OTCPicks.com

For Tuesday, October 7th

PWRM, OPXA, DNDN, BCTE, USPR, UVSS

Our Stocks to Watch tomorrow include Power3 Medical Products Inc. (OTCBB: PWRM), Opexa Therapeutics Inc. (Nasdaq: OPXA), Dendreon Corp. (Nasdaq: DNDN), Big Cat Energy Corp. (OTCBB: BCTE), U.S. Precious Metals Inc. (OTCBB: USPR) and Universal Systems Inc. (OTC: UVSS).

POWER 3 MEDICAL PRODUCTS INCORPORATED (OTCBB: PWRM)
"Up 80.00% on Monday"

Detailed Quote: www.otcpicks.com/quotes/PWRM.php

Power3 Medical Products Inc. is a leading Bio Medical company engaged in the commercialization of cancer and neurodegenerative disease biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets. Power3's patent-pending technologies are being used to develop screening and diagnostic tests for the early detection and prognosis of disease, identify protein biomarkers, and drug targets. Power3 operates a state-of-the-art CLIA certified laboratory in The Woodlands (Houston), Texas. The Company continues to evolve and enhance its IP portfolio.

PWRM News:

October 6 - Power3 Medical Products, Inc. Makes its Diagnostic Tests Ready for Commercialization

Power3 Medical Products, Inc. (OTCBB: PWRM) announced that the Company has taken steps necessary for the commercialization of its early diagnostic tests for breast cancer, Alzheimer’s and Parkinson’s disease, and anticipates revenue from sales and licensing this quarter.

“Power3 Medical is preparing to commercialize its BC SeraPro™, and NuroPro® tests for breast cancer, Alzheimer’s and Parkinson’s. The pre marketing and packaging of the company's early diagnostic test sample kits are complete, and ready for commercialization. Our partners in the foreign markets are primed as the points of release of the tests to the market. Our lab is positioned to run the tests in house with CLIA certification. The initial launch is anticipated for Greece with completion of the clinical validation trials with The University of Thessaly,” stated Dr. Ira L. Goldknopf, President and Chief Scientific Officer of Power3.

“We are delighted to bring these tests into position for commercialization. This is especially timely for the BC SeraPro™ test, with this month’s emphasis on Breast Cancer Awareness,” commented Ms. Helen R. Park, interim CEO of Power3.


OPEXA THERAPEUTICS INCORPORATED (NASDAQ: OPXA)
"Up 9.38% on Monday"

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

Opexa Therapeutics, Inc. a development stage biopharmaceutical company, develops autologous cellular therapies for the treatment of multiple sclerosis, rheumatoid arthritis, and diabetics. Its therapies are based on the company's T-cell and adult stem cell technologies. The company's products include Tovaxin, a T-cell therapeutic vaccine that is in Phase IIb clinical trial for the treatment of multiple sclerosis. Its Rheumatoid Arthritis T-cell vaccination technology, which is in preclinical development stage allows the isolation of pathogenic T-cells from synovial fluid drawn from a patient; as well as Adult Stem Cell technology that is in preclinical development stage is used to treat diabetes; and is in research and development stage to treat heart failure. The company was founded in 2003. It was formerly known as PharmaFrontiers Corp. and changed its name to Opexa Therapeutics, Inc. in 2006. Opexa Therapeutics is based in the Woodlands, Texas.

OPXA News:

September 19 - Unidym Licenses Technology for Semiconductor Applications

Tovaxin Shows Favorable Annualized Relapse Rate and Excellent Safety Profile

Opexa Therapeutics, Inc. (Nasdaq: OPXA), a company dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as multiple sclerosis (MS) and diabetes, today announced top-line data from the company’s Phase IIb TERMS (Tovaxin® for Early Relapsing Multiple Sclerosis) study. Top-line results from the study demonstrated a positive trend in the reduction in annualized relapse rate (ARR) for patients treated with Tovaxin as compared to placebo. However, this finding did not achieve statistical significance. In addition, the study did not achieve statistical significance with its primary endpoint, the cumulative number of gadolinium-enhanced brain lesions.

Top-line results from the study showed that Tovaxin-treated patients experienced an ARR of 0.214 as compared to 0.339 for placebo-treated patients. Despite the low relapse rate in the placebo arm, this still represented a 37 percent decrease in ARR for Tovaxin as compared to placebo in the general population. Additionally, in the group of patients who had an ARR > 1 at study entry, Tovaxin demonstrated a 55 percent reduction in ARR as compared to placebo.

The study also demonstrated that Tovaxin was safe and well tolerated with no serious adverse events related to treatment. The most common adverse event related to Tovaxin was mild injection site reaction. Opexa believes that this favorable safety profile may be an important advantage as patient compliance represents a significant challenge due to serious side effects associated with many currently available MS treatments.

It is important to note that initial review of data revealed that patients in the study’s Tovaxin arm, on average had a substantially greater number of MRI brain lesions and corresponding lesion volumes at baseline compared to the average number of MRI brain lesions and lesion volumes per patient in the placebo group. The company believes that this unexpected imbalance may have contributed to the study not achieving its primary and secondary endpoints as patients in the Tovaxin arm began the study with greater disease burden and increased severity of disease.

“The annualized relapse rate of 0.214 seen in the Tovaxin treatment arm is on par with the lowest relapse rates observed with currently available MS treatments which range from 0.2 to 0.9. This rate is also consistent with ARRs that we have seen in the Tovaxin treatment arms in each of the three previously conducted Tovaxin clinical studies,” stated Neil K. Warma, president and chief executive officer of Opexa. “Findings further showed Tovaxin to possess an impressive safety profile with no serious adverse events related to treatment. This level of safety and tolerability addresses a critical unmet need for MS patients. We believe that these positive ARR results combined with an excellent safety profile and convenient dosing place Tovaxin in a very favorable position for continued development as an innovative MS therapy.”

Top-line data from the TERMS study were presented today by Edward J. Fox, M.D., Ph.D., director of the Multiple Sclerosis Clinic of Central Texas and the study’s principal investigator, at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada.

“Multiple sclerosis is a disease that affects individual patients in distinctly different ways, highlighting the desire for a safe, effective and patient-specific therapy such as Tovaxin. With this in mind, we are pleased with the positive efficacy trend and excellent safety results witnessed in the TERMS study,” stated Dr. Fox. “The Tovaxin-induced reduction in ARR is particularly exciting as it suggests a reduction of clinical activity associated with MS. These study results are encouraging and supportive of further analysis of Tovaxin.”

ABOUT THE TERMS STUDY

The TERMS study was a Phase IIb multi-center, randomized, double blind, placebo-controlled trial in 150 patients with Relapsing-Remitting Multiple Sclerosis or high risk Clinically Isolated Syndrome (CIS). The study involved 2:1 randomization with 100 patients receiving Tovaxin and 50 receiving placebo. According to the study protocol, patients received a total of five subcutaneous injections at weeks 0, 4, 8, 12 and 24. The primary efficacy endpoint of the TERMS trial was the cumulative number of gadolinium-enhanced brain lesions (CELs) using MRI scans summed over weeks 28, 36, 44 and 52. The trial’s secondary efficacy endpoints included annualized relapse rate (ARR), new CELs at weeks 28 through 52 and T2-weighted lesion volume compared to baseline.


DENDREON CORPORATION (NASDAQ: DNDN)
"Up 33.27% on Monday"

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

Dendreon Corporation, a biotechnology company, engages in the discovery, development, and commercialization of novel therapeutics that harness the immune system to fight cancer. The company's product portfolio includes active cellular immunotherapy, monoclonal antibodies, and small molecules products candidates to treat a range of cancers. Its product candidate include Provenge (sipuleucel-T), an active cellular immunotherapy that has completed 2 Phase III clinical trials for the treatment of asymptomatic, metastatic, and androgen-independent prostate cancer; Neuvenge (lapuleucel-T), which has completed phase 1 clinical trials for the treatment of breast, ovarian, and colon cancers. The company also has a range of products in preclinical studies, which include CEA for the treatment of breast, lung, and colon cancer; CA-9 (MN) for the treatment of kidney, colon, and cervical cancer; Anti-Serine Protease for the treatment of multiple cancers; and Trp-p8 for the treatment of lung, breast, prostate, and colon cancer. It has collaborative agreements with Genentech, Inc. for the preclinical research, clinical development, and commercialization of products derived from trp-p8; and with Amgen Fremont, Inc. for using its human antibody technologies to generate and select antibodies against a membrane-bound serine protease. Dendreon Corporation, formerly known as Activated Cell Therapy, Inc., was founded in 1992. The company is headquartered in Seattle, Washington.

DNDN News:

October 6 - Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial

Dendreon Corporation (Nasdaq: DNDN) announced that it has completed the planned interim analysis of the Phase 3, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial designed to assess the safety and efficacy of the investigational active cellular immunotherapy PROVENGE® (sipuleucel-T) in men with metastatic androgen-independent prostate cancer. While Dendreon remains blinded to the data, the independent data monitoring committee (IDMC) reported to Dendreon a 20 percent reduction in the risk of death in the PROVENGE arm relative to placebo (Hazard Ratio= 0.80; 95% Confidence Interval [0.610-1.051]). The IDMC observed no safety concerns and recommended that the study continue to its final analysis.

"The treatment effect we have observed in this interim analysis is consistent with that observed in the integrated analysis of our previous Phase 3 trials in this patient population when analyzed at a similar 24-month follow-up time," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "Given the delayed treatment effect we have seen in previous studies, we are pleased to see evidence suggesting a prolongation of survival in the PROVENGE arm at the time of the interim analysis, as well as a favorable safety profile."

At the final analysis, which is anticipated in the middle of 2009, if the study demonstrates approximately a 22 percent reduction in the risk of death, based on 304 events, the company would expect the study to meet its primary endpoint of overall survival.

"We look forward to the final results next year and the opportunity to make PROVENGE available to the many men with advanced prostate cancer who currently have few appealing treatment options," said Dr. Gold.

The IMPACT trial is a randomized, double-blind, placebo-controlled Phase 3 study which enrolled 512 men with metastatic, androgen-independent prostate cancer with a primary endpoint of overall survival. Following the U.S. Food and Drug Administration (FDA) Advisory Committee vote that there was substantial evidence of efficacy of PROVENGE and that PROVENGE was reasonably safe, the FDA requested additional clinical data to support the proposed efficacy claim. The FDA previously agreed that a positive final analysis for overall survival from the IMPACT trial would be sufficient to meet its request for additional clinical information to support the proposed efficacy claim for PROVENGE.

ABOUT HAZARD RATIOS

The hazard ratio is an estimate of the treatment effect in the treated versus the control group in a trial. The hazard ratio reported means that a PROVENGE patient who at the time of the interim analysis has 0.80 times the chance of dying compared to someone in the placebo group. Its reciprocal, 1.25, means a placebo patient has 1.25 times the chance of dying compared to someone in the PROVENGE group (this is the method that hazard ratios were reported in our previous trials).

ABOUT ACTIVE CELLULAR IMMUNOTHERAPY WITH PROVENGE

PROVENGE may represent the first product in a new class of active cellular immunotherapies that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity.

ABOUT PROSTATE CANCER

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases expected to be diagnosed in 2008, and approximately 28,660 men expected to die this year from the disease. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.


BIG CAT ENERGY CORPORATION (OTCBB: BCTE)
"Up 31.43% on Monday"

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

Big Cat Energy Corporation has developed a patented technology called the ARID Tool (Aquifer Recharge Injection Device), a revolutionary new method of water handling that provides coal bed methane wells with the ability to redistribute produced water. This revolutionary new coal bed methane production technology will allow coal bed methane operators to process produced water at a fraction of the cost of current technology.

BCTE News:

October 6 - Big Cat Energy Announces the Completion of a 90-Day Test with the ARID Tool

Big Cat Energy Corporation (OTCBB: BCTE) announced that a major Coal Bed methane (CBM) operator has conducted and concluded a 90-day test of the ARID tool in a well located in the Powder River Basin Dead Horse Creek area. The test purpose was two fold: to provide the land owner with data demonstrating that injection of CBM water into the receiving aquifer would not impact nearby domestic water wells, and to provide a major CBM operator with data demonstrating ARID's ability to deliver and inject CBM water into the receiving aquifer at the rate required by the well's operating plan. ARID's success in meeting the requirements of both the CBM operator and the landowner has resulted in a decision by the CBM operator to prepare more wells in the test area for ARID installations. In addition, the major CBM operator is gathering data for DEQ permits in new locations throughout the Powder River Basin.

Furthermore, the major CBM operator is in the process of installing four (4) ARID tools in the same area. The decision has been made to squeeze off the initial receiving aquifers of these 4 wells and open up the aquifer that received the water in the well in which the 90-day test was completed. This work has begun and is expected to be concluded shortly.

Commenting on the recent 90-day test of the ARID tool, Tim Barritt, President of Big Cat Energy Corp., stated, "The data received from the recent test period by a major CBM operator confirms our opinion that the ARID tool will change the methods CBM operators use to dispose of water in the Powder River Basin. We at Big Cat Energy Corp. are excited about several new companies coming forward and allowing us to work up pilot prospect areas on both the west and central parts of the Powder River Basin. We have been working to find areas on the west and central parts of the basin as the CBM play moves in that direction. These companies have kept us very busy in the past few months generating geologic evaluations for their pilots. We are convinced through our evaluations that success can be achieved in these areas as well as the ones currently ongoing. Corporately, we are financially sound and in a position to move into these new areas, which will bring expansion of our ARID tool. This will be exactly what we have been working toward for the coming year."


US PRECIOUS METALS (OTCBB: USPR)
"Up 16.67% on Monday"

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

U.S. Precious Metals, Inc. engages in the acquisition, exploration, and development of mineral properties. It focuses on gold and base mineral resource properties primarily located in the southern portion of the states of Michoacan and Sonora, Mexico. The company owns exploration concessions to the Solidaridad properties located in Michoacan, Mexico. It also owns interest in the El Diamante gold and silver mining property in southern Michoacan, Mexico. In addition, it holds an option to conduct geological studies on six mining claims located near Caborca in the state of Sonora, Mexico; and to acquire exploration rights on La Ceibra property, which is located in the state of Sonora, Mexico. The company was founded in 1998 and is based in Lithia, Florida.

USPR News:

October 6 - U.S. Precious Metals Announces Proven Gold, Silver and Copper Reserves Found in Mexican Mining Concession; Road Construction Permits Granted

U.S. Precious Metals, Inc. (OTCBB: USPR) ("USPR") CEO and Chairman of the Board M. Jack Kugler released assay data for selected intervals in drill holes 8 and 9 today. Drill hole number 8 intersected 20 feet of 0.206 opt gold, 0.88 opt silver and 1.06% copper. Drill hole number 9 intersected 18 feet of 0.146 opt gold, 1.46 opt silver and 1.19% copper. The additional drill hole information has increased the proven reserve from 199,200 tons to 276,899 tons. The additional tonnage adds 3190 ounces of Au (gold), 68,878 ounces of Ag (silver) and 1265 tons of Cu (copper) to the proven reserve. Probable reserves have increased by 8060 tons from 763,088 tons to 771,148. The additional tonnage adds 532 ounces of gold, 9027 ounces of silver and 45 tons of copper to the probable reserves. The proven and probable reserves are located on less than 5 acres of the 37,316.84 acre concessions, leaving 99.9% of the holdings unexplored.

Drilling continues on hole numbers 7 and 10 which are expected to be completed within the next 10 days. Drill hole number 7 is a deep exploration drill hole while number 10 is a definition drill hole. Drill holes 11 and 12 have been targeted for definition drilling in the Main Zone.

In other USPR news, the Semarnat, the government environmental protection agency, has issued the required permit changing the land status from forest to mining for the 37,316.76 acre concessions. New roads can now be built accessing drill targets that have previously been inaccessible. USPR will be constructing a warehouse and pilot plant facility on the concession in addition to the laboratory and warehouse facility located in Morelia, Mexico.


UNIVERSAL SYSTEMS INCORPORATED (OTC: UVSS)
"Up 15.38% on Monday"

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

Universal Systems, Inc (USI) is a publicly traded holding company focused on providing economically and ecologically viable water and wastewater treatment solutions. USI offers FULL SERVICE turn-key water treatment services, specializing in "slop oil" and CBM (Coal Bed Methane) produced water. In 2007, USI obtained an exclusive worldwide licensing agreement to provide slop oil and processed wastewater treatment services to the oil industry. The company's mission is to become the leader in the development and delivery of cost effective slop oil and processed wastewater treatment. USI joined Powell Water Systems, Inc. (PWS) and Water Solutions, LLC (WS) to bring PWS' patented electrocoagulation technology to the oil industry, making large flow waste oil and water treatment efficient and cost effective.

UVSS News:

October 6 - Universal Systems and Atlas Monetary International Trust Complete Joint Venture Agreement

Universal Systems, Inc. (OTC: UVSS) announced that it has successfully signed a joint venture agreement with Atlas Monetary International Trust. The agreement encompasses several initiatives that are core to the Atlas mission. The first component of the agreement has been defined and awards to USI a contract for the design and production of a marine system for cleaning petroleum spills at the point of the spill. USI was selected by Atlas Trust for this joint venture based on the performance of its electro-coagulation systems and the environmental focus of the corporation. The patented technologies employed in these systems give them unrivaled volume flow performance and the ability to remove even the smallest traces of petroleum and other contaminants from seawater, potentially leaving it cleaner than it was before the spill. Discussions are underway that will award additional contracts to USI for environmental projects that are on the Atlas Trust strategic roadmap.

Atlas Trust will immediately purchase 8,000,000 shares of Universal common stock for a price of $25.00 per share, equaling $200,000,000 USD. This infusion of capital will enable Universal Systems to move forward with design of the marine-based electro-coagulation equipment and to take over the contract from Ocean Vacuum Corporation to produce ocean platforms to be used for clean up and recovery of oil spills and contaminated water. The contract calls for the design, manufacturing and assembly of approximately 16,000 ("Sixteen Thousand") units. The contract ceiling currently stands at $2.4 billion (USD); however this number will increase to cover the full projected cost of all systems when the final production cost is determined. Engineering will start immediately and a prototype system will be available for test within 9-months. A large portion of the assembly will take place in Puerto Rico while design, engineering and the building of the working prototype will take place in Baker City, Oregon. Universal has initiated negotiations for the purchase of several large blocks of real estate with existing buildings to accommodate its new cast of employees. Universal plans to move its head quarters there as well in order to consolidate operations and its other products. Production units will be leased to major oil companies and stored on their large oil tankers to act as a first line of defense for decontamination at the point of spill, should one occur. Had these systems been available at the time of the Valdez oil spill in Alaska the majority of the environmental effects felt through the release of millions of gallons of oil into the ocean could have been prevented.

Reflecting on the signing of the joint venture agreement with Atlas Trust, Mr. Kevin Chambers, CEO of Universal Systems, commented, "This agreement is the thread tying together the environmental technologies accumulated by USI over the past several years. These years have been spent in building a unique capability to make an impact on the state-of-the art in environmental cleanup. With the signing of this agreement, the long-standing vision is realized and USI stands fully empowered for execution. This is a momentous occasion for USI and for all who have wished for better ways to mitigate the damage of environmental mishaps on our oceans, beaches and marine life. And this is only the beginning!"

 
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