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correct, however ANTISOMA is relatively unknown here
http://www.antisoma.com/
Pipeline: http://www.antisoma.com/asm/products/pipeline/
Partnering opportunities
Out-licensing
Antisoma is looking for worldwide partners for the following products:
AS1413 A novel DNA intercalator in phase III for secondary AML
AS1411 A novel DNA aptamer in phase IIb for relapsed/refractory AML
AS1402 A humanised monoclonal antibody (huHMFG1) which targets the glycoprotein, MUC1, that is overexpressed and aberrantly glycosylated in the majority of epithelial tumors. Phase II data are available
AS1409 A fusion protein combining the anti-tumour cytokine IL-12, with the tumour-targeting antibody BC1. A phase I trial with AS1409 in patients with malignant melanoma and renal cell carcinoma has been completed
PPM1D Inhibitor Programme PPM1D is aberrantly amplified in a range of cancers. Activation results in negative regulation of p53 function and other tumour suppressor pathways. Additional functions include the regulation of the base excision pathways of DNA repair. Programme is at lead optimisation
Dendritic Cell Autoimmune Modulators (DCAM) A novel class of oral agents that target specific populations of dendritic cells to modulate the immune response
...thanks! I'm in ax
IBOX updated!
Discovery Labs Announces Listing Transfer to NASDAQ Capital Market
http://www.globenewswire.com/newsroom/news.html?ref=rss&d=193381
WARRINGTON, Pa., June 2, 2010 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq: DSCO), announced today that The Nasdaq Stock Market, LLC has approved Discovery Labs' application to transfer its stock listing from The NASDAQ Global Market® to The NASDAQ Capital Market®. The transfer will be effective at the opening of the market on June 4, 2010. The Company's common stock will continue to be traded under the symbol "DSCO" and the transfer will have no impact on the ability of investors to trade the stock. The NASDAQ Capital Market is a continuous trading market that operates in the same manner as The NASDAQ Global Market. All companies listed on The NASDAQ Capital Market must meet certain financial requirements and adhere to Nasdaq's corporate governance standards.
On December 2, 2009, the Company received a delisting notification from The NASDAQ Global Market indicating that the Company's common stock had failed to close above $1.00 per share for more than 30 consecutive trading days and, as a result, the Company was not in compliance with the Minimum Bid Price Rule. The delisting notification also granted the Company 180 calendar days, or until June 1, 2010, to regain compliance with the Minimum Bid Price Rule, which would occur if the Company's common stock closed above $1.00 per share for ten consecutive trading days. As the Company's common stock has not closed above $1.00 per share for ten consecutive trading days within the grace period provided, to avoid a second delisting notification, the Company requested and received approval from Nasdaq to transfer the listing of its common stock from The NASDAQ Global Market to The NASDAQ Capital Market. 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. If compliance is not regained by that date, Nasdaq will notify the Company of its determination to delist the Company's common stock, which decision may be appealed to a Nasdaq Listing Qualifications Panel.
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.
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 are: risks relating to the rigorous regulatory requirements required for approval of any drug or drug-device combination products that Discovery Labs may develop, including that: (a) Discovery Labs and the U.S. Food and Drug Administration (FDA) or other regulatory authorities will not be able to agree on the matters raised during regulatory reviews, or Discovery Labs may be required to conduct significant additional activities to potentially gain approval of its product candidates, if ever, (b) the FDA or other regulatory authorities may not accept or may withhold or delay consideration of any of Discovery Labs' applications, or may not approve or may limit approval of Discovery Labs' products to particular indications or impose unanticipated label limitations, and (c) changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval; risks relating to Discovery Labs' research and development activities, including (i) time-consuming and expensive pre-clinical studies, clinical trials and other efforts, which may be subject to potentially significant delays or regulatory holds, or fail, and (ii) the need for sophisticated and extensive analytical methodologies, including an acceptable biological activity test, if required, as well as other quality control release and stability tests to satisfy the requirements of the regulatory authorities; risks relating to Discovery Labs' ability to develop and manufacture drug products and capillary aerosolization systems for clinical studies, and, if approved, for commercialization of drug and combination drug-device products, including risks of technology transfers to contract manufacturers and problems or delays encountered by Discovery Labs, its contract manufacturers or suppliers in manufacturing drug products, drug substances and capillary aerosolization systems on a timely basis or in an amount sufficient to support Discovery Labs' development efforts and, if approved, commercialization; the risk that Discovery Labs may be unable to identify potential strategic partners or collaborators to develop and commercialize its products, if approved, in a timely manner, if at all; the risk that Discovery Labs will not be able in a changing financial market to raise additional capital or enter into strategic alliances or collaboration agreements, or that the ongoing credit crisis will adversely affect the ability of Discovery Labs to fund its activities, or that additional financings could result in substantial equity dilution; the risk that Discovery Labs will not be able to access credit from its committed equity financing facilities (CEFFs), or that the minimum share price at which Discovery Labs may access the CEFFs from time to time will prevent Discovery Labs from accessing the full dollar amount potentially available under the CEFFs; the risk that Discovery Labs or its strategic partners or collaborators will not be able to retain, or attract, qualified personnel; the risk that Discovery Labs will be unable to regain compliance with The Nasdaq Capital Market listing requirements prior to the expiration of the additional grace period currently in effect, which could cause the price of Discovery Labs' common stock to decline; the risk that recurring losses, negative cash flows and the inability to raise additional capital could threaten Discovery Labs' ability to continue as a going concern; the risks that Discovery Labs may be unable to maintain and protect the patents and licenses related to its products, or other companies may develop competing therapies and/or technologies, or health care reform may adversely affect Discovery Labs; risks of legal proceedings, including securities actions and product liability claims; risks relating to health care reform; and other risks and uncertainties 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.
CONTACT: Discovery Laboratories, Inc.
John G. Cooper, EVP and Chief Financial Officer
215-488-9300
Discovery Labs Announces Listing Transfer to NASDAQ Capital_Market
http://www.globenewswire.com/newsroom/news.html?ref=rss&d=193381
WARRINGTON, Pa., June 2, 2010 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq: DSCO), announced today that The Nasdaq Stock Market, LLC has approved Discovery Labs' application to transfer its stock listing from The NASDAQ Global Market® to The NASDAQ Capital Market®. The transfer will be effective at the opening of the market on June 4, 2010. The Company's common stock will continue to be traded under the symbol "DSCO" and the transfer will have no impact on the ability of investors to trade the stock. The NASDAQ Capital Market is a continuous trading market that operates in the same manner as The NASDAQ Global Market. All companies listed on The NASDAQ Capital Market must meet certain financial requirements and adhere to Nasdaq's corporate governance standards.
On December 2, 2009, the Company received a delisting notification from The NASDAQ Global Market indicating that the Company's common stock had failed to close above $1.00 per share for more than 30 consecutive trading days and, as a result, the Company was not in compliance with the Minimum Bid Price Rule. The delisting notification also granted the Company 180 calendar days, or until June 1, 2010, to regain compliance with the Minimum Bid Price Rule, which would occur if the Company's common stock closed above $1.00 per share for ten consecutive trading days. As the Company's common stock has not closed above $1.00 per share for ten consecutive trading days within the grace period provided, to avoid a second delisting notification, the Company requested and received approval from Nasdaq to transfer the listing of its common stock from The NASDAQ Global Market to The NASDAQ Capital Market. 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. If compliance is not regained by that date, Nasdaq will notify the Company of its determination to delist the Company's common stock, which decision may be appealed to a Nasdaq Listing Qualifications Panel.
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.
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 are: risks relating to the rigorous regulatory requirements required for approval of any drug or drug-device combination products that Discovery Labs may develop, including that: (a) Discovery Labs and the U.S. Food and Drug Administration (FDA) or other regulatory authorities will not be able to agree on the matters raised during regulatory reviews, or Discovery Labs may be required to conduct significant additional activities to potentially gain approval of its product candidates, if ever, (b) the FDA or other regulatory authorities may not accept or may withhold or delay consideration of any of Discovery Labs' applications, or may not approve or may limit approval of Discovery Labs' products to particular indications or impose unanticipated label limitations, and (c) changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval; risks relating to Discovery Labs' research and development activities, including (i) time-consuming and expensive pre-clinical studies, clinical trials and other efforts, which may be subject to potentially significant delays or regulatory holds, or fail, and (ii) the need for sophisticated and extensive analytical methodologies, including an acceptable biological activity test, if required, as well as other quality control release and stability tests to satisfy the requirements of the regulatory authorities; risks relating to Discovery Labs' ability to develop and manufacture drug products and capillary aerosolization systems for clinical studies, and, if approved, for commercialization of drug and combination drug-device products, including risks of technology transfers to contract manufacturers and problems or delays encountered by Discovery Labs, its contract manufacturers or suppliers in manufacturing drug products, drug substances and capillary aerosolization systems on a timely basis or in an amount sufficient to support Discovery Labs' development efforts and, if approved, commercialization; the risk that Discovery Labs may be unable to identify potential strategic partners or collaborators to develop and commercialize its products, if approved, in a timely manner, if at all; the risk that Discovery Labs will not be able in a changing financial market to raise additional capital or enter into strategic alliances or collaboration agreements, or that the ongoing credit crisis will adversely affect the ability of Discovery Labs to fund its activities, or that additional financings could result in substantial equity dilution; the risk that Discovery Labs will not be able to access credit from its committed equity financing facilities (CEFFs), or that the minimum share price at which Discovery Labs may access the CEFFs from time to time will prevent Discovery Labs from accessing the full dollar amount potentially available under the CEFFs; the risk that Discovery Labs or its strategic partners or collaborators will not be able to retain, or attract, qualified personnel; the risk that Discovery Labs will be unable to regain compliance with The Nasdaq Capital Market listing requirements prior to the expiration of the additional grace period currently in effect, which could cause the price of Discovery Labs' common stock to decline; the risk that recurring losses, negative cash flows and the inability to raise additional capital could threaten Discovery Labs' ability to continue as a going concern; the risks that Discovery Labs may be unable to maintain and protect the patents and licenses related to its products, or other companies may develop competing therapies and/or technologies, or health care reform may adversely affect Discovery Labs; risks of legal proceedings, including securities actions and product liability claims; risks relating to health care reform; and other risks and uncertainties 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.
CONTACT: Discovery Laboratories, Inc.
John G. Cooper, EVP and Chief Financial Officer
215-488-9300
Sunesis Pharma On Track To Initaite Late Stage Study Of Blood Cancer Drug Voreloxin - Update
6/2/2010 11:36 AM ET
http://www.rttnews.com/ArticleView.aspx?Id=1322846
Sunesis Pharmaceuticals, Inc. (SNSS: News ) on Wednesday said it is on track to initiate the phase 3 study of voreloxin, developed as a blood cancer drug, in the second half of 2010. The decision was made after the South San Francisco, California-based company received a written, scientific advice from the European Medicines Agency on the company's proposed plans for further development of voreloxin.
The consultative review process with the European Medicines Agency studied Sunesis' proposed plans for further development of voreloxin in acute myeloid leukemia, including the plans for a pivotal trial in patients with first relapsed or primary refractory acute myeloid leukemia.
Acute myeloid leukemia is a blood cancer that is mostly seen in older adults. The National Cancer Institute estimated that nearly 13,000 new cases of acute myeloid leukemia were diagnosed and about 9,000 deaths occurred in the US in 2009.
Sunesis' Voreloxin, a DNA-damaging agent, works by targeting cancer cells, inserts itself into the DNA of the cancer cells and finally causes the death of the cell.
The company added that both the European Medicines Agency's advice and the guidance given by US Food and Drug Administration in February will together provide a development clarity towards the submission for marketing approval of voreloxin.
The phase 3 trial, a multi-national, randomized, double-blind, placebo-controlled study, has the primary endpoint of overall survival, along with a favorable benefit-risk ratio in the trial. Both of these goals will enable the company for registration of voreloxin in both the U.S. and Europe.
The trial is expected to evaluate about 450 patients, testing voreloxin in combination with widely used chemotherapy Cytarabine.
The company, which focuses on the development and commercialization of oncology therapeutics, received an orphan drug designation for Voreloxin for the treatment of acute myeloid leukemia in November last year. The designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval and an exemption from user fees.
Voreloxin is also being tested as a potential treatment for platinum-resistant ovarian cancer, whose phase 2 trial demonstrated that the drug is generally well tolerated. Another product in the pipeline is SNS-314, a potential treatment for advanced solid tumors, which has completed its phase 1 study.
Sunesis Pharma On Track To Initaite Late Stage Study Of Blood Cancer Drug Voreloxin - Update
6/2/2010 11:36 AM ET
http://www.rttnews.com/ArticleView.aspx?Id=1322846
Sunesis Pharmaceuticals, Inc. (SNSS: News ) on Wednesday said it is on track to initiate the phase 3 study of voreloxin, developed as a blood cancer drug, in the second half of 2010. The decision was made after the South San Francisco, California-based company received a written, scientific advice from the European Medicines Agency on the company's proposed plans for further development of voreloxin.
The consultative review process with the European Medicines Agency studied Sunesis' proposed plans for further development of voreloxin in acute myeloid leukemia, including the plans for a pivotal trial in patients with first relapsed or primary refractory acute myeloid leukemia.
Acute myeloid leukemia is a blood cancer that is mostly seen in older adults. The National Cancer Institute estimated that nearly 13,000 new cases of acute myeloid leukemia were diagnosed and about 9,000 deaths occurred in the US in 2009.
Sunesis' Voreloxin, a DNA-damaging agent, works by targeting cancer cells, inserts itself into the DNA of the cancer cells and finally causes the death of the cell.
The company added that both the European Medicines Agency's advice and the guidance given by US Food and Drug Administration in February will together provide a development clarity towards the submission for marketing approval of voreloxin.
The phase 3 trial, a multi-national, randomized, double-blind, placebo-controlled study, has the primary endpoint of overall survival, along with a favorable benefit-risk ratio in the trial. Both of these goals will enable the company for registration of voreloxin in both the U.S. and Europe.
The trial is expected to evaluate about 450 patients, testing voreloxin in combination with widely used chemotherapy Cytarabine.
The company, which focuses on the development and commercialization of oncology therapeutics, received an orphan drug designation for Voreloxin for the treatment of acute myeloid leukemia in November last year. The designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval and an exemption from user fees.
Voreloxin is also being tested as a potential treatment for platinum-resistant ovarian cancer, whose phase 2 trial demonstrated that the drug is generally well tolerated. Another product in the pipeline is SNS-314, a potential treatment for advanced solid tumors, which has completed its phase 1 study.
Sunesis Completes Consultative Review Process With EMA for Voreloxin in AML
Date : 06/02/2010 @ 7:30AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals, Inc. (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=43060368&symbol=SNSS
SOUTH SAN FRANCISCO, CA -- (Marketwire)
06/02/10
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that it has received written, scientific advice from the European Medicines Agency (EMA) on the Company's proposed plans for further development of voreloxin in acute myeloid leukemia (AML), including the Company's plans for a pivotal trial in patients with first relapsed or primary refractory AML. The EMA's written advice, similar to guidance previously received from the U.S. Food and Drug Administration (FDA) in February following formal End-of-Phase 2 meetings, is consistent with and supportive of Sunesis' proposed plans, and provides development clarity toward a potential regulatory submission for marketing approval. The EMA issued its advice following its established consultative review process.
The Company continues to anticipate a launch of its multi-national, randomized, double-blind, placebo-controlled Phase 3 trial in the second half of 2010. Based on feedback and guidance received from the FDA and EMA, the Company expects that future results demonstrating a convincing magnitude of improvement in overall survival, the study's primary endpoint, along with a favorable benefit-risk ratio in the planned Phase 3 trial, would be sufficient as the primary basis for registration of voreloxin in both the U.S. and Europe.
"With the EMA's scientific advice, we have successfully completed an important step in our global development strategy for voreloxin in relapsed and refractory AML," stated Daniel Swisher, Chief Executive Officer of Sunesis. "The Company, its advisors and clinical service providers continue to collaborate toward the successful initiation of our multi-national Phase 3 trial in the second half of this year."
About Voreloxin
Voreloxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a fully enrolled single agent Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a fully enrolled Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML. A Phase 2 single agent trial in platinum-resistant ovarian cancer has also completed enrollment. Sunesis anticipates initiating a Phase 3 trial of voreloxin in AML in the second half of 2010.
About the Pivotal Phase 3 Trial
Sunesis anticipates initiating a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or primary refractory AML in the second half of 2010. The trial is designed to evaluate approximately 450 patients, multi-nationally, including leading sites in the U.S. and Europe. Patients are expected to be randomized one to one to receive either voreloxin (90 mg/m2) on days one and four in combination with cytarabine (1 g/m2) daily for five days, or placebo in combination with cytarabine. The study's primary endpoint is overall survival.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The National Cancer Institute estimated that nearly 13,000 new cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. in 2009. Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
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, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including without limitation statements related to the planned commencement of a pivotal trial of voreloxin and its timing. Words such as "anticipates," "upcoming" 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 related to Sunesis' need for additional funding to finance the voreloxin pivotal trial and to continue as a going concern, the risk that Sunesis' drug development activities for voreloxin could be halted or significantly delayed for various reasons, the risk that Sunesis' clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that preliminary data and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical trials may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of voreloxin, and the risk that Sunesis' proprietary rights may not adequately protect voreloxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Annual Report on Form 10-K for the year ended December 31, 2009 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.
NewCardio Selected to Make Presentations at 15th Annual World Congress on Heart Disease
Date : 06/02/2010 @ 8:30AM
Source : Business Wire
Stock : NewCardio, Inc. (NWCI)
http://ih.advfn.com/p.php?pid=nmona&article=43061801&symbol=NWCI
NewCardio, Inc., (OTCBB: NWCI) a cardiac diagnostic technology provider, announced today that two of its most recent medical and technical submissions have been accepted for presentation at the prestigious 15th Annual World Congress on Heart Disease to be held in Vancouver BC on July 24-27, 2010. The Company will present data from both the advanced coronary artery disease (CAD) and atrial fibrillation (AF) clinical studies, with additional information from ongoing CardioBip™ clinical studies. The data supports CardioBip’s suitability for long-term monitoring of patients with CAD and AF.
The Company believes that acceptance of these submissions – which present important clinical data supporting the accuracy and effectiveness of its CardioBip product - reflects the growing interest in telemedicine and the recognition of NewCardio’s technologies as effective solutions in the field. CardioBip is a unique, hand held device that gives accurate and timely diagnoses of acute cardiac events, and facilitates immediate intervention in life-threatening situations – even when the patient is far removed from a medical care center. Images of the CardioBip are available at www.newcardio.com/products-cardio-bip.php.
Branislav Vajdic, Ph.D., NewCardio’s CEO, commented, "Our acceptance to the 15th Annual World Congress on Heart Disease reflects the remarkable and ongoing success of our academic medical collaborators, and our technical and scientific teams. We believe that they will provide strong technical and clinical evidence supporting the potential of CardioBip as a key telemedicine solution for monitoring patients with very serious and unfortunately common cardiac diseases. CardioBip, without any leads and wires, is patient tolerable and provides reconstructed full 12-lead ECG data. Many cardiac patients would benefit from this improved diagnostic tool and its better long-term monitoring options.”
The Congress will provide the opportunity for a comprehensive overview of the latest research developments in cardiovascular medicine, primarily in the areas of molecular biology, coronary artery disease, heart failure, cardiac arrhythmias and cardiac surgery.
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 12-lead 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.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
MSHL ovarian cancer drug fails late stage study
http://ih.advfn.com/p.php?pid=nmona&article=43043020&symbol=N^MSHL
Marshall Edwards Announces Final Results From Halted Phase 3 Clinical Trial of Phenoxodiol
Date : 06/01/2010 @ 8:30AM
Source : MarketWire
Stock : Marshall Edwards, Inc. (MSHL)
SYDNEY, AUSTRALIA and SAN DIEGO, CA -- (Marketwire)
06/01/10
Marshall Edwards, Inc. (NASDAQ: MSHL), an oncology company focused on the clinical development of novel anti-cancer therapeutics, announced today that a final analysis of its Phase 3 OVATURE trial of orally administered phenoxodiol in women with recurrent ovarian cancer determined that the trial did not show a statistically significant improvement in its primary (progression-free survival) or secondary (overall survival) endpoints. As previously announced, the trial was closed for recruitment before completion of enrolment with only 142 out of a planned 340 patients enrolled.
This multi-center, randomized, double-blind trial assessed the safety and efficacy of daily phenoxodiol in combination with weekly carboplatin versus weekly carboplatin with placebo in patients with platinum-resistant or platinum-refractory, late-stage epithelial ovarian, fallopian or primary peritoneal cancer following at least second line platinum therapy.
"Owing to the fact that this trial was significantly underpowered due to the small number of patients enrolled, we were disappointed, but not entirely surprised by the final outcome," said Dr. Daniel P. Gold, newly appointed Chief Executive Officer of Marshall Edwards. "However, we remain confident that our investigational isoflavone platform, including triphendiol, a potentially more potent, second-generation analogue of phenoxodiol, may be of benefit to women with ovarian cancer, particularly when administered intravenously.
"Previously reported results of a Phase 2 trial," continued Dr. Gold, "which tested the activity of intravenous phenoxodiol plus weekly cisplatin in a similar platinum-resistant or refractory patient population, demonstrated a 30% response rate (6 out of 20) compared to less than 1% (1 out of 142) in the OVATURE study in which phenoxodiol was administered orally. In addition, we remain excited with the progress of another product candidate in our pipeline, NV-128, a novel isoflavone analogue with a mode of action distinct from both phenoxodiol and triphendiol.
"Lastly, I want to take this opportunity to personally thank the patients and their families for their participation in this trial. I would also like to thank the clinical investigators and trial coordinators for their dedication and support."
Safety Outcomes
As previously noted, phenoxodiol had a good safety profile and was well tolerated. The number of patients experiencing at least one adverse event was similar in each treatment group, as was the number of patients experiencing adverse events of Grade 3 or higher.
About OVATURE and the Phenoxodiol Clinical Program
The OVATURE ("OVArian TUmor REsponse") trial was a multi-center international Phase 3 clinical trial of orally administered investigational drug phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs to determine its safety and effectiveness when used in combination with carboplatin.
The trial recruited ovarian cancer patients whose cancer initially responded to chemotherapy, but had since become resistant or refractory to traditional platinum treatments. The study was closed to enrolment in April 2009 at which time 142 patients had been randomized to the study. Changes in standards of care over the period of the trial and the stringency of inclusion/exclusion criteria of the OVATURE protocol had slowed patient recruitment rates and consequently the Company deemed it prudent not to continue the trial to completion. The Independent Data Monitoring Committee (IDMC) supported the Company's decision to close the study to accrual, and, in a review of the available safety data, the IDMC confirmed that there were no safety concerns with phenoxodiol in these subjects.
About Phenoxodiol
Phenoxodiol is being developed as a chemosensitizing agent in combination with platinum drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for prostate and cervical cancers. It is believed to have a unique mechanism of action, binding to cancer cells via a cell membrane oxidase, causing major downstream disturbances in expression of proteins necessary for cancer cell survival and responsible for the development of drug resistance.
Phenoxodiol appears to selectively inhibit the regulator known as S-1-P (sphingosine-1-phosphate) that is overexpressed in cancer cells. In response to phenoxodiol, S-1-P content is decreased, with a consequent decrease in expression of the pro-survival proteins XIAP and FLIP, inducing cell death via caspase expression and promoting sensitivity to other chemotherapeutics. In laboratory studies, it has been demonstrated that drug-resistant ovarian cancer cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy drugs. Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing.
Phenoxodiol has been granted Fast Track status from the FDA to facilitate its development as a therapy for recurrent ovarian and prostate cancers. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need and provides the option to file a New Drug Application on a rolling basis. This permits the FDA to review the filing as it is received, expediting the review process. Phenoxodiol is an investigational drug and, as such, is not commercially available. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by FDA as being safe and effective for the intended use.
About Marshall Edwards, Inc.
Marshall Edwards, Inc. (NASDAQ: MSHL) is a specialist oncology company focused on the clinical development of novel anti-cancer therapeutics. These derive from an investigational isoflavone technology platform, which has generated a number of novel compounds characterized by broad ranging activity against a range of cancer cell types with few side effects. The combination of anti-tumor cell activity and low toxicity is believed to be a result of the ability of these compounds to target an enzyme present in the cell membrane of cancer cells, thereby inhibiting the production of pro-survival proteins within the cell. Marshall Edwards has licensed rights from Novogen Limited (ASX: NRT) (NASDAQ: NVGN) to bring oncology drugs phenoxodiol, triphendiol and NV-128 to market globally.
Marshall Edwards is majority owned by Novogen Limited, an Australian biotechnology company that is specializing in the development of therapeutics based on an isoflavone technology platform. Novogen is developing a range of therapeutics across the fields of oncology, cardiovascular disease and inflammatory diseases. More information on Marshall Edwards and on the Novogen group of companies can be found at www.marshalledwardsinc.com and www.novogen.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
Zoom Technologies Raises $1 Million in Common Stock Offering
Date : 06/01/2010 @ 11:30AM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=43047336&symbol=N^ZOOM
BEIJING -- (Marketwire)
06/01/10
Zoom Technologies, Inc. (NASDAQ: ZOOM), a leading China-based manufacturer of mobile phones and other mobile electronic products, today announced that it has raised $1 million through the sale of 166,667 shares of common stock, at $6.00 per share on Friday, May 28, 2010.
The shares were sold at a premium of $0.41 or 7.3% to the closing price of ZOOM as traded on Nasdaq the day before the sale of such 166,667 shares. Proceeds from this offering will be used for a pipeline acquisition.
The shares were sold pursuant to a shelf registration statement on Form S-3 filed with, and has been declared effective by, the Securities and Exchange Commission.
This press release does not constitute an offer to sell any securities.
About Zoom Technologies
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of mobile phones, wireless communication circuitry, related telecommunication equipment and software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its own brand of mobile phones 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
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, including our expansion in other 3G enabled mobile phones and the acquisition of Leimone Culture as mentioned in previous press releases, which may require shareholder approval that cannot be assured. The reader 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.
This Week’s Run-Up Plays
May 31st, 2010 by BioRunUp
http://www.biorunup.com/271/this-weeks-run-up-plays/
...
JAV (Hospira Offer) 6/2/10
CXM (510k) 6/3/10
PGNX (sNDA) 6/4/10
ASCO Plays: HNAB, SNSS, CYCC, ZIOP, KERX, DCTH, etc. 6/4 – 6/8/10
Novartis ovarian cancer drug filings won't proceed
May 27, 2010, 2:18 a.m. EDT
http://www.marketwatch.com/story/novartis-ovarian-cancer-drug-filings-wont-proceed-2010-05-27?siteid=yhoof2
LONDON (MarketWatch) -- Swiss drugmaker Novartis said Thursday that patupilone did not show a significant overall survival advantage in a phase III trial of patients with advanced ovarian cancer, refractory or resistant to platinum-based therapy. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, safety and overall response rate. No new or unexpected serious adverse events in the patupilone arm were identified in the trial. Novartis does not plan to proceed with regulatory filings based on these data.
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http://ih.advfn.com/p.php?pid=nmona&article=42944285
SOUTH SAN FRANCISCO, CA -- (Marketwire)
05/24/10
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that it will host a conference call on Tuesday, June 8, 2010 at 9:00 a.m. Eastern time to review the data from the Phase 2 clinical trials of voreloxin in acute myeloid leukemia (AML) and ovarian cancer, scheduled to be presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting on June 7, 2010 in Chicago, Illinois.
Oral Podium Presentation: Final data from the Phase 2 study of voreloxin in women with platinum-resistant ovarian cancer will be presented on Monday, June 7, 2010 during the Gynecologic Cancer Clinical Science Symposium at 9:45 a.m. local time in the E Arie Crown Theater (Abstract #5002).
U.S. Markets closed for Memorial Day
http://ih.advfn.com/p.php?pid=nmona&article=42944285 ...
SOUTH SAN FRANCISCO, CA -- (Marketwire)
05/24/10
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that it will host a conference call on Tuesday, June 8, 2010 at 9:00 a.m. Eastern time to review the data from the Phase 2 clinical trials of voreloxin in acute myeloid leukemia (AML) and ovarian cancer, scheduled to be presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting on June 7, 2010 in Chicago, Illinois.
Oral Podium Presentation: Final data from the Phase 2 study of voreloxin in women with platinum-resistant ovarian cancer will be presented on Monday, June 7, 2010 during the Gynecologic Cancer Clinical Science Symposium at 9:45 a.m. local time in the E Arie Crown Theater (Abstract #5002).
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http://www.marketwatch.com/story/novartis-ovarian-cancer-drug-filings-wont-proceed-2010-05-27?siteid=yhoof2
May 27, 2010, 2:18 a.m. EDT
Novartis ovarian cancer drug filings won't proceed
LONDON (MarketWatch) -- Swiss drugmaker Novartis said Thursday that patupilone did not show a significant overall survival advantage in a phase III trial of patients with advanced ovarian cancer, refractory or resistant to platinum-based therapy. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, safety and overall response rate. No new or unexpected serious adverse events in the patupilone arm were identified in the trial. Novartis does not plan to proceed with regulatory filings based on these data.
KERX - 2010 NEWS (updated)
01/05/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=40967159&symbol=NASDAQ%3AKERX
Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Registration Program of Zerenex in patients with end-stage renal disease (ESRD)
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01/25/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=41242064&symbol=NASDAQ%3AKERX
Keryx Reports Statistically Significant Benefit in Survival from Updated Results on the clinical activity of KRX-0401 (perifosine), the Company's PI3K/Akt pathway inhibitor for cancer, in combination with capecitabine (Xeloda®) as a treatment for advanced, metastatic colon cancer.
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01/29/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=41314106&symbol=N^KERX
Keryx Biopharmaceuticals Announces Positive Phase 2 Study Results of Perifosine as a Single Agent for the Treatment of advanced Waldenstrom's Macroglobulinemia ("Waldenstrom's")
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02/03/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=41377888&symbol=N^KERX
Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of KRX-0401 (Perifosine) in patients with refractory metastatic colorectal cancer.
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04/05/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=42251074&symbol=N^KERX
Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Refractory Advanced Colorectal Cancer
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04/08/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=42299718&symbol=N^KERX
Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Refractory Advanced Colorectal Cancer
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04/15/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=42392688&symbol=N^KERX
Keryx Biopharmaceuticals Reports Updated Long-Term Data of Zerenex (ferric citrate) Presented at National Kidney Foundation (NKF) 2010 Spring Clinical Meetings
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Date : 05/06/2010 @ 8:00AM
http://ih.advfn.com/p.php?pid=nmona&article=42688680&symbol=KERX
Keryx Biopharmaceuticals Initiates Phase 3 Registration Program of Zerenex (ferric citrate) for the Treatment of Patients with Hyperphosphatemia
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Date : 05/17/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=42848470&symbol=N^KERX
Publication in the Journal of the National Cancer Institute Demonstrates KRX-0401 (Perifosine) Single-Agent Potential in Neuroblastoma Tumors
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Date : 05/21/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=42926420&symbol=N^KERX
Keryx Biopharmaceuticals Announces Presentation of Two Abstracts at ASCO 2010 Annual Meeting
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KERX - 2010 NEWS (updated)
01/05/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=40967159&symbol=NASDAQ%3AKERX
Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Registration Program of Zerenex in patients with end-stage renal disease (ESRD)
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01/25/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=41242064&symbol=NASDAQ%3AKERX
Keryx Reports Statistically Significant Benefit in Survival from Updated Results on the clinical activity of KRX-0401 (perifosine), the Company's PI3K/Akt pathway inhibitor for cancer, in combination with capecitabine (Xeloda®) as a treatment for advanced, metastatic colon cancer.
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01/29/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=41314106&symbol=N^KERX
Keryx Biopharmaceuticals Announces Positive Phase 2 Study Results of Perifosine as a Single Agent for the Treatment of advanced Waldenstrom's Macroglobulinemia ("Waldenstrom's")
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02/03/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=41377888&symbol=N^KERX
Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of KRX-0401 (Perifosine) in patients with refractory metastatic colorectal cancer.
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04/05/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=42251074&symbol=N^KERX
Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Refractory Advanced Colorectal Cancer
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04/08/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=42299718&symbol=N^KERX
Keryx Biopharmaceuticals, Inc. Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) for Treatment of Patients with Refractory Advanced Colorectal Cancer
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04/15/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=42392688&symbol=N^KERX
Keryx Biopharmaceuticals Reports Updated Long-Term Data of Zerenex (ferric citrate) Presented at National Kidney Foundation (NKF) 2010 Spring Clinical Meetings
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Date : 05/06/2010 @ 8:00AM
http://ih.advfn.com/p.php?pid=nmona&article=42688680&symbol=KERX
Keryx Biopharmaceuticals Initiates Phase 3 Registration Program of Zerenex (ferric citrate) for the Treatment of Patients with Hyperphosphatemia
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Date : 05/17/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=42848470&symbol=N^KERX
Publication in the Journal of the National Cancer Institute Demonstrates KRX-0401 (Perifosine) Single-Agent Potential in Neuroblastoma Tumors
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Date : 05/21/2010 @ 8:30AM
http://ih.advfn.com/p.php?pid=nmona&article=42926420&symbol=N^KERX
Keryx Biopharmaceuticals Announces Presentation of Two Abstracts at ASCO 2010 Annual Meeting
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ASCO Abstracts -- Pops and Drops!
By Brian Orelli, Ph.D.
May 24, 2010
http://www.fool.com/investing/high-growth/2010/05/24/asco-abstracts-pops-and-drops.aspx
...yes!
Products in Development:
http://www.sunesis-pharma.com/products-in-development/
CytoSorbents Corporation to Present at BioNJ BioPartnering Conference
Date : 05/24/2010 @ 2:06PM
Source : MarketWire
Stock : CytoSorbents Corporation (CTSO)
http://ih.advfn.com/p.php?pid=nmona&article=42950960&symbol=CTSO
MONMOUTH JUNCTION, NJ -- (Marketwire)
05/24/10
CytoSorbents Corporation (OTCBB: CTSO), formerly known as MedaSorb Technologies Corporation, announced that Dr. Phillip Chan, Chief Executive Officer and President, will present at the BioNJ BioPartnering 2010 Conference on Tuesday, June 15, 2010 at the Westin Princeton in Princeton, New Jersey. The presentation will take place at 10AM in Salon G. http://bionj.org/biopartnering2010
"We have a powerful and flexible, polymer-based purification platform that can remove a variety of substances from blood and other physiologic fluids based on size and surface adsorption," stated Dr. Phillip Chan. "CytoSorb? is a cytokine filter in clinical trials that can potentially be used to reduce deadly inflammation and cytokine storm in a variety of life threatening diseases treated in the intensive care unit, such as severe sepsis, acute respiratory distress syndrome, and burn injury. We also have a number of different polymer resins that have the ability to remove things as small as drugs with, in some cases, more than 90% single pass extraction efficiency to substances as large as antibodies. Our engineers also have the ability to rapidly modify our core technology to remove substances of specific interest to potential partners with a number of key advantages over other standard technologies."
About CytoSorbents and CytoSorb?
CytoSorbents Corporation, and its operating subsidiary CytoSorbents, Inc., 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 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. Severe sepsis is typically triggered by bacterial infections like pneumonia, or viral infections like influenza. However, it is the body's abnormal immune response to the trigger that leads to severe inflammation and the unregulated, massive production of cytokines, often called "cytokine storm," that then causes multi-organ failure and often death. 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 repeatedly 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 CytoSorb? 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 various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, burn and smoke inhalation injury and 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. CytoSorbents 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 Corporation
David Lamadrid
(732) 329-8885 ext. 816
davidl@cytosorbents.com
Sunrise Receives 2010 ALFA Best of the Best Award
Date : 05/24/2010 @ 2:00PM
Source : PR Newswire
Stock : Sunrise Senior Living (SRZ)
http://ih.advfn.com/p.php?pid=nmona&article=42950912&symbol=SRZ
PR Newswire
MCLEAN, Va., May 24
Leading industry association recognizes innovative training program
MCLEAN, Va., May 24 /PRNewswire/ --
Sunrise Senior Living (NYSE: SRZ) today announced that it has been awarded a 2010 Best of the Best Award from The Assisted Living Federation of America (ALFA), a national recognition reserved for the nation's most innovative and effective business practices in the senior living industry. ALFA honored Sunrise for its new team member training program, Sunrise University's Community Training KIOSKs, which moved the company's orientation program online. This is the second year in a row in which Sunrise has received accolades for its leading approach to team member training and development.
"We are honored to receive this recognition as Sunrise has long believed that providing our dedicated team members with dynamic and excellent training opportunities is a great way to help ensure high-quality care and service for our residents," says Mike Rodis, senior vice president of Human Resources for Sunrise. "Our teams are quickly adopting this new KIOSK technology and we look forward to seeing the positive results of this skill-building in all of our communities."
In 2009, Sunrise successfully piloted online orientation training in more than 40 communities via self-contained computer learning stations called Key Instructional Online Skills-based Knowledge centers or KIOSKs. A KIOSK in each community provides training, testing and tracking customized for each team member. Team members also have 24/7 access to a self-paced training program that prompts them to meet completion deadlines and gives immediate feedback on test results.
Since implementation, more than 55 percent of the pilot communities have exceeded the corporate compliance rate of 94 percent for timely completion of orientation training. The number of hours devoted to orientation has also been reduced since the launch of the KIOSKs, resulting in substantial cost savings for the company as well as providing team members more time to serve residents. Sunrise looks forward to introducing the new training method in all of its communities during the course of 2010.
"These innovations recognize companies that have put their imaginations to work to continually improve and streamline operations, enhance resident care and services, train and retain quality employees, and much more," says ALFA President and CEO Richard P. Grimes. "Plus, the industry-wide benefit of the Best of the Best Awards is the program's ability to multiply excellence as these and other companies in senior living adopt these best practices as their own."
Sunrise's winning strategy will be profiled further in a cover story of Assisted Living Executive's May/June 2010 issue. The ALFA 2010 Best of the Best Award winners will also be recognized at the ALFA 2010 Conference & Expo, May 25-27, in Phoenix.
About Sunrise Senior Living
Sunrise Senior Living, a McLean, Va.-based company, employs approximately 40,000 people. As of March 31, 2010, Sunrise operated 365 communities in the United States, Canada, Germany and the United Kingdom, with a combined unit capacity of approximately 36,600 units. Sunrise offers a full range of personalized senior living services, including independent living, assisted living, care for individuals with Alzheimer's and other forms of memory loss, as well as nursing and rehabilitative services. Sunrise's senior living services are delivered by staff trained to encourage the independence, preserve the dignity, enable freedom of choice and protect the privacy of residents. To learn more about Sunrise, please visit http://www.sunriseseniorliving.com .
SOURCE Sunrise Senior Living
Sunesis to Host Conference Call on June 8th to Discuss Voreloxin Data Presented at ASCO 2010 and Upcoming Phase 3 Trial in AML
Date : 05/24/2010 @ 7:30AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=42944285
SOUTH SAN FRANCISCO, CA -- (Marketwire)
05/24/10
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that it will host a conference call on Tuesday, June 8, 2010 at 9:00 a.m. Eastern time to review the data from the Phase 2 clinical trials of voreloxin in acute myeloid leukemia (AML) and ovarian cancer, scheduled to be presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting on June 7, 2010 in Chicago, Illinois. The Company will also discuss the plan for the Phase 3 trial of voreloxin in AML, which is expected to begin in the second half of 2010.
The Company also announced that the European Hematology Association (EHA) has published abstracts related to the presentation of data from the two Phase 2 trials of voreloxin in AML at the upcoming 15th Congress of the EHA, which will be held June 10 - 13 in Barcelona, Spain.
Conference Call and Webcast Slide Presentation
The company will host a conference call and webcast slide presentation Tuesday, June 8th at 9:00 a.m. Eastern time. Robert K. Stuart, M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina, will join the Sunesis senior management team in a discussion of the new Phase 2 data presented at ASCO and review the plans for the upcoming randomized, pivotal Phase 3 clinical trial evaluating the effect on overall survival of voreloxin in combination with cytarabine for the treatment of first relapsed or primary refractory AML. The call can be accessed by dialing (877) 303-9029 (U.S. and Canada) or (914) 495-8584 (international). To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company's website for two weeks.
Voreloxin Presentations at ASCO
Details on the ASCO presentations are included below.
Oral Podium Presentation: Final data from the Phase 2 study of voreloxin in women with platinum-resistant ovarian cancer will be presented on Monday, June 7, 2010 during the Gynecologic Cancer Clinical Science Symposium at 9:45 a.m. local time in the E Arie Crown Theater (Abstract #5002).
Poster Presentation and Discussion: Final results from the Phase 1b/2 combination study of voreloxin and cytarabine in patients with relapsed or refractory AML will be presented in Room E450a during the Leukemia, Myelodysplasia, and Transplantation Poster Session on Monday, June 7, 2010 from 2:00 to 6:00 p.m., with a discussion in Room E354a from 5:00 to 6:00 p.m. (Abstract #6526).
Poster Presentation and Discussion: Final results from the Phase 2 REVEAL-1 study of single agent voreloxin in newly diagnosed elderly patients will be presented in Room E450a during the Leukemia, Myelodysplasia, and Transplantation Poster Session on Monday, June 7, 2010 from 2:00 to 6:00 p.m., with a discussion in Room E354a from 5:00 to 6:00 p.m. (Abstract #6525).
EHA Presentations
Data from the Company's two Phase 2 trials in AML will be presented at the 15th Congress of the EHA during the Acute Myeloid Leukemia Clinical Poster Session on Friday, June 11, 2010 from 5:45 to 7:00 p.m. local time in Hall 6. The details of the abstracts are included below.
Abstract Number 0070: Final results from the Phase 2 REVEAL-1 study of single agent voreloxin in newly diagnosed elderly patients.
Abstract Number 0077: Final results from the Phase 1b/2 combination study of voreloxin and cytarabine in patients with relapsed or refractory AML.
About Voreloxin
Voreloxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a fully enrolled single agent Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a fully enrolled Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML. A Phase 2 single agent trial in platinum-resistant ovarian cancer has also completed enrollment. Sunesis anticipates initiating a Phase 3 trial of voreloxin in AML in the second half of 2010.
About the Pivotal Phase 3 Trial
Sunesis anticipates initiating a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or primary refractory AML in the second half of 2010. The trial is designed to evaluate approximately 450 patients, multi-nationally, including leading sites in the U.S. and Europe. Patients are expected to be randomized one to one to receive either voreloxin (90 mg/m2) on days one and four in combination with cytarabine (1 g/m2) daily for five days, or placebo in combination with cytarabine. The study's primary endpoint is overall survival.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The National Cancer Institute estimated that nearly 13,000 new cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. in 2009. Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
About Ovarian Cancer
In the United States, ovarian cancer remains the leading cause of death from gynecologic malignancies and is the fifth leading cause of cancer death overall in women behind lung, breast, colorectal and pancreatic cancers. According to the American Cancer Society, in 2009 there were an estimated 21,550 new cases and more than 14,000 deaths from ovarian cancer in the U.S. alone. Following frontline treatment, recurrence rates among ovarian cancer patients are high. Treatment options remain limited following relapse, and overall long-term survival has not changed significantly over the past 40 years in women with recurrent disease, with less than 30 percent of patients surviving for more than five years.
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, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including without limitation statements related to the planned commencement of a pivotal trial of voreloxin and its timing. Words such as "anticipates," "upcoming" 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 related to Sunesis' need for additional funding to finance the voreloxin pivotal trial and to continue as a going concern, the risk that Sunesis' drug development activities for voreloxin could be halted or significantly delayed for various reasons, the risk that Sunesis' clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that preliminary data and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical trials may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of voreloxin, and the risk that Sunesis' proprietary rights may not adequately protect voreloxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Annual Report on Form 10-K for the year ended December 31, 2009 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.
Investor and Media Inquiries:
Andrea Rabney
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
SNSS - ASCO Stocks Presenting New Clinical Data
By Adam Feuerstein 05/21/10 - 06:00 AM EDT
http://www.thestreet.com/story/10762345/12/13-asco-stocks-presenting-new-clinical-data.html
Drug: Voreloxin
Abstract No. 5002
Indication: ovarian cancer
Clinical Trial: Final results of a phase II study of voreloxin in women with platinum-resistant ovarian cancer.
Presentation Time: Monday, June 7. Oral session.
Notes: Final response rate across three different dosages of Voreloxin was 11% with a median progression-free survival of 84 days.
Sunesis will also be presenting final phase II data from a study of voreloxin in patients with acute myeloid leukemia.
ASCO Stocks Presenting New Clinical Data - SNSS
By Adam Feuerstein 05/21/10 - 06:00 AM EDT
http://www.thestreet.com/story/10762345/12/13-asco-stocks-presenting-new-clinical-data.html
Drug: Voreloxin
Abstract No. 5002
Indication: ovarian cancer
Clinical Trial: Final results of a phase II study of voreloxin in women with platinum-resistant ovarian cancer.
Presentation Time: Monday, June 7. Oral session.
Notes: Final response rate across three different dosages of Voreloxin was 11% with a median progression-free survival of 84 days.
Sunesis will also be presenting final phase II data from a study of voreloxin in patients with acute myeloid leukemia.
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Posted by: read_this_n0w
http://investorshub.advfn.com/boards/board.aspx?board_id=4349
Voreloxin abstract
http://abstract.asco.org/AbstView_74_49315.html
Final results of a phase II study of voreloxin in women with platinum-resistant ovarian cancer.
http://abstract.asco.org/AbstView_74_48872.html
Final results of a phase II pharmacokinetic/pharmacodynamic (PK/PD) study of combination voreloxin and cytarabine in patients with relapsed or refractory acute myeloid leukemia.
http://abstract.asco.org/AbstView_74_49274.html
Voreloxin single-agent treatment of older patients (60 years or older) with previously untreated acute myeloid leukemia: Final results from a phase II study with three schedules
http://abstract.asco.org/AbstView_74_49315.html
Sunesis to Host Conference Call on June 8th to Discuss Voreloxin Data Presented at ASCO 2010 and Upcoming Phase 3 Trial in AML
Date : 05/24/2010 @ 7:30AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=42944285
SOUTH SAN FRANCISCO, CA -- (Marketwire)
05/24/10
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that it will host a conference call on Tuesday, June 8, 2010 at 9:00 a.m. Eastern time to review the data from the Phase 2 clinical trials of voreloxin in acute myeloid leukemia (AML) and ovarian cancer, scheduled to be presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting on June 7, 2010 in Chicago, Illinois. The Company will also discuss the plan for the Phase 3 trial of voreloxin in AML, which is expected to begin in the second half of 2010.
The Company also announced that the European Hematology Association (EHA) has published abstracts related to the presentation of data from the two Phase 2 trials of voreloxin in AML at the upcoming 15th Congress of the EHA, which will be held June 10 - 13 in Barcelona, Spain.
Conference Call and Webcast Slide Presentation
The company will host a conference call and webcast slide presentation Tuesday, June 8th at 9:00 a.m. Eastern time. Robert K. Stuart, M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina, will join the Sunesis senior management team in a discussion of the new Phase 2 data presented at ASCO and review the plans for the upcoming randomized, pivotal Phase 3 clinical trial evaluating the effect on overall survival of voreloxin in combination with cytarabine for the treatment of first relapsed or primary refractory AML. The call can be accessed by dialing (877) 303-9029 (U.S. and Canada) or (914) 495-8584 (international). To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company's website for two weeks.
Voreloxin Presentations at ASCO
Details on the ASCO presentations are included below.
Oral Podium Presentation: Final data from the Phase 2 study of voreloxin in women with platinum-resistant ovarian cancer will be presented on Monday, June 7, 2010 during the Gynecologic Cancer Clinical Science Symposium at 9:45 a.m. local time in the E Arie Crown Theater (Abstract #5002).
Poster Presentation and Discussion: Final results from the Phase 1b/2 combination study of voreloxin and cytarabine in patients with relapsed or refractory AML will be presented in Room E450a during the Leukemia, Myelodysplasia, and Transplantation Poster Session on Monday, June 7, 2010 from 2:00 to 6:00 p.m., with a discussion in Room E354a from 5:00 to 6:00 p.m. (Abstract #6526).
Poster Presentation and Discussion: Final results from the Phase 2 REVEAL-1 study of single agent voreloxin in newly diagnosed elderly patients will be presented in Room E450a during the Leukemia, Myelodysplasia, and Transplantation Poster Session on Monday, June 7, 2010 from 2:00 to 6:00 p.m., with a discussion in Room E354a from 5:00 to 6:00 p.m. (Abstract #6525).
EHA Presentations
Data from the Company's two Phase 2 trials in AML will be presented at the 15th Congress of the EHA during the Acute Myeloid Leukemia Clinical Poster Session on Friday, June 11, 2010 from 5:45 to 7:00 p.m. local time in Hall 6. The details of the abstracts are included below.
Abstract Number 0070: Final results from the Phase 2 REVEAL-1 study of single agent voreloxin in newly diagnosed elderly patients.
Abstract Number 0077: Final results from the Phase 1b/2 combination study of voreloxin and cytarabine in patients with relapsed or refractory AML.
About Voreloxin
Voreloxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a fully enrolled single agent Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a fully enrolled Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML. A Phase 2 single agent trial in platinum-resistant ovarian cancer has also completed enrollment. Sunesis anticipates initiating a Phase 3 trial of voreloxin in AML in the second half of 2010.
About the Pivotal Phase 3 Trial
Sunesis anticipates initiating a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or primary refractory AML in the second half of 2010. The trial is designed to evaluate approximately 450 patients, multi-nationally, including leading sites in the U.S. and Europe. Patients are expected to be randomized one to one to receive either voreloxin (90 mg/m2) on days one and four in combination with cytarabine (1 g/m2) daily for five days, or placebo in combination with cytarabine. The study's primary endpoint is overall survival.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The National Cancer Institute estimated that nearly 13,000 new cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. in 2009. Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
About Ovarian Cancer
In the United States, ovarian cancer remains the leading cause of death from gynecologic malignancies and is the fifth leading cause of cancer death overall in women behind lung, breast, colorectal and pancreatic cancers. According to the American Cancer Society, in 2009 there were an estimated 21,550 new cases and more than 14,000 deaths from ovarian cancer in the U.S. alone. Following frontline treatment, recurrence rates among ovarian cancer patients are high. Treatment options remain limited following relapse, and overall long-term survival has not changed significantly over the past 40 years in women with recurrent disease, with less than 30 percent of patients surviving for more than five years.
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, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including without limitation statements related to the planned commencement of a pivotal trial of voreloxin and its timing. Words such as "anticipates," "upcoming" 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 related to Sunesis' need for additional funding to finance the voreloxin pivotal trial and to continue as a going concern, the risk that Sunesis' drug development activities for voreloxin could be halted or significantly delayed for various reasons, the risk that Sunesis' clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that preliminary data and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical trials may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of voreloxin, and the risk that Sunesis' proprietary rights may not adequately protect voreloxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Annual Report on Form 10-K for the year ended December 31, 2009 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.
Investor and Media Inquiries:
Andrea Rabney
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
Celldex shares off on cancer data, analyst comment - UPDATE 2
Fri May 21, 2010 6:53pm EDT
http://www.reuters.com/article/idCNN2115899920100521?rpc=44
* Analysts cite favorable data from brain cancer drug
* Say initial misinterpretation of data sowed confusion
* Keryx, Ziopharm, Celgene gain on cancer drug data
(Rewrites first paragraph, adds analyst, Pfizer comment, closing shares)
By Ransdell Pierson
NEW YORK, May 21 (Reuters) - Celldex Therapeutics Inc (CLDX.O) shares fell 9 percent on Friday after an unfavorable analyst comment based on a misinterpretation of preliminary data from a study of its experimental brain cancer drug.
Other analysts saw the data as positive and in line with expectations and suggested Friday's sell-off was unwarranted and created a buying opportunity for investors.
Several other biotech stocks rose after the American Society of Clinical Oncology (ASCO) released on Thursday evening more than 4,000 abstracts -- or brief summaries -- of data from studies to be presented at the organization's annual scientific meeting next month.
"Celldex shares are going in the wrong direction," said Jonathan Aschoff, an analyst with Brean Murray Carret & Co, who cited "very solid data" from a study of the company's therapeutic vaccine, called CDX-110.
Celldex shares closed 9.2 percent down at $6.97 on Nasdaq and rose to $7.05 in after hours trading. Before the data were released, the stock had nearly doubled for the year to date.
Another analyst said on Thursday evening that interim results from the trial, at first glance, did not measure up to data from earlier studies of the vaccine, which Celldex is testing in partnership with Pfizer Inc (PFE.N).
Celldex shares had initially tumbled 20 percent in after-hours trading on Thursday but quickly bounced back to down about 8 percent after that analyst admitted to misreading the data and called the result encouraging.
"The reality is that there was a misinterpretation of the data that was reported," WBB Securities analyst Steve Brozak said of the sell-off.
He said the real news will come at the ASCO meeting in June, when researchers will have a full explanation of the study data.
Early results from the study of 40 patients with glioblastoma tumors -- a form of brain cancer -- showed that 28, or 70 percent, were alive with no signs of their cancer worsening 5-1/2 months after treatment.
That is about 40 percent longer than seen in patients who received standard care, Celldex said.
Patients in the trial were injected with CDX-110 after initial treatment with Temodar, a Merck & Co Inc (MRK.N) drug that is currently the leading treatment for the most common form of brain cancer.
Celldex said the interim results were "very much the same" as those reported last year from two smaller trials of CDX-110.
It expects to have final trial results, involving 65 patients, later this year.
Pfizer spokesman Curtis Allen said the companies will need to examine full data from the trial before deciding whether to pursue late-stage trials of CDX-110.
"Pfizer and Celldex are evaluating the next step," he said. "We don't want to speculate how long that will be."
The shares of Keryx Biopharmaceuticals Inc (KERX.O) rose 11 percent to $4.98 after data showed its drug, KRX-0401, improved overall survival and slowed cancer progression in patients with advanced colorectal cancer.
The medicine, also known as perifosine, was well tolerated and showed "promising activity" over chemotherapy as a second or third-choice drug for patients with colorectal cancer that has spread.
Investors also cheered the first look at new data from a study of Ziopharm Oncology Inc's (ZIOP.O) drug to treat sarcoma, sending its shares up nearly 10 percent.
A summary of the data showed the Ziopharm drug, palifosfamide, combined with chemotherapy delayed the time it took for sarcoma tumors to grow by 77 percent longer than with chemotherapy alone.
The shares of much larger biotech company Celgene Corp (CELG.O) rose as much as 3 percent after two studies demonstrated the value of its blockbuster multiple myeloma drug, Revlimid, as a maintenance therapy. Shares closed up 0.6 percent at $56.15.
The studies showed Revlimid reduced the risk of disease progression by 50 percent.
Maintenance therapy is seen as a major avenue of revenue growth as it means drugs that had been used only after cancer recurs or worsens may be taken by patients for many months in an effort to hold the disease in check. (Reporting by Ransdell Pierson; additional reporting by Bill Berkrot and Deena Beasley; editing by Tim Dobbyn and Andre Grenon)
Biotech Firms May Get Up to $5 Million Tax Credit
(Update1)
http://www.bloomberg.com/apps/news?pid=20601087&sid=a.jlYIJQKrwg&pos=6[/tag]
By Drew Armstrong
May 21 (Bloomberg) -- Biotechnology companies with fewer than 250 employees may get as much as $5 million each in U.S. government tax credits to help pay for development of “promising” new therapies.
The program gives companies with fewer than 250 employees as much as a 50 percent credit on investments that the government judges will create “promising” therapies and products, according to an Obama administration fact sheet. Investments made in 2009 and this year are eligible.
The $1 billion in credits may help offset the effects of the slow economy for companies that don’t yet have products on the market. GlycoMimetics Inc., a closely held company based in Gaithersburg, Maryland with 25 employees, will apply to help pay for the development of its experimental treatments for sickle cell anemia, said Chief Executive Officer Rachel King.
“This is a very difficult environment to raise money in for any biotech company,” King said yesterday in a telephone interview. “To the extent that we can take advantage of these credits, we can put the money in our coffers and it will help the development of this drug.”
The drug, called GMI-1070, is in the second of three stages of testing normally needed for U.S. regulatory approval. Getting the tax credit will help fund the next phase of clinical testing, King said. GlycoMimetics also wants to test the drug for certain types of blood cancer, she said.
Unmet Medical Needs
The tax credit program is part of the health-care overhaul law signed by President Barack Obama in March. Under the program, the government will evaluate biotechnology projects, assessing whether they “produce new therapies, address unmet medical needs, reduce health care costs or advance the goal of curing cancer,” according to the fact sheet, provided by the Treasury Department.
The credits will “help advance research to fund and find life saving treatments” and will also “increase the competitiveness of our biotech industry,” Treasury Secretary Tim Geithner said on a conference call today.
The U.S. recession has tightened access to investment capital, the lifeblood of the biotechnology industry, during the past two year, National Institutes of Health Director Francis Collins said on the conference call.
Much-Needed Shot
“This program brings a much-needed shot in the arm to small life science companies for whom the capital markets have been frozen,” Biotechnology Industry Organization Chief Executive Officer Jim Greenwood said in a press release.
While the administration expects thousands of applications for the credits, it didn’t have an exact estimate of what size each would be or how many companies would qualify, officials said on the conference call.
“We would like to see a scenario where most eligible projects do get a grant,” Ellen Dadisman, spokeswoman for the Biotechnology Industry Organization, said yesterday in a telephone interview.
Biotech firms will have until July 21 to get their applications to the government. The Treasury department plans to evaluate whether the projects that companies are seeking funds for will create jobs or make the U.S. biotechnology industry more competitive. The NIH also will review the applications.
To contact the reporter on this story: Drew Armstrong in Washington at darmstrong17@bloomberg.net.
Last Updated: May 21, 2010 11:50 EDT
Keryx Biopharmaceuticals Announces Presentation of Two Abstracts at ASCO 2010 Annual Meeting
Date : 05/21/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=42926420&symbol=N^KERX
PR Newswire
NEW YORK, May 21
NEW YORK, May 21 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that two presentations on clinical data from KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, will be made at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting will take place at McCormick Place in Chicago from June 4-8, 2010.
Updated clinical trial results will be presented during the following poster discussion sessions:
Pediatric Oncology
Abstract Title: Phase I study of single-agent perifosine for recurrent pediatric solid tumors.
Presentation Date/Time: Sunday, June 6, 2010; 2:00 PM - 6:00 PM with poster discussion from 5:40 PM – 6:00 PM
Author: Oren J Becher, MD, Memorial Sloan-Kettering Cancer Center
Discussion Presenter: Mark Kieran, MD, PhD, Dana-Farber Cancer Institute
Permanent Abstract ID: 9540
Location: S Hall A2, Poster Board #42b, with discussion in S504
Gastrointestinal (Colorectal) Cancer
Abstract Title: Final results of a randomized phase II study of perifosine in combination with capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with second- or third-line metastatic colorectal cancer (mCRC).
Presentation Date/Time: Tuesday, June 8, 2010; 8:00 AM - 12:00 Noon with poster discussion from 11:45 am – 12:00 Noon
Author: Donald A. Richards, MD, PhD, Texas Oncology
Discussion Presenter: Wells Messersmith, MD, University of Colorado
Permanent Abstract ID: 3531
Location: S403, Poster Board #22, with discussion in S406
Abstracts can be accessed through the ASCO website, www.asco.org.
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 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 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 KRX-0401 (perifosine), 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 KRX-0401; the risk that the data (both safety and efficacy) from ongoing clinical trials will not coincide with the data analyses from prior pre-clinical and 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 ASCO website is not incorporated by reference into this press release and is included for reference purposes only.
CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
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Keryx colon cancer drug boosts survival -study
21.05.2010 01:51
http://www.finanznachrichten.de/nachrichten-2010-05/16959775-keryx-colon-cancer-drug-boosts-survival-study-020.htm
CHICAGO, May 20 (Reuters) - An experimental colorectal cancer drug being developed by Keryx Biopharmaceuticals Inc showed it improved overall survival and slowed cancer progression in patients with advanced colorectal cancer, according to a summary of final data from a mid-stage study.
Researchers said the drug KRX-0401, also known as perifosine, was well tolerated and showed 'promising activity' over chemotherapy as a second or third-choice drug for patients with colorectal cancer that has spread.
The study was one of thousands of abstracts, or brief summaries, of studies released on Thursday ahead of presentation at the American Society of Clinical Oncology (ASCO) next month in Chicago.
The study looked at the safety and effectiveness of perifosine in combination with chemotherapy drug capecitabine in 38 patients with advanced colorectal cancer.
All of the patients had already failed to improve on one or two other treatments.
Of the 35 patients evaluated, 20 percent who got the perifosine combination responded to treatment, compared to 7 percent who got chemotherapy plus a dummy pill.
Patients in the treatment group lived 18 months, compared with 11 months among those who got chemotherapy plus a placebo.
The drug, being developed jointly with Canadian drugmaker Aeterna Zentaris, blocks the activation of Akt, a new pathway thought to be linked with cell death and survival.
High levels of activated Akt are seen frequently in many types of cancer, and are often a sign of poor prognosis.
Last month, U.S. regulators granted the drug fast-track approval, a designation that speeds the regulatory approval process. A late-stage study of the drug is expected to begin this quarter.
(Reporting by Julie Steenhuysen; Editing by David Gregorio)
((julie.steenhuysen@thomsonreuters.com ; +1 312 408 8131) Keywords: CANCER COLON/KERYX
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Spectrum Pharmaceuticals Announces Three Additional Belinostat Abstracts at the 2010 Annual Meeting of the American Society of Clinical Oncology
21.05.2010 13:03
http://www.finanznachrichten.de/nachrichten-2010-05/16964295-spectrum-pharmaceuticals-announces-three-additional-belinostat-abstracts-at-the-2010-annual-meeting-of-the-american-society-of-clinical-oncology-004.htm
* Abstracts Now Available for Viewing at ASCO.org
* Additional Information to be Provided During ASCO Annual Meeting
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial stage biotechnology company with a primary focus in hematology and oncology, today announced that clinical data on belinostat will be presented at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held June 4-8, 2010 at the McCormick Place Convention Center in Chicago, Illinois.
Shown below are the summary abstracts that are now available for viewing on the ASCO.org website (www.asco.org). More detailed information will be provided when the posters are presented.
Monday, June 7, 2010 - 8:00 a.m. - 12:00 p.m.
Trials in Progress Poster Session - Special Session, Clinical trials - S Hall A2
Abstract #TPS185: An Open-Label Randomized Phase 2 Trial Of Belinostat (PXD101) In Combination With Carboplatin And Paclitaxel (BelCaP) Compared To Carboplatin And Paclitaxel In Patients With Previously Untreated Carcinoma Of Unknown Primary.
* Karim Fizazi - Institut de Cancerologie Gustave Roussy, Villejuif, France
* John Hainsworth - Tennessee Oncology Sarah Canon Research Institute, US
Treatment options for patients with cancer of unknown primary (CUP) are limited; carboplatin and paclitaxel combination being one of the options. Belinostat, is a hydroxamate, class I and II histone deacetylase inhibitor (HDACi) with a broad antineoplastic activity. Phase I and II trials are ongoing in multiple indications and in more than 500 patients the most common adverse events have been nausea, vomiting and fatigue. Preclinical data shows synergistic effect when combined with carboplatin and paclitaxel in vitro and in vivo. In a Phase I study for patients with pretreated advanced solid tumors, BelCaP was well-tolerated and active with objective responses seen in pancreatic and rectal cancer patients. A patient with CUP (3 prior chemotherapy regimens) had disease control during 29 months of treatment. Therefore, we are conducting a randomized Phase 2 study (N~88) of CaP with or without belinostat in CUP patients.
Randomized, global, multicenter Phase 2 trial in 19 centers. Inclusion criteria include: a confirmed diagnosis of CUP, no prior therapy, ECOG PS 0-2, age > 18 years. Eligible patients are randomized to receive either arm A or B.
* Arm A: BelCaP; belinostat as a 30-min i.v. infusion once daily (1000 mg/m2) on days 1-3, followed by belinostat 2000mg orally once daily on days 4-5, with paclitaxel (175 mg/m2) administered 2-3 hours following belinostat on day 3 and carboplatin (AUC6) following directly after paclitaxel, up to 6 cycles. From cycle 7: belinostat 750 mg is administered orally once daily x 14 days.
* Arm B: Paclitaxel (175 mg/m2) administered day 1 and carboplatin (AUC6) following directly after paclitaxel. Cycles repeated every 3 weeks.
Primary endpoint is progression free survival (PFS) and secondary endpoints assess additional efficacy parameters and safety. Response is evaluated according to RECIST criteria. 33 patients have been randomized as of 06-Jan-2009.
Monday, June 7, 2010 - 8:00 a.m. - 12:00 p.m.
General Poster Session - Developmental Therapeutics - S Hall A2
Abstract #2585 - Phase 1 Pharmacokinetics and Metabolic Pathway of Belinostat in Patients with Hepatocellular Carcinoma.
* L. Z. Wang, et al.
Metabolic inactivation of several hydroxamic acid-derived histone deacetylase inhibitors (HDACi) involves glucuronidation. Vorinostat, a pan-HDACi, undergoes glucuronidation by UGT2B17. We studied the pharmacokinetics and metabolic pathway of belinostat (PXD101).
In vitro glucuronidation of belinostat was investigated; plasma pharmacokinetics of belinostat was studied in a phase I study in patients with hepatocellular carcinoma. Seventeen patients were treated with belinostat at escalating doses of 600 (n = 3), 900 (n = 3), 1200 (n = 6), 1400 (n = 5) mg/m2 daily by intravenous infusion over 30 minutes for 5 days every 21 days; blood was drawn on day 1 before infusion, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5 and 24 hours after the start of infusion, plasma was isolated for determination of belinostat and identification of its metabolites using LC-MS/MS. Pharmacokinetics of belinostat was studied using non-compartmental methods.
Using a panel of 12 UGT isoforms, UGT1A1 was found to be the predominant enzyme for glucuronidation of belinostat with one third of unmetabolized belinostat left after 1 h incubation at 37 ºC. Belinostat glucuronide had no activity against HONE1 cell line at 10 µM, compared to an IC50 of 1.59 ± 0.90 µM for belinostat. Belinostat AUC increased linearly with dose, with a mean clearance of 34.34 ± 10.56 L/h/m2 and terminal half-life of 2.94 ± 0.48 h. Five metabolites in human plasma were identified. Glucuronidation was the most significant pathway of belinostat metabolism; 2 alternate biotransformation pathways involved methylation to methylated belinostat and reduction of hydroxamic group to its corresponding belinostat amide. In addition, two minor metabolites were found to be belinostat N-glucoside and belinostat acid. Belinostat glucuronide increased in levels shortly after administration, reaching the maximum concentration at 1 h from start of infusion.
Phase II biotransformation played a key role on belinostat disposition, with UGT 1A1 likely involved in the major pathway. Further studies should explore the role of common polymorphisms of UGT1A1 on belinostat disposition and pharmacodynamics.
Saturday, June 5, 2010 - 8:00 a.m. - 12:00 p.m.
General Poster Session - Leukemia, Myelodysplasia, and Transplantation - S Hall A2
Abstract #6607 - Phase 2 Study of the Histone Deacetylase (HDAC) Inhibitor Belinostat for the Treatment of Myelodysplastic Syndrome (MDS)
* Amanda Cashen, MD, et al.
Inhibition of HDAC can induce differentiation, growth arrest, and apoptosis in cancer cells. Belinostat is a potent inhibitor of both class I and class II HDAC enzymes. This Phase II study was undertaken to estimate the efficacy of belinostat for the treatment of MDS.
Adults with MDS (any WHO classification, plus at least 1 significant cytopenia if <5% bone marrow blasts) were eligible if they had = 2 prior therapies for MDS, adequate renal and hepatic function, and ECOG 0-2. The primary endpoint was proportion of confirmed responses (CR, PR, and hematologic improvement [HI]) during the first 12 weeks of treatment. Patients were treated with belinostat 1000 mg/m2 as a 30 min IV infusion on days 1-5 of a 21 day cycle for 4 cycles. Responding patients could receive additional cycles until disease progression or unacceptable toxicity. 21 patients were to be enrolled in the first stage, and if 3 or more responses were observed, an additional 29 would be enrolled in stage 2.
21 patients (median age, 67 years) were enrolled, and all are evaluable. Patients were a median 13.4 months from diagnosis (range, 0.3-210) and had bone marrow blasts of <5% (n=14), 5-9% (n=6), and 10-19% (n=1). 13 patients (62%) had good risk cytogenetics, and 7 (33%) had poor risk. 17 patients (81%) were transfusion dependent. Prior therapy included azacitidine (n=7) and chemotherapy (n=8). Patients were treated with a median 2.5 cycles (range, 1-8) of belinostat. There was one confirmed response - HI in neutrophils - that lasted 2.1 months, for an ORR of 5% (95% CI, 0.2-23). Median Overall Survival was 14.5 months. Median time to progression was 15.5 months. Grade 3-4 toxicities considered at least possibly related to belinostat were: neutropenia (n=10), thrombocytopenia (n=9), anemia (n=5), fatigue (n=2), febrile neutropenia (n=1), and headache (n=1). 2 patients had Grade 2 cytokine release syndrome during belinostat infusion, and 2 patients had QTc prolongation. Because the study met the stopping rule in the first stage of enrollment, it was closed to further accrual.
Although well-tolerated, belinostat does not have sufficient efficacy to warrant further investigation as a single agent in MDS. Supported by NCI N01-CM62205
About Belinostat
Belinostat (PXD 101) is a Class I and II HDAC inhibitor that is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. Its anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the resensitization of cells that have become resistant to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including intravenous administration, continuous intravenous infusion and oral administration.
Belinostat is currently in a registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for relapsed or refractory Peripheral T-Cell Lymphoma (PTCL), an indication for which it has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration. The Company currently plans to file a New Drug Application (NDA) in 2011. Belinostat is also under investigation in a randomized Phase 2 trial, as a combination therapy with carboplatin and paclitaxel, for cancer of unknown primary (CUP). Additionally, the National Cancer Institute is currently conducting several clinical trials of Belinostat in a variety of hematological and solid tumors, both as monotherapy as well as combination therapy.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in hematology and oncology. The Company's strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. In addition to building an efficient in-house clinical research organization with regulatory and data management capabilities, the Company has established a commercial infrastructure for its drug portfolio. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs in late stage development, apaziquone and belinostat, along with a diverse pipeline. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company's website at www.sppirx.com.
Forward-looking statement - This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate our business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners around the world to assist us in the execution of our strategy, the safety and efficacy of ZEVALIN, FUSILEV, and Belinostat, initiate additional trials in additional indications for Belinostat, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.®, ZEVALIN®, and FUSILEV® are registered trademark of Spectrum Pharmaceuticals, Inc., and TURNING INSIGHTS INTO HOPE™, BELINOSTAT™ and the Spectrum Pharmaceutical logos are trademarks owned by or licensed to Spectrum Pharmaceuticals, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contacts:
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x216
© 2010 Business Wire
Aeterna Zentaris: Data on Lead Anticancer Compounds Perifosine and AEZS-108 to be Presented at Upcoming ASCO Annual Meeting
21.05.2010 14:36
http://www.finanznachrichten.de/nachrichten-2010-05/16965307-aeterna-zentaris-data-on-lead-anticancer-compounds-perifosine-and-aezs-108-to-be-presented-at-upcoming-asco-annual-meeting-008.htm
QUEBEC CITY, May 21 /PRNewswire-FirstCall/ -- Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS), (the "Company") a late-stage drug development company specialized in oncology and endocrine therapy, today announced that data on two of its lead anticancer compounds, perifosine and AEZS-108, will be presented at the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO), which will be held June 4 through 8, 2010 at McCormick Place in Chicago. Two posters on perifosine, Aeterna Zentaris' novel, potentially first-in-class, oral anticancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, will be presented in pediatric solid tumors and colorectal cancer. A poster will also be presented on the Company's doxorubicin targeted conjugate compound, AEZS-108, in ovarian cancer.
Abstracts selected for presentation are as follows: Perifosine ---------- Abstract # 9540: "Phase I Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors" Lead Author: Oren J. Becher, MD, Memorial Sloan-Kettering Cancer Center Presenter: Mark Kieran, MD, PhD, Dana-Farber Cancer Institute Date and Time: Sunday, June 6, 2010, 2 pm-6 pm (poster discussion 5:40pm-6pm) Poster Board #: 42b Location: S Hall A2 (poster discussion in S504) Abstract # 3531: "Final results of a randomized Phase II study of perifosine in combination with capecitabine (P-CAP) vs. placebo plus capecitabine (CAP) in patients (pts) with second or third line metastatic colorectal cancer (mCRC)" Lead Author: Donald A. Richards, MD, PhD, Texas Oncology Presenter: Wells Messersmith, MD, University of Colorado Date and Time: Tuesday, June 8, 2010, 8 am-12 noon (poster discussion 11:45 am-12 noon) Poster Board #: 22 Location: S403 (poster discussion in S406) AEZS-108 -------- Abstract # 5035: "Phase 2 study of AEZS-108, a targeted cytotoxic LHRH analog, in patients with LHRH receptor positive platinum resistant ovarian cancer" Lead Author: Prof. Gunter Emons, Chairman, Department of Obstetrics&Gynaecology Georg-August University Gottingen, Germany Presenter: Prof. Gunter Emons Date and Time: Saturday, June 5, 2010 2pm- 6pm Poster Board #: 45B Location: S Hall A2
Copies of these abstracts are currently available and can be viewed on-line through the ASCO website: http://www.asco.org/.
About Perifosine
Perifosine, a novel, potentially first-in-class, oral Akt inhibitor, is currently in Phase 3 trials for multiple myeloma and advanced colorectal cancer, under Special Protocol Assessment and Fast Track designation granted by the Food and Drug Administration (FDA) for both indications. FDA has also granted perifosine orphan-drug status for multiple myeloma. Furthermore, the European Medicines Agency (EMA) has issued a positive Scientific Advice as well as a positive opinion for Orphan Medicinal Product designation for perifosine for multiple myeloma.
Perifosine is also in a Phase 1 trial in pediatric patients, as well as in other Phase 1 and Phase 2 trials for several other tumor types.
Keryx Biopharmaceuticals, Inc. (Keryx) is Aeterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Perifosine is also out-licensed to Handok for South Korea, while Aeterna Zentaris retains rights for the rest of the world.
About AEZS-108
AEZS-108, a doxorubicin LHRH receptor targeted conjugate, is currently in a Phase 2 trial in advanced ovarian and endometrial cancer for which final results are expected before year-end. AEZS-108 has been granted orphan-drug designation by the FDA and has received a positive opinion for Orphan Medicinal Product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for the treatment of ovarian cancer. An IND in the U.S. is in place for the treatment of bladder cancer.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. News releases and additional information are available at http://www.aezsinc.com/.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbour 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.
AETERNA ZENTARIS INC.
CONTACT: Investor Relations: Ginette Vallieres, Investor Relations
Coordinator, (418) 652-8525 ext. 265, gvallieres@aezsinc.com; Media Relations:
Paul Burroughs, Director of Communications, (418) 652-8525 ext. 406,
pburroughs@aezsinc.com
© 2010 PR Newswire
Keryx colon cancer drug boosts survival -study
21.05.2010 01:51
http://www.finanznachrichten.de/nachrichten-2010-05/16959775-keryx-colon-cancer-drug-boosts-survival-study-020.htm
CHICAGO, May 20 (Reuters) - An experimental colorectal cancer drug being developed by Keryx Biopharmaceuticals Inc showed it improved overall survival and slowed cancer progression in patients with advanced colorectal cancer, according to a summary of final data from a mid-stage study.
Researchers said the drug KRX-0401, also known as perifosine, was well tolerated and showed 'promising activity' over chemotherapy as a second or third-choice drug for patients with colorectal cancer that has spread.
The study was one of thousands of abstracts, or brief summaries, of studies released on Thursday ahead of presentation at the American Society of Clinical Oncology (ASCO) next month in Chicago.
The study looked at the safety and effectiveness of perifosine in combination with chemotherapy drug capecitabine in 38 patients with advanced colorectal cancer.
All of the patients had already failed to improve on one or two other treatments.
Of the 35 patients evaluated, 20 percent who got the perifosine combination responded to treatment, compared to 7 percent who got chemotherapy plus a dummy pill.
Patients in the treatment group lived 18 months, compared with 11 months among those who got chemotherapy plus a placebo.
The drug, being developed jointly with Canadian drugmaker Aeterna Zentaris, blocks the activation of Akt, a new pathway thought to be linked with cell death and survival.
High levels of activated Akt are seen frequently in many types of cancer, and are often a sign of poor prognosis.
Last month, U.S. regulators granted the drug fast-track approval, a designation that speeds the regulatory approval process. A late-stage study of the drug is expected to begin this quarter.
(Reporting by Julie Steenhuysen; Editing by David Gregorio)
((julie.steenhuysen@thomsonreuters.com ; +1 312 408 8131) Keywords: CANCER COLON/KERYX
COPYRIGHT
Copyright Thomson Reuters 2010. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
© 2010 AFX News
Keryx colon cancer drug boosts survival -study
21.05.2010 01:51
http://www.finanznachrichten.de/nachrichten-2010-05/16959775-keryx-colon-cancer-drug-boosts-survival-study-020.htm
CHICAGO, May 20 (Reuters) - An experimental colorectal cancer drug being developed by Keryx Biopharmaceuticals Inc showed it improved overall survival and slowed cancer progression in patients with advanced colorectal cancer, according to a summary of final data from a mid-stage study.
Researchers said the drug KRX-0401, also known as perifosine, was well tolerated and showed 'promising activity' over chemotherapy as a second or third-choice drug for patients with colorectal cancer that has spread.
The study was one of thousands of abstracts, or brief summaries, of studies released on Thursday ahead of presentation at the American Society of Clinical Oncology (ASCO) next month in Chicago.
The study looked at the safety and effectiveness of perifosine in combination with chemotherapy drug capecitabine in 38 patients with advanced colorectal cancer.
All of the patients had already failed to improve on one or two other treatments.
Of the 35 patients evaluated, 20 percent who got the perifosine combination responded to treatment, compared to 7 percent who got chemotherapy plus a dummy pill.
Patients in the treatment group lived 18 months, compared with 11 months among those who got chemotherapy plus a placebo.
The drug, being developed jointly with Canadian drugmaker Aeterna Zentaris, blocks the activation of Akt, a new pathway thought to be linked with cell death and survival.
High levels of activated Akt are seen frequently in many types of cancer, and are often a sign of poor prognosis.
Last month, U.S. regulators granted the drug fast-track approval, a designation that speeds the regulatory approval process. A late-stage study of the drug is expected to begin this quarter.
(Reporting by Julie Steenhuysen; Editing by David Gregorio)
((julie.steenhuysen@thomsonreuters.com ; +1 312 408 8131) Keywords: CANCER COLON/KERYX
COPYRIGHT
Copyright Thomson Reuters 2010. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
© 2010 AFX News
Keryx Biopharmaceuticals Announces Presentation of Two Abstracts at ASCO 2010 Annual Meeting
Date : 05/21/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=42926420&symbol=N^KERX
PR Newswire
NEW YORK, May 21
NEW YORK, May 21 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that two presentations on clinical data from KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, will be made at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting will take place at McCormick Place in Chicago from June 4-8, 2010.
Updated clinical trial results will be presented during the following poster discussion sessions:
Pediatric Oncology
Abstract Title: Phase I study of single-agent perifosine for recurrent pediatric solid tumors.
Presentation Date/Time: Sunday, June 6, 2010; 2:00 PM - 6:00 PM with poster discussion from 5:40 PM – 6:00 PM
Author: Oren J Becher, MD, Memorial Sloan-Kettering Cancer Center
Discussion Presenter: Mark Kieran, MD, PhD, Dana-Farber Cancer Institute
Permanent Abstract ID: 9540
Location: S Hall A2, Poster Board #42b, with discussion in S504
Gastrointestinal (Colorectal) Cancer
Abstract Title: Final results of a randomized phase II study of perifosine in combination with capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with second- or third-line metastatic colorectal cancer (mCRC).
Presentation Date/Time: Tuesday, June 8, 2010; 8:00 AM - 12:00 Noon with poster discussion from 11:45 am – 12:00 Noon
Author: Donald A. Richards, MD, PhD, Texas Oncology
Discussion Presenter: Wells Messersmith, MD, University of Colorado
Permanent Abstract ID: 3531
Location: S403, Poster Board #22, with discussion in S406
Abstracts can be accessed through the ASCO website, www.asco.org.
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 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 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 KRX-0401 (perifosine), 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 KRX-0401; the risk that the data (both safety and efficacy) from ongoing clinical trials will not coincide with the data analyses from prior pre-clinical and 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 ASCO website is not incorporated by reference into this press release and is included for reference purposes only.
CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Discovery Labs Achieves Key Milestone Towards Potential Surfaxin(R) Approval
Date : 05/19/2010 @ 6:00AM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=42886812
WARRINGTON, Pa., May 19, 2010
GLOBE NEWSWIRE
Discovery Laboratories, Inc. (Nasdaq:DSCO) announces today that the revalidation of its optimized fetal rabbit Biological Activity Test (BAT, an important quality control release and stability test) has been completed, having met all pre-specified acceptance criteria. The optimization and successful revalidation of the BAT is a key milestone in Discovery Labs' plans to resolve the sole remaining Chemistry, Manufacturing & Control (CMC) issue necessary to potentially gain U.S. Food and Drug Administration (FDA) marketing approval for Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The safety and efficacy of Surfaxin for neonatal RDS has been previously demonstrated in a comprehensive Phase 3 clinical program. If approved, Surfaxin would be the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine.
The successful optimization and revalidation of the BAT represents a key component of the comprehensive preclinical program that Discovery Labs is now conducting to potentially address the sole remaining issue to gain FDA approval of Surfaxin. Prior to optimizing and revalidating the BAT, Discovery Labs had several interactions with the FDA and submitted a proposed revalidation protocol, which also included pre-specified acceptance criteria. The BAT optimization and recently completed revalidation has taken into account FDA suggestions and comments.
To complete the comprehensive preclinical program, Discovery Labs will now employ the optimized BAT in a series of prospectively-designed, side-by-side preclinical studies with the well-established preterm lamb model of RDS. Multiple Surfaxin batches will be employed to assess the short-term physiologic response following Surfaxin administration (via measurement of respiratory compliance) in both the preterm lamb model and the optimized BAT at various time points. The resulting data will be examined to evaluate the relative changes, over time, in biological activity upon Surfaxin administration to determine the degree of comparability between the optimized BAT and the preterm lamb model. These studies are intended to satisfy the FDA as to the BAT's ability to adequately discriminate biologically active from inactive Surfaxin drug product and establish the Surfaxin drug product's final acceptance criteria (with respect to biological activity as assessed by the BAT) for release and ongoing stability.
Jerry Orehostky, Senior Vice President, Quality Operations, commented, "We believe that optimizing and revalidating the BAT has improved its performance and increased the likelihood that the results of our preclinical program will demonstrate, to the FDA's satisfaction, a level of comparability between data generated using the BAT and the preterm lamb model."
Discovery Labs has also been communicating with the FDA regarding other important aspects of the comprehensive preclinical program and submitted for FDA review and comment a protocol outlining a proposed study design and success criteria for the side-by-side preclinical studies. Recent communications with the FDA indicate that its written feedback to the protocol should be anticipated in June 2010. Subject to satisfactory FDA feedback, Discovery Labs believes it remains on track to complete the preclinical program and submit its Complete Response to the FDA in the first quarter of 2011.
W. Thomas Amick, Chairman and interim Chief Executive Officer, commented, "We have worked productively with the FDA to improve the performance of the BAT, an important milestone for Surfaxin and our KL4 surfactant pipeline. We will continue to avail ourselves of the FDA's willingness to provide guidance towards potential Surfaxin approval and advancing our other KL4 surfactant pipeline programs."
The BAT as a Quality Control Drug Product Release Assay
The BAT has been validated as a quality control test in accordance with current Good Manufacturing Practices (GMP) and International Conference on Harmonization (ICH) guidelines. The BAT is one of numerous methods that Discovery Labs employs in an extensive quality surveillance program to assess drug product quality and stability. These highly sophisticated release tests monitor drug product quality throughout shelf-life and represent very sensitive methods for detecting changes in quality over time.
Discovery Labs intends to employ the BAT for drug product release and stability testing for Surfaxin and its other pipeline programs, including Surfaxin LS™ and Aerosurf® (each in development for RDS), Surfaxin for Acute Respiratory Failure (enrollment recently completed in a Phase 2 clinical trial), and aerosolized KL4 surfactant for Cystic Fibrosis (currently being evaluated in an investigator-initiated Phase 2 clinical trial with enrollment currently 70% complete).
Surfaxin, Surfaxin LS and Aerosurf are investigational drug candidates that have not been approved by the FDA or any other world health regulatory authority.
DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements relating, among other things, to Discovery Labs' understanding of the remaining issues that must be addressed to gain FDA approval of Surfaxin. Although Discovery Labs currently believes that it may still succeed in gaining approval of its NDA for Surfaxin for the prevention of RDS in premature infants, these activities and the ultimate outcomes remain subject to a variety of risks and uncertainties that could cause actual results to be materially different. These risks and uncertainties include, but are not limited to, risks that (i) the FDA may not approve Surfaxin or may subject the marketing of Surfaxin to onerous requirements that significantly impair marketing activities; and (ii) Discovery Labs may identify unforeseen problems that have not yet been discovered or the FDA could in the future impose additional requirements to gain approval of Surfaxin. Any failure to satisfy the issues raised by the FDA, in the April 2009 Complete Response letter or in related discussions, could significantly delay, or preclude outright, gaining approval of Surfaxin, which could potentially delay or prevent the approval of Discovery Labs' other products.
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.
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 are: risks relating to the rigorous regulatory requirements required for approval of any drug or drug-device combination products that Discovery Labs may develop, including that: (a) Discovery Labs and the U.S. Food and Drug Administration (FDA) or other regulatory authorities will not be able to agree on the matters raised during regulatory reviews, or Discovery Labs may be required to conduct significant additional activities to potentially gain approval of its product candidates, if ever, (b) the FDA or other regulatory authorities may not accept or may withhold or delay consideration of any of Discovery Labs' applications, or may not approve or may limit approval of Discovery Labs' products to particular indications or impose unanticipated label limitations, and (c) changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval; risks relating to Discovery Labs' research and development activities, including (i) time-consuming and expensive pre-clinical studies, clinical trials and other efforts, which may be subject to potentially significant delays or regulatory holds, or fail, and (ii) the need for sophisticated and extensive analytical methodologies, including an acceptable biological activity test, if required, as well as other quality control release and stability tests to satisfy the requirements of the regulatory authorities; risks relating to Discovery Labs' ability to develop and manufacture drug products and capillary aerosolization systems for clinical studies, and, if approved, for commercialization of drug and combination drug-device products, including risks of technology transfers to contract manufacturers and problems or delays encountered by Discovery Labs, its contract manufacturers or suppliers in manufacturing drug products, drug substances and capillary aerosolization systems on a timely basis or in an amount sufficient to support Discovery Labs' development efforts and, if approved, commercialization; the risk that Discovery Labs may be unable to identify potential strategic partners or collaborators to develop and commercialize its products, if approved, in a timely manner, if at all; the risk that Discovery Labs will not be able in a changing financial market to raise additional capital or enter into strategic alliances or collaboration agreements, or that the ongoing credit crisis will adversely affect the ability of Discovery Labs to fund its activities, or that additional financings could result in substantial equity dilution; the risk that Discovery Labs will not be able to access credit from its committed equity financing facilities (CEFFs), or that the minimum share price at which Discovery Labs may access the CEFFs from time to time will prevent Discovery Labs from accessing the full dollar amount potentially available under the CEFFs; the risk that Discovery Labs or its strategic partners or collaborators will not be able to retain, or attract, qualified personnel; the risk that Discovery Labs will be unable to regain compliance with The Nasdaq Global Market listing requirements prior to the expiration of the grace period currently in effect, which could cause the price of Discovery Labs' common stock to decline; the risk that recurring losses, negative cash flows and the inability to raise additional capital could threaten Discovery Labs' ability to continue as a going concern; the risks that Discovery Labs may be unable to maintain and protect the patents and licenses related to its products, or other companies may develop competing therapies and/or technologies, or health care reform may adversely affect Discovery Labs; risks of legal proceedings, including securities actions and product liability claims; risks relating to health care reform; and other risks and uncertainties 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.
CONTACT: Discovery Laboratories, Inc.
John G. Cooper, EVP and Chief Financial Officer
215-488-9300