LevelStock.com: Genta Receives $2.8 Million in Non-Dilutive Proceeds from Tax Sale and Designation by EMEA as a Small Business Entity
Feb 10th 2010, Braintree,Ma. LevelStock.com is pleased to announce to all of its members and investors information on Genta Incorporated (OTCBB: GETA). The Company released news as follows:
Genta Incorporated (OTCBB: GETA) announced that it has received $2.8 million in non-dilutive cash proceeds from the sale of net operating tax losses and research tax credits generated in prior tax years as part of the Technology Business Tax Certificate Program sponsored by the New Jersey Economic Development Authority (NJEDA), pursuant to the rules, regulations and stipulations set forth by the program. This program, which focuses on biotechnology and other research-based companies, is designed to attract and retain knowledge-intensive businesses that will enhance the State’s strategic and competitive interests in these areas.
Genta also announced that the Company’s request for designation as a Small-to-Medium Sized Enterprise (SME) had been granted by the European Medicines Agency (EMEA). SME status provides certain financial and administrative assistance to small businesses as they advance their regulatory filings and submissions through the EMEA.
About the NJ Economic Development Authority
The NJEDA is a state financing and development agency that works to strengthen New Jersey’s economy by retaining and growing businesses through financial assistance, by renewing communities, and by promoting the State’s strategic advantages to attract domestic and international business. Opportunities for business growth throughout New Jersey can be viewed at the State’s business portal: http://www.njeda.com.
About Genta
For more information about Genta, please visit our new website at: http://www.genta.com.
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company’s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company’s lead compound from its DNA/RNA Medicines program. Genasense® is being developed as an agent that may enhance the effectiveness of current anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from its recently completed randomized Phase 3 trial of Genasense® in patients with advanced melanoma. The leading drug in Genta’s Small Molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite®, which have completed preliminary clinical study as a potential treatment for diseases associated with accelerated bone loss. The Company is developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta intends to evaluate the clinical activity of tesetaxel in a range of human cancers. Ganite® and Genasense® are available on a “named-patient” basis in countries outside the United States.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words “potentially”, “anticipate”, “could”, “calls for”, and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
- the Company’s ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
- the safety and efficacy of the Company’s products or product candidates;
- the commencement and completion of any clinical trials;
- the Company’s assessment of its clinical trials;
- the Company’s ability to develop, manufacture, license, or sell its products or product candidates;
- the Company’s ability to enter into and successfully execute any license and collaborative agreements;
- the adequacy of the Company’s capital resources and cash flow projections, the Company’s ability to obtain sufficient financing to maintain the Company’s planned operations, or the Company’s risk of bankruptcy;
- the adequacy of the Company’s patents and proprietary rights;
- the impact of litigation that has been brought against the Company; and
- the other risks described under Certain Risks and Uncertainties Related to the Company’s Business, as contained in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company’s Annual Report on Form 10-K for 2008 and its most recent quarterly report on Form 10-Q.
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LevelStock.com: Lexicon Pharmaceuticals to Present at the 12th Annual BIO CEO & Investor Conference
Braintree,Ma. LevelStock.com is pleased to announce today 4th Feb 2010, to all of its members and investors information on Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) The Company released news Feb 3rd as follows:
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that Arthur T. Sands, M.D., Ph.D., Lexicon’s president and chief executive officer, will present at the 2010 BIO CEO & Investor Conference in New York on Monday, February 8, 2010 at 9:30 a.m., Eastern Time. The conference is hosted by the Biotechnology Industry Organization (BIO) and will take place from February 8-9, 2010.
About BIO CEO & Investor Conference
The BIO CEO & Investor Conference is the largest independent investor conference focused on publicly-traded biotechnology companies. The conference provides a forum where institutional investors, industry analysts, and senior biotechnology executives have the opportunity to shape the future investment landscape of the biotechnology industry through issue-oriented plenary sessions, educational sessions focused on hot therapeutic areas and key business issues, company presentations, and one-on-one meetings.
About Lexicon
Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon currently has five drug candidates in development for autoimmune disease, carcinoid syndrome, diabetes, glaucoma and irritable bowel syndrome, all of which were discovered by Lexicon’s research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs. For additional information about Lexicon and its programs, please visit http://www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon’s ability to successfully conduct preclinical and clinical development of its potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Factors Affecting Forward-Looking Statements” and “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2008, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
About LevelStock.com
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LevelStock.com Reports: Gilead Sciences Announces Notification of ANDA Filing for Viread(R)
Jan 28, 2010- Braintree,Ma. LevelStock.com is pleased to announce to all of its members and investors information on Gilead Sciences, Inc. (Nasdaq:GILD) The Company released news today as follows:
Gilead Sciences, Inc. (Nasdaq:GILD) today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Viread® (tenofovir disoproxil fumarate).
In the Notice Letter, Teva alleges that three patents associated with tenofovir disoproxil – U.S. Patent Numbers 5,922,695; 5,977,089; and 6,043,230; and one patent associated with tenofovir disoproxil fumarate – U.S. Patent Number 5,935,946 – owned by Gilead Sciences are invalid, unenforceable and/or will not be infringed by Teva’s manufacture, use or sale of the product described in its ANDA submission.
Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva’s ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first.
Viread is currently protected by four patents, which are listed in the FDA’s Approved Drug Products List, and all four patents would need to be invalidated or expired before a generic version of Viread could be marketed. The U.S. Patent & Trademark Office (PTO) confirmed the patentability of these four Viread patents in 2008.
Gilead currently has a lawsuit pending against Teva in response to Teva’s attempts to seek approval for generic versions of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on allegations that two emtricitabine patents are invalid, unenforceable and/or will not be infringed by Teva’s manufacture, use or sale of its generic product.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including uncertainty related to whether Gilead will file another patent infringement lawsuit against Teva and whether such a lawsuit or the lawsuit that is currently pending related to Teva’s ANDA filing for Truvada and Atripla would be successful. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the third quarter of 2009, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Viread and Truvada are registered trademarks of Gilead Sciences, Inc.
Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.
For more information on Gilead, please call the Gilead Public Affairs Department at 1-800-GILEAD-5
(1-800-445-3235) or visit http://www.gilead.com
About LevelStock.com
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LevelStock.com is not a registered investment advisor or broker-dealer. The information here is believed to be reliable, but not guaranteed to be accurate by LevelStock.com Please be advised that the information contained may or may not be complete and is solely for informational purposes only. Please read our full disclaimer for complete risks and disclosures http://levelstock.bondwaresite.com/news.php?viewStory=19
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LevelStock.com: Poniard Pharmaceuticals Announces Phase 2 Trial of Picoplatin in Metastatic Colorectal Cancer Meets Primary Endpoint and Study Objectives
Jan 24, 2010- Braintree,Ma. LevelStock.com is pleased to announce to all of its members and investors information on Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), The Company released news today stating”
Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) a biopharmaceutical company focused on innovative oncology therapies, today announced final data from a randomized, controlled Phase 2 trial of picoplatin in metastatic colorectal cancer (CRC) patients. The study met its primary objective, as picoplatin in combination with 5-fluorouracil and leucovorin (FOLPI regimen) was associated with a statistically significant reduction in neurotoxicity (p <0.004) compared to oxaliplatin given in combination with 5-fluorouracil and leucovorin (FOLFOX regimen). Results also suggested that FOLPI had similar efficacy to FOLFOX.
“We believe that these Phase 2 data confirm picoplatin’s potential as an alternative to oxaliplatin in the first-line treatment of metastatic CRC and will support the design of a Phase 3 study,” said Jerry McMahon, Ph.D., chairman and CEO of Poniard. ”We plan to schedule an end of Phase 2 meeting with the U.S. Food and Drug Administration to discuss these data and a potential registration strategy for picoplatin in CRC. Our ultimate goal is to secure a strategic partnership to support further development of picoplatin in CRC and other solid tumor indications, including prostate and ovarian cancers.”
The picoplatin Phase 2 CRC data were presented at the American Society of Clinical Oncology’s 2010 Gastrointestinal Cancers Symposium in Orlando, Fla., during today’s General Poster Session.
Phase 2 CRC Trial Design and Results
The randomized, controlled Phase 2 trial evaluated picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC in 101 patients who had not received prior chemotherapy. The trial’s primary objective was to measure the relative incidence and severity of neuropathy in the FOLPI regimen compared to the FOLFOX regimen. In addition, the study measured comparative safety and efficacy (assessed by disease control, progression-free survival (PFS) and overall survival (OS)) data; however, the study was not powered to assess the statistical significance of these secondary endpoints. The final Phase 2 data indicated that:
-- FOLPI is associated with a statistically significant reduction in neurotoxicity compared to FOLFOX (HR <0.30; p <0.004). Neuropathy, regardless of Grade, was 26 percent in FOLPI-treated patients and 62 percent in FOLFOX-treated patients. No Grade 3/4 neuropathy was observed with FOLPI. -- FOLPI had similar efficacy to FOLFOX as measured by: o Disease Control of 75 percent and 76 percent for FOLPI and FOLFOX, respectively; (Relative risk 1.02 (95 percent Confidence Interval (CI) 0.79-1.32), p=0.9) o PFS of 6.8 months and 7.0 months for FOLPI and FOLFOX, respectively: HR 0.95 (95 percent CI 0.63-1.45), p=0.82 o OS of 13.6 months and 15.6 months for FOLPI and FOLFOX, respectively: HR 1.17 (95 percent CI 0.72-1.91), p=0.53 -- Six-month and one-year survival rates were 80 percent and 52 percent for FOLPI and 83 percent and 55 percent for FOLFOX, respectively. -- More patients who discontinued FOLFOX had associated neuropathy; neurotoxicity was not dose-limiting for FOLPI. More patients who discontinued FOLPI had associated hematological events than with FOLFOX. -- No hypersensitivity, cardiac or nephrotoxicity was observed with FOLPI or FOLFOX. -- FOLPI had more frequent and severe, but manageable, thrombocytopenia and neutropenia; complications were rare, with only 1 patient (2 percent) having febrile neutropenia and 2 patients (4 percent) having minor bleeding issues. -- Most other toxicities, including gastrointestinal toxicity, were similar for both regimens except for alopecia, which was more frequent with FOLPI.
About Picoplatin
Picoplatin is a new and differentiated platinum-based chemotherapeutic agent that is in clinical development for multiple cancer indications, treatment combinations and by two routes of administration. It is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date suggest that picoplatin has an improved safety profile relative to existing platinum-based cancer therapies and can be safely administered in combination with multiple approved oncology products. Approximately 1,100 patients have received picoplatin. Results obtained to date suggest that hematologic events are common but manageable. Kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) are less frequent and less severe than is commonly observed with other platinum chemotherapy drugs. Picoplatin has demonstrated anti-tumor activity in a variety of solid tumors.
In addition to the Phase 2 clinical trial of picoplatin in patients with metastatic CRC, Poniard has evaluated intravenous picoplatin in the treatment of small cell lung cancer in its Phase 3 SPEAR trial. This trial did not meet its primary endpoint of overall survival, and the Company plans to meet with the FDA to discuss a potential regulatory path forward for picoplatin in this indication. Poniard is also evaluating picoplatin in a Phase 2 clinical trial in patients with metastatic hormone-refractory prostate cancer. Final results of the Company’s Phase 1 cardiac safety trial and the Phase 1 trial of an oral formulation of picoplatin were presented in 2009.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products to impact the lives of people with cancer. For additional information please visit http://www.poniard.com.
Forward-Looking Statement
This release contains forward-looking statements interpreting the results of the Company’s Phase 2 clinical trial of picoplatin in metastatic colorectal cancer and describing the Company’s regulatory and partnering strategies with respect to such product candidate. Actual results and events may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties inherent in the Company’s business, including, but not limited to, the potential safety, efficacy and commercial viability of picoplatin; the risk that the Company’s additional analyses of data from clinical trials of picoplatin may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted trials, including the Phase 2 trial described in this press release; the results and timing of the Company’s discussions with the FDA; the Company’s anticipated operating losses, need for future capital and ability to obtain future funding; the Company’s ability to attract and retain key personnel and enter into strategic partnerships on favorable terms, or at all; competition from third parties; the Company’s ability to preserve and protect its intellectual property rights; the Company’s dependence on third-party manufacturers, suppliers and other contractors; changes in technology, government regulation and general market conditions; the receipt and timing of any FDA and other required regulatory approvals; and the risks and uncertainties described in the Company’s current and periodic reports filed with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2008, and its Quarterly Report on Form 10-Q for the period ended September 30, 2009. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.
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About LevelStock.com
We are an investor community and investors relations website specializing in emerging growth stocks in today’s Hot Sectors and providing a platform of services for SmallCap, MicroCap, NanoCap Companies. Join Us Today! http://www.levelstock.com/ and http://twitter.com/levelstock
LevelStock.com is not a registered investment advisor or broker-dealer. The information here is believed to be reliable, but not guaranteed to be accurate by LevelStock.com Please be advised that the information contained may or may not be complete and is solely for informational purposes only. Please read our full disclaimer for complete risks and disclosures http://levelstock.bondwaresite.com/news.php?viewStory=19
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