Anacor Pharmaceuticals Partnership Advances Novel Drug Candidate to Combat Sleeping Sickness

June 28, 2011 - PLoS Journal article highlights initial research success of a boron-based compound, ready to enter into clinical development, resulting from collaboration between Anacor Pharmaceuticals, DNDi, and SCYNEXIS - Anacor Pharmaceuticals (NASDAQ:ANAC), the Drugs for Neglected Diseases initiative (DNDi), and SCYNEXIS Inc. announced the successful completion of pre-clinical studies for the first new oral drug candidate discovered specifically to combat human African trypanosomiasis (HAT), also known as sleeping sickness. An article released in the open-access journal PLoS Neglected Tropical Diseases, reveals the initial successful results of pre-clinical studies of the new compound, which will soon advance to Phase I human clinical trials.

Sleeping sickness, which threatens millions in 36 countries in sub-Saharan Africa, is fatal if left untreated. The disease is caused by parasites transmitted by the bite of a tsetse fly and is often asymptomatic for years until the infection reaches "stage 2" where it crosses into the central nervous system and brain. Without effective treatment, sleeping sickness is fatal. Currently available treatments are limited to drugs developed decades ago that are either highly toxic, difficult to administer in resource-limited settings, or are only effective in one stage of the disease. In addition, prior to being treated, the stage of the disease must be determined using a diagnostic spinal tap to extract cerebrospinal fluid from the patient.


Two-thirds of all reported sleeping sickness cases are found in the Democratic Republic of the Congo (DRC), where healthcare is often inaccessible to large parts of the population due to violent conflict, great distances patients must travel to health facilities, and extreme poverty. Dr. Miaka Mia Bilenge, special advisor to the National Control Program for Human African Trypanosomiasis in the DRC, explained that if the new drug candidate proves to be successful, it could become a major weapon to control sleeping sickness.
"People in the DRC and many countries in Africa have hoped for a safe, easy-to-use, and effective treatment against sleeping sickness for generations," Dr. Miaka Mia Bilenge said. "We very much look forward to the start of human trials, and we hope that at long last this will give us a tool for sustainable elimination of this dreaded disease."

In pre-clinical studies, the new drug candidate, SCYX-7158, also registered as AN5568, demonstrated safety and the ability to cross the blood-brain barrier making it efficacious against stage 1 and stage 2 of the disease. In addition, its oral formulation, short duration of therapy and excellent pre-clinical safety profile imply that SCYX-7158 (AN5568) could change the way sleeping sickness is treated, reduce its incidence in humans, and contribute to elimination of the disease... Anacor Pharmaceuticals' Press Release - SCYNEXIS' Press Release -

SeptRx begins CE Mark trial of the SeptRx® Intrapocket PFO Occluder (IPO)

June 16, 2011—SeptRx, an emerging medical device company that is developing the SeptRx® Intrapocket PFO Occluder (IPO)—a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO)—announced that the first implants have been completed in the InterSEPT™ clinical trial at the CardioVascular Center at Sankt Katharinen Hospital, Frankfurt, under principal investigator Horst E. Sievert, M.D.
InterSEPT™ (In-tunnel SeptRx European PFO Trial) is a prospective, multi-center, single-arm safety and efficacy trial of the SeptRx® IPO. Data from InterSEPT™ will be used to apply for CE marking. The SeptRx® Intrapocket PFO Occluder has already completed a successful 11-patient first-in-human (FIH) clinical trial. SeptRx’s FIH trial was the first and only PFO device trial to demonstrate 100% closure and 100% safety (out to 3 years)...

[...]

...PFO is a tunnel-like defect connecting the right atrium with the left atrium. A remnant of fetal circulation, it usually seals itself within a few months after birth. Unfortunately, in about 25% of the population the PFO does not fully close and may allow blood (and emboli) to pass directly between the right and left atria. The presence of a PFO has been identified as a contributing factor in cryptogenic stroke, chronic migraine, decompression sickness, and obstructive sleep apnea. A PFO contributes to these conditions by providing a pathway for emboli (blood clots, air bubbles) in the venous system to reach the arterial system by passing directly from the right atrium to the left... [PDF] SeptRx' s Press Release -

DynaFlex : FDA Clearance for Sleep Aid Devices

MARCH 9, 2011 - DynaFlex, a manufacturer specializing in orthodontic appliances, has obtained FDA 510(k) clearance (K103076) from the US Food and Drug Administration for its DynaFlex® Anti-Snoring & Sleep Apnea Devices line of sleep aid products. Designed to treat snoring and sleep apnea, the DynaFlex products function by repositioning patients’ lower jaws to improve breathing ability during sleep. The devices are available in four model types, and are custom-fitted for each patient based on jaw measurements taken by prescribing health care providers.

The company undertook its FDA 510(k) clearance process in early 2010 with the assistance of Emergo Group, a medical device regulatory and quality assurance consultancy. Emergo Group provided an initial analysis of DynaFlex® Anti-Snoring & Sleep Apnea Devices to determine the most cost-effective and accurate method for submitting DynaFlex’s 510(k) documents, followed by preparation and submission of the 510(k) application to the FDA for review and clearance. Emergo Group also assisted DynaFlex in assuring compliance with the FDA Quality System Regulation, 21 CFR Part 820... DynaFlex's Press Release -

Somaxon and Paladin : Silenor® EX-US Collaboration

June 8, 2011 - Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX) and Paladin Labs Inc. (TSX:PLB) announced that they have entered into an exclusive collaboration under which Paladin will commercialize Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance in Canada, South America and Africa. According to IMS Canada, the value of the Canadian insomnia market, mainly comprised of zopiclone, exceeded $79 million in 2010 alone and has been growing at a 5 year CAGR of 10%.


Under the terms of the agreements, Somaxon will receive an up-front payment of US$500,000, and Paladin will purchase 2,184,769 shares of Somaxon's common stock for a purchase price of US$5 million. Once Silenor is commercialized in the licensed territories, Somaxon will also be eligible to receive sales-based milestone payments of up to US$128.5 million as well as a tiered double-digit percentage of net sales in the licensed territories. Paladin will be responsible for regulatory submissions for Silenor in the licensed territories and will have the exclusive right to commercialize Silenor in the licensed territories. Governance of the collaboration will occur through a joint committee structure... Somaxon's Press Release - Paladin Labs' Press Release -

ResMed : New iPhone App

May 24, 2011 - Are you always tired? Examine your risk of sleep apnea with ResMed's Sleep Assessment app for iPhone® or iPod Touch® - ResMed (NYSE: RMD) released the ResMed Sleep Assessment app, a novel new app for iPhone that lets users record themselves during sleep. The app also includes a clinically validated questionnaire that assesses their risk and other helpful features to empower users to discuss their sleep health with their physician.

Excessive tiredness may be due to sleep apnea

Feeling excessively tired or fatigued is often the result of disrupted, unhealthy sleep. Numerous factors can lead to poor quality sleep, some of which have significant negative health effects. One possible cause of fatigue is sleep apnea, a common sleep disorder. People with sleep apnea report feeling like they're living in a fog, and that no matter how much they sleep they still feel exhausted.
Sleep apnea is a serious health condition in which a person stops breathing temporarily during sleep. After several seconds, the brain triggers a wake-up response, causing the person to awaken gasping. These events may happen hundreds of times per night, though the sleeper usually won't remember waking up. Often a spouse or partner will notice that the person snores loudly during sleep.
Sleep apnea affects approximately one in five U.S. adults, although it is estimated that as many as 80% of sleep apnea sufferers are undiagnosed and untreated.(1) A known cause of hypertension, untreated sleep apnea has also been linked with type 2 diabetes, cardiovascular disease, depression and stroke.(2-6) People who have sleep apnea feel chronically fatigued and may experience a variety of other symptoms, such as headaches, difficulty concentrating and irritability, to name just a few. Additionally, the loud snoring of sleep apnea can be disruptive to relationships, wreaking equal havoc on a spouse or partner's quality of sleep...


...ResMed's Sleep Assessment app combines a clinically validated questionnaire that quantifies a person's risk of sleep apnea based on known characteristics with an overnight snore recorder that lets them compare their snoring to the snoring of an actual sleep apnea patient. With the snore recorder feature, the user simply starts the app and sets their device by their bedside before sleep. The device records them throughout the night. Users can play back their recording and compare it to sample recordings from actual sleep apnea patients. They may also refer to their recording and questionnaire results when speaking with a physician about their sleep concerns.
In addition to the snore recorder and questionnaire, ResMed's Sleep Assessment app also includes a Sleep Lab Locator, which helps users find a sleep center in their area. Additionally, the app includes a "Sounds to Sleep By" feature with recordings of soothing sounds to play while drifting off to sleep... ResMed's Press Release -

Cortex Pharmaceuticals : Ampakine CX1739 Improves Respiratory Parameters In Obstructive Sleep Apnea Patients

February 2, 2011 — Cortex Pharmaceuticals, Inc. (OTCBB (CORX)) announced top-line results from an exploratory clinical study with its AMPAKINE® compound, CX1739 in subjects with sleep apnea. The study enrolled 20 relatively healthy adults with moderate-to-severe obstructive sleep apnea, 16 of which were administered a single oral dose of CX1739 and 4 of which received matching placebo for one night. The objective of the study was to further explore safety and tolerability in the sleep apnea population, as well as to assess putative efficacy of CX1739 on a range of sleep apnea parameters assessed by overnight polysomnography.

The study demonstrated that selected oxygen saturation parameters were statistically improved by one dose of CX1739, but the interpretation of these results was complicated by a reduced sleep time during the night following drug treatment. CX1739 did not reduce the mean apnea/hypopnea index (AHI; frequency of apnea or hypopnea events per hour of sleep). However, in the AHI responder analysis, defined as a greater than 40% reduction in the AHI, three subjects (20%) in the CX1739 treatment group were responders, and there were no responders in the placebo group. Furthermore, CX1739 significantly (p<0.05) reduced the apnea/hypopnea time (AHT; cumulative time of all apneas and hypopneas over the night) between the baseline and the treatment night by an average of 21 min, compared to an increase of 12 min in the placebo group. In the AHT responder analysis, defined as a greater than 40% reduction in the AHT, five subjects (30%) in the drug treatment group were responders, with no AHT responders in the placebo group.

There were also statistically significant improvements in a number of blood oxygenation measurements: mean blood oxygen saturation was increased (p<0.01); minimum blood oxygen saturation was increased (p < 0.001); there was a reduction in the total time that blood oxygen saturation was reduced below 90% (p<0.01); and a reduction of the number of times per hour of sleep time that the blood oxygen saturation went below 90% (p<0.05).

Sleep efficiency, the percent of time asleep while in bed for the eight hour session, was significantly (p<0.001) reduced by about 20% after administration of CX1739, although the level of daytime sleepiness, determined by the Clinical Global Impressions Daytime Vigilance test given the morning following treatment, was unaffected by CX1739... Cortex Pharmaceuticals' Press Release -

Ventus Medical : Publication in Sleep Journal Demonstrates Positive Results of Large Multi-Center Clinical Trial for Provent® Sleep Apnea Therapy

April 4, 2011 - 19 Center, 250 Patient Study Shows Non-Invasive Provent Therapy Significantly Improves Sleep Apnea with High Patient Compliance – Ventus Medical, Inc. reported positive results from a 19 center clinical trial using its FDA-cleared Provent® Sleep Apnea Therapy device to treat obstructive sleep apnea. Provent Therapy uses the patient’s own breathing to create expiratory positive airway pressure (EPAP) to keep the airway open during sleep. The full results of this three month study were published in the April 2011 issue of the peer-reviewed medical journal SLEEP, an official publication of the American Academy of Sleep Medicine.
“This randomized, sham-controlled study demonstrates that Provent Therapy significantly improves the apnea hypopnea index (AHI), a scale to measure the number of breathing interruptions or stoppages per hour of sleep, as well as subjective sleepiness, as measured by the Epworth Sleepiness Scale (ESS) in patients with obstructive sleep apnea,” said study author Richard B. Berry, M.D., professor of medicine at the University of Florida College of Medicine, medical director of the University of Florida and Shands Sleep Disorders Center, and former president of the American Sleep Medicine Foundation. “Importantly, self-reported patient adherence on Provent Therapy was almost 90 percent.” ... [PDF] Ventus Medical's Press Release -