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
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
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
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
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
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
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
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
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
"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
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
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.
OTCPicks.com is located at
DO NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND ON THIS REPORT. We are not registered as a securities broker-dealer or an investment adviser either with the U.S. Securities and Exchange Commission (the "SEC") or with any state securities regulatory authority. We are neither licensed nor qualified to provide investment advice. OTCPicks.com makes no recommendation that the purchase of securities of companies profiled in this web site is suitable or advisable for any person or that an investment such securities will be profitable. In general, given the nature of the companies profiled and the lack of an active trading market for their securities, investing in such securities is highly speculative and carries a high degree of risk. You are receiving this email because you have registered on OTCPicks.com or one of our affiliate companies.
The information contained in our report should be viewed as commercial advertisement and is not intended to be investment advice. The report is not provided to any particular individual with a view toward their individual circumstances. The information contained in our report is not an offer to buy or sell securities. We distribute opinions, comments and information free of charge exclusively to individuals who wish to receive them.
Our newsletter and website have been prepared for informational purposes only and are not intended to be used as a complete source of information on any particular company. An individual should never invest in the securities of any company profiled based solely on information contained in our reports. Individuals should assume that all information contained in the report about profiled companies is not trustworthy unless verified by their own independent research.
Any individual who chooses to invest in any securities should do so with caution. Investing in securities is speculative and carries a high degree of risk; you may lose some or all of the money that is invested. Always research your own investments and consult with a registered investment advisor or licensed stockbroker before investing.
Information contained in our report will contain "forward looking statements" as defined under Section 27A of the Securities Act of 1933 and Section 21B of the Securities Exchange Act of 1934. Subscribers are cautioned not to place undue reliance upon these forward-looking statements. These forward-looking statements are subject to a number of known and unknown risks and uncertainties outside of our control that could cause actual operations or results to differ materially from those anticipated. Factors that could affect performance include, but are not limited to, those factors that are discussed in each profiled company's most recent reports or registration statements filed with the SEC. You should consider these factors in evaluating the forward-looking statements included in the report and not place undue reliance upon such statements. We are committed to providing factual information on the companies that are profiled. However, we do not provide any assurance as to the accuracy or completeness of the information provided, including information regarding a profiled company's plans or ability to effect any planned or proposed actions. We have no first-hand knowledge of any profiled company's operations and therefore cannot comment on their capabilities, intent, resources, nor experience and we make no attempt to do so. Statistical information, dollar amounts, and market size data was provided by the subject company and related public information sources which we believe to be reliable but we cannot guarantee the accuracy of the information. To the fullest extent of the law, we will not be liable to any person or entity for the quality, accuracy, completeness, reliability, or timeliness of the information provided in the report, or for any direct, indirect, consequential, incidental, special or punitive damages that may arise out of the use of information we provide to any person or entity (including, but not limited to, lost profits, loss of opportunities, trading losses, and damages that may result from any inaccuracy or incompleteness of this information). We encourage you to invest carefully and read investment information available at the websites of the SEC at http://www.sec.gov and FINRA at http://www.finra.org.
Disclosure: OTCPicks.com has been compensated eight thousand dollars by a third party (Stock Guru) for UVSE advertising and promotional services.