dallas tx 8/12/2009 9:41:38 PM
News / Finance

TYRIA, UVSE, ARIO, VIPR, BBDA, AVNR OTCPicks.com Stocks to Watch for Wednesday, August 12th

Visit http://www.otcpicks.com/microcap.htm to register for our Daily Market Mover's Digest Newsletter, and Email Stock Watch Alerts.

Our Stocks to Watch tomorrow include Trey Resources Inc. (OTCBB: TYRIA), Universal Energy Corp. (OTCBB: UVSE), AmeriResource Technologies Inc. (OTC: ARIO), VIPR Industries Inc. (OTC: VIPR), Bebida Beverages Co. (OTC: BBDA) and AVANIR Pharmaceuticals Inc. (Nasdaq: AVNR).

 

Visit http://www.otcpicks.com/microcap.htm to register for our Daily Market Mover's Digest Newsletter, and Email Stock Watch Alerts.

 

TREY RESOURCES INCORPORATED (OTC BB: TYRIA)

"Up 100.00% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/TYRIA.php

 

Trey Resources is involved in the acquisition and build-out of technology and software companies. The Company's growth strategy is to acquire firms in this extensive and expanding, but highly fragmented segment, as it seeks to create substantial value for shareholders. Since June 2004, Trey has acquired SWK Technologies, Inc., Business Tech Solutions Group, Inc., Wolen Katz Associates, and AMP-BEST Consulting, Inc.

 

TYRIA News:

 

June 6 - Trey Resources Posts Second Consecutive Profitable Quarter

 

Visit http://bit.ly/MTS8d to view the recent quarterly financial report for Trey Resources Inc. (OTCBB: TYRIA).

 

UNIVERSAL ENERGY CORPORATION (OTCBB: UVSE)

"Up 100.00% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/UVSE.php

 

Universal Energy Corp., an independent energy company, engages in the acquisition and development of crude oil and natural gas leases in the United States and Canada. As of December 31, 2007, it had working interest in approximately 7,095 acres of land in Louisiana and Texas, as well as in Alberta, Canada. The company, formerly Universal Tanning Ventures, Inc., was founded in 2002 and is based in Lake Mary, Florida.

 

UVSE News:

 

August 1 - Universal Energy Corp. Launches Aggressive 2009 Acquisition Plan

 

Visit http://bit.ly/TJz2b to view the recent quarterly financial report for Universal Energy Corp. (OTCBB: UVSE), an emerging U.S. oil and gas exploration and production company.

 

AMERIRESOURCE TECHNOLOGIES INCORPORATED (OTC: ARIO)

"Up 100.00% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/ARIO.php

 

AmeriResource is a diversified holding company with headquarters in Las Vegas, Nevada. For more information on the Company's subsidiary, visit www.attosolutions.com.

 

ARIO News:

 

August 7 - AmeriResource Holds Stock Portfolio in the Face Value Exceeding $750,000 in Pink Sheet Companies

 

AmeriResource Technologies, Inc. (OTC: ARIO) announced that it holds common stock and convertible preferred with a face value exceeding $750,000 in Nexia Holdings, Inc. (OTC: NXHD) and Green Endeavors, LTD. (OTC: GRNE).

 

"We believe Nexia Holdings and Green Endeavors both have sound business models that offer their shareholders and investors a diversification of industries for their investments. It is our anticipation and belief that AmeriResource and its subsidiaries stock portfolios will have a greater value upon the conversion of the stock portfolios and after meeting the requirements of Rule 144," Janovec comments.

 

"AmeriResource also is in the process of updating its own website as well as its ATTO Solutions website which has dated information. We are committed to delivering up to date and accurate information to potential customers and investors alike. Management is working diligently to bring AmeriResource filings current with the SEC and revamping our website to be in compliance with the current information requirements," concluded Janovec.

 

VIPR INDUSTRIES INCORPORATED (OTC: VIPR)

"Up 246.15% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/VIPR.php

 

VIPR Industries, Inc. offers construction and mining services. It owns and operates gold and uranium mines in Tanzania and Democratic Republic of the Congo. The company, formerly known as Synergy Media, Inc. is headquartered in Toronto, Canada.

 

VIPR News:

 

May 28 - VIPR Industries Provides Corporate Update

 

VIPR Industries Inc. (OTC: VIPR) ("VIPR") announces update on funding and projects.

 

Within the past quarter, VIPR Industries (the "Company") has received funding in various tranches and sizes from accredited investors with the expectations of further funds being received. The company is currently evaluating all options as it anticipates using most of its cash reserves towards further exploration on existing assets and possible acquisitions. In its most recent press release, the company indicated that it was attempting to identify further target zones for further exploration on its Singida-Londoni property in Tanzania. This information is currently being reviewed by the company and Geologists which also includes a budget brought forth towards the drafting of a possible NI 43-101 report on its Singida-Londoni property.

 

In addition, VIPR's Chief Operating Officer and Chief Geologist has recently brought to the attention of the company other potential acquisitions that may be in more advanced stages or possess significant potential. These prospective projects are located in other parts of the world, most notably within certain parts of South America where various countries are expected to have an estimated $40 Billion in exploration to be spent within the next several years. The Company expects a decision on its various options to be concluded in the very near term. In other developments, a recent proposal was made by VIPR to further its current position at the Mwamunguli Diamond Prospect. The offer was not accepted by the current license holder.

 

BEBIDA BEVERAGE COMPANY (OTC: BBDA)

"Up 50.00% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/BBDA.php

 

The company, formerly known as Fortis Enterprises, was founded in 2000 and is based in Casselberry, Florida. On Sept. 4, 2008, Renovo Holdings announced that the company had changed its name to Bebida Beverage Company and would be locating the base of the company's North American presence in Las Vegas, NV. Bebida Beverage Company hopes to concentrate operations on the bottled water and enhanced beverage markets of North and South America. Bebida's management will focus the company's business efforts within the United States and key target markets within Latin America.

 

BBDA News:

 

August 11 - Bebida Beverages Says CHILLAX With a KOMA UNWIND in 2009

 

Bebida Beverages Company (OTC: BBDA) and its Koma Unwind brand have announced final can design and flavors have been choose and a September full production is now scheduled for Koma Unwind a brand new "Chillaxation Drink Upon the purchase of Bebida Beverages.

 

CEO Brian Weber had made early on changes to the product portfolio and the direction of the company for the future growth, prosperity and increased shareholder value.

 

"We got a little ahead of ourselves when we made this change from an energy drink to a relaxation drink early on,” Weber said. “With the economy picking up, designers and flavor houses at capacity, it took a bit longer for us to get the final product where we wanted.”

 

“We are very happy with the final product and now taking orders from our many distributors looking to add Koma Unwind to their portfolio in the coming months,” Weber added.

 

Another change aside from design and flavor recently has been the down size from 20 oz bottle to a 12 oz can. “After extensive research it was really a no brainer, as most people unwinding don't care to drink so much liquid before sleep or 'Chillaxing,'” said VP Daisy Ramirez.

 

Bebida is also excited about continued interest in its products: Potencia Energy Drink, Potencia Blast Energy Shot, Koma Unwind & Piranha Water. The company has been in talks with several national C-Store retailers about co-branding with its NASCAR Camping World Truck Series team and driver. The opportunities for massive media exposure during the NASCAR events along with the marketing rollout make these deals unbelievably viable for retailers. Their investment in Bebida’s team is more about shelf space and purchase orders than hard cash, which during these economic recovery times is more viable.

 

“It's pretty simple, they purchase our products (which they do anyway) we give them national media exposure and a rallying point with our race team,” said Weber. “We are always looking for retailers that are interested in participating in these type deals.”

 

Potencia Energy Drink is a 3-year-old all natural fruit energy drink developed for Latino's but loved by everyone! With the initial flavor of Tamarind and the second flavor mandarin due out soon.

 

Bebida Beverages Co. is the maker and developer of several beverages, including Piranha Water, Guppy Water, Koma Unwind (Chillaxation Beverage) and Koma Shot.

 

AVANIR PHARMACEUTICALS (NASD: AVNR)

"Up 29.68% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/AVNR.php

 

AVANIR Pharmaceuticals, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders. AVANIR's lead product candidate, Zenvia, is being developed for the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain. AVANIR has licensed its MIF inhibitor program to Novartis International Pharmaceuticals Ltd. and has sold its anthrax monoclonal antibody program to Emergent BioSolutions. The Company's first commercialized product, Abreva® (docosanol), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores.

 

AVNR News:

 

August 11 - AVANIR Announces Positive Phase III Study Results for Zenvia

 

* Zenvia Met Primary Efficacy Endpoint in Confirmatory Trial

* Zenvia Demonstrated Improved Safety and Tolerability Profile

 

AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) announced that the investigational drug Zenvia™ (dextromethorphan/quinidine) met its primary efficacy endpoint in the treatment of pseudobulbar affect (PBA) in the confirmatory Phase III STAR trial. Both Zenvia 30/10 mg and 20/10 mg provided a statistically significant reduction in episode rates over the course of the study when compared to placebo (p<0.0001). In an additional analysis of the primary endpoint, at week twelve (end of study), patients in the Zenvia 30/10 mg group reported a statistically significant mean reduction of 88% from baseline in PBA episode rates (p=0.01). Also in this study, Zenvia was generally safe and well tolerated. AVANIR management will conduct a conference call to discuss this announcement on August 11 at 5:00 AM PDT (8:00 AM EDT).

 

"Frequent, unpredictable and often intense emotional outbursts may take a devastating toll on patients with PBA and their loved ones. The results of the STAR trial indicate that the new low dose formulation of Zenvia can substantially reduce the number of PBA episodes that these patients experience," said Jeffrey Cummings, MD, Augustus Rose Professor of Neurology at the David Geffen School of Medicine at UCLA and Steering Committee Chairman for the STAR trial. "With no FDA approved treatments currently available, there is a real unmet medical need for the estimated 2 million patients in the U.S. living with the burden of PBA."

 

"The STAR data indicate that the new low dose Zenvia formulations offer an improved safety and tolerability profile while continuing to deliver statistically significant and clinically meaningful efficacy in the treatment of PBA," said Keith Katkin, AVANIR's President and CEO. “We are very encouraged by the top-line results and we believe that the STAR data should be sufficient to address the issues outlined in the FDA approvable letter. We hope to have a full presentation of the STAR trial results at a scientific meeting later this year and plan to submit our complete response to the FDA in the first half of 2010."

 

Efficacy Results

 

The primary efficacy analysis was based on the changes from baseline in crying/laughing episode rates recorded in the patient diary. Episode counts were reported and analyzed as a rate expressed as episodes per day. The primary outcome was the additional reduction in episode rates experienced with Zenvia 30/10 mg compared to placebo. In the STAR trial, Zenvia 30/10 mg provided a 47.2% incremental reduction in episode rates compared to placebo over the course of the study (p<0.0001). In a secondary analysis of the primary endpoint, Zenvia 20/10 mg also provided a statistically significant incremental reduction of episode rates compared to placebo (p<0.0001).

 

An important secondary endpoint analysis was based on the change from baseline to end of study using the Center for Neurologic Studies Lability Scale (CNS-LS). The CNS-LS is a validated instrument measuring the frequency and severity of PBA. In this secondary endpoint analysis, patients receiving Zenvia 30/10 mg reported a significantly greater reduction in mean CNS-LS score compared to patients who received placebo (p=0.0002).

 

Additional secondary endpoints were included to help expand the Company’s understanding of the potential clinical utility of Zenvia. These additional endpoints include: 1) SF-36 Health Survey, 2) Neuropsychiatric Inventory Questionnaire (NPI-Q), 3) Beck Depression Inventory (BDI-II), and 4) Pain Rating Scale score (MS patients only). Data from these secondary efficacy endpoints, as well as additional exploratory analyses, are expected to be reported at an upcoming scientific meeting later this year.

 

Safety and Tolerability Results

 

Overall, Zenvia was generally safe and well tolerated in this study. In the STAR trial, 90.9%, 82.2% and 86.2% of patients completed the 12-week double blind phase of the study in the Zenvia 30/10 mg, Zenvia 20/10 mg and placebo groups, respectively. The most common reason for early withdrawals was due to adverse events (AEs). Early withdrawal due to AEs occurred in 3.7%, 7.8% and 1.9% for the Zenvia 30/10 mg, Zenvia 20/10 mg and placebo groups, respectively. The proportion of patients reporting at least one AE was 83.2% in the Zenvia 30/10 mg group, 80.4% in the Zenvia 20/10 mg group and 81.1% in the placebo group. Reported AEs were generally mild to moderate in nature. The most commonly reported adverse events that appeared to be more frequent than placebo were dizziness, nausea and diarrhea. While commonly reported, falls, headache, somnolence and fatigue were no different than placebo.

 

The proportion of patients reporting at least one serious adverse event (SAE) was 6.5% in the Zenvia 30/10 mg group, 8.8% in the Zenvia 20/10 mg group and 10.4% in the placebo group. A total of 38 SAEs occurred in 27 patients over the course of the study. Of the 38 SAEs reported in the study, only two were deemed by the investigators to be possibly or probably treatment-related; zero in the Zenvia 30/10 mg group, two in the Zenvia 20/10 mg group and zero in the placebo group. In addition, there was a numerical difference in respiratory SAEs with five patients (4.7%) in the Zenvia 30/10 mg group, three patients (2.9%) in the Zenvia 20/10 mg group and two patients (1.9%) in the placebo group experiencing respiratory SAEs.

 

Overall, there were seven deaths in the study, all in patients with underlying ALS. In total, three deaths occurred in the Zenvia 30/10 mg arm, three in the 20/10 mg arm and one in the placebo arm. Of the seven deaths that were reported, five of the deaths (four in the Zenvia treatments arms and one in the placebo arm) occurred at least five days after study drug had been discontinued. There was one reported death in the Zenvia 20/10 mg group that was considered possibly treatment-related, which occurred five days after study drug had been discontinued.

 

During the study, there were no significant changes observed in laboratory values from baseline to end of study in any treatment group. In order to evaluate the potential for respiratory depression, nocturnal oxygen saturation was measured. There was a decrease in mean nocturnal oxygen saturation of 0.7% in the Zenvia 20/10 mg group (p=0.0472); however, no difference was observed in the higher 30/10 mg dose group relative to placebo.

 

Cardiovascular Safety

 

During the course of the study, no new cardiovascular safety signals were observed. There were no clinically meaningful changes in QT interval, no reported pro-arrhythmic events and no reports of any cardiovascular SAEs.

 

“Overall, the STAR data would suggest that the new low dose formulation of Zenvia provides an improved safety and tolerability profile relative to the previous formulation,” said Randall Kaye, MD, AVANIR's Chief Medical Officer. “We look forward to receipt and analysis of the full data set from the double blind phase of the STAR trial as well as results from the open-label extension study to further evaluate the safety and efficacy of the new dose formulations.”

 

Star Trial Design

 

The STAR (Safety, Tolerability and Efficacy Results of AVP-923 in PBA) trial is a confirmatory Phase III trial of Zenvia in patients with pseudobulbar affect (PBA). The randomized, multi-center, international STAR trial compares active treatment with Zenvia 30/10 mg BID and Zenvia 20/10 mg BID to placebo during a three-month, double-blinded phase, followed by a three-month, open-label extension study. At the conclusion of enrollment, AVANIR had enrolled a total of 326 patients (197 with underlying ALS and 129 with underlying MS) who exhibited signs and symptoms of PBA across 52 sites in the U.S. and Latin America. A total of 110, 107 and 109 patients were randomized to the Zenvia 30/10 mg group, the Zenvia 20/10 mg group and the placebo group, respectively. The primary efficacy analysis is based on the changes in crying/laughing episode rates recorded in patient diaries. Secondary endpoints for this clinical trial include: 1) Center for Neurologic Study-Lability Scale (CNS-LS) score; 2) Neuropsychiatric Inventory Questionnaire (NPI-Q); 3) SF-36 Health Survey; 4) Beck Depression Inventory (BDI-II); and 5) Pain Rating Scale score (MS patients only). Safety and tolerability of Zenvia are determined by reporting adverse events, physical exam, vital signs, electrocardiogram, respiratory function tests and clinical assessment of clinical laboratory variables. The STAR trial is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA).

 

ABOUT PBA

 

Pseudobulbar affect (PBA), also known as emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays. PBA is estimated to impact approximately 2 million people in the United States with underlying neurologic conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease, dementias including Alzheimer's disease, stroke, and traumatic brain injury. PBA episodes may occur when disease or injury damages the area of the brain that controls normal expression of emotion. This damage can disrupt brain signaling causing a "short circuit" and triggering involuntary PBA episodes. PBA has been shown to impair the lives of patients in both social and occupational settings. There are currently no FDA approved treatments for PBA.

 

ABOUT ZENVIA

 

Zenvia™ (dextromethorphan/quinidine) is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways: through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia is being developed for the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain. In October 2006, the Company received an approvable letter for Zenvia in the treatment of PBA. The Company is conducting a confirmatory Phase III study under a Special Protocol Assessment (SPA) agreement with the FDA utilizing a new lower quinidine dose formulation of Zenvia intended to address safety concerns raised in the Agency's approvable letter for Zenvia in the treatment of PBA. For more information about this trial visit www.pbatrial.com. For more information about the Agency's SPA process, see www.fda.gov/cder/guidance/3764fnl.htm. In addition, AVANIR has conducted a Phase III study of Zenvia in DPN pain where the primary endpoints were successfully met. Subsequently the Company released top-line results of a formal PK study that identified alternative lower-dose quinidine formulations of Zenvia for DPN pain intended to deliver similar efficacy and improved safety/tolerability versus the formulations previously tested for this indication. AVANIR is now engaged in discussions with the FDA under the SPA process regarding the design of the next Phase III study in DPN pain and overall program requirements.

 

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