For Thursday, September 17th
WLSI, TLCV, LLBO, KERX, DARA, IMYN
Our Stocks to Watch tomorrow include Wellstar International Inc. (OTCBB: WLSI), TLC Vision Corp. (Nasdaq: TLCV), Lifeline Biotechnologies Inc. (OTC: LLBO), Keryx Biopharmaceuticals Inc. (Nasdaq: KERX), DARA BioSciences Inc. (Nasdaq: DARA) and Immunosyn Corp. (OTCBB: IMYN).

WELLSTAR INTERNATIONAL INCORPORATED (OTCBB: WLSI)
"Up 100.00% on Wednesday"
Detailed
Quote: http://www.otcpicks.com/quotes/WLSI.php
Wellstar International, Inc., through its wholly owned operating subsidiary Trillenium Medical Imaging, Inc. (TMI), is poised to become a leading diagnostic company in the health care industry. TMI has developed and is marketing fully calibrated and functional, thermal imaging systems that utilize state-of-the-art infrared technologies and proprietary software to accurately and cost-effectively measure physiological changes in the human body. More information on the Company and its unique diagnostic software and product line is available on Wellstar's corporate Website.
WLSI News:
March 9 -
Wellstar International, Inc. Secures $250,000 of New Financing
Wellstar International, Inc. (OTCBB: WLSI), a provider of specialized diagnostic software and equipment, announced today that it has secured $250,000 in financing through a private transaction with an accredited private investor. The financing will provide the Company adequate initial funding to start the roll-out of its thermal imaging systems that detect early signs of pressure ulcers among patients that are bed-ridden. However, the Company will need additional capital to implement its first installations, in which the Company is in final stages of agreement with private equity firm, Fairhills Capital, who earlier this week signed a LOI for up to $1 Million in equity funding.
Wellstar's CEO John Antonio stated, "We are pleased with the confidence that our newest investor has placed in our ability to reach our next milestone. Through our innovative thermal imaging systems, Wellstar will become the leader in early detections of pressure ulcers throughout the healthcare industry. Our goal is simple; we want to provide the healthcare industry with a critical tool that will help them save lives and curtail potential liability by simply detecting the pressure ulcers before its outbreak."
The company has developed its thermal imaging system for various applications. The TMI technology and software has been approved by the FDA as an Adjunctive Diagnostic Screening Procedure for early breast cancer detection, differential diagnoses of pain dysfunctions (such as Reflex Sympathetic Dystrophy, Neuromuscular Skeletal Syndromes and neurological disorders), for the early detection of pressure ulcers, deep tissue injuries, and bedsores, as well as for orthopedic applications. The company has plans to market diagnostic systems for all of the above mentioned applications.
TLC VISION CORPORATION (NASDAQ: TLCV)
"Up 58.10%
on Wednesday"
Detailed
Quote: http://www.otcpicks.com/quotes/TLCV.php
TLCVision is North America's premier eye care services company, providing eye doctors with the tools and technologies needed to deliver high-quality patient care. Through its centers' management, technology access service models, extensive optometric relationships, direct to consumer advertising and managed care contracting strength, TLCVision maintains leading positions in Refractive, Cataract and Eye Care markets.
TLCV
News:
September 10 - TLCVision Secures Extension of Credit Facility Limited Waiver to September 30, 2009
TLC Vision Corporation (Nasdaq: TLCV) (TSX: TLC), North America's premier eye care services company, announced that it has secured from its lenders holding a majority amount of its secured credit facility, an extension to September 30, 2009 of the previously announced limited waiver and forbearance with respect to its credit facility that was set to expire on September 9, 2009.
The credit agreement, dated June 21, 2007, as amended, provides for a US$85 million term loan and a US$25 million revolving credit line. As of August 31, 2009, the principal amount outstanding under the credit facility was US$100.1 million.
The extension and forbearance agreement is contained in an amendment to the limited waiver no. 4 and amendment no. 5 to the credit agreement, dated as of September 8, 2009, which, among other things, provides a limited waiver through September 30, 2009 of specified defaults and provides that the lenders will, until October 1, 2009, forbear from exercising their rights arising out of the non-payment of certain principal, interest and other payments previously due. The agreement also provides for the Company to negotiate in good faith and use its best efforts to agree by September 28, 2009 to (i) a term sheet reflecting terms of proposed additional financing acceptable to lenders representing a majority of the outstanding debt under the credit agreement, and (ii) a term sheet reflecting terms of a debt and/or equity restructuring acceptable to those lenders required to approve such debt and/or equity restructuring under applicable law. A copy of the amendment to the limited waiver no. 4 and amendment no. 5 to the credit agreement will be included as an exhibit to a Form 8-K to be filed promptly by the Company.
LIFELINE BIOTECHNOLOGIES INCORPORATED (OTC: LLBO)
"Up 92.31% on Wednesday"
Detailed
Quote: http://www.otcpicks.com/quotes/LLBO.php
Lifeline Biotechnologies, Inc. operates as a medical technology company in the United States. Its technologies focus on prevention, early detection, diagnosis, and quick recovery of various disease conditions. The company is developing a non-imaging technology, known as the First Warning System, which measures tissue activity for the early detection of breast cancer in women.
LLBO News:
August 31 -
Lifeline Biotechnologies Files Additional Patents on Its First Warning System
Lifeline Biotechnologies, Inc. (OTC: LLBO) announced that it has filed four additional patents on its First Warning System™ methods and technology.
The First Warning System™ has been designed, developed and tested, a process that assists in identifying abnormalities of the breast.
Jim Holmes, Lifeline’s CEO, said that “We are extending patent protection on our proprietary neural net diagnostic technologies with the filing of three additional patent applications in the United States. These filings relate to four essential elements in its system for analyzing temperature readings of breast tissue to identify cancerous tissue. The patents address the First Warning System’s ™ method for the placement of temperature sensors to obtain reliable temperature readings, its method for analyzing the temperature readings, and its placeholder for assuring proper sensor placement. In addition, a fourth application was filed under the Patent Cooperation Treaty (PCT) to extend Lifeline Biotechnologies’ protection, internationally, on all of the existing patent filings and existing intellectual property including these new filings.”
Lifeline Biotechnologies previously received two patents on its First Warning System™ hardware and has in the past year filed for a patent on the technological advancements of the First Warning System ™ software. The software has achieved the robust capability of identifying and classifying tissue abnormalities of the breast with sensitivities (ability to identify) of 95% to 100% and specificities (verify) of 87% to 90%. Currently, it is widely recognized that mammograms miss an estimated 20 to 30% of the breast cancers.
Lifeline competes in the money markets for funds to continue the development of its products as well as supporting operating and administrative expenses. The cost of funds for companies such as Lifeline is expensive and the terms have been, and may continue to be, dilutive. The Company is seeking other means of financing in an effort to reduce the dilutive aspects.
KERYX BIOPHARMACEUTICALS INCORPORATED (NASDAQ: KERX)
"Up 42.95% on Wednesday"
Detailed
Quote: http://www.otcpicks.com/quotes/KERX.php
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease. The Company is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types. The Company also has an in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.
KERX News:
September 16 -
Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma
Phase 3 registration trial under SPA expected to start by year-end
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced that KRX-0401 (perifosine) has received Orphan-Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. In August, the Company announced that it had reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial in relapsed/refractory multiple myeloma and that the study is expected to start by year-end.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "The Orphan-Drug designation for perifosine in multiple myeloma is a very important milestone for Keryx, as the market exclusivity protection provided by this designation significantly enhances the commercial opportunity of perifosine in this indication." Mr. Bentsur continued, "Following our exciting announcement last month that we had reached an agreement with the FDA on an SPA for a Phase 3 trial for perifosine in relapsed/refractory multiple myeloma, it is encouraging to further add to the value of the perifosine program with this Orphan-Drug designation. We look forward to commencing the Phase 3 study by year-end."
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. in the United States, Canada and Mexico.
ABOUT ORPHAN-DRUG DESIGNATION
Orphan-drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
ABOUT SPECIAL PROTOCOL ASSESSMENTS
The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.
Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety.
ABOUT MULTIPLE MYELOMA
Multiple myeloma, a cancer of the plasma cells, is an incurable but treatable disease. Multiple myeloma is the second most-common hematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths. According to the American Cancer Society, in 2009 there will be an estimated 20,580 new cases of multiple myeloma and an estimated 10,500 deaths from multiple myeloma in the United States. To date, several FDA approved therapies exist for the treatment of multiple myeloma. Despite this progress, patients continue to relapse, become refractory to prior treatments and eventually die from their disease. Thus, new therapies are needed to treat these patients and extend their survival.
DARA BIOSCIENCES INCORPORATED (NASDAQ: DARA)
"Up 37.00% on Wednesday"
Detailed
Quote: http://www.otcpicks.com/quotes/DARA.php
DARA BioSciences™ Inc. ("DARA") is a Raleigh, North Carolina based development-stage pharmaceutical company that acquires promising therapeutic small molecules and develops them through proof of concept in humans for subsequent sale or out-licensing to larger pharmaceutical companies. Presently DARA has two drug candidates with cleared IND's (Investigational New Drug) Applications from the US FDA. One of these drug candidates KRN5500 has successfully completed a Phase 2a clinical trial treating cancer patients for neuropathic pain. It has a portfolio of drug candidates for neuropathic pain, type 2 diabetes, and psoriasis.
DARA News:
September 15 -
DARA BioSciences Will Present Phase 2a Study Results for KRN5500 At the '12th International Conference on the Mechanisms and Treatment of Neuropathic Pain' Meeting
KRN5500 Results Were Statistically Significant for the Primary Endpoint of Pain Reduction
DARA BioSciences, Inc. (Nasdaq: DARA) announced that results of its KRN5500 study have been selected for presentation at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain to be held in San Francisco, November 19-21, 2009. Sharon M. Weinstein, MD, a leading investigator in the study, will present a poster entitled, "KRN5500 Demonstrates Significant Reduction in Neuropathic Pain Intensity in Patients with Cancer."
The presentation will provide an overview of the results from the recently completed multicenter, placebo-controlled, blinded, randomized, parallel group study designed to evaluate the safety and efficacy of KRN5500 in patients with neuropathic pain and advanced cancer. In this study KRN5500 demonstrated proof of concept by meeting the primary efficacy endpoint of pain reduction.
Dr. Weinstein is a physician at the University of Utah and Huntsman Cancer Institute in Salt Lake City, UT, and is a Fellow in the American Academy of Hospice and Palliative Medicine (FAAHPM).
Linda Jett, MSN, leader of the Program at DARA, said, "It is an honor to have our study results selected for presentation to leaders in the field of pain management. While poly-therapeutic treatment approaches to cancer have improved survival and cure rates, patients with cancer may, in the process, suffer severe pain and a profound reduction in quality of life as a secondary effect of the cancer and/or its treatment. We are hopeful that the positive results from this proof-of-concept study are indicative of the viability of KRN5500 as a treatment option for this potentially debilitating condition."
Earlier this year, DARA announced statistically significant results for the primary endpoint of this study, comparing the effect of KRN5500 and placebo on pain levels in patients with neuropathic pain and cancer. Based on these promising results the Company is planning to conduct a Phase 2b trial.
IMMUNOSYN CORPORATION (OTCBB: IMYN)
"Up 38.87% on Wednesday"
Detailed
Quote: http://www.otcpicks.com/quotes/IMYN.php
Immunosyn Corporation, a development stage company, engages in the marketing, distribution, and sale of a biopharmaceutical drug product, SF-1019. The company owns license rights from Argyll Biotechnologies, LLC to offer SF-1019, an experimental extract from caprine serum containing various lipopeptide molecules. SF-1019 is used for the treatment of various diseases and pathological conditions, including Chronic Inflammatory Demyelinating Polyneuropathy, Diabetic Neuropathy, and diabetic ulcers. The company was founded in 2006 and is headquartered in La Jolla, California. Immunosyn Corporation is a subsidiary of Argyll Biotechnologies, LLC.
IMYN News:
September 12 -
Immunosyn Files Quarterly Report
Immunosyn Corporation (OTCBB: IMYN) recently filed its quarterly report for the three months ending June 30, 2009. It can be viewed at http://bit.ly/3VtjP.
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