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BARCHART -
http://quote.barchart.com/texpert.asp?sym=enco&code=BSTK
Composite Indicator
Trend Spotter TM Buy
Short Term Indicators
7 Day Average Directional Indicator Buy
10 - 8 Day Moving Average Hilo Channel Buy
20 Day Moving Average vs Price Buy
20 - 50 Day MACD Oscillator Buy
20 Day Bollinger Bands Buy
Short Term Indicators Average: 100% - Buy
20-Day Average Volume - 1588720
Medium Term Indicators
40 Day Commodity Channel Index Buy
50 Day Moving Average vs Price Buy
20 - 100 Day MACD Oscillator Buy
50 Day Parabolic Time/Price Buy
Medium Term Indicators Average: 100% - Buy
50-Day Average Volume - 646404
Long Term Indicators
60 Day Commodity Channel Index Buy
100 Day Moving Average vs Price Buy
50 - 100 Day MACD Oscillator Sell
Long Term Indicators Average: 33% - Buy
100-Day Average Volume - 348751
Overall Average: 88% - Buy
Price Support Pivot Point Resistance
5.46 3.78 5.50 7.22
19th – 22nd of April 2010 - World_Vaccine_Congress_Washington_DC
Please visit our Vaccine page at: www.encorium.com/vaccines
http://www.terrapinn.com/2010/wvcdc/index.stm
Gold Sponsor: i.e. ENCORIUM
http://www.terrapinn.com/2010/wvcdc/confspon.stm
Speakers
http://www.terrapinn.com/2010/wvcdc/speakerList.stm
... Dr George Lautscham,
Director Business Development, Encorium
19th – 22nd of April 2010 - World_Vaccine_Congress_Washington_DC
Please visit our Vaccine page at: www.encorium.com/vaccines
http://www.terrapinn.com/2010/wvcdc/index.stm
Gold Sponsor: i.e. ENCORIUM
http://www.terrapinn.com/2010/wvcdc/confspon.stm
Speakers
http://www.terrapinn.com/2010/wvcdc/speakerList.stm
... Dr George Lautscham,
Director Business Development, Encorium
SEC accuses Goldman Sachs of civil fraud
SEC accuses Goldman Sachs of fraud in failing to disclose conflict in mortgage securities
Marcy Gordon, AP Business Writer,
Friday April 16, 2010, 11:41 am
http://finance.yahoo.com/news/SEC-accuses-Goldman-Sachs-of-apf-1523020722.html?x=0
WASHINGTON (AP) -- The government has accused Goldman Sachs & Co. of defrauding investors by failing to disclose conflicts of interest in mortgage investments it sold as the housing market was faltering.
The Securities and Exchange Commission announced Friday civil fraud charges against the Wall Street powerhouse and one of its vice presidents. The agency alleges Goldman failed to disclose that one of its clients helped create -- and then bet against -- subprime mortgage securities that Goldman sold to investors.
Investors in the mortgage securities are alleged to have lost more than $1 billion, the SEC noted. The agency is seeking to recoup profits reaped on the deal.
The Goldman client implicated in the fraud is one of the world's largest hedge funds, Paulson & Co., which paid Goldman roughly $15 million for structuring the deals in 2007.
Goldman Sachs shares fell more than 12 percent after the SEC announcement, which also caused shares of other financial companies to sink. The Dow Jones industrial average fell more than 120 points in midday trading.
The civil lawsuit filed by the SEC in federal court in Manhattan was the government's most significant legal action related to the mortgage meltdown that ignited the financial crisis and helped plunge the country into recession.
A Goldman Sachs spokesman didn't immediately return a call seeking comment.
The agency also charged a Goldman vice president, Fabrice Tourre, 31, who it said was principally responsible for devising the deal and marketing the securities.
The SEC is seeking unspecified fines and restitution from Goldman Sachs and Tourre.
Goldman told investors that a third party, ACA Management LLC, had selected the underlying mortgages in the investment. But, the SEC alleges, Goldman misled investors by failing to disclose that Paulson & Co. also played a role in selecting the mortgages and stood to profit from their decline in value.
"Goldman wrongly permitted a client that was betting against the mortgage market to heavily influence which mortgage securities to include in an investment portfolio, while telling other investors that the securities were selected by an independent, objective third party," SEC Enforcement Director Robert Khuzami said in a statement.
Stock Alert for Encorium Group Inc. Issued by MicroStockProfit
Date : 04/16/2010 @ 6:50AM
Source : GlobeNewswire Inc.
Stock : (ENCO)
http://ih.advfn.com/p.php?pid=nmona&article=42409451&symbol=ENCO
DALLAS, April 16, 2010
GLOBE NEWSWIRE
MicroStockProfit.com announces an investment report featuring Encorium Group Inc. (Nasdaq:ENCO). The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.
The full report is available at: www.microstockprofit.com/ads/ENCO
Encorium Group Inc. (ENCO) is a clinical research organization (CRO), which is engaged in the design and management of clinical trials for the pharmaceutical, biotechnology and medical device industries. The Company's clients consist of companies in the pharmaceutical, biotechnology and medical device industries. The Company offers a range of clinical research and development services supporting phase I through phase IV clinical trials, such as strategic trial planning, project management, monitoring, data management and biostatistics, pharmacovigilance, medical writing, quality assurance, outsourcing of clinical staff and medical device certification in the European Union. The Company's services include study protocol design, clinical trials management, global data management services, biostatistics, medical and regulatory affairs, quality assurance and compliance, and medical report writing.
In the report, the analyst notes:
"ENCO recently announced that it will file a Form 12b-25 with the Securities and Exchange Commission, which will provide the Company with a 15-calendar day extension for filing its Annual Report on Form 10-K for the fiscal year ended December 31, 2009. The Company's independent registered accounting firm has not completed its audit of the Company's financial statements and has not provided its report and consent for the Company's Annual Report. The Company will file its Form 10-K as soon as its independent registered accounting firm provides its report on those financial statements and its consent."
To read the entire report visit: www.microstockprofit.com/ads/ENCO
MicroStockProfit.com is a small-cap research and investment commentary provider. MicroStockProfit.com strives to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in their research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on MicroStockProfit please visit: http://www.microstockprofit.com.
MicroStockProfit.com Disclosure
MicroStockProfit.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. MicroStockProfit.com is a Web site wholly owned by BlueWave Advisors, LLC. Neither MicroStockProfit.com nor its affiliates have a beneficial interest in the mentioned company; nor have they received compensation of any kind for any of the companies listed in this communication. Please read our report and visit our Web site, MicroStockProfit.com, for complete risks and disclosures.
CONTACT: MicroStockProfit.com
Brian Johnson
1-888-307-2850
info@microstockprofit.com
Outlook Q1/2010
For the first quarter ended March 31, 2010, management expects revenue of at least $480,000, compared to revenue of $179,000 for the first quarter last year. This estimate is based on:
•Total un-audited Internet sales for its partner website www.CountyImports.com have surpassed $393,000 for the first three months of 2010. These transactions are not associated with goods sold at any Buggy World brick & mortar locations or affiliate shops. This represents a 33.5% increase compared to total, un-audited online sales for the corresponding period of 2009 and is essentially flat on a year-over-year basis compared to the $402,000 for the first quarter of 2009, which represented the highest quarterly online sales in the Company's more than five year existence. Average online orders grew nearly 21% from $1,141 per transaction over the comparative period to nearly $1,700 per order over the first three months of 2010.
•Internet sales increased sequentially for each month of 2010 thus far, indicating acceleration due to the more highly-targeted web traffic being driven to www.CountyImports.com through more innovative online advertising.
Mr. Drechsler concluded, "San West and CountyImports.com management continue to be excited about the future. As we move into the seasonally slower first quarter, we are in the strongest position in our company's history. We have diversified our product offerings to begin to mitigate the seasonal slowness in our scooter business. Like many retailers, we did not experience the large holiday season bump we had anticipated, but our weekly and monthly sales levels continue to increase from our online properties. We believe 2010 will be a record year for San West."
http://www.marketwire.com/press-release/San-West-Inc-Reports-Fourth-Quarter-and-Full-Year-2009-Results-1148919.htm
ADVENTRX Resolves NYSE Amex Listing Deficiencies / Plans Reverse Stock Split to Address Exchange's Low Stock Price Concern
16.04.2010 14:06
http://www.finanznachrichten.de/nachrichten-2010-04/16645736-adventrx-resolves-nyse-amex-listing-deficiencies-plans-reverse-stock-split-to-address-exchange-s-low-stock-price-concern-008.htm
SAN DIEGO, April 16 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it has resolved the stockholders' equity continued listing deficiencies originally identified by the NYSE Amex in a June 2009 letter to the Company. In part to address the NYSE Amex's requirement that the Company address its low stock price, ADVENTRX also announced that its Board of Directors has approved a 1-for-25 reverse split of its common stock, which was authorized by its stockholders at a special meeting held in August 2009. The Company's common stock will begin trading on a split adjusted basis on the NYSE Amex when the market opens on Monday, April 26, 2010.
In June 2009, the NYSE Amex notified the Company that it was not in compliance with the NYSE Amex's continued listing standards related to stockholders' equity. Through financing activity in 2009, ADVENTRX increased its stockholder's equity to approximately $6.7 million as of December 31, 2009, which exceeds continued listing standards related to stockholders' equity. In April 2010, the NYSE Amex notified the Company that, based on a review of publicly available information, ADVENTRX has resolved the continued listing deficiencies originally identified in the June 2009 letter. According to the April 2010 letter, the Company must demonstrate compliance with the continued listing standards for two consecutive quarters and/or by December 1, 2010, otherwise the NYSE Amex may initiate delisting procedures. In part as a result of a financing completed in January 2010, the Company anticipates complying with continued listing standards related to stockholders' equity at March 31, 2010.
The reverse stock split is intended to satisfy the NYSE Amex's determination in the June 2009 letter that it is appropriate for the Company to effect a reverse stock split to address its low price per share and that, if a reverse stock split is not completed within a reasonable amount of time, the NYSE Amex may initiate delisting procedures. The Company also believes that a higher share price could broaden ADVENTRX's appeal to investors, in addition to reducing per share transaction fees and certain administrative costs.
The reverse split will be effective upon the close of trading on Friday, April 23, 2010, and the Company's common stock will begin trading on a split adjusted basis on the NYSE Amex when the market opens on Monday, April 26, 2010. The reverse split will reduce the number of shares of the Company's common stock outstanding from approximately 257 million to approximately 10.3 million. Proportional adjustments will be made to ADVENTRX's outstanding stock options, warrants and other equity awards and to its equity compensation plans. Par value and the number of authorized shares of common stock will not change. The Company will not issue any fractional shares. Stockholders will receive cash in lieu of fractional shares to which they would otherwise be entitled.
Information for Stockholders regarding Reverse Stock Split
Registered holders of ADVENTRX common stock will receive a letter of transmittal shortly after the effective date of the reverse stock split with instructions for the exchange of their old stock certificates or the electronic adjustment of their holdings through the direct registration system, as applicable. American Stock Transfer and Trust Company will act as the exchange agent and can be contacted at (877) 2486417. Stockholders with shares in brokerage accounts will be contacted by their brokers with instructions.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are designed to improve the performance of existing cancer treatments by addressing limitations associated principally with their safety and use. More information can be found on the Company's web site at http://www.adventrx.com/.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that ADVENTRX will not meet the NYSE Amex's stockholders' equity continued listing standards for two consecutive quarters and/or by December 1, 2010 and that the NYSE Amex staff will commence delisting proceedings; the risk of negative market reaction following announcement and/or implementation of the planned reverse stock split, resulting in stock price decline; the risk of unexpected delays in completing the reverse stock split; the risk that NYSE Amex will commence delisting proceedings based on a future low selling price per share; the risk that ADVENTRX will pursue development activities at levels or on timelines, or will incur unexpected expenses, that shortens the period through which it is able to comply with NYSE Amex continued listing requirements related to stockholders' equity; the risk that ADVENTRX will be unable to raise sufficient additional capital to continue to develop, seek regulatory approval of and commercialize its product candidates while maintaining compliance with NYSE Amex continued listing requirements related to stockholders' equity; the risk of difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ADVENTRX's lead product candidates; ADVENTRX's reliance on the performance of third parties to assist in the conduct of its bioequivalence trials, regulatory submissions, CMC activities and other important aspects of its product candidate development programs, and that such third parties may fail to perform as expected; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2009. ADVENTRX's public filings with the Securities and Exchange Commission are available at http://www.sec.gov/.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to update any forward-looking statement as set forth in this press release to reflect events or circumstances arising after the date on which it was made.
Company Contact: Investor Contact:
ADVENTRX Pharmaceuticals Lippert/Heilshorn&Associates, Inc.
Brian Culley, Chief Executive Officer Don Markley (dmarkley@lhai.com)
858-552-0866 310-691-7100
ADVENTRX Pharmaceuticals, Inc.
CONTACT: Brian Culley, Chief Executive Officer of ADVENTRX
Pharmaceuticals , +1-858-552-0866; or Investors, Don Markley of
Lippert/Heilshorn&Associates, Inc., +1-310-691-7100, dmarkley@lhai.com, for
ADVENTRX Pharmaceuticals
Web Site: http://www.adventrx.com/
© 2010 PR Newswire
Æterna Zentaris Receives Positive Scientific Advice from the European Medicines Agency for its Phase 3 Program with Perifosine in Multiple Myeloma
Date : 04/15/2010 @ 7:30AM
Source : PR Newswire
Stock : Aeterna Zentaris (MM) (AEZS)
http://ih.advfn.com/p.php?pid=nmona&cb=1271342956&article=42391362&symbol=N^AEZS
PR Newswire
QUEBEC CITY, April 15
Company Has Also Requested Scientific Advice on its Phase 3 Program with Perifosine in Refractory Advanced Colorectal Cancer.
QUEBEC CITY, April 15 /PRNewswire-FirstCall/ - Æterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company"), a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it has requested Scientific Advice from the European Medicines Agency (EMA) to assure the acceptability of the recently initiated Phase 3 programs for the development of its lead anticancer compound, perifosine, in its two lead indications, multiple myeloma and refractory advanced colorectal cancer. Previously, agreement was reached with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the pivotal studies in each of the lead indications, which will be sponsored by Keryx Biopharmaceuticals Inc., (Keryx), (NASDAQ: KERX), Æterna Zentaris's licensee for perifosine in North America.
In multiple myeloma, the SPA-agreed upon Phase 3 study is a double-blind, placebo-controlled study of perifosine combined with bortezomib (Velcade(R)) in bortezomib pretreated patients. Progression-free survival will be the primary efficacy endpoint in this trial, which will include follow-up for overall survival. The advice from the EMA indicates that, in principle, the proposed study is considered sufficient to provide all data necessary to support a marketing authorization of perifosine in combination with bortezomib (Velcade(R)). At the relevant time, the actual approved indication in Europe will have to take into account the availability of liposomal doxorubicin (Caelyx(R)), which in the European Union is approved in bortezomib pretreated patients with multiple myeloma. Further, the EMA has confirmed that the planned electrocardiogram (ECG) evaluations included in the Phase 3 study will suffice to assess the cardiac safety of perifosine. Therefore, the Company does not intend to initiate any additional study with perifosine in Europe for the multiple myeloma indication.
Æterna Zentaris has also requested Scientific Advice for the development of perifosine in refractory advanced colorectal cancer, where the SPA-agreed upon Phase 3 study is a double-blind placebo-controlled study comparing the combination of perifosine and capecitabine (Xeloda(R)) with single-agent capecitabine (Xeloda(R)). Patients in this study will be intensively pretreated and will have failed all available treatment options except capecitabine (Xeloda(R)). Overall survival will be analyzed as the primary efficacy endpoint. For both indications, safety data from studies of perifosine in other indications and drug combinations will be used as supportive information to define the clinical safety profile of perifosine.
Dr. Juergen Engel, President and CEO of Æterna Zentaris stated, "We are very pleased with the outcome of our discussions with the European Medicines Agency so far. For the development of perifosine in multiple myeloma, we believe that the planned North American clinical program, which is sponsored by our partner Keryx, is sufficient to support an application for marketing authorization in Europe and the rest of the world. We are looking forward to the outcome of our discussions with the EMA which is expected during the third quarter of this year, regarding our development program in colorectal cancer."
About Scientific Advice
Scientific Advice is a procedure offered by the European Medicines Agency to stakeholders for clarification of questions arising during development of medicinal products. The scope of Scientific Advice is limited to scientific issues, i.e. to quality, non-clinical and clinical aspects of the concerned medicinal product not yet unequivocally covered by published scientific guidelines. Scientific Advice focuses on development strategies rather than pre-evaluation of data to support a Marketing Authorization Application. Scientific Advice is legally non-binding and is based on the current scientific knowledge which may be subject to future changes.
About Perifosine
Perifosine is a novel, potentially first-in-class, oral anticancer agent that modulates Akt, and a number of other key signal transduction pathways, including the JNK and MAPK pathways, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. The effects of perifosine on Akt are of particular interest because of the importance of this pathway in the development of most cancers, with evidence that it is often activated in tumors that are resistant to other forms of anticancer therapy, and the difficulty encountered thus far in the discovery of drugs that will inhibit this pathway without causing excessive toxicity. High levels of activated Akt (pAkt) are seen frequently in many types of cancer and have been correlated with poor prognosis.
About Æterna Zentaris Inc.
Æterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. News releases and additional information are available at www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are required by a governmental authority or applicable law.
SOURCE AETERNA ZENTARIS INC.
Keryx Biopharmaceuticals Reports Updated Long-Term Data of Zerenex (ferric citrate) Presented at National Kidney Foundation (NKF)
Date : 04/15/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=42392688&symbol=KERX
PR Newswire
NEW YORK, April 15
NEW YORK, April 15 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today reported updated long-term efficacy and safety data on Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of hyperphosphatemia (elevated phosphate levels) from an open-label extension study in patients with end-stage renal disease (ESRD) who are on dialysis. This data was presented yesterday at the National Kidney Foundation (NKF) 2010 Spring Clinical Meeting taking place in Orlando, Florida in a poster entitled "Long-Term Use of Ferric Citrate in End-Stage Renal Disease Patients."
After the completion of a 28-day fixed dose Phase 2 clinical trial of ferric citrate in ESRD patients, 29 patients who had participated in this trial at the site in Taiwan were offered to continue onto an Open-Label Extension (OLE) trial for up to one year. There was approximately a two month period between the completion of the Phase 2 dose-ranging trial and enrollment into the OLE trial. During this time interval, no patient was exposed to ferric citrate as a phosphate binder. Patients were immediately switched back to ferric citrate from other phosphate binders and there was no washout period prior to starting ferric citrate treatment in the OLE trial. Of the 29 patients enrolled, 28 were exposed to ferric citrate. The patients were started on doses of ferric citrate of 2 to 6 g/day. The maximum allowed dose was 6 g/day. The average dose per patient throughout the study was approximately 4.5 g/day. The average duration of the patient's participation in the trial was 306 +/- 85 days. The primary objective of this OLE trial of ferric citrate was to assess the long-term efficacy and safety of ferric citrate as a phosphate binder in ESRD patients for up to one year. The secondary objective of this OLE trial was to assess for the potential for iron absorption.
The therapeutic goal of the study was to achieve and maintain a serum phosphorus level below 5.5 mg/dL. The mean levels of serum phosphorus (SP) and phosphorus x calcium product (PxC) for the evaluable patients at each time point over the treatment period were as follows:
SP (mg/dL)
PxC (mg/dL)2
Baseline (sd)
5.63 (1.22)
50.79 (12.74)
3 months (sd)
5.48 (1.33)
51.84 (12.67)
6 months (sd)
5.16 (1.20)
48.40 (9.60)
9 months (sd)
5.24 (1.20)
48.72 (12.04)
12 months (sd)
5.21 (1.09)
50.05 (11.82)
Iron Absorption
Iron parameters were measured at baseline and then quarterly through month 9. On average, slight increases were observed over time, across all key parameters, as follows:
Baseline (sd)
9 Months (sd)
Ferritin (ng/mL)
520 (328)
781 (364)
TSAT (%)
39.2 (19.7)
45.5 (21.1)
Iron (mcg/dL)
87.8 (37.9)
88.3 (37.2)
HCT (%)
30.8 (6.9)
32.9 (9.7)
If a patient had a ferritin > 600 ng/mL and a TSAT > 50%, the use of IV iron was withheld until the patient's ferritin and TSAT were below the above levels during the treatment period. If a patient had a hematocrit (HCT) > 36%, the use of EPO was withheld until the HCT was < 36% during the treatment period.
There were 8 patients that had IV iron supplements withheld for approximately 3 to 6 months and there were 8 patients that had EPO withheld for approximately 1 to 10 months during the OLE trial. Out of the 16 patients in the two groups, three patients had both IV iron and EPO withheld.
Ferric citrate was well-tolerated throughout the OLE study. There were no patient deaths during the OLE and no serious adverse events reported related to ferric citrate.
The investigators concluded that in this OLE trial of ferric citrate with doses as high as 6 g/day, ferric citrate demonstrated the potential to be used long-term as a phosphate binder in ESRD patients. Ferric citrate appeared to be efficacious in controlling serum phosphorus and well-tolerated and safe for up to one year. Additionally, it is the investigators' opinion that this OLE trial, along with data from both animal studies and the Phase 2 high dose trial supports the notion that some iron absorption may be occurring with the use of ferric citrate as a phosphate binder in ESRD patients and that if a reduction in the use of IV-iron supplements and/or EPO are documented in future long-term clinical trials, the cost-benefit and cost-effectiveness of ferric citrate as a phosphate binder, as compared to currently marketed phosphate binders, would be significant.
Ron Bentsur, CEO of Keryx Biopharmaceuticals, commented, "This long-term data provides further evidence of the potential utility of Zerenex as an effective phosphate binder. Also of importance, is Zerenex's potential ability, as an iron-based phosphate binder, to lower the need for IV-iron and/or EPO in this patient population, which could be another advantage, compared to the currently marketed phosphate binders. We intend to monitor for this potential benefit in our upcoming Phase 3 program."
The Company's Phase 3 clinical program of Zerenex as a treatment for hyperphosphatemia in patients with end-stage renal disease who are on dialysis is pending commencement under a Special Protocol Assessment (SPA) agreement with the FDA.
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.
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 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex™ (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 pending commencement under 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 and business prospects for Zerenex (ferric citrate), 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 program will not coincide with the data analyses from the Phase 2 clinical trials previously reported by the Company, including the effects on IV iron and erythropoietin use observed in the long-term safety extension trial; 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 intend 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 in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals Reports Updated Long-Term Data of Zerenex (ferric citrate) Presented at National Kidney Foundation (NKF)
Date : 04/15/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=42392688&symbol=KERX
PR Newswire
NEW YORK, April 15
NEW YORK, April 15 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today reported updated long-term efficacy and safety data on Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of hyperphosphatemia (elevated phosphate levels) from an open-label extension study in patients with end-stage renal disease (ESRD) who are on dialysis. This data was presented yesterday at the National Kidney Foundation (NKF) 2010 Spring Clinical Meeting taking place in Orlando, Florida in a poster entitled "Long-Term Use of Ferric Citrate in End-Stage Renal Disease Patients."
After the completion of a 28-day fixed dose Phase 2 clinical trial of ferric citrate in ESRD patients, 29 patients who had participated in this trial at the site in Taiwan were offered to continue onto an Open-Label Extension (OLE) trial for up to one year. There was approximately a two month period between the completion of the Phase 2 dose-ranging trial and enrollment into the OLE trial. During this time interval, no patient was exposed to ferric citrate as a phosphate binder. Patients were immediately switched back to ferric citrate from other phosphate binders and there was no washout period prior to starting ferric citrate treatment in the OLE trial. Of the 29 patients enrolled, 28 were exposed to ferric citrate. The patients were started on doses of ferric citrate of 2 to 6 g/day. The maximum allowed dose was 6 g/day. The average dose per patient throughout the study was approximately 4.5 g/day. The average duration of the patient's participation in the trial was 306 +/- 85 days. The primary objective of this OLE trial of ferric citrate was to assess the long-term efficacy and safety of ferric citrate as a phosphate binder in ESRD patients for up to one year. The secondary objective of this OLE trial was to assess for the potential for iron absorption.
The therapeutic goal of the study was to achieve and maintain a serum phosphorus level below 5.5 mg/dL. The mean levels of serum phosphorus (SP) and phosphorus x calcium product (PxC) for the evaluable patients at each time point over the treatment period were as follows:
SP (mg/dL)
PxC (mg/dL)2
Baseline (sd)
5.63 (1.22)
50.79 (12.74)
3 months (sd)
5.48 (1.33)
51.84 (12.67)
6 months (sd)
5.16 (1.20)
48.40 (9.60)
9 months (sd)
5.24 (1.20)
48.72 (12.04)
12 months (sd)
5.21 (1.09)
50.05 (11.82)
Iron Absorption
Iron parameters were measured at baseline and then quarterly through month 9. On average, slight increases were observed over time, across all key parameters, as follows:
Baseline (sd)
9 Months (sd)
Ferritin (ng/mL)
520 (328)
781 (364)
TSAT (%)
39.2 (19.7)
45.5 (21.1)
Iron (mcg/dL)
87.8 (37.9)
88.3 (37.2)
HCT (%)
30.8 (6.9)
32.9 (9.7)
If a patient had a ferritin > 600 ng/mL and a TSAT > 50%, the use of IV iron was withheld until the patient's ferritin and TSAT were below the above levels during the treatment period. If a patient had a hematocrit (HCT) > 36%, the use of EPO was withheld until the HCT was < 36% during the treatment period.
There were 8 patients that had IV iron supplements withheld for approximately 3 to 6 months and there were 8 patients that had EPO withheld for approximately 1 to 10 months during the OLE trial. Out of the 16 patients in the two groups, three patients had both IV iron and EPO withheld.
Ferric citrate was well-tolerated throughout the OLE study. There were no patient deaths during the OLE and no serious adverse events reported related to ferric citrate.
The investigators concluded that in this OLE trial of ferric citrate with doses as high as 6 g/day, ferric citrate demonstrated the potential to be used long-term as a phosphate binder in ESRD patients. Ferric citrate appeared to be efficacious in controlling serum phosphorus and well-tolerated and safe for up to one year. Additionally, it is the investigators' opinion that this OLE trial, along with data from both animal studies and the Phase 2 high dose trial supports the notion that some iron absorption may be occurring with the use of ferric citrate as a phosphate binder in ESRD patients and that if a reduction in the use of IV-iron supplements and/or EPO are documented in future long-term clinical trials, the cost-benefit and cost-effectiveness of ferric citrate as a phosphate binder, as compared to currently marketed phosphate binders, would be significant.
Ron Bentsur, CEO of Keryx Biopharmaceuticals, commented, "This long-term data provides further evidence of the potential utility of Zerenex as an effective phosphate binder. Also of importance, is Zerenex's potential ability, as an iron-based phosphate binder, to lower the need for IV-iron and/or EPO in this patient population, which could be another advantage, compared to the currently marketed phosphate binders. We intend to monitor for this potential benefit in our upcoming Phase 3 program."
The Company's Phase 3 clinical program of Zerenex as a treatment for hyperphosphatemia in patients with end-stage renal disease who are on dialysis is pending commencement under a Special Protocol Assessment (SPA) agreement with the FDA.
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.
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 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex™ (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 pending commencement under 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 and business prospects for Zerenex (ferric citrate), 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 program will not coincide with the data analyses from the Phase 2 clinical trials previously reported by the Company, including the effects on IV iron and erythropoietin use observed in the long-term safety extension trial; 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 intend 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 in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
LINK back -
Annual Report (10-K)
Date : 03/31/2010 @ 4:06PM
Source : Edgar (US Regulatory)
Stock : (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1270091713&article=42215627&symbol=N^NEXM
...Vitaros ®
In February 2010, we met with Health Canada to discuss their concerns and were able to reach agreement with them on the necessary action steps which would be completed and included in our response to the Notice due on or before April 14, 2010.
May 16-18, 2010 -
http://www.rodmanandrenshaw.com/conferences?id=44&link=presenters
Presenting companies: i.e.
NexMed and Ångstrom Pharmaceuticals to Present Data on Å6 Drug at AACR
Date : 04/13/2010 @ 11:00AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1271170984&article=42359149
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that Bio-Quant, its wholly-owned subsidiary, and Ångstrom Pharmaceuticals, a privately-held pharmaceutical company, will jointly present data at the 101st Annual Meeting of the American Association for Cancer Research (AACR), in Washington, D.C. from April 17-21, 2010. The poster presentation, entitled, “Å6 peptide binds to CD44 and inhibits migration and metastasis of CD44+ cell lines in in vitro and in vivo studies,” covers pre-clinical work completed by Bio-Quant on Ångstrom’s lead product, Å6, currently in Phase 2 development for ovarian cancer.
Bassam Damaj, Ph.D., President and Chief Executive Officer of NexMed, and one of the presenters at AACR, stated, “We are pleased to have supported Ångstrom in their target identification of the Å6 drug. Å6 has demonstrated activity in in vitro models of cell migration, invasion and angiogenesis, as well as in breast, prostate and brain tumor models. Similar activity was also seen in animal models of ocular disease. The results support the efficacy of Å6 across various cancer cells, which suggests that the drug is addressing a fundamental pathway for proliferative and invasive diseases.”
Malcolm Finlayson, Ph.D., President and Chief Executive Officer of Ångstrom, noted, “The work done by NexMed’s Bio-Quant team on behalf of Ångstrom is a testament to their expertise in the field of oncology. We look forward to the results of the ongoing studies on the mechanism of action of Å6.”
About Ångstrom Pharmaceuticals and Å6
Based in San Diego, CA, Ångstrom is developing a new class of drugs targeting CD44 for the treatment of diseases involving cell migration, invasion, and metastasis. Results from a completed Phase 1a safety clinical trial on Å6 showed there were no systemic drug-related adverse events in healthy volunteers. Ångstrom has also successfully completed a Phase 1b clinical trial evaluating Å6 in women with advanced gynecologic cancer, and a Phase 2 clinical trial evaluating Å6 in women with asymptomatic CA125 progression of epithelial ovarian cancer after first-line chemotherapy. Treatments were well tolerated and more than 40% of the patients dosed continuously with Å6 experienced disease stabilization. For further information, go to www.angstrominc.com.
About NexMed
NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. The Company’s goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites: http://www.nexmed.com or http://www.bio-quant.com.
NexMed and Ångstrom Pharmaceuticals to Present Data on Å6 Drug at AACR
Date : 04/13/2010 @ 11:00AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1271170984&article=42359149
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that Bio-Quant, its wholly-owned subsidiary, and Ångstrom Pharmaceuticals, a privately-held pharmaceutical company, will jointly present data at the 101st Annual Meeting of the American Association for Cancer Research (AACR), in Washington, D.C. from April 17-21, 2010. The poster presentation, entitled, “Å6 peptide binds to CD44 and inhibits migration and metastasis of CD44+ cell lines in in vitro and in vivo studies,” covers pre-clinical work completed by Bio-Quant on Ångstrom’s lead product, Å6, currently in Phase 2 development for ovarian cancer.
Bassam Damaj, Ph.D., President and Chief Executive Officer of NexMed, and one of the presenters at AACR, stated, “We are pleased to have supported Ångstrom in their target identification of the Å6 drug. Å6 has demonstrated activity in in vitro models of cell migration, invasion and angiogenesis, as well as in breast, prostate and brain tumor models. Similar activity was also seen in animal models of ocular disease. The results support the efficacy of Å6 across various cancer cells, which suggests that the drug is addressing a fundamental pathway for proliferative and invasive diseases.”
Malcolm Finlayson, Ph.D., President and Chief Executive Officer of Ångstrom, noted, “The work done by NexMed’s Bio-Quant team on behalf of Ångstrom is a testament to their expertise in the field of oncology. We look forward to the results of the ongoing studies on the mechanism of action of Å6.”
About Ångstrom Pharmaceuticals and Å6
Based in San Diego, CA, Ångstrom is developing a new class of drugs targeting CD44 for the treatment of diseases involving cell migration, invasion, and metastasis. Results from a completed Phase 1a safety clinical trial on Å6 showed there were no systemic drug-related adverse events in healthy volunteers. Ångstrom has also successfully completed a Phase 1b clinical trial evaluating Å6 in women with advanced gynecologic cancer, and a Phase 2 clinical trial evaluating Å6 in women with asymptomatic CA125 progression of epithelial ovarian cancer after first-line chemotherapy. Treatments were well tolerated and more than 40% of the patients dosed continuously with Å6 experienced disease stabilization. For further information, go to www.angstrominc.com.
About NexMed
NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. The Company’s goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites: http://www.nexmed.com or http://www.bio-quant.com.
Keryx Biopharmaceuticals Announces Poster Presentations Highlighting Clinical Activity of Zerenex (ferric citrate) at National Kidney Foundation (NKF) 2010 Spring Clinical Meetings
Date : 04/13/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&cb=1271165086&article=42355644
Long-term data to be presented suggest that use of Zerenex may also potentially reduce the need for intravenous iron and erythropoietin in hyperphosphatemia patients on dialysis
PR Newswire
NEW YORK, April 13
NEW YORK, April 13 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that several posters on Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease who are on dialysis, have been accepted for presentation at the National Kidney Foundation (NKF) 2010 Spring Clinical Meeting taking place April 13-17, 2010, in Orlando, Florida.
The following posters will be presented tomorrow, April 14, 2010, from 6:00pm-7:30pm:
LONG-TERM USE OF FERRIC CITRATE IN ESRD PATIENTSTHE SAFETY AND TOLERABILITY OF HIGHER DOSES OF FERRIC CITRATE (FC) IN CONTROLLING SERUM PHOSPHORUS (P) IN ESRD PATIENTSIRON ABSORPTION WITH HIGHER DOSES OF FERRIC CITRATE IN CONTROLLING SERUM PHOSPHORUS IN ESRD PATIENTSThe Company's Phase 3 clinical program of Zerenex as a treatment for hyperphosphatemia in patients with end-stage renal disease who are on dialysis is pending commencement under a Special Protocol Assessment (SPA) agreement with the FDA.
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.
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 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements 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 pending commencement under 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 and business prospects for Zerenex (ferric citrate), 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 program will not coincide with the data analyses from the Phase 2 clinical trials previously reported by the Company, including the effects on IV iron and erythropoietin use observed in the long-term safety extension trial; 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 intend 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 in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
CONTACT: Lauren Fischer, Director, Investor Relations, Keryx Biopharmaceuticals, Inc., +1-212-531-5962, lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals Announces Poster Presentations Highlighting Clinical Activity of Zerenex (ferric citrate) at National Kidney Foundation (NKF) 2010 Spring Clinical Meetings
Date : 04/13/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&cb=1271165086&article=42355644
Long-term data to be presented suggest that use of Zerenex may also potentially reduce the need for intravenous iron and erythropoietin in hyperphosphatemia patients on dialysis
PR Newswire
NEW YORK, April 13
NEW YORK, April 13 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that several posters on Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease who are on dialysis, have been accepted for presentation at the National Kidney Foundation (NKF) 2010 Spring Clinical Meeting taking place April 13-17, 2010, in Orlando, Florida.
The following posters will be presented tomorrow, April 14, 2010, from 6:00pm-7:30pm:
LONG-TERM USE OF FERRIC CITRATE IN ESRD PATIENTSTHE SAFETY AND TOLERABILITY OF HIGHER DOSES OF FERRIC CITRATE (FC) IN CONTROLLING SERUM PHOSPHORUS (P) IN ESRD PATIENTSIRON ABSORPTION WITH HIGHER DOSES OF FERRIC CITRATE IN CONTROLLING SERUM PHOSPHORUS IN ESRD PATIENTSThe Company's Phase 3 clinical program of Zerenex as a treatment for hyperphosphatemia in patients with end-stage renal disease who are on dialysis is pending commencement under a Special Protocol Assessment (SPA) agreement with the FDA.
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.
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 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements 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 pending commencement under 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 and business prospects for Zerenex (ferric citrate), 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 program will not coincide with the data analyses from the Phase 2 clinical trials previously reported by the Company, including the effects on IV iron and erythropoietin use observed in the long-term safety extension trial; 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 intend 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 in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
CONTACT: Lauren Fischer, Director, Investor Relations, Keryx Biopharmaceuticals, Inc., +1-212-531-5962, lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
MedaSorb Technologies Corporation Reports Full Year 2009 Financial Results
Date : 04/12/2010 @ 4:45PM
Source : MarketWire
Stock : MedaSorb Technologies Corporation (MSBT)
http://ih.advfn.com/p.php?pid=nmona&article=42346448&symbol=MSBT
MONMOUTH JUNCTION, NJ -- (Marketwire)
04/12/10
MedaSorb Technologies Corporation (OTCBB: MSBT) and its wholly-owned subsidiary, CytoSorbents, Inc., announced its financial results for the fiscal year ended December 31, 2009.
The Company's research and development costs were $1,961,960 and $1,983,483 for the years ended December 31, 2009 and 2008, respectively. The Company had net losses of $2,736,715 and $3,017,890 for the years ended December 31, 2009 and December 31, 2008, respectively. Historically, our losses have resulted principally from costs incurred in the research and development of our polymer technology, and general and administrative expenses, which together were $2,719,410 and $2,892,855 for the years ended December 31, 2009 and December 31, 2008 respectively.
Dr. Phillip Chan, Chief Executive Officer and President, stated, "2009 was a positive year for the company, where we demonstrated first human proof of concept of our CytoSorb? device in septic patients with respiratory failure in a small pilot study. We also had broad support from our Series B shareholders, raising $1.3M in the Series B warrant exercise in October 2009 and supplemented these funds with non-dilutive money from grants and the sale of a portion of our net operating loss carryforwards. We also significantly expanded the market awareness of our Company and technology through a number of conference presentations, interviews, and greater shareholder communication.
"In 2010, we are pleased with an acceleration of enrollment in our European Sepsis Trial, a direct result of increasing our clinical trial sites to 14 last year and our ongoing efforts to boost recruitment. We now have CytoSorb? safety data on roughly 550 human treatments, including approximately 175 treatments in sepsis patients in our current trial. We continue to be excited by the many potential opportunities that we are pursuing with CytoSorb and our broad technology platform. As we complete our corporate name change to CytoSorbents Corporation in the near future, we will consolidate our websites and introduce several new features such as a frequently asked questions (FAQ) page to answer questions and keep our shareholder base informed. Select information can still be downloaded from our website http://www.cytosorbents.com/invest.htm."
For additional information please see our Form 10-K filed with the SEC on April 9, 2010, which is available at www.sec.gov.
About MedaSorb, CytoSorbents and CytoSorb?
MedaSorb Technologies Corporation, and its operating subsidiary CytoSorbents, is a therapeutic device company in clinical trials to treat severe sepsis, often called "overwhelming infection," with a novel blood purification device called CytoSorb?. Severe sepsis is typically caused by bacterial infections like pneumonia, or viral infections like influenza. It afflicts more than 1 million people in the United States and an estimated 18 million people worldwide each year, killing one in every three patients despite the best treatment. In the United States, more die from severe sepsis than from either heart attacks, strokes or any single form of cancer. Much of the organ failure and mortality in severe sepsis is caused by the abnormal massive production of cytokines by the immune system, often called "cytokine storm." CytoSorb? is a cartridge containing highly porous polymer beads that are designed to filter cytokines and treat potentially fatal cytokine storm. As blood is pumped through the CytoSorb? cartridge using standard dialysis equipment, the beads bind and remove cytokines and other toxins from blood. The treated blood is then returned to the patient. The Company is currently conducting its European Sepsis Trial -- a multi-center, randomized, controlled clinical trial using its flagship CytoSorb? device to treat up to 100 patients with severe sepsis in the setting of respiratory failure. Pending a successful trial, the Company will seek CE Mark approval and commercialization of CytoSorb? in the European Union. CytoSorb? is one of a number of different resins designed for different medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, treatment of rhabdomyolysis in trauma, removal of chemotherapy during treatment of cancer with high dose regional chemotherapy, drug detoxification and others. Additional information is available for download on the Company's website: www.cytosorbents.com
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. MedaSorb Technologies Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and CE Mark approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of pending and potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Form 10-K filed with the SEC on April 9, 2010, which is available at http://www.sec.gov.
Contact:
CytoSorbents, Inc.
David Lamadrid
(732) 329-8885 ext. 816
davidl@cytosorbents.com
PSBJ Pulitzer finalist for WaMu coverage
Monday, April 12, 2010, 12:25pm PDT
http://www.bizjournals.com/seattle/stories/2010/04/12/daily7.html?surround=lfn
The Puget Sound Business Journal has been named a finalist for the 2010 Pulitzer Prize for explanatory reporting for its coverage of the collapse of Washington Mutual and its comprehensive coverage of mortgage foreclosures.
Reporters Kirsten Grind, Jeanne Lang Jones and Managing Editor Alwyn Scott were cited for “their meticulous examination of the collapse of Washington Mutual, the biggest bank failure in U.S. history, plumbing causes and raising troubling questions about federal regulation."
Keryx shares jump on media report
12.04.2010 19:50
http://www.finanznachrichten.de/nachrichten-2010-04/16603567-keryx-shares-jump-on-media-report-020.htm
April 12 (Reuters) - Shares of Keryx Biopharmaceuticals Inc rose to their highest in two years Monday, a day after a media report said the stock could triple in value over the next year.
Brean Murray Carret and Co analyst Jonathan Aschoff pointed to a report Sunday on the Seeking Alpha website that suggests that Keryx's stock could reach $14 by 2011.
Keryx shares, which have gained about 30 percent in the last one month, were up 21 percent at $4.20 Monday afternoon. They touched a high of $4.22 earlier in the day.
On April 5, Keryx stock gained as much as 22 percent as its experimental cancer drug perifosine received fast-track status from the U.S. health regulator.
The status grants the company and its Canadian partner Aeterna Zentaris seven years of market exclusivity.
(Reporting by Vidya L Nathan in Bangalore; Editing by Unnikrishnan Nair) Keywords: KERYXBIOPHARMACEUTICALS/SHARES
(vidya.loganathan@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: vidya.loganathan.reuters.com@reuters.net)
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Apr 12-15, 2010
Las Vegas Convention Center
Las Vegas, NV
http://ih.advfn.com/p.php?pid=nmona&article=42316327&symbol=EMKR ** New openGear 3Gbps HD Broadcast Video Signal Transport Platform
EMCORE will be displaying these new products ** at the NABSHOW, April 12-15, 2010 at the Las Vegas Convention Center, Las Vegas, Nevada at Booth C10039 in the Central Hall.
The Hartford Enhances Leave Management Capabilities With Reporting, Communications, Self-service Tools
Date : 04/12/2010 @ 9:38AM
Source : Business Wire
Stock : The Hartford (HIG)
http://ih.advfn.com/p.php?pid=nmona&article=42339157&symbol=HIG
Time seems to fly when you’re not keeping track of it. And in the current economy, many business owners can’t afford to miss a minute, much less days or weeks of productive time. But the strain of managing absences can take a toll on businesses today. Understanding these dual pressures on employers, The Hartford Financial Services Group, Inc. (NYSE: HIG) is expanding its leave management capabilities to help employers’ maximize productivity.
The Hartford is enhancing its leave management capabilities with streamlined reporting and tracking capabilities, powerful self-service capabilities, and flexible communication tools for employers with 500 or more workers.
“Employers are struggling with tracking leaves, determining whether a condition qualifies as a serious health condition, and understanding new and existing regulations. We understand that strain combined with lost productivity can be taxing on a company’s bottom line,” said Ron Gendreau, executive vice president of The Hartford’s Group Benefits Division. “We have invested in people and capabilities that remove that burden from employers, allowing them to focus on growing their business.”
The Hartford’s in-house leave management team manages a variety of leaves – federal, state and company-sponsored – while coordinating them with short- and/or long-term disability leaves in compliance with applicable federal and state leave laws and/or regulations. With nearly a decade of providing leave and absence management services, The Hartford’s medical professionals are among the most knowledgeable in the industry.
Round-the-Clock Access
The enhancements to The Hartford’s leave management capabilities include flexible reporting and tracking to keep employers updated on the status of their workforce and manage production effectively. “Today employers aren’t necessarily aware of where they are losing productivity within their complex organizations. It’s a real challenge when they have a workforce in several locations and multiple lines of business,” Gendreau said. “Our robust reporting is designed to help employers understand the causes of their employees’ absences and better manage their productivity.”
In addition, The Hartford is boosting its self-service tools, providing employers with round-the-clock access to important information on their employee absences. These online resources include secure submission of leave requests and reports on the status of leaves.
The new leave management capabilities also include flexible communications tools that help employers better connect with their workers on a leave. “We know from our years of experience that employees have an easier transition back to productivity when there is communication early and often during their absence,” Gendreau said.
About The Hartford
Celebrating nearly 200 years of helping its customers achieve what’s ahead, The Hartford (NYSE: HIG) is an insurance and wealth management company. Through its unique focus on customer needs, the company serves businesses and consumers by providing the products and solutions they need to protect their assets and income from risks and manage their wealth and retirement needs. A Fortune 500 company, The Hartford is recognized widely for its service expertise and as one of the world's most ethical companies. More information on the company and its financial performance is available at www.thehartford.com.
HIG-L
Some of the statements in this release may be considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. We caution investors that these forward-looking statements are not guarantees of future performance, and actual results may differ materially. Investors should consider the important risks and uncertainties that may cause actual results to differ. These important risks and uncertainties include those discussed in our Quarterly Reports on Form 10-Q, our 2009 Annual Report on Form 10-K and the other filings we make with the Securities and Exchange Commission. We assume no obligation to update this release, which speaks as of the date issued.
Keryx Biopharmaceuticals Could Easily Triple Within the Next Year
April 11, 2010
http://seekingalpha.com/article/198045-keryx-biopharmaceuticals-could-easily-triple-within-the-next-year?source=feed
NOTICE OF ANNUAL MEETING OF SHAREHOLDERS TO BE HELD ON FRIDAY, MAY 21, 2010
http://ih.advfn.com/p.php?pid=nmona&cb=1270880690&article=42325266
The Proxy Statement and 2009 Annual Report are available at http://materials.proxyvote.com/290846 .
To our Shareholders:
The 2010 Annual Meeting of Shareholders (the “Annual Meeting”) of EMCORE Corporation (the “Company”) will be held at 10:00 A.M. local time on Friday, May 21, 2010, at the Albuquerque Marriott Hotel, 2101 Louisiana Blvd. NE, Albuquerque, New Mexico 87110, for the following purposes:
(1)
To elect three (3) members to the Company’s Board of Directors;
(2)
To ratify the selection of KPMG LLP as the Company’s independent registered public accounting firm for the fiscal year ending September 30, 2010;
(3)
To approve the adoption of the EMCORE Corporation 2010 Equity Incentive Plan and authorize the reservation of 4,000,000 shares of the Company’s common stock for issuance under such plan; and
(4)
To transact such other business as may properly come before the Annual Meeting and any adjournments or postponements thereof.
The Board of Directors has fixed the close of business on April 2, 2010 as the record date for determining those shareholders entitled to notice of, and to vote at, the Annual Meeting and any adjournments or postponements thereof. Whether or not you expect to be present, please vote and submit your proxy as promptly as possible in order to assure the presence of a quorum. You may vote by telephone, internet or mail. If you vote by telephone or internet, you do not have to send a proxy card via the mail.
By Order of the Board of Directors,
/s/ Keith J. Kosco
Keith J. Kosco, Esq.
Secretary
April 9, 2010
Albuquerque, New Mexico
As of the close of business on April 2, 2010 (the “Record Date”), the Company had 84,000,256 shares of no par value common stock (“Common Stock”) issued and outstanding.