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Cardium Announces Launch of Its MedPodium Healthy Lifestyle Product Initiative and New Web Boutique / MedPodium: Lifestyle Medicinals for a New Generation
http://www.finanznachrichten.de/nachrichten-2010-11/18450756-cardium-announces-launch-of-its-medpodium-healthy-lifestyle-product-initiative-and-new-web-boutique-medpodium-lifestyle-medicinals-for-a-new-genera-008.htm
SAN DIEGO, Nov. 4, 2010 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced the launch of its MedPodium healthy lifestyle product platform and new Web boutique at http://www.medpodium.com/. MedPodium(TM) is being developed as a portfolio of premium, science-based, easy to use medicinals, neurologics, metabolics, nutraceuticals and aesthetics designed to promote and manage personal health.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO) (Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
The MedPodium product portfolio, which currently consists of seven podiatry-focused advanced skin care products to promote foot health and comfort, was initially developed as a line extension to Cardium's Excellagen formulated collagen topical gel wound care dressing, which is currently the subject of a pending FDA 510(k) clearance application for marketing and sales in the United States. Under Cardium's current sales and marketing program, qualified physicians, healthcare providers, podiatrists and online affiliate partners will have the opportunity to participate in MedPodium's Affiliate Program that provides participants to certain economic incentives upon the purchase of products by their patients and customers through the MedPodium Web boutique.
Cardium plans to broaden and expand its in-house MedPodium brand initiative to include a wide array of products designed to address the lifestyle issues confronting the large and growing newly-emerging adult market. The Company recently announced plans to launch Linee(TM), a plant-derived, non-prescription dietary supplement for healthy weight management which is expected to be commercially available in mid-November. The addition of Linee to the MedPodium product line represents an important step toward broadening the Company's product initiative to include healthy lifestyle medicinals.
"We are pleased to announce the formal launch of our MedPodium healthy lifestyle product initiative and new Web boutique. We plan to expand and broaden the MedPodium product platform over the next 12 months to encompass other products such as aesthetics, metabolics, neurologics and nutraceuticals that will be designed to address emerging lifestyle issues for highly-targeted market segments, including the over 50 million Millennials who currently span the ages of 18 to 29. Over 90% of Millennials and 87% of Gen Xers are users of the Internet. Our MedPodium products will initially be available at our Web boutique and through affiliate partners. In the future, we plan to expand distribution by selling certain MedPodium products through various select distributors and/or retailers in the United States," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.
About MedPodium
MedPodium is a portfolio of premium science-based, easy to use medicinals, neurologics, metabolics, nutraceuticals and aesthetics being developed to promote and manage personal health. The MedPodium product line initially includes seven podiatry-focused advanced skin care products to promote foot health and comfort and Linee(TM), a dietary supplement designed for healthy weight management. Cardium plans to further broaden and expand its in-house MedPodium brand initiative to encompass a wide array of healthy lifestyle medicinals that address lifestyle issues of the large and growing newly-emerging adult market. Additional information about MedPodium is available at http://www.medpodium.com/.
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's current investment portfolio includes the Tissue Repair Company, Cardium Biologics, and the Company's in-house MedPodium lifestyle medicinals brand platform. The Company's lead product candidates include: (1) Excellagen(TM) topical gel, for wound care management, which Cardium plans to market launch in the fourth quarter subject to pending FDA 510(k) clearance; and (2) Generx®, a DNA-based angiogenic cardiovascular biologic for patients in international markets with coronary artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com/.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that the MedPodium product platform will be commercially successful or will effectively enhance our businesses or their market value, that the MedPodium product line can be successfully broadened to include additional healthy lifestyle opportunities, that we can effectively promote commercialization of our products on our own or through third parties, that our products will prove to be sufficiently safe and effective after introduction into a broader patient population, that results or trends observed in clinical studies or other observations will be reproduced in subsequent studies or in broader use, that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive, that FDA or other health regulatory agencies will not introduce additional or more restrictive regulations covering naturally-derived products such as those in our MedPodium product line, that our in-house or external product commercialization efforts will be successful or will effectively enhance our businesses or their market value, or that any of the third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of biologics and in the conduct of human clinical trials and other product development efforts, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition and regulation, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/.
Cardium Therapeutics(TM) Generx® and MedPodium(TM) are trademarks of Cardium Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM), Osteorate(TM), Appexium(TM) and Linee(TM) are trademarks of Tissue Repair Company. (Other trademarks belong to their respective owners)
Photo: hhttp://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
AP Archive: http://photoarchive.ap.org/
PRN Photo Desk, photodesk@prnewswire.com
Cardium Therapeutics; MedPodium
CONTACT: Investors, Bonnie Ortega, Director, Investor/Public Relations,
+1-858-436-1018, InvestorRelations@cardiumthx.com; Media and Sales, Hanna
Wagari, Director of Marketing, +1-858-436-1042, hwagari@cardiumthx.com, both
of Cardium Therapeutics
Web Site: http://www.cardiumthx.com/
http://www.medpodium.com/
© 2010 PR Newswire
Cardium Awarded Grant Under Qualifying Therapeutic Discovery Project Program
http://www.finanznachrichten.de/nachrichten-2010-11/18435895-cardium-awarded-grant-under-qualifying-therapeutic-discovery-project-program-008.htm
SAN DIEGO, Nov. 3, 2010 /PRNewswire/ -- Cardium Therapeutics (NYSE AMEX: CXM) today announced that it was awarded a cash grant of approximately $245,000 under the U.S. Government's Qualifying Therapeutic Discovery Project ("QTDP") program to further its Generx clinical development program. The QTDP program was created by Congress as part of the Patient Protection and Affordable Care Act and provides a tax credit or grant equal to 50% of eligible 2009 research and development expenditures. The Department of Treasury further allocated these credits and grants among qualified applicants since the program was oversubscribed. The funds are immediately available and the Company will recognize the full award that was authorized on October 29, 2010 as revenue during the fourth quarter 2010.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO) (Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO) About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's current investment portfolio includes the Tissue Repair Company, Cardium Biologics, and the Company's in-house MedPodium lifestyle medicinals brand platform. The Company's lead product candidates include: (1) Excellagen(TM) topical gel, for wound care management, which Cardium plans to market launch in the fourth quarter subject to pending FDA 510(k) clearance; and (2) Generx®, a DNA-based angiogenic cardiovascular biologic for patients in international markets with coronary artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com/.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that the U.S. Food and Drug Administration (the "FDA") will grant marketing clearance of the Excellagen product candidates or that we or a partner can successfully introduce these or additional products into advanced wound care markets; that Cardium can maintain its exchange listing compliance with NYSE Amex; that Excellagen, Excellarate or our other candidates will prove to be sufficiently safe and effective, or that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that the Excellagen or Excellarate product candidates offer the potential for simpler or more cost-effective treatment for physicians and patients than other FDA-approved products that currently are or will be on the market; that improvements in the formulation or use of Generx will be commercially practicable, or that Generx could be successfully advanced as a therapeutic in developing markets or that the results of studies in such markets could be used to advance or broaden the commercialization of Generx in the U.S. or other markets; that our product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that our clinical study programs can be conducted and completed in an efficient and successful manner; that we can develop a DNA-based orthobiologics product portfolio; that the FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; or that third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/.
Cardium Therapeutics(TM) Generx® and MedPodium(TM) are trademarks of Cardium Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM),
Osteorate(TM), Appexium(TM) and Linée(TM) are trademarks of Tissue Repair Company.
(Other trademarks belong to their respective owners)
Photo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
AP Archive: http://photoarchive.ap.org/
PRN Photo Desk, photodesk@prnewswire.com
Cardium Therapeutics
CONTACT: Bonnie Ortega, Director, Investor/Public Relations of Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
Web Site: http://www.cardiumthx.com/
© 2010 PR Newswire
Northeast Securities Issues Investment Opinion on Apricus Biosciences, Inc. (APRI)
Date : 10/27/2010 @ 10:30AM
Source : Business Wire
Stock : Northeast Securities (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=44956844
Northeast Securities published an initiation of coverage research report on Apricus Biosciences, Inc. (APRI) with an Attractive rating and a 12-month price target of $4.50 on September 2, 2010. A subsequent research note was published updating clinical and financial developments and reiterating the Attractive rating with a new $4.00 12-month price target on October 22, 2010.
*Industry: Pharmaceuticals & Biotechnology
*Current Rating: Attractive
*Current Rating Assigned: 10-22-2010
*Closing Price: $1.72
*Current Target Price (12months): $4.00
*Analyst: Harry Russell
Additional information on these reports including all regulatory disclosures may be obtained by contacting Northeast Securities.
About Northeast Securities
Northeast Securities is a privately held New York based firm which provides a full complement of Investment Banking services as well as Institutional Sales, Trading and Research. A Northeast Securities research report or note is not intended as an offering or solicitation of an offer to buy or sell the securities mentioned or discussed. Northeast Securities is a member of FINRA and the SIPC.
Apricus Bio Announces Formation of Clinical Advisory Board
Date : 10/25/2010 @ 12:40PM
Source : Business Wire
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=44923847
Apricus Biosciences, Inc., (“Apricus Bio”) (Nasdaq: APRI) today announced the formation of a Clinical Advisory Board focused on the development of its investigational oncology compound, PrevOnco™. The Clinical Advisory Board is chaired by Stephen B. Howell, who also serves as Chairman of the Company’s Scientific Advisory Board (“SAB”). Additional members of the Clinical Advisory Board include, Drs. Ghassan K. Abou-Alfa, Melanie Thomas, Robert G. Gish and Yehuda Patt.
Apricus Bio is developing PrevOnco, a marketed anti-ulcer compound, lansoprazole, to treat patients with advanced, unresectable hepatocellular carcinoma (“HCC”), or liver cancer. The Company is finalizing the Special Protocol Assessment (“SPA”) Phase 3 registration protocol for a comparator study against doxorubicin in patients who have failed treatment with Nexavar® (the currently marketed first-line anti-cancer treatment for patients with either HCC, or advanced renal cell carcinoma). Subject to positive data, the Phase 3 study would be expected to support the filing of a New Drug Application for marketing approval in the U.S. and Europe. Management expects to submit the SPA Phase 3 protocol to the U.S. Food & Drug Administration (“FDA”) before year-end 2010.
In the U.S., Nexavar is marketed by Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc., and is approved in more than 90 countries for the treatment of patients with liver cancer.
Commenting on today’s news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We are pleased to be able to, once more, tap the extraordinary expertise of Dr. Howell. Additionally, we are delighted to welcome Drs. Abou-Alfa, Thomas, Gish and Patt. Together, they will be instrumental in helping us move this important clinical program forward.”
Dr. Howell, Chairman of the Company’s SAB, commented, “We have assembled an impressive group of key opinion leaders. Having been involved in the clinical development of Nexavar, their experience in developing new HCC therapies will be invaluable to us as we finalize the SPA for submission to the FDA.”
Dr. Howell is a medical oncologist and Professor of Medicine at the University of California, San Diego. He also serves as Associate Director for Clinical Research and Director of the Cancer Therapeutics Training Program at the Moores Comprehensive Cancer Center at the University of California, San Diego, and runs the Clayton Foundation Drug Resistance Laboratory at the Cancer Center. During his career, Dr. Howell has co-founded three pharmaceutical companies, including DepoTech (1989), Beacon Laboratories (1995), and Targa Pharmaceuticals (2003), serving as Medical Director of each. He holds a number of patents for his innovative work in chemotherapeutics, drug-delivery systems, and diagnostic assays and is the recipient of numerous awards. He is currently one of the main organizers of the American Association of Cancer Research.
Dr. Ghassan K. Abou-Alfa is a board-certified medical oncologist at Memorial Sloan-Kettering Cancer Center, specializing in primary liver cancer (hepatocellular carcinoma), pancreas, gallbladder, and bile duct tumors. He is involved in research focusing on improving the effectiveness of cancer therapy by incorporating small, novel biological molecules that target cancer into the treatment of chemotherapy-resistant gastrointestinal malignancies, particularly hepatobiliary and pancreatic cancers. Dr. Abou-Alfa received his M.D. from American University of Beirut, and completed residencies and fellowships at Yale University School of Medicine.
Dr. Melanie Thomas, M.S., is an Associate Professor and Associate Director of Clinical Investigations and the Grace E. DeWolf Chair of Medical Oncology at MUSC Hollings Cancer Center in Charleston, South Carolina. She earned her M.D. from Boston University School of Medicine and her M.S. from Harvard University. Dr. Thomas’ professional interests include, hepatocellular, pancreatic, gallbladder, biliary and colorectal cancer.
Dr. Robert G. Gish serves as Chief of Clinical Hepatology, Professor of Clinical Medicine and co-director of the Center for Hepatobiliary Disease and Abdominal Transplantation (CHAT) at the University of California, San Diego School of Medicine. He is a NIH-funded researcher whose work focuses on the epidemiology of liver disease, biomarkers for liver disease and multi-targeted therapies for liver cancer. Dr. Gish received his medical degree from the University of Kansas in Kansas City. He completed his internship and residency in internal medicine at the University of California, San Diego School of Medicine and a fellowship in Gastroenterology and Hepatology at the University of California, Los Angeles. He is board certified in Internal Medicine and Gastroenterology and has the advance Certificate of Added Qualification (CAQ) in Liver Transplantation and is a UNOS certified Liver Transplant Physician.
Dr. Yehuda Patt is a Professor of Internal Medicine and the Director of Gastrointestinal Oncology Research at the University of New Mexico Cancer Center in Albuquerque, NM. He attended the Hebrew University and Hadassah Medical School, and completed his residency at Sheba Medical Center in Tel Aviv, Israel, and fellowship at the Anderson Hospital and Tumor Institute in Houston, Texas.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to successfully develop PrevOnco or obtain FDA approval for the proposed Phase 3 SPA, enter into partnership agreements and successfully execute business plans. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
Midway Announces US$4 Million Offering of Units
Date : 11/02/2010 @ 6:00PM
Source : Business Wire
Stock : (MDW)
http://ih.advfn.com/p.php?pid=nmona&article=45046579
Midway Gold Corp. (“Midway” or the “Company”) (MDW:TSX-V; MDW:NYSE-AMEX) announced today that it has filed a preliminary prospectus supplement to its short form base shelf prospectus filed with the securities commissions in each of the provinces of British Columbia, Alberta and Ontario, and a corresponding shelf prospectus as part of an effective registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "SEC"), pursuant to which it intends to offer up to 6,660,000 units at US$0.60 per unit, each unit comprising one common share and one half of one non-transferable common share purchase warrant. Each whole warrant will entitle the holder to purchase one common share of Midway at a price of US$0.90 per share for a period of 24 months from the closing date. Midway can accelerate the expiry of the Warrants to a date 30 days after giving notice to the Warrantholders if the common shares of Midway trade at a volume weighted average price of greater than $1.15 per share for a period of 20 consecutive trading days on the NYSE-Amex.
Midway intends to use the net proceeds of the offering to advance its projects, to fund its general and administrative costs (including property maintenance fees) and for general working capital purposes.
Haywood Securities Inc. has been engaged as the agent (the “Agent”) for the offering and will receive a cash commission of 6% of the total gross proceeds.
A copy of the preliminary prospectus supplement and the accompanying base shelf prospectus relating to the offering filed with the securities commissions in each of the provinces of British Columbia, Alberta and Ontario may be obtained by accessing the website maintained by the Canadian securities regulatory authorities at www.sedar.com, and has been filed with the SEC as a free writing prospectus. Midway also has filed a prospectus supplement to its registration statement on Form S-3 (including a base shelf prospectus), and you may get these documents for free by visiting EDGAR on the SEC Web site at www.sec.gov. Before you invest, you should read the prospectus and other documents the issuer has filed with the Canadian securities commissions and the SEC for more complete information about the issuer and this offering. Midway, any agent or any dealer participating in the offering will arrange to send you the prospectus and supplement if you request it from the Agent at:
Haywood Securities Inc.
Suite 2000-400 Burrard Street
Vancouver, BC, Canada
V6C 3A6
Attention: Michelle Jankovich
Telephone: 604-697-7126
E-mail: mjankovich@haywood.com
ON BEHALF OF THE BOARD
"Daniel Wolfus"
Daniel Wolfus, Chairman and CEO
About Midway Gold Corp.
Midway Gold Corp. is a precious metals company with a vision to design, build, and operate mines in a manner accountable to all stakeholders while producing an acceptable return to its shareholders. Midway controls over 65 square miles of mineral rights in the western United States; four advanced projects include: Spring Valley, Pan, Golden Eagle, and Midway. Two early stage exploration targets are Gold Rock and Burnt Canyon. For more information about Midway, please visit our website at www.midwaygold.com or contact R.J. Smith, Manager of Corporate Administration, at (877) 475-3642 (toll-free).
This press release contains “forward-looking statements” and "forward-looking information" within the meaning of Canadian and United States securities laws, which may include, but is not limited to, the intended terms of the offering and use of proceeds. Such forward-looking statements and forward-looking information reflect our current views with respect to future use of proceeds and are subject to certain risks, uncertainties and assumptions. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated or expected. We do not undertake to update forward-looking statements or forward-looking information, except as may be required by law.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
NewCardio to Conduct Corporate Update Conference Call on November 15, 2010
Date : 10/29/2010 @ 8:00AM
Source : PR Newswire
Stock : Newcardio (BB) (NWCI)
http://ih.advfn.com/p.php?pid=nmona&article=44991460
NewCardio, Inc. (OTC Bulletin Board: NWCI), a cardiovascular diagnostic solutions developer, announced today that the Company expects to file its Form 10-Q for the third quarter ended September 30, 2010 on November 15, 2010 and management will conduct a conference call to provide a corporate update and discuss progress as follows:
What: NewCardio Corporate Update Conference Call
When: 1:30 p.m. PT/ 4:30 p.m. ET, Monday, November 15, 2010
Where: Please dial 1-888-846-5003 (domestic) or 1-480-629-9856 (International) five to 10 minutes before the call. Investors will also have the opportunity to listen to the conference call and the replay on the News and Events section of the NewCardio website at: http://www.newcardio.com.
Questions: Select questions for the conference call will also be taken via email at nwci@haydenir.com and can be sent any time prior to the conference call's starting time.
Replay: A replay of the call will be available by dialing 1-877-870-5176 (domestic) or 1-858-384-5517 (international) and referencing passcode 4381453.
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12L ECG. NewCardio's 3-D ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit www.newcardio.com.
To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0
Investor Contact:
Hayden IR
Jeff Stanlis, Partner
(602) 476-1821
jeff@haydenir.com
SOURCE NewCardio, Inc.
Discovery Labs Announces Pipeline and Business Update Conference Call
Date : 11/02/2010 @ 5:00PM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=45045634
Discovery Laboratories, Inc. (Nasdaq:DSCO) announced today that it will be hosting a conference call on Tuesday, November 9, 2010, at 10:00 AM EST. Management will provide a pipeline and business update addressing:
* Status of program to gain FDA approval for Surfaxin® for the prevention of respiratory distress syndrome (RDS) in premature infants
* Status of key pipeline programs including: additional data analysis from the recently completed comprehensive analysis of the Phase 2 clinical trial of Surfaxin in children with Acute Respiratory Failure (ARF); review of recently completed Phase 2a clinical study of aerosolized KL4 surfactant in patients with cystic fibrosis (CF); update of next generation RDS programs – Surfaxin LS™ and Aerosurf®
* Strategic initiatives and financial overview
Participants are encouraged to access this audio webcast through a live broadcast on the Company's website at www.discoverylabs.com. The webcast is also accessible on the Internet: http://us.meeting-stream.com/discoverylabs_110910. It is recommended that participants log onto one of these sites at least 15 minutes prior to the call. The Internet broadcast will be available for up to 90 days after the call at both website addresses.
The call in number is 866-332-5218. The international call in number is 706-679-3237. A replay of the conference call will be available two hours after the call's completion and remain available through November 16, 2010. The replay number to hear the conference call is 800-642-1687 or 706-645-9291. The passcode is 22279770.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing KL4 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 believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at www.Discoverylabs.com.
CONTACT: Linnden Communications
Media relations:
Michelle Linn
508-362-3087
Discovery Laboratories, Inc.
Investor relations:
John G. Cooper, President and Chief Financial Officer
215-488-9490
Sunesis Awarded $244,000 Grant Under the U.S. Qualified Therapeutic Discovery Project Program
Date : 11/02/2010 @ 7:30AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=45029356
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) announced today that it has been awarded $244,000 under the IRS Qualifying Therapeutic Discovery Project (QTDP) program, which was created by Congress as part of the Patient Protection and Affordable Care Act of 2010. Sunesis will use the grant to advance the development of its lead program, vosaroxin, as a treatment for acute myeloid leukemia (AML). Eligibility for the grant requires that a project: have the potential to develop new treatments that address "unmet medical needs" or chronic and acute diseases; reduce long-term health care costs; or represent a significant advance in finding a cure for cancer.
"This award recognizes vosaroxin's potential as an advancement for the treatment of refractory and relapsed AML, a disease for which there is an enduring unmet medical need," said Daniel Swisher, Chief Executive Officer of Sunesis. "Being acknowledged for the potential to improve cancer treatment is gratifying as we move forward with plans to launch our pivotal Phase 3 trial of vosaroxin in AML, the VALOR trial, in the fourth quarter of this year."
Sunesis expects to receive the amount allocated to them as a cash grant in the near future.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of hematologic and solid tumor cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.
This press release contains forward-looking statements, including statements regarding Sunesis' expectations regarding the anticipated use of the proceeds of the award. Words such as "expects," "potential," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties related to Sunesis and its business, which will impact Sunesis' ability to use the proceeds of the award for the currently intended uses. Risk factors related to Sunesis and its business are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
November 1, 2010 1:12:50 PM EDT
S&P MAINTAINS HOLD RECOMMENDATION ON SHARES OF YRC WORLDWIDE
(Standard & Poor's)
http://research.tdameritrade.com/public/markets/news/story.asp?docKey=7397-umsactI4201011011224-1&clauses
Workers at YRCW voted to accept the latest restructuring plan, proposed in late September. In our view, this marks another step forward in YRCW's efforts to address its cost structure and reduce liquidity constraints. We expect the shares to remain volatile as YRCW works to balance the demands of lenders, labor and shareholders through this process. We note that new capital still must be raised through an equity offering as a condition of the agreement. We are maintaining our price-to-sales based target price at $6.50, on what we view as a high risk investment.
Discovery Labs' KL4 Surfactant Granted Orphan Drug Designation for the Treatment of Cystic Fibrosis
Date : 11/01/2010 @ 7:00AM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=45011007
Discovery Laboratories, Inc. (Nasdaq:DSCO), today announced that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to Discovery's KL4 surfactant for the treatment of cystic fibrosis (CF). Orphan designation provides for up to seven years of U.S. market drug product exclusivity for the designated indication following marketing authorization.
Dr. Thomas F. Miller, Discovery Labs' Chief Operating Officer commented, "To date, Discovery Labs has successfully procured orphan designations for several respiratory disease targets in both the U.S. and Europe. We are pleased that the FDA's Office of Orphan Products Development has granted orphan designation for KL4 surfactant for CF treatment."
CF is caused by a genetic mutation that leads to the production of thick, viscous mucus that is difficult to clear from the airways of the lung. The abnormal mucus allows for chronic airway infections that lead to airway destruction, decreased lung function, and ultimately, death. Dr. Miller continued, "Previous preclinical and exploratory clinical studies suggest that surfactant may improve mucociliary clearance, thereby potentially preventing further compromise of lung function. Our preclinical and recent clinical experience suggests that CF may be a viable therapeutic target for our aerosolized KL4 surfactant technology."
Discovery recently announced the completion of a double-blind, randomized crossover Phase 2a study that evaluated the safety, tolerability and effectiveness of aerosolized KL4 surfactant in a CF population. The trial was presented at the 2010 North American Cystic Fibrosis Conference, and the principle investigator concluded that aerosolized KL4 surfactant delivery was feasible to CF patients, was generally safe and well tolerated, was not associated with serious adverse events (SAEs) and demonstrated evidence of pharmacologic response via improvement in mucociliary clearance (MCC) versus patient baseline. Previously, Discovery reported that KL4 surfactant improved MCC in an established pre-clinical model designed to assess drug effect on mucociliary clearance.
The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Orphan drug designation in the United States is awarded to compounds that offer potential therapeutic value in the treatment of rare diseases, defined as those affecting fewer than 200,000 Americans. If the company complies with certain FDA specifications and receives marketing approval for the designated indication, orphan drug designation qualifies the sponsor for up to seven years of marketing exclusivity, tax credits related to clinical research, and exemption from the Prescription Drug User Fee Act filing fees. The Company is also in the process of applying for Orphan Designation for CF treatment in Europe.
About Cystic Fibrosis (CF)
CF is a fatal genetic disease that causes life-threatening lung infections and premature death. It affects approximately 30,000 patients in the United States and nearly 70,000 worldwide. It is one of the most common genetic disorders in the United States. To date, treatment of pulmonary conditions in CF primarily includes antibiotics to address lung infection and airway clearance therapies to break down and remove mucus. Despite advances in research and medical therapies, the predicted median age of survival for patients with CF in the United States is currently 37 years.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing KL4 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 and 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 believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at www.Discoverylabs.com.
Forward Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those related to Discovery Labs' pre-clinical and clinical research and development activities, are described in Discovery Labs' filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Except as otherwise required by law, Discovery Labs undertakes no obligation to update or revise any forward-looking statements.
CONTACT: Linnden Communications
Media relations:
Michelle Linn
508-362-3087
Investor relations:
John G. Cooper, President and Chief Financial Officer
215-488-9490
Teamsters Ratify Concessions Aimed At Keeping YRC Worldwide Viable
Date : 10/30/2010 @ 2:34PM
Source : Dow Jones News
Stock : YRC Worldwide Inc. (YRCW)
http://ih.advfn.com/p.php?pid=nmona&article=45002915
Members of the Teamsters union have approved a new round of deep employee concessions at YRC Worldwide Inc. (YRCW), in a vote both union and YRC leadership viewed as crucial to the struggling trucking company's survival.
"We firmly believe this plan is the only hope for saving our members' jobs as this recession continues to cause so much hardship," said Tyson Johnson, director of the Teamsters National Freight Division, in a prepared statement after the vote count was released Saturday.
The International Brotherhood of Teamsters said the agreement "is aimed at saving more than 25,000 union jobs." It noted that about 67% of YRC Worldwide union members cast ballots overall.
The concessions were ratified 62% to 38% by union members at the company's YRC and Holland division, and 69% to 31% at its New Penn unit.
A YRC representative wasn't immediately available for comment Saturday.
Among other things, the new concessions extend a previously agreed-upon 15% wage reduction for an additional two years, until March 31, 2015. The date upon which YRC must resume pension contributions also is delayed until June 1, 2011, with the new contribution to be 25% of the contribution rate in effect on July 1, 2009.
But the agreement also requires the company to reduce its debt and raise new equity, with a deadline of Dec. 31 for a definitive agreement with an equity player or YRC will have to convert some debt to equity. In addition, the plan provides union members with equity, with the precise amount to be determined during negotiations with the new equity investor and lenders.
The Teamsters also can void the concessions in the event of a YRC bankruptcy.
YRC, which teetered under a heavy debt load last year and teetered on the edge of bankruptcy in December, has won extensive concessions over the past two years, both from the union and from its lenders, and it has cut thousands of employees.
The company announced last week that it expects to show improved third-quarter results when it reports the figures Friday. It said it expects a third-quarter operating loss of $18 million to $22 million, compared with $118 million a year ago and $35 million in the second quarter, excluding a stock-compensation gain.
Meanwhile, YRC said its national and regional operations saw per-day tonnage rise 1.2% and 2.1%, respectively, from the second quarter. It said revenue per shipment increased 1.9% and 3.7%, respectively, from a year ago.
-By Bob Sechler, Dow Jones Newswires; 512-258-1690; bob.sechler@dowjones.com
Teamsters Ratify Concessions Aimed At Keeping YRC Worldwide Viable
Date : 10/30/2010 @ 2:34PM
Source : Dow Jones News
Stock : YRC Worldwide Inc. (YRCW)
http://ih.advfn.com/p.php?pid=nmona&article=45002915
Members of the Teamsters union have approved a new round of deep employee concessions at YRC Worldwide Inc. (YRCW), in a vote both union and YRC leadership viewed as crucial to the struggling trucking company's survival.
"We firmly believe this plan is the only hope for saving our members' jobs as this recession continues to cause so much hardship," said Tyson Johnson, director of the Teamsters National Freight Division, in a prepared statement after the vote count was released Saturday.
The International Brotherhood of Teamsters said the agreement "is aimed at saving more than 25,000 union jobs." It noted that about 67% of YRC Worldwide union members cast ballots overall.
The concessions were ratified 62% to 38% by union members at the company's YRC and Holland division, and 69% to 31% at its New Penn unit.
A YRC representative wasn't immediately available for comment Saturday.
Among other things, the new concessions extend a previously agreed-upon 15% wage reduction for an additional two years, until March 31, 2015. The date upon which YRC must resume pension contributions also is delayed until June 1, 2011, with the new contribution to be 25% of the contribution rate in effect on July 1, 2009.
But the agreement also requires the company to reduce its debt and raise new equity, with a deadline of Dec. 31 for a definitive agreement with an equity player or YRC will have to convert some debt to equity. In addition, the plan provides union members with equity, with the precise amount to be determined during negotiations with the new equity investor and lenders.
The Teamsters also can void the concessions in the event of a YRC bankruptcy.
YRC, which teetered under a heavy debt load last year and teetered on the edge of bankruptcy in December, has won extensive concessions over the past two years, both from the union and from its lenders, and it has cut thousands of employees.
The company announced last week that it expects to show improved third-quarter results when it reports the figures Friday. It said it expects a third-quarter operating loss of $18 million to $22 million, compared with $118 million a year ago and $35 million in the second quarter, excluding a stock-compensation gain.
Meanwhile, YRC said its national and regional operations saw per-day tonnage rise 1.2% and 2.1%, respectively, from the second quarter. It said revenue per shipment increased 1.9% and 3.7%, respectively, from a year ago.
-By Bob Sechler, Dow Jones Newswires; 512-258-1690; bob.sechler@dowjones.com
Cool down! please... (until November 29, 2010)
In addition, in connection with the transfer to the NASDAQ Capital Market, Nasdaq granted the Company an additional 180 calendar days, or until November 29, 2010, to regain compliance with the Minimum Bid Price Rule.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=50838151
Statement of Changes in Beneficial Ownership (4)
Date : 10/20/2010 @ 2:17PM
Source : Edgar (US Regulatory)
Stock : (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=44867847&symbol=N^DSCO
Apricus Bio Announces First Patent Grant for Femprox® In Japan
Date : 10/18/2010 @ 12:30PM
Source : Business Wire
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=44830803
Apricus Biosciences, Inc., (“Apricus Bio”) (Nasdaq: APRI) backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today announced that the Japanese Patent Office has issued a Decision to Grant a Patent for the Company’s application on Femprox entitled, “Compositions and Methods for Amelioration of Human Female Sexual Dysfunction.” This patent, when issued, will provide Japanese patent protection to December 2019, and is one in a series of patents and pending applications that Apricus Bio owns on Femprox and the underlying NexACT technology.
Commenting on today’s news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, “We are very pleased with our first patent allowance for Femprox in Japan. We continue to aggressively pursue intellectual property (“IP”) coverage for our technology and product candidates under development and this allowance adds to the strength of our overall IP position. In addition to the newly allowed claims in Japan, we have corresponding coverage and protection for Femprox in many other major international markets. The advancement of our patent portfolio comes at an optimal time, as we are in active discussions with potential partners to out-license Femprox.”
Femprox is an alprostadil-based cream intended for the treatment of female sexual arousal disorder. Apricus has completed nine clinical studies to date, including one, 98-patient Phase 2 study in the U.S. and a 400-patient proof-of-concept Phase 2/3 study in China, where the cost for conducting clinical studies was significantly lower than in the U.S.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including but not limited to, its ability to obtain and/or enforce patent coverage in major markets and the Company’s ability to successfully enter into partnership agreements for its product candidates and platform technology. Readers are cautioned not to place undue reliance on these forward-looking statements and are urged to read the Risk Factors set forth in the Company’s most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q, which contain these and other factors that could cause actual results to differ from the expected results expressed through forward-looking statements.
Zoom Technologies Expects Preliminary Third Quarter 2010 Results to Exceed Previous Guidance
Date : 10/18/2010 @ 7:00AM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=44824149&symbol=ZOOM
Zoom Technologies, Inc. (NASDAQ: ZOOM), a leading China-based manufacturer of mobile phones and other mobile electronic products, today announced preliminary results for the third quarter ended September 30, 2010 that are expected to exceed previous guidance.
Zoom expects to report net revenue in the range of $68 million to $71 million for the third quarter of 2010, which represents a sequential increase of approximately 59 percent to 66 percent from the net revenue of $42.9 million for the second quarter of 2010. This updated expected net revenue is higher than the previous guidance of $55 million to $61 million.
The Company anticipates reporting net income in the range of $3.3 million to $3.5 million for the third quarter of 2010, a sequential increase of approximately 63 percent to 72 percent from the net income of $2.03 million in the second quarter of 2010. This is higher than the previous guidance of $2.7 million to $3.3 million.
Mr. Lei Gu, Chairman and Chief Executive Officer of Zoom Technologies, commented, "Our third quarter preliminary results exceeded our expectations and reflects our momentum and success in the dynamic mobile phone industry in China. We are proud of our continued expansion in the rapidly growing China 3G market and our partnerships with top tier Chinese mobile phone carriers. Contributing to our overall strong revenue results was the continued success of our LEIMONE brand phones, which captured $14 million in revenue in the third quarter. We sold 232,000 units of our LEIMONE brand mobile phones in this quarter, of which 27% were 3G units. We continue to gain market share with our branded phones and remain confident that the strength in our overall EMS business will bring further revenue growth in the remainder of 2010."
All figures in this press release remain subject to the completion of normal quarter-end accounting review procedures by Zoom's independent certified public accountants, which could result in changes to these preliminary figures.
The Company will provide more detail when it releases its financial results for the third quarter of 2010. Details on the earnings release date and conference call will be announced in the coming weeks.
About Zoom Technologies, Inc.
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for the latest generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its own brand under the brand name of Leimone. The company's products are both exported and sold domestically. For more information about Zoom Technologies please visit Zoom's corporate website at http://www.zoomleimone.com.
Forward-Looking Statements
This information and other statements by the Company in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to, among other items: projections and estimates of earnings, revenues, or other financial items; statements regarding future economic, industry or market conditions or performance; and preliminary financial results prior to the completion of the quarterly review by our independent certified public accountants. Forward-looking statements are typically identified by words or phrases such as "believe," "expect," "anticipate," "preliminary" and similar expressions. You should not place undue reliance on these forward-looking statements because actual performance or results could differ materially from that anticipated by these forward-looking statements, and such forward looking statements speak only as of the date they are made, and the Company undertakes no obligation to update or revise any forward-looking statement. If the Company does update any forward-looking statement, no inference should be drawn that the Company will make additional updates with respect to that statement or any other forward-looking statements. Information concerning factors that could cause our actual results to differ materially from these forward-looking statements can be found in our periodic reports filed with the Securities and Exchange Commission which are available to the public at www.sec.gov.
Midway Completes Core Drilling at Pan Gold Project, Nevada
Date : 10/13/2010 @ 8:00AM
Source : Business Wire
Stock : (MDW)
http://ih.advfn.com/p.php?pid=nmona&article=44767367&symbol=A^MDW
Midway Gold Corp. (“Midway”) is pleased to announce that it has completed a first round of diamond drilling on its Pan Gold Project, White Pine County, Nevada. A total of 1,757 meters (5,764 feet) in 14 core holes were completed in the North and South Pan areas. Assay results are pending.
“The core drilling program was conducted to provide key information for our engineering, metallurgy, and permitting at the Pan deposit,” said Ken Brunk, President and COO of Midway. “This critical data will allow us to complete a Feasibility Study on the project early next year. The core samples also gave our geologists new understanding of the geology and alteration and this understanding will enable us to rigorously design processing methods for the ore.”
Midway also plans to conduct a major resource expansion program for this Fall Season and 2011 to expand the gold resource. The goal of this program is to potentially increase the gold resource to one million ounces or greater and to assist in updating the geology and the alteration models of the deposit. Initial drilling will be focused at South Pan which is still open to the south and at depth. Condemnation drilling will also be conducted to locate unmineralized ground for siting of proposed mine facilities. A program of 3,960 meters (13,000 feet) of RC drilling is planned for this Fall. An additional 10,060 meters (33,000 feet) of RC drilling is planned in 2011. A field office has been opened in Ely, Nevada to support exploration, development, and permitting activities at Pan and the nearby Gold Rock project, which is only 8 miles away.
Samples from the core drilling program will be used for engineering, environmental and mine design tests, which will include:
* Metallurgical tests to confirm and optimize gold recoveries from various zones within the deposit
* Geotechnical features for pit slope designs
* Waste rock characterization tests required for mine permitting and design
* Engineering designs required for a Feasibility Study in 2011
Midway recently announced results of an independently prepared Preliminary Economic Assessment (“PEA”) which demonstrates robust economics and technically favorable attributes of the Pan project. The PEA projects a total operating cost of $453 per ounce (mining cost $155/oz, processing and refining costs $226/oz, G&A $31/oz, and operating contingency $41/oz). At a $1200 gold price, the pre-tax IRR was 41% and pre-tax NPV was $109 million. (See press release dated July 20, 2010 and the subsequent NI 43-101 Technical Report filed on SEDAR July 20, 2010.) The PEA included an independent audit of an internal 2009 mineral resource estimate calculated by Midway. Measured and Indicated Mineral Resources are 38.8 million metric tonnes (42.7 million short tons) containing 682,000 ounces of gold at a grade of 0.55 grams per tonne (0.016 ounces per ton), at a 0.14 gpt (0.004 opt) gold cutoff grade.
Environmental studies are underway to support a Plan of Operations and a reclamation plan submittal to the management agencies. These studies include waste rock characterization, hydrogeology, archaeology, soils, vegetation, wildlife, air quality, and visual resource considerations.
Engineering design work is advancing for the leach pad, the waste rock dump, the crushers, the utilities and the gold recovery plant. Completion of a Feasibility Study is scheduled for the first quarter of 2011.
This release has been reviewed and approved by William S. Neal (M.Sc. and CPG), Vice President of Geological Services, a “qualified person” as that term is defined in National Instrument 43-101.
ON BEHALF OF THE BOARD
“Ken Brunk”
______________________________
Ken Brunk, President and COO
About Midway Gold Corp.
Midway Gold Corp. is a precious metals company with a vision to design, build, and operate mines in a manner accountable to all stakeholders while producing an acceptable return to its shareholders. Midway controls over 65 square miles of mineral rights in the western United States; four advanced projects include: Spring Valley, Pan, Golden Eagle, and Midway. Two early stage exploration targets are Gold Rock and Burnt Canyon.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release contains forward-looking statements about the Company and its business. Forward looking statements are statements that are not historical facts and include resource estimates. The forward-looking statements in this press release are subject to various risks, uncertainties and other factors that could cause the Company's actual results or achievements to differ materially from those expressed in or implied by forward looking statements. These risks, uncertainties and other factors include, without limitation risks related to fluctuations in gold prices; uncertainties related to raising sufficient financing to fund the planned work in a timely manner and on acceptable terms; changes in planned work resulting from weather, logistical, technical or other factors; the possibility that results of work will not fulfill expectations and realize the perceived potential of the Company's properties; uncertainties involved in the interpretation of drilling results and other tests and the estimation of gold resources; the possibility that required permits may not be obtained on a timely manner or at all; the possibility that capital and operating costs may be higher than currently estimated and may preclude commercial development or render operations uneconomic; the possibility that the estimated recovery rates may not be achieved; risk of accidents, equipment breakdowns and labor disputes or other unanticipated difficulties or interruptions; the possibility of cost overruns or unanticipated expenses in the work program; and other factors identified in the Company's SEC filings and its filings with Canadian securities regulatory authorities. Forward-looking statements are based on the beliefs, opinions and expectations of the Company's management at the time they are made, and other than as required by applicable securities laws, the Company does not assume any obligation to update its forward-looking statements if those beliefs, opinions or expectations, or other circumstances, should change.
This press release uses the terms “Measured resources”, “Indicated resources” and “Inferred resources”, which are calculated in accordance with the Canadian National Instrument 43-101 and the Canadian Institute of Mining and Metallurgy Classification system. Mineral Resources are not Mineral Reserves and do not have demonstrated economic viability. We advise investors that while those terms are recognized and required by Canadian regulations, the U.S. Securities and Exchange Commission does not recognize them. U.S. investors are cautioned not to assume that any part or all of mineral deposits in these categories will ever be converted into reserves. In addition, “Inferred resources” have a great amount of uncertainty as to their existence, and great uncertainty as to their economic and legal feasibility. It cannot be assumed that all or any part of an Inferred Mineral Resource will ever be upgraded to a higher category. Under Canadian rules, estimates of Inferred Mineral Resources may not form the basis of feasibility or pre-feasibility studies, except in rare cases. U.S. investors are cautioned not to assume that part or all of an inferred resource exists, or is economically or legally minable.
Proxy Statement - Notice of Shareholders Meeting (preliminary) (PRE 14A)
Date : 10/15/2010 @ 1:34PM
Source : Edgar (US Regulatory)
Stock : (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=44810415&symbol=N^ZOOM
University of Toronto Grants Exclusive Rights to Wound Healing Technology to Cardium Therapeutics / - Deal signed less than 18 months after MaRS Innovation takes the lead on commercializing the U of T technology. - Cardium deal validates MaRS Innovatio
14.10.2010 17:50
http://www.finanznachrichten.de/nachrichten-2010-10/18241338-university-of-toronto-grants-exclusive-rights-to-wound-healing-technology-to-cardium-therapeutics-deal-signed-less-than-18-months-after-mars-inno-256.htm
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University of Toronto Grants Exclusive Rights to Wound Healing Technology to Cardium Therapeutics / - Deal signed less than 18 months after MaRS Innovation takes the lead on commercializing the U of T technology. - Cardium deal validates MaRS Innovatio
14.10.2010 17:50
http://www.finanznachrichten.de/nachrichten-2010-10/18241338-university-of-toronto-grants-exclusive-rights-to-wound-healing-technology-to-cardium-therapeutics-deal-signed-less-than-18-months-after-mars-inno-256.htm
TORONTO, ONTARIO -- (Marketwire) -- 10/14/10 -- Of the approximately 300 million people around the world who are diabetics, 45 million of them develop foot ulcers that bleed - and the infection from those ulcers can spread.
Working to halt this is Dr. Ping Lee, a Professor at the University of Toronto's Leslie Dan Faculty of Pharmacy and GlaxoSmithKline Chair in Pharmaceutics and Drug Delivery. He and his team have created a new sustained-release form of nitric oxide (NO) that can not only stop the infections at wound sites, but also has the potential to speed up wound-healing.
Still, the technology may have stayed on the shelf, even with three years worth of data demonstrating therapeutic relevance. The ultimate success of the technology is due to an effective collaboration between Dr. Lee, the Innovations and Partnerships Office (IPO) at U of T and MaRS Innovation. Lee worked with IPO and MaRS Innovation to formulate a development plan in consultation with numerous industry advisors.
For Dr. Lee's discovery to have a chance of helping those millions of diabetics, it had to move from the laboratory and be readied for the marketplace. The first step in that often long and harsh process took place in June of 2009 when U of T agreed to work to validate the new diabetic wound-healing technology, with MaRS Innovation (www.marsinnovation.com), the commercialization agent that's partnered with 14 leading Toronto universities, research institutes and hospitals to transform discovery research into new jobs, companies, opportunities and growth for Canadians.
An even bigger step took place last week when Cardium Therapeutics Inc. (NYSE Amex: CXM) of San Diego (www.cardiumthx.com) acquired the rights to use this Canadian discovery to expand its wound-healing portfolio, which includes dressings, topical creams and gels, and electrospun fibres for bandages. The company already has a wound-healing product in review with the U.S. Food and Drug Administration (FDA) and the new technology will give the company a platform to develop follow-on products once FDA approval is obtained.
"Dr. Lee's discovery was one of the first opportunities we committed to when we opened our doors just last year," said Dr. Rafi Hofstein, President and CEO of MaRS Innovation. "There is a growing market for wound healing products and advances, given the unfortunate rise in the incidence of diabetes worldwide. We recognized the need for innovation in this field and the real potential to help transform his research into pioneering product opportunities. What was needed was funding, market intelligence and a knowledge of deal-making with multiple partners from different sectors."
Peter Lewis, associate vice president of research at the University of Toronto and interim executive director of the Innovations and Partnerships Office, said: "With U of T's commitment to research excellence and commercialization, our relationship with MaRS Innovation is crucial. We're thrilled that it's already successful."
For Cardium Therapeutics, which works with multiple technology commercialization offices across North America, partnering with MaRS Innovation was beneficial, says Cardium's CEO, Christoper J. Reinhard: "MI brought great business understanding to the process. The team understood our needs quickly and they worked efficiently to get the deal done."
Finally, praise from the inventor himself. "I'm a chemist and an academic, not a business strategist. I've been working with MaRS Innovation for over a year now and can say they understand the world of academic research and its requirements as discoveries are advanced from the laboratory to the marketplace."
About MaRS Innovation
MaRS Innovation (www.marsinnovation.com) provides an integrated commercialization platform that harnesses the economic potential of the exceptional discovery pipeline of 14 leading Toronto academic institutions. MaRS Innovation is a non-profit organization with an independent industry-led Board of Directors, funded through the Government of Canada's Networks of Centres of Excellence and contributions of its member institutions.
Designed to enhance the commercial output of Toronto's outstanding scientific research cluster, MaRS Innovation will make a significant contribution to Canada's economic outlook and the quality of life for Canadians and others around the world. MaRS Innovation will advance commercialization through industry partnerships, licensing and company creation. The MaRS Innovation mission is to put Canada on the global innovation stage, by better connecting research with industry and strengthening Canada's competitive capacity in knowledge based businesses - in short, to launch a new generation of robust, high-growth Canadian companies that will become global market leaders.
About the University of Toronto (U of T):
The University of Toronto (www.utoronto.ca) has assembled one of the strongest research and teaching faculties in North America, presenting top students at all levels with an intellectual environment unmatched in breadth and depth on any other Canadian campus.
U of T faculty co-author more research articles than their colleagues at any university in the US or Canada other than Harvard. As a measure of impact, U of T consistently ranks alongside the top five US universities whose discoveries are most often cited by other researchers around the world. The U of T faculty are also widely recognized for their teaching strengths and commitment to graduate supervision.
Established in 1827, the University of Toronto today operates in downtown Toronto, Mississauga and Scarborough, as well as in ten renowned academic hospitals. The Innovations and Partnerships Office (IPO) was established as The Innovations Foundation in 1980. IPO's mission is to enrich the stature of the University of Toronto by building partnerships with the private, public and government sectors to enable and facilitate the transfer of research results, problem solving, new technologies and social innovation to all sectors for the benefit of society.
Contacts:
Innovations&Partnerships Office, University of Toronto
Jennifer Fraser
Director, Business Development&Commercialization
416.946.5515
jen.fraser@utoronto.ca
MaRS Innovation
Rafi Hofstein
President&CEO
647.260.7868
rhofstein@marsinnovation.com
© 2010 MarketWire
Cardium Announces New Research Findings: Excellagen Product Candidate Activates Platelet Release of PDGF, an Important Growth Factor Fundamental to the Wound Healing Process
13.10.2010 15:08
http://www.finanznachrichten.de/nachrichten-2010-10/18226263-cardium-announces-new-research-findings-excellagen-product-candidate-activates-platelet-release-of-pdgf-an-important-growth-factor-fundamental-to-th-008.htm
SAN DIEGO, Oct. 13 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today reported on new preclinical research findings that Excellagen, a topically applied formulated collagen wound management gel product candidate, activates platelet release of platelet-derived growth factor (PDGF) locally at the wound site. This growth factor has been shown to play an essential role in the wound healing process.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO) (Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
This research effort was undertaken for Cardium by an independent contract testing laboratory in an effort to further understand the statistically significant accelerated wound healing (as measured by the overall reduction in wound radius) in chronic diabetic foot ulcers that was observed in Cardium's Matrix clinical study during the first two weeks following administration of Excellagen formulated collagen (2.6%) topical gel, compared to the study's standard of care arm. In addition, detailed reviews of previous preclinical studies, the Matrix clinical study protocol and Excellagen application practices were undertaken.
Based on data from this new research study and review, Cardium researchers now believe that the Excellagen product candidate activates the release of PDGF (and potentially other important growth factors) from platelets that migrate into the wound site with the influx of blood resulting from surgical wound debridement, a procedure that is commonly used by physicians and wound care specialists as a component of standardized wound care. In the Matrix clinical study, Excellagen formulated collagen was applied immediately following debridement, and researchers believe that the interplay of Cardium's formulated collagen with platelets triggers the release of endogenous PDGF and potentially other growth factors, and that this effect may be a significant contributing factor promoting the immediate accelerated wound healing observed in the Matrix study.
Background
In Cardium's controlled, double blind Matrix Phase 2b clinical study of chronic diabetic lower extremity ulcers, wounds treated with the Excellagen formulated collagen product candidate showed a statistically significant acceleration of wound healing during the first week following a one-time application compared to patients receiving standard of care therapy, a response that was sustained over a 14 day period. In accordance with the study protocol, wounds were debrided prior to application of Excellagen, thus removing necrotic tissue and wound debris and causing an influx of blood (including platelets) into the wound bed. In light of the immediate and rapid healing response following Excellagen application, it was reasoned that localized platelet activation by Excellagen formulated collagen and the corresponding release of a cascade of endogenous growth factors at the wound site may be a contributing factor to the early accelerated healing response observed in the study.
Generally, platelet activation results in the release of an array of cytokines and growth factors including platelet-derived growth factors (PDGF), vascular endothelial growth factors (VEGF), and transforming growth factor-Beta (TGF-Beta) which are essential for the initiation and progression of the wound healing process. Activation of platelets can be replicated in vitro by combining bovine thrombin and human platelet concentrate with resultant clot formation and secretion of growth factors into the surrounding media. Using bovine thrombin as a positive control, and buffered saline as a negative control, Excellagen (2.6% formulated bovine type I collagen) was tested for its ability to activate platelets.
New Preclinical Study and Clinical Implications
For these supplemental studies, the release of PDGF-AB was measured using an Enzyme-Linked Immunosorbent Assay (ELISA). Data from this study now confirm that Excellagen combined with human platelet concentrate results in clot formation and platelet activation. At 24 hours after clot initiation, comparable levels of released PDGF-AB (~10 ng/mL) were detected in the thrombin- and Excellagen-induced clots. By 48 hours, measurable PDGF-AB was still detectable in the thrombin samples, whereas Excellagen samples had returned to baseline (negative control level).
The Excellagen product candidate is believed to have several attributes beneficial to the promotion of wound healing, including providing binding sites for growth factors (e.g. PDGF-BB) and a scaffold for migration of cells responsible for generation of granulation tissue. The current findings add to this repertoire of attributes and are consistent with a role of platelet activation and the release of growth factors for 24-48 hours immediately following application of Excellagen to newly-debrided wounds.
Based on the Matrix Phase 2b study protocol, treatment with Excellagen was limited to one application or a second application (if the wound had not healed) four weeks following the initial treatment during the 12 week study period. Data from this study indicated that the Excellagen product candidate was safe and well-tolerated by all patients receiving one or two treatments. Based on this safety data and the immediate acceleration of healing, the Company believes that the treatment response observed in the Matrix study offers the potential to be further amplified and sustained in actual clinical practice through multiple treatments with increased frequency. Cardium's Excellagen formulated collagen topical gel wound care dressing is currently the subject of a pending FDA 510(k) clearance application for marketing and sales in the United States.
"These important new findings provide further insight into the significant and rapid healing response that our Excellagen product candidate demonstrated in the Matrix clinical study. We believe that multiple treatments over a 12-week treatment period provide an opportunity to sustain accelerated healing rates and enhance the wound care management process for patients suffering with non-healing chronic diabetic foot ulcers. We look forward to the market launch of Excellagen planned for this year, upon clearance by the FDA of our pending 510(k) notification, and to the development of new product extensions based on our custom formulated collagen product platform for additional wound healing applications," stated Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer.
About Excellagen
Excellagen is a highly-refined fibrillar bovine Type I collagen-based topical gel (2.6% collagen concentration) which has been evaluated in a controlled, double-blind randomized, multi-center Phase 2b clinical study at 23 U.S.-based medical centers for the treatment of chronic non-healing diabetic foot ulcers (the Matrix Study). If the pending 510(k) notification to the FDA is cleared as submitted, Excellagen would be indicated for the management of wounds, including partial and full thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers and certain other wounds, such as surgical and trauma wounds.
Analysis of data from the Matrix Study indicates that the Excellagen product candidate appeared to be both safe and well tolerated, demonstrated improved wound area reductions and wound closure rates at 12 weeks following one or two treatments, and showed a statistically significant acceleration of wound healing during the first week following a one-time application compared to patients receiving standard of care therapy. In the first week following treatment, the radius of Excellagen-treated wounds decreased on average by 0.21 cm compared to 0.08 cm for standard of care-treated wounds (N=47, p = 0.018). The apparent treatment effect was particularly evident in patients with larger-sized wounds (>3.0 cm2). For example, at 12-weeks, 45% of all Excellagen-treated wounds achieved complete closure, compared to 31% in the standard of care group, representing a 45% overall improvement. For wounds >3 cm2 in area at screening, 33% of Excellagen-treated wounds achieved closure by 12 weeks compared to 0% for standard of care. In addition, 74% of all Excellagen-treated wounds achieved >/= 90% wound area reduction at 12 weeks compared to 44% in the standard of care group, representing a 68% relative improvement.
Excellagen is pending clearance by the U.S. Food and Drug Administration (FDA) and until such time as the product is cleared for marketing by the FDA, all claims of safety and effectiveness remain subject to review by the FDA.
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's current investment portfolio includes the Tissue Repair Company, Cardium Biologics, and the Company's in-house MedPodium lifestyle medicinals brand platform. The Company's lead product candidates include: (1) Excellagen(TM) topical gel, for wound care management, which Cardium plans to market launch in the fourth quarter subject to pending FDA 510(k) clearance; and (2) Generx®, a DNA-based angiogenic cardiovascular biologic for patients in international markets with coronary artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com/.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that the U.S. Food and Drug Administration will grant marketing clearance of our product candidates or that we or a partner can successfully introduce our products into advanced wound care markets; that our product candidates will be perceived as being sufficiently safe and effective to lead to product advancement or partnering; that our product candidates offer the potential for simpler or more cost-effective treatments for physicians and patients than other products that currently are or will be on the market; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or its perceived value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; that discussions with potential strategic partners will be successful or that any partner will be able to efficiently and effectively commercialize our products in U.S. or international markets; or that third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of biologics and other therapeutic products and devices, and in the conduct of human clinical trials and other product development efforts, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition and regulation, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/.
Cardium Therapeutics(TM) Generx® and MedPodium(TM) are trademarks of Cardium Therapeutics, Inc. Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM), Osteorate(TM), Appexium(TM) and Linee(TM) are trademarks of Tissue Repair Company.
(Other trademarks belong to their respective owners)
Photo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO
AP Archive: http://photoarchive.ap.org/
PRN Photo Desk, photodesk@prnewswire.com
Cardium Therapeutics
CONTACT: Bonnie Ortega, Director, Investor/Public Relations of Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
Web Site: http://www.cardiumthx.com/
© 2010 PR Newswire
Apricus Biosciences to Present at the PrecisionIR Informed Investors Forum Biotech, Healthcare & Pharma Virtual Conference
Date : 10/11/2010 @ 10:38AM
Source : Business Wire
Stock : Apricus Biosciences (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=44738233&symbol=APRI
Apricus Biosciences (“Apricus Bio”) (Nasdaq: APRI), backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today announced that Bassam Damaj, Ph.D., President and Chief Executive Officer, will present at PrecisionIR's Informed Investors Forum Biotech, Healthcare and Pharma Virtual Conference on October 13, 2010 at 12:00pm Eastern time. Interested parties can access the audio webcast with slide presentation at http://www.vcall.com/customevent/conferences/biotech/20101013/index.html.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
AdvaMed 2010 (October 18-20, 2010)
http://www.advamed2010.com/
MedTech Companies & Coulter Foundation Translational Research Partnership Universities Present Life Changing Medical Devices/Technologies and Company Profiles to Industry Leaders and Investors at AdvaMed 2010
http://www.prnewswire.com/news-releases/medtech-companies--coulter-foundation-translational-research-partnership-universities-present-life-changing-medical-devicestechnologies-and-company-profiles-to-industry-leaders-and-investors-at-advamed-2010-104418653.html
"Funding Forums" Address Venture Capital and Government Funding Opportunities
WASHINGTON, Oct. 6 /PRNewswire-USNewswire/ -- More than 60 innovative medical technology companies have been competitively selected to present company profiles before potential investors, partners and industry stakeholders, October 19 and 20 at AdvaMed 2010: The MedTech Conference. Selected companies represent innovation at all stages of development from various medical device sectors, and come from across the United States, Austria, Canada, Chile, Israel, Luxembourg, Switzerland and the United Kingdom. New this year are 20 company presentations from Coulter Foundation Translational Research Partnership Universities and two "Funding Forums" to highlight venture capital and government funding opportunities for emerging growth and established companies.
"We have selected a diverse group of companies with technologies that range from addressing traumatic brain injuries with medical neurotechnology to photonic tumor therapy and everything in-between," said Etienne Lagace, a Principal of Inovia Healthcare Ventures of Canada and a member of the AdvaMed 2010 company presentation selection committee. "These presentations and funding forums will provide companies with insights into the latest and most innovative technologies of today and tomorrow, as well as the funding opportunities available to develop these new, life saving and life changing medical devices. As an investor and an industry stakeholder, I look forward to hearing from all the companies and academic entrepreneurs."
AdvaMed 2010 presenting companies include the following:
4ibio, Pickering, Ontario, Canada
20/20 GeneSystems, Inc., Rockville, Maryland
Activiews, Inc., Lynnfield, Massachusetts
Advanced Dental Technology, Richmond, Virginia
Altrika, Inc. Sheffield, United Kingdom
Alverix, Inc., San Jose, California
AMES Technology, Inc., Portland, Oregon
Avancen MOD Corporation, Mount Pleasant, South Carolina
Biocompatibles International plc., Farnham, United Kingdom
BrainScope Company, Inc., Bethesda, Maryland
Calgary Scientific Inc., Calgary, Alberta, Canada
CerviLenz, Inc, Chagrin Falls, Ohio
Circuport, Inc., Morristown, New Jersey
Claro Scientific, St. Petersburg, Florida
Cohera Medical, Inc., Pittsburgh, Pennsylvania
CogniSens, Montreal, Quebec, Canada
ConvaTec Inc., Skillman, New Jersey
CSA Medical, Baltimore, Maryland
CytoPherx, Inc, Ann Arbor, Michigan
CytoSorbents Corporation, Monmouth Junction, New Jersey
DioGenix, Gaithersburg, Maryland
eSight Corporation, Ottawa, Ontario, Canada
EastMed Inc, Halifax, Nova Scotia, Canada
Echometrix, Madison, Wisconsin
EGI, Eugene, Oregon
Endosense SA, Geneva, Switzerland
Endomimetrics, Birmingham, Alabama
Flowsense Medical Ltd., Misgav, Israel
GeneEx, Inc., Hialech, Florida
Hadasit Medical Research Services & Development Ltd., Jerusalem, Israel
Healionics Corporation, Seattle, Washington
Healthpoint, Ltd., Fort Worth, Texas
Interface Biologics, Toronto, Ontario, Canada
Jabil, Inc., St. Petersburg, Florida
Lineagen, Inc., Salt Lake City, Utah
MONITOR-it S.A., Esch-sur-alzette, Luxembourg
NovaScan, Milwaukee, Wisconsin
Noxilizer, Inc, Baltimore, Maryland
Oncoscope, Inc, Durham, N. Carolina
Photo Dynamic Therapy LLC, Vienna, Austria
Profound Medical Inc., Toronto, Ontario, Canada
Regenesis Biomedical Inc, Scottsdale, Arizona
S.E.A. Medical Systems, Inc, Santa Clara, California
Semprus BioSciences, Cambridge, Massachusetts
SendSor Group, Lafayette, Indiana
Sphere Medical, Cambridge, United Kingdom
StemCellRX, Chile
Tissue Fusion, LLC, Colorado Springs, Colorado
TrusTech, Manchester, England
ValveXchange, Inc., Aurora, Colorado
ZSX Medical, LLC, King of Prussia, Pennsylvania
In addition to the companies listed above, from 2:50 p.m. to 4:50 p.m. Tuesday, October 19, the Coulter Foundation Translational Research Partnership Universities -- Boston University, Case Western Reserve University, Duke University, Georgia Institute of Technology and Emory University, Stanford University, University of Michigan, University of Maryland, University of Virginia, University of Washington and University of Wisconsin -- will present 20 innovative and exciting advances solving pressing, unmet clinical needs. These presentations will focus on advances in the following areas -- cardiovascular, IVD diagnostics, imaging, neurology, ophthalmology, orthopedics, surgical tools, tissue regeneration and wound healing.
"To further assist emerging growth companies and foster innovation, AdvaMed 2010 will host two funding forums on Tuesday, October 19," said Mr. Richard Holdren, a Texas-based angel investor with Healthcare Angels and AdvaMed 2010 Business Development Committee member. The two forums are titled "Tap Into $2 Billion in Government Funding" and "Venture Funding." "These forums will focus on the SBIR and STTR federal small business grant and contract programs and today's venture capital investment environment," Holdren said.
Pete Shagory, Principal with Baird Venture Partners will lead the Venture Funding forum. Both the National Venture Capital Association and the Angel Capital Association support AdvaMed 2010: The MedTech Conference activities.
About AdvaMed:
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.AdvaMed.org.
About AdvaMed 2010:
AdvaMed 2010 is the premier MedTech conference for business leaders, entrepreneurs, policymakers, media, financiers, and other industry stakeholders from around the world. In its second year, AdvaMed 2009 attracted 1,400 plus industry leaders – including 500+ CEOs, Presidents and C-level executives.
In today's economic and political climate, AdvaMed 2010 is this year's can't miss MedTech event for networking; conducting partnering meetings; influencing policymakers and the media; and participating in educational sessions. Whether you need to finance, partner, or license technology; learn the latest important developments in reimbursement, regulatory, legal, intellectual property, and other critical areas; or meet with and hear from leaders in the Obama Administration and Congress, AdvaMed 2010 is your introduction to key decision-makers. For more information, visit www.AdvaMed2010.com .
SOURCE AdvaMed; AdvaMed 2010
Apricus Bio Highlighted in Investment Newsletter
Date : 10/08/2010 @ 9:00AM
Source : Business Wire
Stock : Apricus Biosciences (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=44716784&symbol=APRI
Apricus Biosciences (“Apricus Bio”) (Nasdaq: APRI), backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today announced that the Company is featured as a special stock pick in the October 2010 issue of the KonLin Letter, an independent New York-based investment newsletter (www.konlin.com) published by KonLin Research & Analysis. The investment letter highlights Apricus Bio’s proprietary technology and pipeline of 13 clinical and pre-clinical product candidates in various stages of development.
“We are pleased with this latest recognition by the Wall Street community, which serves to highlight our continued successful efforts to re-brand the Company and pursue the significant product development, out-licensing and partnering opportunities before us,” stated Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio.
About "The KonLin Letter"
"The KonLin Letter" is a newsletter service that recommends five low-priced selections each month, including a featured stock of the month, and reviews 30-35 different stocks while monitoring a broad range of technical indicators for the best possible Market Timing Advice. For more information go to http://www.konlin.com.
The opinions expressed in "The KonLin Letter" are those of the analyst and not of Apricus Biosciences, Inc. Apricus Bio does not accept responsibility for the accuracy of any of the information or statements contained in the report. For information provided by Apricus Bio with respect to its business and business prospects, as well as associated risks with an investment in Apricus Bio stock, Please see the Company's reports filed with the Securities and Exchange Commission, copies of which are available at http://www.sec.gov/ and also on the Company's website http://www.apricusbio.com/
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
Midway Gold Reports High Gold Recoveries at Spring Valley, Nevada
06.10.2010 14:08
http://www.finanznachrichten.de/nachrichten-2010-10/18161565-midway-gold-reports-high-gold-recoveries-at-spring-valley-nevada-004.htm
Midway Gold Corp. ("Midway") continues to find excellent gold recovery results for its Spring Valley gold project, Pershing County, Nevada. Test results report gold recoveries up to 98% with conventional oxide ore leaching treatment, and showed high gold recoveries across all the grade ranges tested. These tests were conducted at McClelland Laboratories Inc., Reno, Nevada, and were overseen by Barrick Gold Exploration Inc., a wholly owned subsidiary of Barrick Gold Corporation (NYSE:ABX, TSX:ABX), Midway's earn-in partner at Spring Valley.
Ken Brunk, President and COO of Midway said: "These positive metallurgical results speak well for the high quality of this gold resource at Spring Valley. The results show that several commonly used production options exist for processing and recovering the gold from Spring Valley and these include heap leaching, typical oxide leaching and recovery by gravity methods."
Thirteen composite samples representing oxide, transition and reduced ores were tested by column leaching, bottle roll and gravity methods. Grades of the composite samples ranged from 0.21 grams per tonne (gpt) to 5.07 gpt (0.006 ounces per ton - "opt" to 0.148 opt1); nine of the samples had grades less than 1.03 gpt (0.030 opt). Because coarse gold is known to be present at Spring Valley, the reported gold grades were determined by metallic screen fire assays.
Column Leach Tests
Column leach tests simulate heap leach conditions, and these tests conducted over 260 days yielded gold recoveries from 46% to 98% and average 73%. Individual results for the oxide, transition and reduced ores averaged 77%, 80% and 68% respectively. Rocks tested by column leach methods were crushed such that 80% of the rocks were less than 12.7 millimeters (one-half inch) in diameter.
Bottle Roll Tests
Bottle roll tests were conducted for 96 hours on ores ground to minus 300, 150, and 75 microns (48, 100 and 200 mesh sizes); these recoveries were 91%, 94% and 95% respectively.
Gravity Tests
Gravity test recoveries ranged from 78% to 97% and averaged 86%. The tests were conducted on ores at 850, 212, 150, and 75 microns (20, 65, 100 and 200 mesh sizes). The tests used a Knelson concentrator; more than half of the recovered gold was coarser grained than 850 and 212 microns (20 and 65 mesh size screens).
Spring Valley is a large gold project covering 18.4 square miles and located about 20 miles northeast of Lovelock, Nevada. Spring Valley currently has an Inferred Resource of at least 1.8 million ounces of gold in 79.61 million tonnes grading 0.72 gpt (0.021 opt). (See the Midway press release dated March 2, 2009 and the subsequent NI 43-101 Technical Report filed on SEDAR March 30, 2009.) Midway and Barrick entered into an agreement on March 9, 2009 for the exploration and development of the Spring Valley project. Under the terms of the agreement, Barrick may earn a 60% interest in the project by spending US$30 million in work expenditures before December 31, 2013.
Data reported to Midway by Barrick and disclosed in this press release has been reviewed for Midway by Richard D. Moritz, (B.Sc., MBA), a "qualified person" as that term is defined in National Instrument 43-101.
1 Conversion factor: 1 ounce per short ton equals 34.2857 grams per tonne.
ON BEHALF OF THE BOARD
"Ken Brunk"
______________________________
Ken Brunk, President and COO
For further information, please contact R.J. Smith at Midway Gold Corp. at (877) 475-3642 (toll-free).
About Midway Gold Corp.
Midway Gold Corp. is a precious metals company with a vision to design, build, and operate mines in a manner accountable to all stakeholders while producing an acceptable return to its shareholders. Midway controls over 65 square miles of mineral rights in the western United States, including four advanced projects: Spring Valley, Pan, Golden Eagle, and Midway, as well as two early stage exploration targets: Gold Rock and Burnt Canyon.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release contains forward-looking statements about the Company and its business. Forward looking statements are statements that are not historical facts and include resource estimates. The forward-looking statements in this press release are subject to various risks, uncertainties and other factors that could cause the Company's actual results or achievements to differ materially from those expressed in or implied by forward looking statements. These risks, uncertainties and other factors include, without limitation risks related to fluctuations in gold prices; uncertainties related to raising sufficient financing to fund the planned work in a timely manner and on acceptable terms; changes in planned work resulting from weather, logistical, technical or other factors; the possibility that results of work will not fulfill expectations and realize the perceived potential of the Company's properties; uncertainties involved in the interpretation of drilling results and other tests and the estimation of gold resources; the possibility that required permits may not be obtained on a timely manner or at all; the possibility that capital and operating costs may be higher than currently estimated and may preclude commercial development or render operations uneconomic; the possibility that the estimated recovery rates may not be achieved; risk of accidents, equipment breakdowns and labor disputes or other unanticipated difficulties or interruptions; the possibility of cost overruns or unanticipated expenses in the work program; and other factors identified in the Company's SEC filings and its filings with Canadian securities regulatory authorities. Forward-looking statements are based on the beliefs, opinions and expectations of the Company's management at the time they are made, and other than as required by applicable securities laws, the Company does not assume any obligation to update its forward-looking statements if those beliefs, opinions or expectations, or other circumstances, should change.
This press release uses the terms "Measured resources", "Indicated resources" and "Inferred resources", which are calculated in accordance with the Canadian National Instrument 43-101 and the Canadian Institute of Mining and Metallurgy Classification system. Mineral Resources are not Mineral Reserves and do not have demonstrated economic viability. We advise investors that while those terms are recognized and required by Canadian regulations, the U.S. Securities and Exchange Commission does not recognize them. U.S. investors are cautioned not to assume that any part or all of mineral deposits in these categories will ever be converted into reserves. In addition, "Inferred resources" have a great amount of uncertainty as to their existence, and great uncertainty as to their economic and legal feasibility. It cannot be assumed that all or any part of an Inferred Mineral Resource will ever be upgraded to a higher category. Under Canadian rules, estimates of Inferred Mineral Resources may not form the basis of feasibility or pre-feasibility studies, except in rare cases. U.S. investors are cautioned not to assume that part or all of an inferred resource exists, or is economically or legally minable.
Contacts:
Midway Gold Corp.
R.J. Smith, 877-475-3642 (toll-free)
www.midwaygold.com
© 2010 Business Wire
Statement of Changes in Beneficial Ownership (4)
Date : 10/01/2010 @ 6:00PM
Source : Edgar (US Regulatory)
Stock : (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=44626934
Share Structure (as of 06.17, 2010) -
http://www.midwaygold.com/s/ShareStructure.asp
Presentation - September 2010
http://www.midwaygold.com/i/pdf/MDWSept2010CorpOverviewWeb.pdf
Zoom Technologies Raises Leimone Brand Sales Guidance
Date : 09/28/2010 @ 7:30AM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=44555427&symbol=N^ZOOM
Zoom Technologies, Inc. (NASDAQ: ZOOM), a leading China based manufacturer of mobile phones and related products, today announced that orders for its Leimone brand mobile phones continue to be strong in the second half of 2010. As a result of this trend, the Company is increasing its unit sales guidance for 2010 by 17% for the Leimone propriety brand mobile phones to 700,000 units from 600,000 units. This annual unit guidance represents a ten-fold increase from 2009. In the first half of 2010, Zoom sold approximately 128,000 Leimone mobile phones. For the second half of 2010, Zoom now expects to sell 580,000 Leimone mobile phones, including 100,000 units of the latest 3G design. The Leimone brand phones have a higher profit margin than Zoom's traditional EMS business and they are sold through China Telecom and various retail outlets.
Zoom's Leimone brand product line currently includes 17 models of Leimone feature-rich mobile phones equipped with state of the art technologies, with four models for China's 3G networks. Zoom unveiled its first Leimone brand 3G phone designed specifically for China Telecom's 3G market in early 2010. The successful E63 model was followed quickly by two additional 3G models, the Leimone E66 phone designed for professionals and the feature-rich Leimone E33 phone aimed at the price sensitive youth market.
Mr. Leo Gu, Chairman and Chief Executive Officer of Zoom Technologies, stated, "We are proud of our continued expansion in the rapidly growing China 3G market and our ability to produce mobile products for top tier Chinese mobile phone companies. Leimone brand mobile phones are extremely popular with the growing number of young people in China who seek feature-rich, mid-priced and sleek designed mobile phones. In addition, our ability to significantly increase our manufacturing capabilities in the second half of 2010 underscores our strong position in the robust China mobile phone market."
About Zoom Technologies
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for the latest generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its Own Brand Manufacturing (OBM) under the Leimone brand name. The company's products are both exported and sold domestically.
Investor Presentation - September 2010
... http://files.shareholder.com/downloads/YRCW/961109928x0x300779/870EF38B-B9BA-479B-B80D-30BCE0C0EE53/IP_0210.pdf
FDA Grants Type B Meeting to Be Held November 8, 2010 to Discuss Phase III Protocols for Androxal®
Date : 09/30/2010 @ 6:30AM
Source : Business Wire
Stock : Repros Therapeutics Inc. (RPRX)
http://ih.advfn.com/p.php?pid=nmona&article=44593492
Repros Therapeutics Inc.® (NasdaqCM:RPRX) today announced that the Company has been granted a Type B meeting to be held on November 8, 2010 with the Division of Reproductive and Urologic Products to review the Company’s Phase III pivotal efficacy protocols for Androxal® in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.
The Phase III studies are designed to compare Androxal to a topical testosterone and placebo. In a similarly designed small pilot study previously conducted by Repros, only Androxal resulted in consistent normalization of both testosterone and sperm counts in a majority of subjects. In this population of men that previously used a topical testosterone, after three months of treatment, no men on testosterone or placebo exhibited normal concentrations for both measures. Per FDA recommendation, benefit will be determined by “normalization of serum testosterone levels while preserving fertility.”
The proposed Phase III efficacy program is designed to have two trials with a total of 80 subjects enrolled in each study, randomized into four 20 subject arms. The four arms are 12.5 and 25 mg Androxal, placebo and open label approved topical testosterone. The Androxal and placebo arms will be double blind. The topical testosterone will be used per manufacturers’ instructions. Subjects will be dosed for three months. The primary endpoint for the two studies is a responder analysis, with a responder being defined as an individual that exhibits a morning testosterone greater than 300 ng/dl and a total sperm count greater than 39 million sperm (or sperm concentration >15x106/ml) at the end of the three month dosing period. The World Health Organization Laboratory Manual for the Examination of Human Semen, 5th Edition, has set the mean lower reference limits (5th percentiles) for semen characteristics of fertile men at 39x106 total sperm per ejaculate and a concentration of 15x106 sperm per ml.
The two studies will recruit related but different subjects. The first study will recruit men that have been currently using a topical testosterone for at least three months. These men will be required to stop taking their current topical testosterone for three weeks. Based on one of the Company’s previously completed pilot studies, the Company believes this group of men will exhibit morning testosterone levels <250 ng/dl and sperm counts below 39x106 total sperm per ejaculate after the three week washout.
The second pivotal study will enroll men that are naïve to testosterone treatment or have not used topical testosterone for at least 6 months. The men will be screened to ensure that their morning testosterone is <250 ng/dl (FDA recommendation). Based on the previously completed study, the Company believes this group of men will exhibit sperm counts greater than 39x106 total sperm per ejaculate at baseline.
If results from previous studies are consistent with outcomes for the planned trials the Company believes the outcome from both studies will be the same. At the end of the three month dosing period only Androxal administration will result in normalization of both testosterone and sperm counts in a majority of subjects. Though these two pivotal studies for efficacy are small, Repros believes they are properly powered based on expected outcomes. The Company engaged Dr. J. Richard Trout, Professor Emeritus Rutgers, biostatistician and consultant to the pharmaceutical industry, to assess the two study designs. Based on previous experience suggesting the 12.5 mg dose of Androxal will exhibit a responder rate of 70% and topical testosterone will exhibit a responder rate of 15%, Dr. Trout opined that a study with 20 subjects per arm would be powered at the 80% level and should be more than adequate to demonstrate a statistically significant efficacy signal. Comparing the higher 25 mg dose of Androxal, which exhibited a responder rate of roughly 85% to topical testosterone, the study is powered to an even greater degree.
In the briefing package, submitted along with the protocols, the Company also presented data to support both 12.5 and 25 mg doses as suitable for Phase III testing. In September of 2004 the Company held an “end of Phase II” meeting with the FDA during which Repros presented data supporting the selection of the two doses for a study designed to assess the ability of Androxal to normalize morning testosterone in men with secondary hypogonadism. The FDA took no issue with the dose selection but opined that testosterone as an endpoint was not suitable for a drug such as Androxal and that the Company would need to determine an additional clinically relevant outcome. Male fertility is clinically relevant. In general, men with secondary hypogonadism are fertile. It is the treatment with exogenous testosterone that induces an infertile state due to suppression of important reproduction related pituitary hormones. Therefore, in the case of Androxal, dose selection is based on the ability of the oral drug to normalize testosterone.
As part of the meeting the Company has asked if the Agency will be willing to review the two pivotal protocols under a Special Protocol Assessment (SPA). The Company expects the FDA will likely request modifications to the two protocols before and if agreeing to SPA review.
It should be noted that even though Androxal may be proceeding to pivotal Phase III studies, the FDA will be reviewing the drug as a New Chemical Entity and as such Repros will be required to conduct large open label safety studies (100 subjects for a year and 300-600 subjects for six months) as well as special population and drug-drug interaction studies amongst others before a new drug application can be submitted. Over 50 men have taken Androxal for over a year and over 100 men have been administered the drug for longer than 6 months. In all previous studies Androxal has been generally well tolerated.
Repros expects to commence the Phase III studies early in 2011 and, depending on the rate of recruitment, to have reportable data from one of the studies near the end of that year. The Company is presently exploring partnering and various financing options to fund the Androxal program.
About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros' ability to have the partial hold on Proellex® lifted and to determine a safe and effective dose for Proellex, maintain its listing on the NASDAQ Capital Market, raise needed additional capital on a timely basis in order for it to continue to fund its operations and pursue its development activities, and such other risks which are identified in the Company's most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please visit the Company's website at http://www.reprosrx.com
Sunesis Granted 180-Day Extension by NASDAQ to Regain Compliance With Minimum Bid Price Rule
Date : 09/29/2010 @ 8:00AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=44575564&symbol=N^SNSS
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) announced today that it received a letter, dated September 28, 2010, from The NASDAQ Stock Market notifying Sunesis that it has been granted an additional 180-day compliance period, or until March 28, 2011, to regain compliance with the $1.00 per share minimum bid price rule for continued listing on The NASDAQ Capital Market, as set forth in NASDAQ Listing Rule 5550(a)(2). The letter states that, pursuant to Listing Rule 5810(c)(3)(A), Sunesis is eligible for an additional compliance period because it meets all other NASDAQ Capital Market initial listing criteria set forth in Listing Rule 5505. The new compliance period is an extension of the initial 180-day period provided for in NASDAQ's deficiency notice to Sunesis, dated March 31, 2010.
The NASDAQ letter does not impact Sunesis' listing on The NASDAQ Capital Market at this time and Sunesis' common stock will continue to trade under its current symbol "SNSS" during the additional 180-day compliance period.
Sunesis may regain listing compliance by maintaining a closing bid price of its common stock of at least $1.00 per share for a minimum of 10 consecutive business days at any time before March 28, 2011. If, pursuant to Listing Rule 5810(c)(3)(A), Sunesis meets the outlined requirements, NASDAQ will provide written confirmation to Sunesis that it complies with Listing Rule 5550(a)(2), unless NASDAQ exercises its discretion to extend this 10-day period pursuant to Listing Rule 5810(c)(3)(F). If Sunesis is not in compliance following the additional 180-day period, NASDAQ will notify Sunesis that its common stock is subject to delisting. At that time, Sunesis may appeal to a NASDAQ Hearings Panel ("NASDAQ Panel"), and Sunesis would remain listed pending such NASDAQ Panel's decision following a hearing. Sunesis cannot provide any assurances that a NASDAQ Panel will allow Sunesis to remain listed in the event of any appeal.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis Pharmaceuticals, please visit http://www.sunesis.com.
This press release contains forward-looking statements, including without limitation statements related to the continued listing of Sunesis' common stock on The NASDAQ Capital Market and potential outcomes in the event of Sunesis' continued non-compliance with the NASDAQ listing standards. Words such as "may," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks associated with Sunesis' failure to comply with the continued listing requirements of The NASDAQ Capital Market and the risk that Sunesis becomes subject to delisting proceedings by NASDAQ. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals, Inc.
650-266-3717
Keryx Biopharmaceuticals Initiates Long-Term Study Component of Phase 3 Registration Program of Zerenex (ferric citrate) for the Treatment of Hyperphosphatemia
Date : 09/29/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=44576255&symbol=KERX
Keryx Biopharmaceuticals Initiates Long-Term Study Component of Phase 3 Registration Program of Zerenex (ferric citrate) for the Treatment of Hyperphosphatemia in Patients with End-Stage Renal Disease on Dialysis Short-Term Study Component of Phase 3 Registration Program to be Completed by Year End
PR Newswire
NEW YORK, Sept. 29
NEW YORK, Sept. 29 /PRNewswire/ --Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today the initiation of the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. The initiation of this study marks the commencement of the final component of the Company's Phase 3 registration program for Zerenex, which is being conducted in accordance with a Special Protocol Assessment (SPA) agreement with the FDA. Pursuant to the SPA agreement, the Zerenex Phase 3 registration program consists of a short-term efficacy study, which was initiated in May 2010 and is expected to be completed in the fourth quarter of 2010, and the 58-week long-term safety and efficacy study initiated today.
The long-term study initiated today is a multicenter, randomized, open-label, safety and efficacy clinical trial with a planned enrollment of approximately 300 ESRD patients on hemodialysis or peritoneal dialysis. The study will consist of a 2-week washout period followed by a 52-week safety assessment in which patients will be randomized 2:1 to receive either Zerenex or an active control. The 52-week safety assessment period will be followed by a 4-week efficacy assessment in which only patients randomized to treatment with Zerenex during the safety assessment period will be randomized in a 1:1 ratio to either continue treatment with Zerenex or switch to placebo for a 4-week efficacy assessment period. Approximately 45 sites in the U.S. and select ex-U.S. sites will participate in the study. Patient enrollment is expected to take approximately 6 to 9 months.
Dr. Julia Lewis, Professor of Medicine, Department of Nephrology, Vanderbilt University School of Medicine, and member of the Executive Committee of the Collaborative Study Group, is the Study Chair of the Zerenex Phase 3 registration program. Dr. Samuel S. Blumenthal, Professor of Medicine at Medical College of Wisconsin, is the study's Co-Principal Investigator.
Dr. Lewis commented, "We are excited to be leading this long-term safety and efficacy study of Zerenex and are looking forward to the pending completion of the short-term study. While there are treatment options available to patients with hyperphosphatemia, there are safety and compliance concerns associated with the currently marketed therapies. The Phase 3 registration program is designed to confirm prior clinical data which suggests that Zerenex is potentially an attractive, differentiated treatment option for ESRD patients with hyperphosphatemia."
Ron Bentsur, Chief Executive Officer of Keryx, commented, "The initiation of the Phase 3 long-term study is an important milestone for the Company and brings us one step closer to potentially providing patients living with hyperphosphatemia with a viable alternative to the marketed phosphate binders. We also look forward to the completion of the Phase 3 short-term efficacy study by year end."
Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
PHASE 3 PROGRAM DESIGN:
In accordance with the Company's SPA agreement with the FDA, the Phase 3 clinical program for Zerenex will consist of two clinical studies, as follows:
Short-term efficacy study: A multicenter, randomized, open-label clinical trial with a planned enrollment of approximately 150 ESRD patients on hemodialysis, who will be randomized to fixed doses of Zerenex, ranging from 1 gram per day to 8 grams per day, for a treatment period of 28 days. Patients will undergo a 2-week washout period prior to randomization. The primary endpoint of the study will be to demonstrate a dose response in the change of serum phosphorus from baseline (end of washout period) to end of the treatment period (day 28).
Long-term safety and efficacy study: A multicenter, randomized, open-label, safety and efficacy clinical trial with a planned enrollment of approximately 300 ESRD patients on hemodialysis or peritoneal dialysis. The long-term study will consist of a 2-week washout period followed by a 52-week safety assessment period in which patients will be randomized 2:1 to receive either Zerenex or an active control. The 52-week safety assessment period will be followed by a 4-week efficacy assessment in which only patients randomized to treatment with Zerenex during the safety assessment period will be randomized in a 1:1 ratio to either continue treatment with Zerenex or switch to placebo for a 4-week efficacy assessment period.
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 efficacy and safety results, including the adverse event profile, and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 clinical program. 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. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf.
About Hyperphosphatemia
In the United States, according to data from the U.S. Renal Data System, there are approximately 485,000 patients with end-stage renal disease, or ESRD, and the number of ESRD patients is projected to rise 60% to approximately 785,000 by 2020. The majority of ESRD patients, close to 400,000, require dialysis. Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are usually associated with secondary hyperparathyroidism (and its related cardiovascular complications), renal osteodystrophy and soft tissue mineralization. ESRD patients usually require treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. The need for alternative phosphate-binding agents has long been recognized, especially given the increasing prevalence of ESRD as well as shortcomings with current therapies. Zerenex has the potential to be an effective and safe treatment in lowering and/or maintaining normal serum phosphorus levels in patients with ESRD and hyperphosphatemia.
The market for phosphate binders to treat hyperphosphatemia in ESRD patients in 2009 was approximately $750 million in the U.S. and is approaching $1.5 billion worldwide.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for Zerenex™ may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for Zerenex™; the risk that the data (both safety and efficacy) from the Phase 3 trials will not coincide with the data analyses from the Phase 2 clinical trials previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website and the FDA website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Apricus Bio Announces Pricing of Securities Offering
Date : 09/29/2010 @ 8:30AM
Source : Business Wire
Stock : Apricus Biosciences (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=44576188&symbol=N^APRI
Apricus Biosciences (“Apricus Bio”) (Nasdaq: APRI), backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today announced that it has entered into agreements with selected investors to sell up to 1,728,882 Units at a price per Unit of $5.40, for aggregate gross proceeds of approximately $9.3 million. Each Unit consists of three shares of common stock and one warrant, exercisable at a price of $2.27 per share. The warrants may be exercised at any time after six months from the date of the closing and will expire after five years. The offering is expected to close on or about October 4, 2010, subject to customary closing conditions.
Apricus Bio intends to use the net proceeds from this offering for product development and general corporate purposes. Dawson James Securities acted as the exclusive placement agent for the offering.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com. (Apricus Bio was previously named NexMed, Inc. The corporate name was changed in September 2010 in recognition of the evolution and expansion of the Company’s business.)
Zoom Technologies Raises Leimone Brand Sales Guidance
Date : 09/28/2010 @ 7:30AM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=44555427&symbol=ZOOM
Zoom Technologies, Inc. (NASDAQ: ZOOM), a leading China based manufacturer of mobile phones and related products, today announced that orders for its Leimone brand mobile phones continue to be strong in the second half of 2010. As a result of this trend, the Company is increasing its unit sales guidance for 2010 by 17% for the Leimone propriety brand mobile phones to 700,000 units from 600,000 units. This annual unit guidance represents a ten-fold increase from 2009. In the first half of 2010, Zoom sold approximately 128,000 Leimone mobile phones. For the second half of 2010, Zoom now expects to sell 580,000 Leimone mobile phones, including 100,000 units of the latest 3G design. The Leimone brand phones have a higher profit margin than Zoom's traditional EMS business and they are sold through China Telecom and various retail outlets.
Zoom's Leimone brand product line currently includes 17 models of Leimone feature-rich mobile phones equipped with state of the art technologies, with four models for China's 3G networks. Zoom unveiled its first Leimone brand 3G phone designed specifically for China Telecom's 3G market in early 2010. The successful E63 model was followed quickly by two additional 3G models, the Leimone E66 phone designed for professionals and the feature-rich Leimone E33 phone aimed at the price sensitive youth market.
Mr. Leo Gu, Chairman and Chief Executive Officer of Zoom Technologies, stated, "We are proud of our continued expansion in the rapidly growing China 3G market and our ability to produce mobile products for top tier Chinese mobile phone companies. Leimone brand mobile phones are extremely popular with the growing number of young people in China who seek feature-rich, mid-priced and sleek designed mobile phones. In addition, our ability to significantly increase our manufacturing capabilities in the second half of 2010 underscores our strong position in the robust China mobile phone market."
About Zoom Technologies
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for the latest generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its Own Brand Manufacturing (OBM) under the Leimone brand name. The company's products are both exported and sold domestically.
Forward-Looking Statements
Certain statements in this press release may constitute "forward looking statements" that involve risks and uncertainties. These include statements about our expectations, plans, objectives, assumptions or future events. You should not place undue reliance on these forward-looking statements. Information concerning factors that could cause our actual results to differ materially from these forward-looking statements can be found in our periodic reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly release revisions to these forward-looking statements to reflect future events or circumstances or reflect the occurrence of unanticipated events.
Contacts:
Cynthia Hiponia
The Blueshirt Group
+1 415-217-4966