical treatment prescribed to nearly 1.5 million Medicare patients annually who suffer from respiratory illnesses such as chronic obstructive pulmonary disease (COPD). (National Heart, Lung, and Blood Institute and American Thoracic Society)

HomeLox includes a liquid oxygen generation and storage unit that remains in the user’s home, and a lightweight and long-lasting portable device, GoLox. HomeLox generates liquid oxygen by converting room air into oxygen, and then chilling and converting it to liquid form using a proprietary refrigerant along with standard refrigeration technology found in industrial and household applications. The liquid oxygen is stored within the HomeLox unit until transferred to GoLox for portable use.



In addition to giving users the ability to generate and store liquid oxygen at home, the HomeLox system features a new hands-free clean filling process. To fill the GoLox portable device, the user simply places the unit on top of HomeLox, turns and locks the unit, and pulls the filling lever. The hands-free process helps reduce freezing, overfilling, and under filling.

For homecare providers, the new HomeLox liquid system reduces the cost and complexity of current systems commonly associated with delivered liquid oxygen systems which may include the purchase of specialized vehicles, testing equipment, and storage containers, as well as recurrent deliveries and filling-related service calls... Philips' Press Release -

Cephalon : Encouraging Results of Obatoclax in Extensive-Stage Small Cell Lung Cancer at ASCO Annual Meeting

June 7, 2011 – Cephalon presented new phase 2 data on an investigational compound, obatoclax, at the 47th Annual Meeting of the American Society of Clinical Oncology in Chicago, Ill. The data show that patients with extensive-stage small cell lung cancer receiving obatoclax in addition to standard chemotherapy demonstrated a trend toward improved overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) when compared to chemotherapy alone. This is the first presentation of solid tumor data for the Company following its acquisition of Gemin X in March 2011, which developed the drug. Obatoclax expands the Cephalon portfolio in oncology beyond hematologic malignancies.
“Small cell lung cancer is a deadly and fast-growing tumor type. Approximately 65 percent of patients with this type of lung cancer have extensive disease at presentation and new approaches to treatment are needed,” said Lesley Russell, Chief Medical Officer at Cephalon. “The results of this study, suggest that obatoclax could be a new treatment option for patients if these treatment effects are replicated in a larger phase 3 study.”... Cephalon's Press Release -

Insmed : ARIKACE® Demonstrates Sustained Benefit Through Six Cycles of Treatment for Cystic Fibrosis Patients With Pseudomonas Lung Infections

June 10, 2011 - Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, announced positive data through six treatment cycles (72 weeks total duration) of its Phase 2 clinical trial program for ARIKACE® (liposomal amikacin for inhalation) in cystic fibrosis (CF) patients with Pseudomonas lung infections. The data were presented at the 34th European Cystic Fibrosis Conference in Hamburg, Germany, by Predrag Minic, M.D., Professor of Pediatrics and Head of Pediatrics Pulmonology Department, Mother and Child Health Institute, Belgrade, Serbia, and co-lead investigator of the study.

The open label Phase 2 study was designed to evaluate ARIKACE over multiple treatment cycles in CF patients with Pseudomonas lung infections. The study enrolled 49 patients to receive ARIKACE 560 mg once daily for 28 days of therapy, followed by a 56-day off-treatment observation period. ARIKACE was administered using an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH).

The data demonstrated that ARIKACE, delivered once-daily for 28 consecutive days, followed by 56 days off-treatment, for a total of six cycles, resulted in statistically significant improvement in lung function that was sustained over a 72 week period. Specifically, inhalation of 560 mg of ARIKACE produced a mean increase in pulmonary function (FEV1) of 11.7% at the end of the 28 day treatment period of the sixth cycle (p<0.0001).

During the course of the study, FEV1 improvement was also sustained at the end of 56 days off-treatment in each of cycles one through six, with an estimated relative increase in FEV1 of 5.7% (95% CI +3.0%, +8.5%; p=0.0001). Overall, ARIKACE was well-tolerated during all six cycles, with adverse events reported as consistent with those expected in a population of CF patients receiving inhaled medicines... Insmed's Press Release -

CytRx Increases Clinical Sites to 15 in Tamibarotene Phase 2b Clinical Trial in 1st Line Non-Small-Cell Lung Cancer to Expedite Patient Recruitment

Apr 20, 2011 - Clinical Trial Data Could Be Available in Second Half of 2012 - Development of Tamibarotene for Potential Multibillion Dollar Market is Major Priority for CytRx - CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, has expanded enrollment to 15 clinical sites in its Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). The large number of sites is expected to accelerate recruitment, and full enrollment of the approximately 140 patients is now anticipated in 12 months.
"We have opened enrollment in 15 clinical sites in the U.S. and Mexico for our tamibarotene clinical trial in 1st line NSCLC to expedite recruitment for an indication that could represent a blockbuster opportunity," said CytRx CEO Steven A. Kriegsman. "We expect these additional sites will accelerate enrollment, which means we could have data from this Phase 2b clinical trial by the end of 2012. What makes NSCLC so compelling is that it is responsible for more deaths than breast, prostate and ovarian cancers combined."
Daniel Levitt, MD, Ph.D., CytRx's Chief Medical Officer, said, "Tamibarotene is 10 times more potent than all trans retinoic acid (ATRA), while simultaneously showing properties that suggest it may lead to fewer adverse effects than ATRA. Recent published clinical data demonstrated that ATRA in combination with chemotherapeutical agents was statistically significant as a treatment for advanced NSCLC, which may open the door for tamibartotene based on its greater potency and lower side effect profile than ATRA."
In December 2010, CytRx initiated the Phase 2b clinical trial in patients with advanced NSCLC at a single clinical site. In this randomized clinical trial, patients with advanced NSCLC are treated with paclitaxel plus carboplatin and either tamibarotene or placebo. The primary objective of this trial is to determine the objective response rate (complete and partial responses) and progression-free survival. Secondarily, the trial will evaluate overall survival, quality-of-life and examine the pharmacokinetics of tamibarotene in this population, among other measures... CytRx's Press Release -