Dallas TX 9/16/2009 1:15:40 AM
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ALRT, SCII, IRSN, DSCO, PWRM, HTDS OTCPicks.com Stocks to Watch for Tuesday, September 15th

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Our Stocks to Watch tomorrow ALR Technologies Inc. (OTCBB: ALRT), Stem Cell Therapy International Inc. (OTCBB: SCII), Irvine Sensors Corp. (Nasdaq: IRSN), Discovery Laboratories Inc. (Nasdaq: DSCO), Power3 Medical Products Inc. (OTCBB: PWRM) and Hard to Treat Diseases Inc. (OTC: HTDS).

 

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ALR TECHNOLOGIES INCORPORATED (OTCBB: ALRT)

"Up 500.00% on Monday"

 

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

 

The ALRT Health-E-Connect Disease Management System is designed to enhance compliance of prescribed therapies and report diagnostic data from a number of devices to health professionals for monitoring of patients. The System facilitates cost effective continued oversight of patients by authorized health professionals in-between visits to their physician.

 

ALRT News:

 

September 14 - Patent Application Approval for Remote Monitoring of Patient's Use of Nebulizer Compressors Facilitates Enhanced Coordination of Care for Patients With Respiratory Disease

 

ALR Technologies (OTCBB: ALRT) announces that it has received notice from the US Patent and Trademark Office that ALRT has been granted approval of its patent application regarding patient compliance and remote monitoring of patient's use of nebulizer compressors. This approval from the US patent office will protect ALRT's Health-E-Connect health management communications system and more importantly, will grant ALRT the exclusive ability to remotely monitor the use of nebulizer compressors in the delivery of medications to patients with COPD, chronic asthma and cystic fibrosis.

 

COPD is one of the leading causes of death in the world. With 16 million people in the US with COPD and 20 million plus with asthma, utilizing ALRT's Health-E-Connect system to monitor their use of nebulizer compressor creates the opportunity to significantly improve quality of life and reduce healthcare costs. Health Professionals will now be able to remotely monitor and evaluate compliance in delivery of aerosolized medications to their patients with respiratory diseases thereby helping these patients to reduce health complications and improve their quality of life.

 

The use of monitoring-ready nebulizer compressors and ALRT's Health-E-Connect health management communications system can become an important new service provided by health professionals. Furthermore, the Health-E-Connect system is on target with the growing recognition in the US to use electronic health records to improve the efficiency and effectiveness of patient care.

 

ALRT announced earlier this year that insurance carriers will reimburse physicians for the remote care of patients with the use of its Health-E-Connect system. This will result in new revenue for physicians as they provide the additional service to their patients with respiratory disease. ALRT's Health-E-Connect and complementary Constant Health Companion is the only system in the US and International markets that allows for remote monitoring of patients' use of nebulizer compressors. This capability will allow for enhanced patient compliance and health professional coordination of care.

 

STEM CELL THERAPY INTERNATIONAL (OTCBB: SCII)

"Up 122.22% on Monday"

 

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

 

Stem Cell Therapy International, Inc., through its wholly owned subsidiary, Stem Cell Therapy International Corp., engages in licensing of stem cell technology and the sale of stem cell products, as well as the provision of information, education, and referral services. It provides allo stem cell biological solutions that are used in the treatment of patients suffering from degenerative disorders of the human body, such as Alzheimer's Disease, Parkinson's Disease, ALS, leukemia, muscular dystrophy, multiple sclerosis, arthritis, spinal cord injuries, brain injury, stroke, heart disease, liver and retinal disease, and diabetes, as well as certain types of cancer. The company's stem cell biological solutions can be used to alleviate the side effects of chemotherapy. Its principal stem cell products are solutions containing allo stem cell biological solutions, either adult stem cells, and stem cells that are extracted from umbilical cord blood. It intends to offer biological solutions containing stem cell products primarily in the United States to universities, institutes, and privately funded laboratory facilities for research purposes and clinical trials. The company was incorporated in 2004 and is headquartered in Tampa, Florida.

 

SCII News:

 

September 10 - Stem Cell Therapy International Inc. Announces Histostem Litigation Settlement

 

Stem Cell Therapy International Has Agreed to Be a Party to the Settlement; Settlement Requires Histostem and Stem Cell Therapy International Inc. to Merge

 

Stem Cell Therapy International Inc. (OTCBB: SCII) announced that the Company has agreed to be a party to the settlement between Histostem, Incorporated, a Delaware Corporation ("Histostem USA") and Histostem Corporation, a Korean Corporation ("Histostem Korea"). The agreement is contingent upon the close of the SCII and Histostem Korea merger, and specifically, the agreement is contingent that at the close of the merger, SCII will acquire no less than 90% of the total fully diluted equity of Histostem Korea.

 

For the consideration provided by Histostem USA, including but not limited to a waiver of claims and a general release, Histostem Korea and SCII have agreed to pay Histostem USA $100,000 in cash, which will be divided into three equal payments over a two year period; and seven and one half percent (7.50%) of the fully diluted total outstanding shares of SCII common stock following the close of the merger between Histostem Korea and SCII. The management of Stem Cell Therapy International, Inc. will continue to finalize a new merger agreement between SCII and Histostem Korea in the next fifteen days.

 

Andrew J. Norstrud, Chief Financial Officer, states, "Over the past year, it has been very challenging to make significant progress in operations, obtain the necessary financing to execute our global strategy and complete the merger while we were waiting for the final resolution in the Histostem Korea litigation." Mr. Norstrud also stated, "We appreciate all of the investors that have continued to support SCII and we look forward to completing this merger and obtaining the necessary financing to enable us to accelerate our strategic initiatives in the near future."

 

The Company plans to leverage Histostem Korea's technology to be the state-of-the-art conduit for bringing Asian adult stem cells into the U.S. for clinical trials and the treatment of conditions on which Americans spend billions of dollars annually. This is predicated on successful clinical trial results by Histostem Korea for Male Pattern Baldness, Buerger's Disease and other conditions, whose repository of over 80,000 cord blood units has consistently met the rigorous standards of the Korean FDA. This has made Histostem Korea the largest repository of cord blood in the world, and one of the first to actually profit from sales of its own stem cell-derived products.

 

ABOUT AMSTEM INTERNATIONAL, INC.

 

AmStem International, Inc. is a wholly owned subsidiary of SCII, and a new biotechnology company based in Northern California, in the watershed of stem cell innovation fueled by President Obama's recent announcement to lift Federal funding limitations for stem cell research. AmStem provides biotherapeutic and cosmetic stem cell products, stem cell collection and storage know-how, and access to nanotechnology vital to cutting edge stem cell research. Further information about AmStem International, Inc. can be found by contacting David Stark, SCII President, at the email posted below.

 

ABOUT HISTOSTEM CORPORATION, LTD.

 

Histostem Corp., Ltd. started in Seoul, Korea in 2000. To date it has treated more than 500 patients with stem cells and currently has 56 full-time employees and 28 part-time employees. Histostem's intellectual property portfolio consists of five patents that have been granted and six patents pending. To its knowledge Histostem is one of the very few stem cell companies in the world currently earning several million dollars in income from its products and technology. Further information about Histostem Corporation, Ltd. can be found by contacting David Stark, SCII President, at the email posted below.

 

IRVINE SENSORS CORPORATION (NASDAQ: IRSN)

"Up 50.00% on Monday"

 

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

 

Irvine Sensors Corporation, headquartered in Costa Mesa, California, is a vision systems company engaged in the development and sale of miniaturized infrared and electro-optical cameras, image processors and stacked chip assemblies and sale of higher level systems incorporating such products and research and development related to high density electronics, miniaturized sensors, optical interconnection technology, high speed network security, image processing and low-power analog and mixed-signal integrated circuits for diverse systems applications.

 

IRSN News:

 

September 14 - Irvine Sensors Receives Announces $4.6 Million in New Awards

 

Irvine Sensors Corporation (Nasdaq: IRSN) announced that it has received $4.6 million in new development contract awards in approximately the last 30 days. These awards bring the aggregate of new contract and product funding received by Irvine Sensors in the second half of fiscal 2009 to $9.3 million. Much of the recent awards are focused on or related to potential cyber security applications.

 

DISCOVERY LABS INCORPORATED (NASDAQ: DSCO)

"Up 27.94% on Monday"

 

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

 

Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 Surfactant Technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary Capillary Aerosolization Technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the deep lung without the complications currently associated with liquid surfactant administration. Discovery Labs is focused initially on developing its KL4 surfactant pipeline to build a pediatric franchise that will potentially address several respiratory conditions affecting neonates and young children, beginning with Respiratory Distress Syndrome (RDS).

 

DSCO News:

 

September 10 - Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for SURFAXIN Approval

 

Discovery Laboratories, Inc. (Nasdaq: DSCO) has received written notification from the U.S. Food and Drug Administration (FDA) that a meeting has been scheduled for September 29, 2009. This meeting will serve as a follow-up to the June 2 meeting with the FDA and the FDA's April 17 Complete Response letter. The objective of this meeting is to define the options available to Discovery Labs to resolve the remaining primary issue that Discovery Labs must address to gain U.S. marketing approval of Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

 

At the upcoming September 29 meeting, Discovery Labs plans to discuss with the FDA a limited Surfaxin clinical trial design and whether conducting such trial, while simultaneously employing the fetal rabbit Biological Activity Test (BAT, a quality control and stability release test), could potentially address the key remaining requirement for Surfaxin approval. This approach was suggested by the FDA at the June 2 meeting as a way for Discovery Labs to increase the likelihood of gaining Surfaxin approval. In addition, Discovery Labs plans to review its ongoing quality improvement efforts, intended to further refine the BAT in accordance with Discovery Labs' continuing quality improvement initiatives, with the FDA.

 

Background

 

The April 17 Complete Response letter from the FDA and the June 2 meeting focused primarily on certain aspects of the BAT, specifically whether preclinical data generated using both the BAT and a well-established preterm lamb model of RDS adequately supports the comparability of Surfaxin clinical drug product to the to-be-manufactured Surfaxin, and whether the BAT can adequately distinguish change in Surfaxin biological activity over time.

 

During the conduct of Phase 3 clinical trials for Surfaxin, Discovery Labs employed an array of quality control tests, but did not employ the BAT to evaluate biological activity of the Surfaxin clinical drug product. After completing the Phase 3 clinical trials, in accordance with discussions with the FDA, Discovery Labs validated and implemented the BAT as a recurring quality control test to confirm biological activity for Surfaxin release and stability testing. Based on agreements reached in meetings with the FDA in 2006 and 2008, Discovery Labs conducted a series of preclinical experiments to establish comparability between Surfaxin drug product used in Phase 3 clinical trials and the Surfaxin drug product intended to be manufactured for commercial use. Accordingly, Discovery Labs initiated a series of side-by-side studies employing both the preterm lamb model of RDS and the BAT and believes that the correlated results demonstrate comparability and support approval of Surfaxin.

 

At the June 2 meeting with the FDA, Discovery Labs presented data from the preterm lamb model and BAT studies, together with a comprehensive statistical evaluation of such data, intended to establish the comparability of clinical drug product to Surfaxin drug product to be manufactured for commercial use. The comprehensive statistical evaluation was a comparative regression analysis using an accepted FDA statistical method. Discovery Labs believes that the data and related statistical evaluation are highly supportive of the comparability of clinical drug product to commercial Surfaxin.

 

However, the FDA stated at the June 2 meeting, that data generated from the preterm lamb model and BAT studies must demonstrate, in a point-to-point analysis, the same relative changes in respiratory compliance between both models over time. Based on this standard, Discovery Labs believes that establishment of comparability in this manner would be an extremely high hurdle and that, from the FDA's perspective, the data analysis provided by Discovery Labs did not meet that standard.

 

In addition, the FDA suggested that the comparability studies in the preterm lamb model and the BAT would not be necessary if the BAT had been implemented to assess Surfaxin drug product used in the Phase 3 clinical trials. The FDA also suggested that, to increase the likelihood of gaining Surfaxin approval and as an alternative to demonstrating comparability using the preterm lamb model and BAT, Discovery Labs could consider conducting a limited clinical trial, while simultaneously employing the BAT, as a path forward to Surfaxin approval.

 

POWER 3 MEDICAL PRODUCTS INCORPORATED (OTCBB: PWRM)

"Up 38.18% 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:

 

September 2 - Transgenomic and Power3 Medical Report Identification of Abnormal Serum Proteins in Parkinson's Disease

 

On-line Publication of Biomarker Panel that Forms Basis for NuroPro®PD Diagnostic Test

 

Transgenomic, Inc. (OTCBB: TBIO) and Power3 Medical Products, Inc. (OTCBB: PWRM) announced the advance on-line publication of a clinical research paper entitled "Abnormal Serum Concentrations of Proteins in Parkinson's Disease" in the scientific journal Biochemical and Biophysical Research Communications. The study demonstrates the usefulness of a protein biomarker panel to distinguish Parkinson's disease (PD) patients from age-matched normal controls independent of the severity of symptoms, using clinical blood serum samples.

 

The analytic technology forms the basis for the NuroProPD test for PD being commercialized by Transgenomic as per a licensing/collaboration agreement with Power3 Medical signed in early 2009. The publication of the peer-reviewed article is a significant validation milestone in the ongoing clinical development of the NuroProPD diagnostic assay.

 

The article describes the use of analytically validated quantitative 2D gel electrophoresis to identify protein biomarkers for diagnosing PD using serum from routinely collected blood samples. 57 protein biomarkers, which had been discovered using retrospective blood serum samples from various neurodegenerative diseases, were then applied specifically to PD in a prospective clinical investigation using freshly collected blood serum from PD patients and age-matched normal controls. A multi-variate statistical method, stepwise linear discriminant analysis, selected a combination of 21 of the biomarkers as optimal to distinguish PD patients from controls. When applied to the PD samples, the 21-protein set had sensitivity of 93.3% (52 of 56 PD correctly classified) and specificity of 92.9% (28 of 30 controls correctly classified); 15 of 15 patients with mild and 28 of 30 with moderate to severe symptoms were correctly classified, as were all 6 PD samples from an independent site.

 

"We are enthusiastic about the acceptance of our paper in this established peer-reviewed scientific journal. It represents independent external validation of the clinical data, and so increases the confidence that we have in NuroProPD to be a meaningful tool for the diagnosis of Parkinson's disease, especially early in its course," said Craig Tuttle, CEO of Transgenomic. "We are completing the clinical validation of the assay in our CLIA-certified molecular testing laboratory and will be launching the assay in the very near future."

 

"In the U.S., there are an estimated 1.5 million individuals with Parkinson's disease. Unfortunately, by the time patients are given a probable diagnosis, many have already suffered substantial and irreparable brain damage, rendering treatment less effective," said Dr. Ira Goldknopf, President and CSO of Power3 Medical and lead author on the paper. "The fact that these results were obtained using fresh blood serum, in the same way that the test will be performed in a clinical diagnostic setting, provides further support for their robustness and their commercial value."

 

Clinical investigators in the study were Dr. Katerina Markopoulou of the University of Thessaly, Greece, Drs. Marwan Sabbagh and Holly Shill of Banner Sun Health Research Institute, Sun City, Arizona, and Dr. Stanley Appel of the Texas Methodist Health System, Houston.

 

ABOUT TRANSGENOMIC, INC.

 

Transgenomic, Inc. (OTCBB: TBIO) is a global biotechnology company specializing in high sensitivity genetic variation and mutation analysis, providing products and services in DNA mutation detection and discovery for clinical research, clinical molecular diagnostics and pharmacogenomics analyses. Its product offerings include the WAVE® Systems and associated consumables specifically designed for use in genetic variation detection and single- and double-strand DNA/RNA analysis and purification. With broad applicability to genetic research, over 1,450 systems have been shipped to customers in more than 30 countries. The SURVEYOR® Mutation Detection Kits and SURVEYOR Check-It Kit provide reagents and protocols for high sensitivity detection of mutations in DNA. In addition, HANABI automated chromosome harvesting systems improve laboratory productivity with consistent quality compared to manual methods for cytogenetic analyses. Service offerings include the Transgenomic Molecular Laboratory, which provides reference laboratory services specializing in molecular diagnostics including Mitochondrial Disorders, Oncology and Hematology, Molecular Pathology and Inherited Diseases. Transgenomic Pharmacogenomic Services is a CRO for pharmacogenomic, translational research and clinical trials.

 

HARD TO TREAT DISEASES INCORPORATED (OTC: HTDS)

"Up 116.67% on Monday"

 

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

 

In June 2003, International Foam Solutions, Inc. changed its name to Hard to Treat Diseases, Inc. in connection with the completion of a share exchange agreement with Hard to Treat Diseases and T-19, Inc. Hard to Treat Diseases, Inc. holds the international marketing rights, except South Korea, to Tubercin, a patented immunostimulant developed for combating cancer and rheumatoid arthritis under medical patent. Tubercin promotes good health by enhancing the immune system. The nasal spray would be distributed through major holistic retailers and providers worldwide.

 

HTDS News:

 

September 14 - Hard To Treat Diseases Receives H1N1 Vaccine Clinical Approval and Production

 

Hard To Treat Diseases (OTC: HTDS) provides the following update to its shareholders and followers on the (H1N1) Vaccine for Mellow Hope Inc, its China based subsidiary and other general business matters:

 

At the beginning of September, Mellow Hope completed the clinical trial of Influenza A (H1N1) Vaccine (Split Virion). The company received the clinical approval from the State Food and Drug Administration (SFDA). Production will be started shortly.

 

Mr. Terry Yuan CEO of HTDS said (sic) "Mellow Hope has received many inquiries from different countries, asking about the supply of this vaccine. The company is currently in overdrive preparing all the relevant documents to obtain the approval in all of these regions, from various jurisdictional authorities. We are very confident and expect that several significant deals will be finalized by the middle of October, or early November. We remind our shareholders that we beat out a lot of our competitors with our tenders, and we note that some are out in full force planting doubt about our business activities to our novice and unsuspecting shareholders."

 

Mr. Yuan exclaimed "Our business is doing fantastic! I can't say that any clearer or louder. Our revenues will spike in this 3rd or 4th quarter and once the numbers are released our shareholders will have plenty to smile about. Our audit has commenced, with our aspirations to become an OTCBB Company. I know that our North American office and our representatives there are busy providing the auditors data they require. Few weeks ago when we set the target of our share price of 3 cents per share we did so confidently. Now, with our H1N1 done and completed, HTDS en route to getting its audits completed, OTCBB listed, the cancer and anti aging project's of Slavica Bio Chem, actions we are taking against the naked shorting that has affected our stock, plus the sizable outstanding share reduction; in all fairness a 5 cent target is not an unreasonable or unrealistic target for HTDS."

 

On that note, Slavica Bio Chem is pleased to provide a video stream of its work. The web stream and English translations are available on www.htdsmedical.com under the section "Company News" The video is split in 3 segments. Permission was obtained from RTS TV for non commercial and informative use and to be placed on HTDS website.

 

Dr. Sanja Pekovic, Chief Project Scientist and Chief Strategy Officer summarized as following: "A few years ago Serbian government TV did a feature about our work, and it took a great public attention. It was about Multiple sclerosis, current therapies, there were also some patients, and our whole team. In the video Dr. Sanja Pekovic, Chief Project Scientist and Chief Strategy Officer and Prof Dr. Mirjana Stojiljkovic, Slavica Bio Chme's Medical Advisor can be seen and viewed in the TV documentary.

 

Special thanks go out to Professor Rakic. Professor Rakic was pivotal in making Slavica Bio Chem a reality a project that began in 2005 and has expanded to encompass cancer research and anti aging projects.

 

In other company news, the company through its IR Company retained a former economic crimes prosecutor to investigate trading of its security, and its belief that its security is subject to naked shorting. Mr. Essman is an International business attorney and former Assistant State Attorney of Hillsborough County (Tampa), Florida, where he served with the Special Prosecutions Unit for Economic and White Collar Crimes. His has offices in Tarpon Springs and St. Petersburg, Florida.

 

The issuer's shareholders and followers can expect updates on these matters shortly as the Company is adamant to get to the bottom of that topic and has instructed its barrister to vigorously pursue the matter.

 

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Disclosure: OTCPicks.com has been compensated six thousand dollars by a third party (Mercom Capital) for ALRT advertising and promotional services.