SOURCE: LearningRx

  Apr 05, 2011 16:49 ET

COLORADO SPRINGS, CO–(Marketwire – April 5, 2011) – Studies indicate more than two million American children will be retained, or held back a grade level, at the end of this school year, and for many families the agonizing process of deciding to retain or promote is already underway. the brain training experts at LearningRx urge parents to consider another, better option before that decision is made.

“Brain training helps struggling students develop the mental skills, confidence and motivation to break away from the back of the class,” says Tanya Mitchell, LearningRx Vice President of Research and Development. “After brain training our students are often able to eliminate the need for accommodations, medications, remediation, and even special education programs. For many struggling learners, brain training may be the only way to avoid the pitfalls of being retained a grade or promoted into a higher grade when unprepared.”

Hundreds of studies have examined the effects of holding back struggling students to master necessary skills and knowledge (retention) vs. promoting them to the next grade, despite poor performance, to keep them with their age-mates and friends (social promotion). In general, the studies show:

• Children who are retained have no measurable long-term academic advantage over similarly performing classmates who were promoted, and many studies show repeating a grade makes students fall further behind
• Students who were retained at least one grade are much more likely to drop out of school.
• Grade retention is widely used, but reporting efforts vary drastically. according to the National Center for Education Statistics, in 2004, just 9.6 percent of American kids age 16-19 had been held back at least one grade. however, other studies indicate that number could be as high as 50 percent.

“For so many struggling students, weak cognitive skills are the root cause of the problem — low achievement, poor grades and even behavior issues are simply the symptoms,” says Mitchell. “LearningRx brain training strengthens those underlying mental skills and leads to a faster, smarter, more efficient brain. It’s the most effective way to give kids the tools they need to succeed in school, and at grade level, for the rest of their school days. “

A review of 2009 LearningRx results shows impressive gains for students of all levels of academic abilities, including those diagnosed with dyslexia, ADHD, speech and language disorders, autism spectrum disorders and general learning disabilities. Students enrolled in a specialized LearningRx reading program gained an average of 2.9 years of reading ability in less than six months of brain training.

For more information on brain training, contact Tanya Mitchell or visit learningrx.com.

About LearningRx LearningRx brain training specializes in treating the cause — not the symptoms — of learning struggles. the programs’ game-like exercises and 1:1 trainer-to-student ratios provide guaranteed dramatic improvement in as little as 12 to 24 weeks. With more than 70 centers across the country, LearningRx brain training can help anyone — from 5 to 85 — increase the speed, power or function of their brain.

SOURCE: National MS Society, Greater Delaware Valley Chapter

  Mar 14, 2011 09:30 ET

PHILADELPHIA, PA–(Marketwire – March 14, 2011) – to most people living with it, the letters “MS” mean more than “multiple sclerosis.” MS can mean:

• Not being able to walk your daughter down the aisle on her wedding day
• Losing your ability to work full time
• Not being able to see your children play sports
• Depending on others to do daily tasks

MS isn’t just a collection of symptoms such as a paralysis, debilitating fatigue or loss of vision — it’s an unpredictable disease that can rob you of your independence and overall quality of life. and MS doesn’t just affect those who are diagnosed — spouses, children and other loved ones are also impacted.

Many people simply don’t understand what MS is or what it does to all those affected by it.

That’s why the Greater Delaware Valley Chapter of the National MS Society is launching its “MS Means” campaign during MS Awareness Week, March 14-20.

We’re asking everyone who has been touched by MS to tell us what MS means to them at MSmeans.org. By collecting just a few of the thousands of local MS stories, we hope to make more people aware of what MS really is and get more people involved in our movement to create a world free of MS.

About Multiple Sclerosis Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain and between the brain and the body. Every hour in the United States, someone is newly diagnosed with the disease. Symptoms range from numbness and tingling to blindness and paralysis. the progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with more than twice as many women as men being diagnosed with the disease. MS affects more than 400,000 people in the U.S. and 2.1 million worldwide.

About the National Multiple Sclerosis Society MS stops people from moving. the National MS Society exists to make sure it doesn’t. We help each person address the challenges of living with MS. Last year alone, through our national office and 50-state network of chapters, we devoted over $161 million to programs that enhanced more than one million lives. to move us closer to a world free of MS, the Society also invested more than $37 million to support 325 new and ongoing research projects around the world. We are people who want to do something about MS now. Join the movement at nationalMSsociety.org.

Note to editors: Please contact Anne Krishnan to speak with someone in your community about what MS means to them.

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SOURCE: TheraBiogen, inc.

  Jan 18, 2011 09:00 ET

NEW YORK, NY–(Marketwire – January 18, 2011) –  TheraBiogen, inc. (OTCBB: TRAB) announced it has shipped TheraMax® to Hannaford Supermarket and Sweetbay Supermarket.

TheraBiogen, inc.: TheraBiogen the developer and distributor of TheraMax® nasal spray products, is pleased to announce that TheraMax® Cold & Flu Relief and TheraMax® Allergy Relief are now being sold at all the Hannaford Supermarkets. Hannaford stores are located in Maine, New Hampshire, Vermont, Massachusetts, and New York. Sweetbay Supermarket located entirely in Florida, the sister company of Hannaford Bros., is also carrying both TheraMax® products. TheraMax® products are Homeopathic Nasal sprays that do not contain Zinc. 

TheraBiogen has been selling TheraMax® Cold & Flu Relief and TheraMax® Allergy Relief since the beginning of the 2010 Fall Season for cold and flu relief. Consumers nationwide have embraced the new products since their initial launch in October 2010. Kelly Hickel, CEO of TheraBiogen, inc., said “We are very pleased that Hannaford has chosen to add our products to their stores and add to our market distribution of TheraMax® Cold & Flu Relief and TheraMax® Allergy Relief.”

About TheraBiogen, inc. TheraBiogen, inc. is the manufacturer and distributor of homeopathic nasal sprays for aiding in the relief of allergies and cold and flu symptoms. The products are made from natural, homeopathic ingredients and contain no zinc, which has been identified as potentially causing  nasal problems in other similar products on the market. for further information please visit theramaxrelief.com.

Safe Harbor Statement This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21 E of the Securities Exchange Act of 1934, as amended. Investors are cautioned that these forward-looking statements involve uncertainties and risk that could cause actual performance and results of operations to differ materially from those anticipated. These risks are set forth in the Company’s most recently filed form 10-K and Form 10-Q reports. TheraBiogen, inc. assumes no obligation to update the statements contained in this release except as required by applicable securities disclosure rules.

LONDON, ONTARIO–(Marketwire – Jan. 6, 2011) - Stellar Pharmaceuticals Inc. (“Stellar” or “the Company”) (OTCBB:SLXCF), a Canadian pharmaceutical developer and marketer of high quality, cost-effective products for select health care markets, announces the approval by the Korean Food and Drug Administration (“KFDA”) of one of the Company’s lead products, Uracyst® (a sterile sodium chondroitin sulfate solution, 2%) for the treatment of interstitial cystitis / painful bladder syndrome (“IC/PBS”).

Stellar markets Uracyst® directly in Canada. In addition, Uracyst® is currently being distributed in Germany, Italy, Belgium, Luxemburg, the Netherlands, Denmark, Sweden, Norway, Finland, Iceland, Turkey, United Kingdom and the Republic of Ireland through out-license agreements. With this approval, Uracyst® will now also be distributed in South Korea by Stellar’s licensee in that market, Jeilmedix Pharmaceutical Co. (“Jeilmedix”).

Established in 1998, Jeilmedix, based in Daegu, South Korea, is a major importer of prescription medicines and medical devices from Germany, the United States and Canada into Korea. one of Jeilmedix’s major focus areas is urology, the primary target market for Uracyst®.

Stellar expects to deliver the initial commercial order to Jeilmedix in January 2011 and Jeilmedix expects to commercially launch the product in South Korea in the first quarter of 2011.

Peter Riehl, Stellar’s President and Chief Executive Officer, stated, “KFDA approval of Uracyst® marks the achievement of a major regulatory and commercialization milestone for Stellar. we are also very pleased to be working with Jeilmedix, a company that has a strong presence in this significant territory with a population of over 46 million. we are confident that, with Jeilmedix’s support, Uracyst® will enjoy commercial success in South Korea as awareness, acceptance and adoption of the product grows.”

About Jeilmedix Pharmaceutical Co.

Jeilmedix is a privately owned importer and distributor specializing in pharmaceutical products and medical devices based in South Korea. The company imports and distributes directly to a customer base of 2,500, utilizing a well-trained sales force currently totaling 68 representatives. Urology, OBGYN, dermatology and orthopedics are Jeilmedix’s major therapeutic areas.

About Uracyst®

It is believed that over 70% of IC/PBS patients have defects in their bladder glycosaminoglycan layers. The glycosaminoglycan (“GAG”) is a mucosa lining of the bladder that acts as a protective barrier against irritants and toxins in the urine and defends against bacterial adherence. when the GAG is damaged, these irritants and toxins in the urine seep through, causing an irritation to the bladder wall. this results in increased frequency and urgency to void (up to 60 times a day). Many IC/PBS patients also experience severe pelvic pain. these symptoms can be debilitating and have a serious impact on a patient’s quality of life.

Chondroitin sulfate (ChS) is believed to be the major proteoglycan responsible for the GAG barrier function. Uracyst® was developed to replenish this defect. Uracyst® 2% (400 mg) ChS dose has been shown to be the ideal dosage to saturate the bladder, thus restoring the barrier function. Instilled fluid volume of Uracyst® 20 mL also allows patients to retain the treatment in the bladder for a longer period of time thus a better uptake of the delivered dosage and a faster onset of symptomatic relief. Uracyst® is also one of the most cost effective treatments for these patients. Combine treatment efficacy with the most cost effective therapy and it becomes understandable why Uracyst® is becoming the product of choice in treating IC/PBS.

About Stellar Pharmaceuticals Inc.

Stellar has developed and is marketing direct in Canada and in countries around the world through out-license agreements two products based on its core polysaccharide technology: NeoVisc®, for the treatment of osteoarthritis; and Uracyst®, its patented technology for treatment of interstitial cystitis/painful bladder syndrome, an inflammatory disease of the urinary bladder wall. Stellar also has in-licensing agreement for the distribution and sale of NMP22® BladderChek®, a proteomics-based diagnostic test for the diagnosis and monitoring of bladder cancer. for more information, please visit stellarpharma.com.

Forward-looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of risks and uncertainties impacting the Company’s business including increased competition; the ability of the Company to expand its operations, to attract and retain qualified professionals, technological obsolescence; general economic conditions; and other risks detailed from time to time in the Company’s filings.   

SOURCE: Corcept Therapeutics

  Dec 22, 2010 07:30 ET

MENLO PARK, CA–(Marketwire – December 22, 2010) – Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced positive top-line results from its Phase 3 study of CORLUX for the treatment of Cushing’s Syndrome. the study evaluated the response of two patient groups to CORLUX treatment: one included patients who were glucose intolerant and one included patients who were hypertensive. Statistically significant improvement in the primary endpoint was achieved for both groups: with 60% responding in the glucose intolerant group and 43% in the hypertensive group. An initial review of safety data indicates that CORLUX was well tolerated by Cushing’s Syndrome patients in this Phase 3 study. “The results of the study demonstrate that CORLUX has the potential to become an important treatment option for patients suffering from Cushing’s Syndrome,” said Joseph Belanoff, M.D., Chief Executive Officer of Corcept. “We remain on track to submit a New Drug Application (NDA) to the FDA for CORLUX in Cushing’s Syndrome by the end of the first quarter of 2011 and continue to work toward our goal of making CORLUX available to patients with this severe disease.” 

Primary Endpoints Met in both Patient Groups

Each group in the study had its own primary endpoint. the primary analysis is a responder analysis. in the “glucose intolerant group” (patients with diabetes or carbohydrate intolerance) a responder was defined as a patient who achieved a 25% or greater improvement in glucose tolerance as measured by a standard 2-hour glucose tolerance test at 24 weeks (or at the early termination visit) compared to baseline. in the “hypertension group” (patients with a diagnosis of hypertension) a responder was defined as a patient who achieved a 5 millimeter or greater improvement in diastolic blood pressure at 24 weeks (or at the early termination visit) compared to baseline.

The protocol for the trial dictates that if a sufficient number of patients in either the glucose intolerant group or the hypertension group are responders, such that the lower limit of the exact one-sided 95% binomial confidence interval (CI) for the responder rate is greater than 20%, then the trial will have demonstrated efficacy for the treatment of Cushing’s Syndrome. the calculation, which was predetermined in the study design, is based on analyzing the response rates in a modified intention to treat group (mITT) defined as those patients treated for at least 30 days (the mITT group).

• 15 of 25, or 60%, of patients in the glucose intolerant group responded to treatment with CORLUX, significantly higher than the 20% hurdle rate (lower bound of the 95% CI = 41.7 which equates to p < 0.0001).
• 9 of 21, or 43%, of patients in hypertension group responded to treatment with CORLUX, significantly higher than the 20% hurdle rate (lower bound of the 95% CI = 24.5 which equates to p < 0.01).

CORLUX Was Well Tolerated in the Trial

CORLUX was well tolerated in the trial population. although the detailed analysis of the safety data from the study has not yet been completed, the tolerability of CORLUX in the treatment of Cushing’s Syndrome in the Phase 3 study met our expectations. Adverse events related to treatment included symptoms of adrenal insufficiency, endometrial thickening, and hypokalemia, all of which were consistent with earlier published reports. the majority of the serious adverse events (SAEs) reported in the study were not related to CORLUX treatment, as determined by the clinical investigators. of those that were related to treatment, all resolved with clinical management. We plan to present detailed safety data at scientific conferences during 2011.

Ninety percent of the patients who completed the Phase 3 study opted to enter the long-term extension study.

About the Phase 3 Trial Design

The Phase 3 trial was a 50-patient open-label study in endogenous Cushing’s Syndrome patients conducted at 17 clinical sites in the United States. Patients met the trial enrollment criteria if they were either not eligible for, had failed or had relapsed from surgery and were glucose intolerant or were diagnosed with hypertension at entry. Patients in the Phase 3 study were placed in one of two groups: those with glucose intolerance and those who were diagnosed with hypertension but were not glucose intolerant. in the trial, each patient’s CORLUX dose was titrated by their study investigator to the level necessary to achieve clinical benefit. the FDA indicated that this trial may provide a reasonable basis for the submission of an NDA for the treatment of endogenous Cushing’s Syndrome.

In addition to the primary endpoints described above, the key secondary endpoint in the trial was global clinical improvement, designed to capture the broader clinical benefit CORLUX may confer in this patient population. This endpoint is based on the evaluation of broader clinical outcomes by a Data Review Board, an independent three-member panel of academic physicians with expertise in Cushing’s Syndrome. Data on this key secondary endpoint is expected to be available in the first quarter of 2011.

Additional secondary measures of efficacy include changes from baseline to the end of the study in fasting plasma glucose, hemoglobin A1c (HgbA1c), change in glucose lowering medications, systolic blood pressure, change in antihypertensive medications, body composition, weight, bone turnover and bone density, cognitive/psychiatric assessments, metabolic functions, Quality of Life (SF-36 questionnaire), muscle strength and physical function. Detailed data, including data on these secondary endpoints is expected to be announced at scientific conferences during 2011.

CORLUX Regulatory Status Update

Corcept is planning to submit an NDA to the FDA late in the first quarter of 2011 based on the positive results of this Phase 3 study. the final Phase 3 trial design and our statistical analysis plan reflect the feedback Corcept received in discussions with the FDA. 

CORLUX was granted Orphan Drug Designation by the FDA for the treatment of endogenous Cushing’s Syndrome in 2007. Drugs that receive Orphan Drug Designation obtain seven years of marketing exclusivity from the date of drug approval as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process.

Corcept Therapeutics Conference Call

Corcept will hold a conference call this morning, Wednesday, December 22, 2010 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss this announcement. To participate in the live call please dial 1 (866) 712-7678 from the United States or +1 (847) 413-2425 internationally. the pass code is 6158584. please dial in approximately 10 minutes prior to the start of the call. 

A replay of the conference call will be available for 7 days following the call at (877) 213-9653 from the United States and +1 (630) 652-3041 internationally. the pass code is 6158584.

About Cushing’s Syndrome

Endogenous Cushing’s Syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing’s Syndrome is an orphan indication which most commonly affects adults aged 20 to 50. An estimated 10 to 15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients in the United States. An estimated 20,000 patients in the United States have Cushing’s Syndrome. Symptoms vary, but most people have one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s Syndrome can affect every organ system in the body and can be lethal if not treated effectively.

About CORLUX

Corcept’s first-generation compound, CORLUX, also known as mifepristone, directly blocks the cortisol (GR-II) receptor and the progesterone (PR) receptor. Intellectual property protection is in place to protect important methods of use for CORLUX. Corcept retains worldwide rights to its intellectual property related to CORLUX.

About Corcept Therapeutics Incorporated

Corcept is a pharmaceutical company engaged in the discovery and development of drugs for the treatment of severe metabolic and psychiatric disorders. the company has two Phase 3 programs: CORLUX for the treatment of Cushing’s Syndrome, and CORLUX for the treatment of the psychotic features of psychotic depression. Corcept also has a Phase 1 program for CORT 108297 and an IND-enabling program for CORT 113083. Corcept has developed an extensive intellectual property portfolio that covers the use of GR-II antagonists in the treatment of a wide variety of psychiatric and metabolic disorders, including the prevention of weight gain caused by the use of antipsychotic medication, as well as composition of matter patents for our selective GR-II antagonists.

Statements made in this news release, other than statements of historical fact, are forward-looking statements, including, for example, statements relating to Corcept’s clinical development and research programs, the timing of the NDA submission and introduction of CORLUX and future product candidates, including CORT 108297 and CORT 113083, estimates of the timing of enrollment or completion of our clinical trials and the anticipated results of those trials, the ability to create value from CORLUX or other future product candidates and our estimates regarding our capital requirements, spending plans and needs for additional financing. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. for example, there can be no assurances with respect to the cost, rate of spending, completion or success of clinical trials; financial projections may not be accurate; there can be no assurances that Corcept will pursue further activities with respect to the development of CORLUX, CORT 108297, CORT 113083 or any of its other selective GR-II antagonists. These and other risk factors are set forth in the Company’s SEC filings, all of which are available from our website (corcept.com) or from the SEC’s website (sec.gov). We disclaim any intention or duty to update any forward-looking statement made in this news release.