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Memory Pharmaceuticals Corp. (Nasdaq: MEMY - http://finance.yahoo.com/q?s=memy ) (Fri, November 2, 2007, 6:00am EDT) Memory Pharmaceuticals Corp. today announced positive top-line data from the randomized, placebo-controlled, multi-center Phase 2a proof-of-concept trial of MEM 3454, the Company's lead nicotinic alpha-7 receptor partial agonist, in 80 patients with mild to moderate Alzheimer's disease over an eight week treatment period. The trial was an exploratory efficacy study to learn about MEM 3454 as a potential treatment for Alzheimer's disease. The primary endpoint of the trial was the change from baseline in the Quality of Episodic Secondary Memory (QESM) factor score of the Cognitive Drug Research (CDR) battery. QESM is a composite score derived from memory tests in the CDR battery that measure the ability to store, hold and retrieve information. There were three oral daily doses of MEM 3454 tested in the trial, 5 mg, 15 mg and 50 mg. The CDR battery was administered at baseline and on six days during the treatment period, at four time points (pre-dosing and 2, 4 and 8 hours post-dosing) each day. For the eight hour post-dose time points over the treatment period, subjects receiving 5 mg and 15 mg of MEM 3454 demonstrated a statistically significant effect on the QESM compared to placebo (p=0.023 and p=0.050, respectively).
Secondary endpoints in the trial included other composite scores from the CDR battery that measure working memory, attention and executive function, and the Alzheimer's Disease Assessment Scale -- cognitive subscale (ADAS-Cog). On secondary CDR battery measures, using all time points combined over the treatment period, the trial showed that the 5 mg and 15 mg doses achieved statistically significant positive results on Quality of Working Memory (p=0.031 and p=0.047). The 15 mg group also demonstrated trends to efficacy on Speed of Memory (p=0.080). Quality of Working Memory is a composite score derived from accuracy measures in the CDR battery that reflect how well subjects can hold information in working memory. The Speed of Memory composite score reflects the time it takes to recall an item from memory. For the ADAS-cog, the 15 mg group showed numeric improvements favoring treatment over placebo. There were two additional secondary endpoints in the study from the CDR battery, Power of Attention and Continuity of Attention, and on these measures the study found no statistically significant differences between treatment and placebo. The 50 mg group also showed no statistically significant differences favoring treatment at any endpoint in the study.
In analyses of QESM at certain other time points, and for all time points combined, the placebo group performed statistically significantly better than the treatment groups due to substantially lower QESM scores at baseline for the placebo group, at the 2 and 4-hour time points, as compared to the treatment groups. After adding a covariate for baseline scores to the statistical model, the MEM 3454 5 mg group demonstrated a statistically significant change from baseline on QESM at all time points combined compared to placebo (p=0.032). The MEM 3454 5 mg and 15 mg dose groups demonstrated statistical significance (p=0.003 and p=0.023, respectively), and the 50 mg dose group demonstrated a trend favoring treatment (p=0.083) for the eight hour post-dose time points on QESM. In addition, the 5 mg and 15 mg dose groups demonstrated a statistically significant effect on Quality of Working Memory, over all time points combined (p=0.006 and p=0.004, respectively). The 5 mg dose group also demonstrated a statistically significant effect on Speed of Memory (p<0.001) over all time points combined.
"Overall, the data from this study demonstrate that MEM 3454 is providing cognitive benefit and these results are consistent with our previous work with this compound in volunteers. When an appropriate baseline covariate is included, the results of this trial are even more robust," stated Keith Wesnes, Ph.D., the developer of the CDR battery. "It is exciting to improve the ability of Alzheimer's patients to store and retrieve information from both working and episodic memory, not only in terms of accuracy but also speed. These improvements have clinical relevance."
"We believe these trial results provide evidence of MEM 3454's potential to treat Alzheimer's disease," stated Stephen R. Murray, M.D., Ph.D., Chief Medical Officer of Memory Pharmaceuticals. "This data is consistent with our preclinical and Phase 1 results and reinforces our belief that MEM 3454 warrants continued development. We look forward to commencing our Phase 2a trial of MEM 3454 in cognitive impairment associated with schizophrenia in the near term."
MEM 3454 was well-tolerated in this trial, with the exception that the number of subjects with constipation was higher in the treatment groups (43%) compared to placebo (5%). There was one treatment-emergent serious adverse event in the 15 mg group, which was deemed not to be treatment-related by the investigator.
Osteologix Inc. (OTCBB: OLGX - http://finance.yahoo.com/q?s=olgx.ob ) (Thu, November 1, 2007, 4:20pm EDT) Osteologix Inc., a specialty pharmaceutical company, today announced that Malene Weis M.SC.Pharm., Director of Clinical Development of Osteologix, will give a presentation entitled "Challenges for Small Pharma in Setting up and Managing a Clinical Trial" during a Symposium regarding outsourcing challenges for small pharma and biotech at the 6th Annual Partnerships in Clinical Trials Congress and Exhibition 2007 on Monday, November 5, 2007 in Amsterdam RAI, The Netherlands. Following her presentation, Weis will participate as a panel member during the Discussion Session entitled "Developing an Outsourcing Strategy that Keeps Pace with Your Company's Growth". Weis has worked with all stages of clinical development at both pharmaceutical companies and contract research organizations (CROs). She has held prime responsibility for the design and operational execution of numerous clinical trials within various therapeutic areas, including Osteologix's latest Phase II STRONG Study of the company's lead drug candidate for the treatment and prevention of osteoporosis, NB S101. The data for the STRONG Study will be released in the 4th quarter of 2007.
Environmental Control Corporation (OTCBB: EVCC - http://finance.yahoo.com/q?s=evcc.ob ) (Thu, November 1, 2007, 4:55pm EDT) Environmental Control Corporation ("EVCC"). With over 20,000 people attending the Green Industry and Equipment EXPO (GIE+EXPO 2007) held this past weekend in Louisville, Kentucky, EVCC had great success in expanding its global awareness and exposure to the lawn and garden equipment industry. EVCC's exhibit, featuring prototypes and product information for both its two-stroke and four-stroke designs, attracted significant attention and gave corporate personnel the opportunity to meet one-on-one with prominent representatives from several companies, including: Kohler Co., Tecumseh Products Company, Club Cadet, Honda Motor Co, Ecocat Oy, RotaMax Inc, ATOM Industries, and more.
Michael Mugford, Vice-President of Sales and Marketing for EVCC, commented: "EVCC's Executive and Board of Directors are very pleased with the company's performance at the GIE+EXPO 2007 held last week in Kentucky. The company had the opportunity to meet with executive engineers, top-level decision makers and other key representatives from several companies holding significant market potential. EVCC is now looking to capitalize on the interest garnered from the tradeshow, transforming these prospective affiliations into strategic business relationships."
Raven Moon Entertainment, Inc. (OTCBB: RAEM - http://finance.yahoo.com/q?s=RAEM.OB ) (Fri, November 2, 2007, 8:16am EDT) Raven Moon Entertainment, Inc. announced today that its newest 90 minute three episode DVD that has just been released called "SAFETY, HEALTH & FITNESS" received the 2007 Greatest Products iParenting Media Award. (Go to www.iparentingmediaawards.com)
iParenting Media is the premier media company focused on parents. The company operates iParenting Media Awards, the premiere product evaluation and testing service in the country. iParenting Media's Award Program provides a credible and objective method of determining the best products and recognizes those products with our iParenting Media Award. We are the only consumer awards program that has achieved an ISO 9001:2000 certification. We are dedicated to informing, inspiring and uniting the parenting community we serve via our multiple media platforms of the Internet, syndicated newspaper column, radio show and video.
We acknowledge our responsibility to fairness, integrity and sound judgment and recognize the importance of a thorough and independent process.
We hold ourselves accountable to the stringent and objective process of evaluating and scoring products and are committed to relaying reviewer feedback to the manufacturers that submit their products.
About the three episode DVD:
In "Safety First" "Gina D and her Kids Club friends gently guide young viewers on how to think about being safe. This outstanding episode also includes the lovable BOBO Blocks in "BOBO's Train Ride." In "Visit to the Doctor" Gina D, Simon Wannabe and the rest of the Kids Club friends help calm Hammy's fear of a first doctor's visit. Includes BOBO Blocks feature called "BOBO Cover Your Nose!" In "Let's Get Fit" Gina D and her friends encouraging young viewers to get fit and learn the benefits of good exercise and healthy foods. Includes the musical BOBO Blocks bonus feature, "BOBO's Square Dance."
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