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HEB Keeps Going Strong...News
New Animal Model for Evaluating Antiviral Agents Against the SARS Virus Indicates Potential Effect of Ampligen(R), an Experimental Therapeutic
Independent University Researchers Find Ampligen(R) "Fully Protective" in Study
globenewswire
Companies:
o Hemispherx Biopharma, Inc.
Press Release Source: Hemispherx Biopharma, Inc. On Monday February 8, 2010, 8:45 am
PHILADELPHIA, Feb. 8, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company") reported a recent study, published in the December 20th issue of Virology (2009) by a consortium of researchers at Utah State University and the University of North Carolina, on a newly developed animal model of severe acute respiratory disease syndrome (SARS) which, according to the authors, " ... largely mimicked human disease". SARS emerged in 2002 in the Guangdong province of Southern China as a new infectious respiratory disease characterized by influenza-like symptoms with a very high mortality rate. The researchers characterized and adapted a new strain of the SARS virus (SARS-CoV) to mice that was 100% lethal and was associated with the overproduction of cytokines and severe lung pathology (Day CW, et al. Virology, 395:210-222, 2009).
Multiple agents with purported antiviral activity were evaluated for activity in this unique mouse model of the human disease, including Ampligen® (Poly I : Poly C12U), ribavirin (a commercially available antiviral with multiple modes of action for certain respiratory diseases) and other experimental agents. The researchers found that, uniquely among the agents tested, Ampligen®, an experimental therapeutic, " ... protected against death and gross damage to the lungs in the presence of lethal SARS-CoV" and was associated with a reduction in IL-6 concentration in which high levels of the cytokine correlated with the mortality of SARS-CoV infection. Mortality was high, under the conditions tested, for all the other antiviral agents examined, including ribavirin, that have previously been used extensively in humans with SARS without definitive evidence of efficacy (Stockman LJ, et al. PLoS Med 3 (9),e 343).
To date, there are no approved agents for treating SARS. Animal experiments do not necessarily predict safety or efficacy in man. Encouraged by these results, Hemispherx is now in discussions with Chinese clinical research organizations to institute clinical antiviral programs in China.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon LDO. Ampligen® represents experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes agents for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties, including, but not limited to, the risk that the results of the animal studies are not representative of the safety or efficacy profile of Ampligen® when used as a treatment in humans and the risk that we are not able to come to an agreement to institute a clinical antiviral program in China or elsewhere in connection with the use of Ampligen® as a treatment for SARS. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection® do not imply that the product will ever be specifically approved commercially for these other treatment indications.
Contact:
Hemispherx Biopharma, Inc.
Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
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Genta Gaining Steam...News
Genta Initiates Phase 2 Study of Tesetaxel, the Leading Clinical-Stage Oral Taxane, in Patients with Advanced Melanoma
businesswire
Companies:
o Genta Incorporated
Press Release Source: Genta Incorporated On Monday February 8, 2010, 8:05 am
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA - News) announced that the Company has initiated treatment of the first subject in a new Phase 2 trial of tesetaxel in advanced melanoma. Tesetaxel is the Company’s newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development. The new trial builds on more than ten years of Genta’s experience in melanoma clinical research.
Unlike standard taxanes (paclitaxel [Taxol®] or docetaxel [Taxotere®]) that must be infused intravenously, tesetaxel is a capsule that can be taken by mouth. The study will examine the effects of tesetaxel in patients with advanced melanoma who have developed progressive disease after treatment with a single first-line regimen. Endpoints of the study include response rate, durable response, disease control, progression-free survival, and safety. The study was initiated at M.D. Anderson Cancer Center in Houston, TX, which has been the lead center for Genta’s last two clinical trials in melanoma that together have enrolled approximately 1,100 patients.
“Despite lack of regulatory approval, taxanes have been increasingly used for treatment of patients with metastatic melanoma,” said Dr. Agop Bedikian, Professor of Medicine at M.D. Anderson Cancer Center and the new study’s Principal Investigator. “For patients who have failed first-line treatment, response rates – particularly durable responses – have been increasingly accepted as important clinical endpoints. Tesetaxel is a highly exciting and novel tubulin inhibitor with a pharmacokinetic profile that appears extremely promising. We are enthusiastic about being the lead center for this new endeavor.”
“Taxanes are the most widely used drug class in oncology,” commented Dr. Raymond P. Warrell, Jr., Genta’s Chief Executive Officer. “A successful oral taxane has been a research objective of many leading pharmaceutical companies. Our compound has been tested in preliminary studies involving more than 280 patients with various types of cancer in the U.S., Europe, and Japan. By eliminating serious hypersensitivity infusion reactions, as well as potentially reducing nerve damage and overcoming resistance to standard taxanes, tesetaxel may offer important new treatment options for patients with advanced cancer.”
About Tesetaxel
Tesetaxel is a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. However, both of these agents suffer from serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
With administration as an oral capsule, tesetaxel was developed with a goal of maintaining the high antitumor activity of the taxane drug class while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral route also enables the development of novel schedules that may expand dosing options when tesetaxel is used alone or in combination with other anticancer drugs, including “all oral” chemotherapy programs. Preclinically, tesetaxel has demonstrated substantially higher activity against cell lines that were resistant to paclitaxel and docetaxel, since acquired resistance is not mediated by the multidrug-resistant p-glycoprotein.
As a late Phase 2 oncology product, tesetaxel has demonstrated anticancer activity in its initial clinical trials, and the drug has not been associated with the severe infusion reactions that are linked with other taxanes. Moreover, unlike other oral taxanes that have been developed, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity. More than 280 patients worldwide have been treated with oral tesetaxel in Phase 1 and Phase 2 clinical trials.
About Genta
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 study of Genasense® in patients with advanced melanoma (the AGENDA trial). 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. For more information about Genta, please visit our website at: www.genta.com.
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.
Contact:
Genta Investor Relations
908-286-3980
info@genta.com
Genta Gaining Steam...News
Genta Initiates Phase 2 Study of Tesetaxel, the Leading Clinical-Stage Oral Taxane, in Patients with Advanced Melanoma
businesswire
Companies:
o Genta Incorporated
Press Release Source: Genta Incorporated On Monday February 8, 2010, 8:05 am
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA - News) announced that the Company has initiated treatment of the first subject in a new Phase 2 trial of tesetaxel in advanced melanoma. Tesetaxel is the Company’s newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development. The new trial builds on more than ten years of Genta’s experience in melanoma clinical research.
Unlike standard taxanes (paclitaxel [Taxol®] or docetaxel [Taxotere®]) that must be infused intravenously, tesetaxel is a capsule that can be taken by mouth. The study will examine the effects of tesetaxel in patients with advanced melanoma who have developed progressive disease after treatment with a single first-line regimen. Endpoints of the study include response rate, durable response, disease control, progression-free survival, and safety. The study was initiated at M.D. Anderson Cancer Center in Houston, TX, which has been the lead center for Genta’s last two clinical trials in melanoma that together have enrolled approximately 1,100 patients.
“Despite lack of regulatory approval, taxanes have been increasingly used for treatment of patients with metastatic melanoma,” said Dr. Agop Bedikian, Professor of Medicine at M.D. Anderson Cancer Center and the new study’s Principal Investigator. “For patients who have failed first-line treatment, response rates – particularly durable responses – have been increasingly accepted as important clinical endpoints. Tesetaxel is a highly exciting and novel tubulin inhibitor with a pharmacokinetic profile that appears extremely promising. We are enthusiastic about being the lead center for this new endeavor.”
“Taxanes are the most widely used drug class in oncology,” commented Dr. Raymond P. Warrell, Jr., Genta’s Chief Executive Officer. “A successful oral taxane has been a research objective of many leading pharmaceutical companies. Our compound has been tested in preliminary studies involving more than 280 patients with various types of cancer in the U.S., Europe, and Japan. By eliminating serious hypersensitivity infusion reactions, as well as potentially reducing nerve damage and overcoming resistance to standard taxanes, tesetaxel may offer important new treatment options for patients with advanced cancer.”
About Tesetaxel
Tesetaxel is a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. However, both of these agents suffer from serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
With administration as an oral capsule, tesetaxel was developed with a goal of maintaining the high antitumor activity of the taxane drug class while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral route also enables the development of novel schedules that may expand dosing options when tesetaxel is used alone or in combination with other anticancer drugs, including “all oral” chemotherapy programs. Preclinically, tesetaxel has demonstrated substantially higher activity against cell lines that were resistant to paclitaxel and docetaxel, since acquired resistance is not mediated by the multidrug-resistant p-glycoprotein.
As a late Phase 2 oncology product, tesetaxel has demonstrated anticancer activity in its initial clinical trials, and the drug has not been associated with the severe infusion reactions that are linked with other taxanes. Moreover, unlike other oral taxanes that have been developed, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity. More than 280 patients worldwide have been treated with oral tesetaxel in Phase 1 and Phase 2 clinical trials.
About Genta
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 study of Genasense® in patients with advanced melanoma (the AGENDA trial). 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. For more information about Genta, please visit our website at: www.genta.com.
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.
Contact:
Genta Investor Relations
908-286-3980
info@genta.com
L2 5x.0002 1x.0003
2x.0003 and 3x.0004
Alert...LLBO NEWS...Lifeline Biotechnologies Reports on FDA Filing Preparation
businesswire
Companies:
o Lifeline Biotechnologies, Inc.
Related Quotes
Symbol Price Change
Press Release Source: Lifeline Biotechnologies, Inc. On Tuesday February 2, 2010, 1:20 pm
RENO, Nev.--(BUSINESS WIRE)--Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO - News) today reported the regulatory strategy for its First Warning System™ is well underway and the development of an FDA submission for a 510(k) marketing clearance is expected to be filed later this year.
Jim Holmes, Lifeline's CEO, said, "The FDA, in its recent response, opined that the claims concerning the First Warning System’s ability to identify prospective cancerous conditions of the breasts, as set forth in Lifeline’s submission to the FDA in July 2009, would require modification or a premarketing approval process for a Class 3 device. In the development of our regulatory strategy, we have engaged the services of an FDA consulting firm, whose task will be to review the claims made and recommend the appropriate modifications to said claims in order to allow our device to comply with the 510(k) Class 1 or Class 2 medical device guidelines. Our FDA consulting firm is also conducting a thorough review and validation of the testing processes Lifeline utilized in the gathering of physiological patient data obtained from over 600 patients in three different clinical trials. In addition, the FDA consulting firm will make a thorough review of our patent pending interpretative computer software system in order to ensure compliance with FDA verification and validation requirements. Our software system technology was developed by Lifeline Biotechnologies, together with our ‘Pattern Recognition’ experts at Nanyang Technological University, Singapore.
"Once the review has been completed we intend to move forward a fully-compliant 510(k) submission. The submission will be based on the regulatory strategy and could/should be filed by midyear 2010.
"We've also received many questions concerning the prospect of a reverse split of the common stock. Even though the outstanding common stock is approximately 2.9 billion shares, and may be increased from time to time for additional required funding or other services, we have no plans for a reverse split at this time."
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, the ability to obtain financing, successful development of the Company's product or market acceptance of the product and regulatory and shareholder approval for anticipated actions.
Contact:
Lifeline Biotechnologies, Inc.
Jim Holmes, 775-324-1933
Jholmes@lbti.com
www.lbti.com
LLBO NEWS...Lifeline Biotechnologies Reports on FDA Filing Preparation
businesswire
Companies:
o Lifeline Biotechnologies, Inc.
Related Quotes
Symbol Price Change
Press Release Source: Lifeline Biotechnologies, Inc. On Tuesday February 2, 2010, 1:20 pm
RENO, Nev.--(BUSINESS WIRE)--Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO - News) today reported the regulatory strategy for its First Warning System™ is well underway and the development of an FDA submission for a 510(k) marketing clearance is expected to be filed later this year.
Jim Holmes, Lifeline's CEO, said, "The FDA, in its recent response, opined that the claims concerning the First Warning System’s ability to identify prospective cancerous conditions of the breasts, as set forth in Lifeline’s submission to the FDA in July 2009, would require modification or a premarketing approval process for a Class 3 device. In the development of our regulatory strategy, we have engaged the services of an FDA consulting firm, whose task will be to review the claims made and recommend the appropriate modifications to said claims in order to allow our device to comply with the 510(k) Class 1 or Class 2 medical device guidelines. Our FDA consulting firm is also conducting a thorough review and validation of the testing processes Lifeline utilized in the gathering of physiological patient data obtained from over 600 patients in three different clinical trials. In addition, the FDA consulting firm will make a thorough review of our patent pending interpretative computer software system in order to ensure compliance with FDA verification and validation requirements. Our software system technology was developed by Lifeline Biotechnologies, together with our ‘Pattern Recognition’ experts at Nanyang Technological University, Singapore.
"Once the review has been completed we intend to move forward a fully-compliant 510(k) submission. The submission will be based on the regulatory strategy and could/should be filed by midyear 2010.
"We've also received many questions concerning the prospect of a reverse split of the common stock. Even though the outstanding common stock is approximately 2.9 billion shares, and may be increased from time to time for additional required funding or other services, we have no plans for a reverse split at this time."
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, the ability to obtain financing, successful development of the Company's product or market acceptance of the product and regulatory and shareholder approval for anticipated actions.
Contact:
Lifeline Biotechnologies, Inc.
Jim Holmes, 775-324-1933
Jholmes@lbti.com
www.lbti.com
Interesting info on BIEL's Japan initial order
Spencer February 1, 2010 at 11:54 am
Joe,
The PR about the large sale from Japan was well into the six figures and does not state the exact amount the sale was for. What is the exact number?
Joe Noel
February 1, 2010 at 12:37 pm
Spencer – Thanks for you question. The contract calls for 180,000 units for the first year – the value, depending on exact packaging, is between $1.62 million and $1.8 million. The first installment was for $150,000 as a pre-order. Hope this helps. As you can see, we believe Japan will be a large market. Joe Noel
BIEL discussion on international sales
Question to Joe Noel...The international market is important for revenue generation. How are the international sales doing , and exactly how many countries are selling BIEL products? I realize that the list keeps changing, but could you also give us a current list of each country?
Joe February 1, 2010 at 9:33 am
Answer...I think the strongest distributors are in Northern Europe and Italy. Andy was in Miami on Friday – they reviewed the recent changes to the TV spots and went over the latin america rollit schedule. He was also recently in China where there will be an Allay rollout soon. And of course there is a major effort gettng uderway in Japan – Canada is also a priority. Joe Noel
Interesting info on BIEL's Japan initial order
from YHB
Spencer February 1, 2010 at 11:54 am
Joe,
The PR about the large sale from Japan was well into the six figures and does not state the exact amount the sale was for. What is the exact number?
Joe Noel
February 1, 2010 at 12:37 pm
Spencer – Thanks for you question. The contract calls for 180,000 units for the first year – the value, depending on exact packaging, is between $1.62 million and $1.8 million. The first installment was for $150,000 as a pre-order. Hope this helps. As you can see, we believe Japan will be a large market. Joe Noel
SPPI worth a 2nd look..News
Spectrum Pharmaceuticals Announces Receipt of $16 Million from Asian Partners Related to Apaziquone Collaboration Agreements Announced in November 2009
* $15 Million Received From Nippon Kayaku Co., Ltd.
* $1 Million Received From Handok Pharmaceuticals Co., Ltd.
* Total Potential Value of Asian Collaborations Exceed $170 Million
businesswire
Companies:
o Spectrum Pharmaceuticals, Inc.
Press Release Source: Spectrum Pharmaceuticals, Inc. On Friday January 29, 2010, 7:00 am EST
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI - News), announced today that it has received $15 million from Nippon Kayaku in connection with the collaboration agreement for apaziquone (EOquin®) announced on November 10, 2009, and $1 million from Handok Pharmaceuticals announced on November 23, 2009.
The Company previously announced strategic collaboration agreements with Allergan, Inc. (NYSE: AGN - News) for North America, Europe, and other key markets; Nippon Kayaku Co., Ltd. for Asian countries; and Handok Pharmaceuticals Co., Ltd. for South Korea.
Under terms of the three agreements, in addition to the upfront payments received, Spectrum Pharmaceuticals may receive potential milestone payments based on the achievement of certain clinical, regulatory, and commercialization milestones of more than $450 million. Spectrum will also receive royalties on all ex-U.S. sales.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in 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 continues to build a team that has the necessary education, experience, skills, and passion for success. 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.
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 to Spectrum’s 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, 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 Spectrum’s existing and new drug candidates may not prove safe or effective, the possibility that Spectrum’s 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 Spectrum’s existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that Spectrum’s efforts to acquire or in-license and develop additional drug candidates may fail, Spectrum’s lack of significant revenues, limited marketing experience, dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum’s reports filed with the Securities and Exchange Commission. Spectrum does 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.® is a registered trademark of Spectrum, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
EOquin® is a registered trademark of Allergan, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact:
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x216
TDLP webinar link from the recent 2010 Biotech Conference
http://www.corporate-ir.net/ireye/conflobby.zhtml?ticker=TDLP&item_id=2659948
It happened already...The Biotech Showcase, Marines' Club & Hotel, San Francisco, Ca USA, January 12-13, 2010
Here is the link to the webinar http://www.corporate-ir.net/ireye/conflobby.zhtml?ticker=TDLP&item_id=2659948 It had great DD.Note it was up 28% today.
New Data..Time to wake up this potential beast!
- Current report filing (8-K)
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): January 27, 2010
TRANSDEL PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware
(State of Incorporation) 000-52998
(Commission File Number) 45-0567010
(I.R.S. Employer Identification No.)
4225 Executive Square, Suite 485, La Jolla, California
(Address of Principal Executive Offices) 92037
(Zip Code)
Registrant’s telephone number, including area code: (858) 457-5300
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events.
Transdel Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, provides an update on the Phase 3 clinical study results with its lead pain drug Ketotransdel ® . Ketotransdel ® is comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal Anti-inflammatory Drug), and the Company’s innovative proprietary Transdel™ drug delivery system.
The double-blind, randomized, placebo-controlled, multi-center Phase 3 study enrolled a total of 364 patients with acute soft tissue injuries in 26 centers in the United States. The primary efficacy endpoint was the difference between Ketotransdel ® and placebo in the change from baseline in pain intensity as measured by the 100 mm Visual Analogue Scale (VAS) during daily activities over the past 24 hours on the Day 3 visit.
The Company has recently completed an in-depth analysis of the Ketotransdel ® Phase 3 study data and found that Ketotransdel ® demonstrated a statistically significant higher reduction in pain intensity than placebo in the Intent-To Treat- Analysis (ITT) of patients who met study entry criteria (p< 0.05). In addition, relevant other key endpoint analyses of the ITT population such as Pain Curves over Time show consistent separation between treatment groups reaching statistical significance in favor of Ketotransdel ® . Details are expected to be presented at a pain conference during 2010. This information is the result of detailed analysis of data that was not available at the time the top-line data were announced in October 2009.
As previously reported, the study achieved statistical significance in its primary endpoint in the per protocol analysis. Ketotransdel ® also demonstrated an excellent safety and tolerability profile. In particular, there were no Ketotransdel ® treatment related gastrointestinal, cardiovascular, hepatic or other clinically relevant adverse events reported, which are commonly observed with oral NSAIDs.
Ketotransdel ® was well absorbed through the skin with minimal blood concentrations of ketoprofen detected in a subset of patients who underwent blood sampling for pharmacokinetic (PK) analyses following repeated topical applications. These PK results are consistent with the Company’s previous clinical study findings and support the excellent safety profile.
Transdel continues to work with the FDA to meet the requirement for two adequate and well controlled Phase 3 clinical trials in order to obtain regulatory approval to market Ketotransdel ® .
The Company expects that Ketotransdel, if and when approved by the United States Food and Drug Administration (FDA), could become the first topical NSAID cream product available by prescription in the United States for acute pain management. Transdel is seeking a commercial partner for Ketotransdel ® , and is actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Dated: January 27, 2010
TRANSDEL PHARMACEUTICALS, INC.
By: /s/ Juliet Singh
Juliet Singh, Ph.D.
President & Chief Executive Officer
TDLP- Under Radar..Time to take a look
- Current report filing (8-K)
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): January 27, 2010
TRANSDEL PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware
(State of Incorporation) 000-52998
(Commission File Number) 45-0567010
(I.R.S. Employer Identification No.)
4225 Executive Square, Suite 485, La Jolla, California
(Address of Principal Executive Offices) 92037
(Zip Code)
Registrant’s telephone number, including area code: (858) 457-5300
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events.
Transdel Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, provides an update on the Phase 3 clinical study results with its lead pain drug Ketotransdel ® . Ketotransdel ® is comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal Anti-inflammatory Drug), and the Company’s innovative proprietary Transdel™ drug delivery system.
The double-blind, randomized, placebo-controlled, multi-center Phase 3 study enrolled a total of 364 patients with acute soft tissue injuries in 26 centers in the United States. The primary efficacy endpoint was the difference between Ketotransdel ® and placebo in the change from baseline in pain intensity as measured by the 100 mm Visual Analogue Scale (VAS) during daily activities over the past 24 hours on the Day 3 visit.
The Company has recently completed an in-depth analysis of the Ketotransdel ® Phase 3 study data and found that Ketotransdel ® demonstrated a statistically significant higher reduction in pain intensity than placebo in the Intent-To Treat- Analysis (ITT) of patients who met study entry criteria (p< 0.05). In addition, relevant other key endpoint analyses of the ITT population such as Pain Curves over Time show consistent separation between treatment groups reaching statistical significance in favor of Ketotransdel ® . Details are expected to be presented at a pain conference during 2010. This information is the result of detailed analysis of data that was not available at the time the top-line data were announced in October 2009.
As previously reported, the study achieved statistical significance in its primary endpoint in the per protocol analysis. Ketotransdel ® also demonstrated an excellent safety and tolerability profile. In particular, there were no Ketotransdel ® treatment related gastrointestinal, cardiovascular, hepatic or other clinically relevant adverse events reported, which are commonly observed with oral NSAIDs.
Ketotransdel ® was well absorbed through the skin with minimal blood concentrations of ketoprofen detected in a subset of patients who underwent blood sampling for pharmacokinetic (PK) analyses following repeated topical applications. These PK results are consistent with the Company’s previous clinical study findings and support the excellent safety profile.
Transdel continues to work with the FDA to meet the requirement for two adequate and well controlled Phase 3 clinical trials in order to obtain regulatory approval to market Ketotransdel ® .
The Company expects that Ketotransdel, if and when approved by the United States Food and Drug Administration (FDA), could become the first topical NSAID cream product available by prescription in the United States for acute pain management. Transdel is seeking a commercial partner for Ketotransdel ® , and is actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Dated: January 27, 2010
TRANSDEL PHARMACEUTICALS, INC.
By: /s/ Juliet Singh
Juliet Singh, Ph.D.
President & Chief Executive Officer
Alert TDLP..time to take a look!
- Current report filing (8-K)
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): January 27, 2010
TRANSDEL PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware
(State of Incorporation) 000-52998
(Commission File Number) 45-0567010
(I.R.S. Employer Identification No.)
4225 Executive Square, Suite 485, La Jolla, California
(Address of Principal Executive Offices) 92037
(Zip Code)
Registrant’s telephone number, including area code: (858) 457-5300
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)
Item 8.01. Other Events.
Transdel Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, provides an update on the Phase 3 clinical study results with its lead pain drug Ketotransdel ® . Ketotransdel ® is comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal Anti-inflammatory Drug), and the Company’s innovative proprietary Transdel™ drug delivery system.
The double-blind, randomized, placebo-controlled, multi-center Phase 3 study enrolled a total of 364 patients with acute soft tissue injuries in 26 centers in the United States. The primary efficacy endpoint was the difference between Ketotransdel ® and placebo in the change from baseline in pain intensity as measured by the 100 mm Visual Analogue Scale (VAS) during daily activities over the past 24 hours on the Day 3 visit.
The Company has recently completed an in-depth analysis of the Ketotransdel ® Phase 3 study data and found that Ketotransdel ® demonstrated a statistically significant higher reduction in pain intensity than placebo in the Intent-To Treat- Analysis (ITT) of patients who met study entry criteria (p< 0.05). In addition, relevant other key endpoint analyses of the ITT population such as Pain Curves over Time show consistent separation between treatment groups reaching statistical significance in favor of Ketotransdel ® . Details are expected to be presented at a pain conference during 2010. This information is the result of detailed analysis of data that was not available at the time the top-line data were announced in October 2009.
As previously reported, the study achieved statistical significance in its primary endpoint in the per protocol analysis. Ketotransdel ® also demonstrated an excellent safety and tolerability profile. In particular, there were no Ketotransdel ® treatment related gastrointestinal, cardiovascular, hepatic or other clinically relevant adverse events reported, which are commonly observed with oral NSAIDs.
Ketotransdel ® was well absorbed through the skin with minimal blood concentrations of ketoprofen detected in a subset of patients who underwent blood sampling for pharmacokinetic (PK) analyses following repeated topical applications. These PK results are consistent with the Company’s previous clinical study findings and support the excellent safety profile.
Transdel continues to work with the FDA to meet the requirement for two adequate and well controlled Phase 3 clinical trials in order to obtain regulatory approval to market Ketotransdel ® .
The Company expects that Ketotransdel, if and when approved by the United States Food and Drug Administration (FDA), could become the first topical NSAID cream product available by prescription in the United States for acute pain management. Transdel is seeking a commercial partner for Ketotransdel ® , and is actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Dated: January 27, 2010
TRANSDEL PHARMACEUTICALS, INC.
By: /s/ Juliet Singh
Juliet Singh, Ph.D.
President & Chief Executive Officer
HEB Alert!News Out
Stanford University Publishes New Data on Immuno-potential of Hemispherx's Ampligen(R)
May Enhance Bioactivity of Cancer Immunotherapies
globenewswire
Companies:
o Hemispherx Biopharma, Inc.
Press Release Source: Hemispherx Biopharma, Inc. On Thursday January 28, 2010, 1:36 pm
PHILADELPHIA, Jan. 28, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the “Company”), announced the publication of a peer-reviewed article providing study data on Ampligen® [rintatolimod; poly(I)·poly(C12,U)] , an experimental therapeutic, in the current issue of the American Journal of Obstetrics and Gynecology (Epub ahead of print Jan 15, 2010 vol 202). The report, whose lead author is Dr. Jonathan S. Berek, Professor and Chair, Obstetrics and Gynecology, Stanford University School of Medicine, and colleagues, further details results presented at the Pacific Coast Oncology Gynecology Society Meeting, La Jolla, California, on October 1, 2009. Entitled “Toll-like receptor-3 as a target to enhance bioactivity of cancer immunotherapy,” the article discusses the value of stimulating a periodic “danger signal” with a TLR3 agonist such as poly(I)·poly(C12,U) as part of immunotherapeutic cancer treatment regimens, and suggests such regimens may have broad potential application to boost the effects of many immunotherapies of cancer.
The authors concluded that “poly(I)·poly(C12,U) shows promise as a potential agent for selective enhancement of effect with currently available and future cancer immunotherapies.” The authors also provided the following experimental observations in this report: “Dendritic cells are matured and T-cell stimulation is enhanced in the presence of poly(I)·poly(C12,U) . In addition, poly(I)·poly(C12,U) induced the release of proinflammatory chemokines and cytokines. Prostate-specific antigen-specific T-cell and antibody responses were enhanced significantly in a BALB/c prostate-specific antigen transgenic mouse model. Finally, rituximab [Rituxan®]-mediated antibody-dependent cellular cytotoxicity against tumor targets was improved significantly by the addition of poly(I)·poly(C12,U) .”
According to the authors, “immunotherapy of cancer holds the promise of disease-specific intervention without the toxicity that is associated with traditional therapeutic modalities."
The reported study was supported by an Ovarian Cancer Research Fund COGI Grant, Advanced Immune Therapeutics, Hemispherx Biopharma, and grants from the National Institute of Health (Grants CA 33399, CA 34233), the Ruth Kirschstein Award (Grant 5 T32 AI07290, and the Ruth L. Kirschstein Award (Grant F32 DKO78416).
Ampligen® (poly(I)·poly(C12,U)), an experimental immunotherapeutic, is also being studied as an influenza vaccine enhancer (Japanese National Institute of Infectious Diseases) and as potential monotherapy for chronic fatigue syndrome (CFS).
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® Oragens®, and Alferon LDO. Ampligen® and Oragens® represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx’s platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 50 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen®, Alferon® LDO and Oragens®) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company’s judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection® do not imply that the product will ever be specifically approved commercially for these other treatment indications.
Contact:
Hemispherx Biopharma, Inc.
Dianne Will
518-398-6222
ir@hemispherx.net
Alert! HEB NEWS!!
Stanford University Publishes New Data on Immuno-potential of Hemispherx's Ampligen(R)
May Enhance Bioactivity of Cancer Immunotherapies
globenewswire
Companies:
o Hemispherx Biopharma, Inc.
Press Release Source: Hemispherx Biopharma, Inc. On Thursday January 28, 2010, 1:36 pm
PHILADELPHIA, Jan. 28, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the “Company”), announced the publication of a peer-reviewed article providing study data on Ampligen® [rintatolimod; poly(I)·poly(C12,U)] , an experimental therapeutic, in the current issue of the American Journal of Obstetrics and Gynecology (Epub ahead of print Jan 15, 2010 vol 202). The report, whose lead author is Dr. Jonathan S. Berek, Professor and Chair, Obstetrics and Gynecology, Stanford University School of Medicine, and colleagues, further details results presented at the Pacific Coast Oncology Gynecology Society Meeting, La Jolla, California, on October 1, 2009. Entitled “Toll-like receptor-3 as a target to enhance bioactivity of cancer immunotherapy,” the article discusses the value of stimulating a periodic “danger signal” with a TLR3 agonist such as poly(I)·poly(C12,U) as part of immunotherapeutic cancer treatment regimens, and suggests such regimens may have broad potential application to boost the effects of many immunotherapies of cancer.
The authors concluded that “poly(I)·poly(C12,U) shows promise as a potential agent for selective enhancement of effect with currently available and future cancer immunotherapies.” The authors also provided the following experimental observations in this report: “Dendritic cells are matured and T-cell stimulation is enhanced in the presence of poly(I)·poly(C12,U) . In addition, poly(I)·poly(C12,U) induced the release of proinflammatory chemokines and cytokines. Prostate-specific antigen-specific T-cell and antibody responses were enhanced significantly in a BALB/c prostate-specific antigen transgenic mouse model. Finally, rituximab [Rituxan®]-mediated antibody-dependent cellular cytotoxicity against tumor targets was improved significantly by the addition of poly(I)·poly(C12,U) .”
According to the authors, “immunotherapy of cancer holds the promise of disease-specific intervention without the toxicity that is associated with traditional therapeutic modalities."
The reported study was supported by an Ovarian Cancer Research Fund COGI Grant, Advanced Immune Therapeutics, Hemispherx Biopharma, and grants from the National Institute of Health (Grants CA 33399, CA 34233), the Ruth Kirschstein Award (Grant 5 T32 AI07290, and the Ruth L. Kirschstein Award (Grant F32 DKO78416).
Ampligen® (poly(I)·poly(C12,U)), an experimental immunotherapeutic, is also being studied as an influenza vaccine enhancer (Japanese National Institute of Infectious Diseases) and as potential monotherapy for chronic fatigue syndrome (CFS).
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® Oragens®, and Alferon LDO. Ampligen® and Oragens® represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx’s platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 50 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen®, Alferon® LDO and Oragens®) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company’s judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection® do not imply that the product will ever be specifically approved commercially for these other treatment indications.
Contact:
Hemispherx Biopharma, Inc.
Dianne Will
518-398-6222
ir@hemispherx.net
Working on it!
MedCI Announces Strategic Alliance With Genta Incorporated to Secure Tesetaxel Licensing Partner
Oncology Focused Companies Targeted for Tesetaxel and Oral Gallium Partnerships
SANTA CLARA, Calif., Jan 27, 2010 (BUSINESS WIRE) -- MedCI LLC, a life-science business consulting services company, announced the formation of a new strategic alliance with Genta Incorporated /quotes/comstock/11k!geta (GETA 0.09, +0.00, +2.31%) to secure licensing partners for Genta's small molecule oncology compound, tesetaxel. Tesetaxel is the leading oral taxane in clinical development and is a core component of Genta's investigational drug portfolio. Under the agreement, MedCI will continue and extend current discussions with leading pharmaceutical companies in South Korea that focus on oncology.
With this agreement, MedCI joins an existing three-party alliance that complements Genta's Business Development initiatives in East Asia (Japan, China and Korea) for oral tesetaxel, as well as a global licensing program for oral gallium. The goal of this alliance is to evaluate partners and terms for co-development and commercialization and to rapidly close a transaction.
Tesetaxel has demonstrated anticancer activity in several Phase 2 clinical trials. The drug has not caused severe infusion reactions that are associated with other taxanes. Moreover, unlike other taxanes, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug may offer substantial opportunities to improve patient convenience, safety, and anticancer activity. More than 280 patients worldwide have been treated with oral tesetaxel in Phase 1 and Phase 2 clinical trials. Genta plans to rapidly expand its clinical development program for tesetaxel into a number of new indications and is seeking partners for both territorial and global development.
"We are delighted that MedCI has been selected by Genta to lead the tesetaxel licensing discussions in South Korea," said Manish Singhal, M.D., MedCI's lead partner. "Our existing relationships within the Korean pharmaceutical industry and expert knowledge of best business practices, combined with the significant business potential of tesetaxel, positions MedCI and Genta for success in this endeavor."
"Gastric cancer is the most commonly diagnosed neoplastic disease in East Asia and the basis for our targeted partnership efforts in Japan, Korea and China. It is a lead indication in our global clinical development program for tesetaxel," noted Lloyd Sanders, Genta's Chief Operating Officer. "While we continue productive discussions with a number of potential partners in Korea, we look forward to the expertise of the MedCI team in optimizing, closing, and managing a productive development and commercial relationship on this core initiative."
About MedCI
MedCI is a consulting services company facilitating cross-border business transactions with biotech and pharmaceutical companies in East Asia. With on the ground presence in the rapidly growing markets of South Korea and China as well as USA and Japan, MedCI integrates local market intelligence with comprehensive support services to ensure maximum strategic and financial returns for its clients. Services include in-depth market research, full business and corporate development activities, and post-deal alliance management. For information about MedCI, please email: info@medci.com.
About Genta
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(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense(R) 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(R) in patients with advanced melanoma. The leading drug in Genta's Small Molecule program is Ganite(R) (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(R), which have completed preliminary clinical trials, 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(R) and Genasense(R) are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit: www.genta.com.
MedCI Announces Strategic Alliance With Genta Incorporated to Secure Tesetaxel Licensing Partner
Oncology Focused Companies Targeted for Tesetaxel and Oral Gallium Partnerships
SANTA CLARA, Calif., Jan 27, 2010 (BUSINESS WIRE) -- MedCI LLC, a life-science business consulting services company, announced the formation of a new strategic alliance with Genta Incorporated /quotes/comstock/11k!geta (GETA 0.09, +0.00, +2.31%) to secure licensing partners for Genta's small molecule oncology compound, tesetaxel. Tesetaxel is the leading oral taxane in clinical development and is a core component of Genta's investigational drug portfolio. Under the agreement, MedCI will continue and extend current discussions with leading pharmaceutical companies in South Korea that focus on oncology.
With this agreement, MedCI joins an existing three-party alliance that complements Genta's Business Development initiatives in East Asia (Japan, China and Korea) for oral tesetaxel, as well as a global licensing program for oral gallium. The goal of this alliance is to evaluate partners and terms for co-development and commercialization and to rapidly close a transaction.
Tesetaxel has demonstrated anticancer activity in several Phase 2 clinical trials. The drug has not caused severe infusion reactions that are associated with other taxanes. Moreover, unlike other taxanes, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug may offer substantial opportunities to improve patient convenience, safety, and anticancer activity. More than 280 patients worldwide have been treated with oral tesetaxel in Phase 1 and Phase 2 clinical trials. Genta plans to rapidly expand its clinical development program for tesetaxel into a number of new indications and is seeking partners for both territorial and global development.
"We are delighted that MedCI has been selected by Genta to lead the tesetaxel licensing discussions in South Korea," said Manish Singhal, M.D., MedCI's lead partner. "Our existing relationships within the Korean pharmaceutical industry and expert knowledge of best business practices, combined with the significant business potential of tesetaxel, positions MedCI and Genta for success in this endeavor."
"Gastric cancer is the most commonly diagnosed neoplastic disease in East Asia and the basis for our targeted partnership efforts in Japan, Korea and China. It is a lead indication in our global clinical development program for tesetaxel," noted Lloyd Sanders, Genta's Chief Operating Officer. "While we continue productive discussions with a number of potential partners in Korea, we look forward to the expertise of the MedCI team in optimizing, closing, and managing a productive development and commercial relationship on this core initiative."
About MedCI
MedCI is a consulting services company facilitating cross-border business transactions with biotech and pharmaceutical companies in East Asia. With on the ground presence in the rapidly growing markets of South Korea and China as well as USA and Japan, MedCI integrates local market intelligence with comprehensive support services to ensure maximum strategic and financial returns for its clients. Services include in-depth market research, full business and corporate development activities, and post-deal alliance management. For information about MedCI, please email: info@medci.com.
About Genta
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(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense(R) 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(R) in patients with advanced melanoma. The leading drug in Genta's Small Molecule program is Ganite(R) (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(R), which have completed preliminary clinical trials, 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(R) and Genasense(R) are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit: www.genta.com.
MedCI Announces Strategic Alliance With Genta Incorporated to Secure Tesetaxel Licensing Partner
Oncology Focused Companies Targeted for Tesetaxel and Oral Gallium Partnerships
SANTA CLARA, Calif., Jan 27, 2010 (BUSINESS WIRE) -- MedCI LLC, a life-science business consulting services company, announced the formation of a new strategic alliance with Genta Incorporated /quotes/comstock/11k!geta (GETA 0.09, +0.00, +2.31%) to secure licensing partners for Genta's small molecule oncology compound, tesetaxel. Tesetaxel is the leading oral taxane in clinical development and is a core component of Genta's investigational drug portfolio. Under the agreement, MedCI will continue and extend current discussions with leading pharmaceutical companies in South Korea that focus on oncology.
With this agreement, MedCI joins an existing three-party alliance that complements Genta's Business Development initiatives in East Asia (Japan, China and Korea) for oral tesetaxel, as well as a global licensing program for oral gallium. The goal of this alliance is to evaluate partners and terms for co-development and commercialization and to rapidly close a transaction.
Tesetaxel has demonstrated anticancer activity in several Phase 2 clinical trials. The drug has not caused severe infusion reactions that are associated with other taxanes. Moreover, unlike other taxanes, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug may offer substantial opportunities to improve patient convenience, safety, and anticancer activity. More than 280 patients worldwide have been treated with oral tesetaxel in Phase 1 and Phase 2 clinical trials. Genta plans to rapidly expand its clinical development program for tesetaxel into a number of new indications and is seeking partners for both territorial and global development.
"We are delighted that MedCI has been selected by Genta to lead the tesetaxel licensing discussions in South Korea," said Manish Singhal, M.D., MedCI's lead partner. "Our existing relationships within the Korean pharmaceutical industry and expert knowledge of best business practices, combined with the significant business potential of tesetaxel, positions MedCI and Genta for success in this endeavor."
"Gastric cancer is the most commonly diagnosed neoplastic disease in East Asia and the basis for our targeted partnership efforts in Japan, Korea and China. It is a lead indication in our global clinical development program for tesetaxel," noted Lloyd Sanders, Genta's Chief Operating Officer. "While we continue productive discussions with a number of potential partners in Korea, we look forward to the expertise of the MedCI team in optimizing, closing, and managing a productive development and commercial relationship on this core initiative."
About MedCI
MedCI is a consulting services company facilitating cross-border business transactions with biotech and pharmaceutical companies in East Asia. With on the ground presence in the rapidly growing markets of South Korea and China as well as USA and Japan, MedCI integrates local market intelligence with comprehensive support services to ensure maximum strategic and financial returns for its clients. Services include in-depth market research, full business and corporate development activities, and post-deal alliance management. For information about MedCI, please email: info@medci.com.
About Genta
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(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense(R) 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(R) in patients with advanced melanoma. The leading drug in Genta's Small Molecule program is Ganite(R) (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(R), which have completed preliminary clinical trials, 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(R) and Genasense(R) are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit: www.genta.com.
Spectrum Pharmaceuticals Terminates Ozarelix Development Program in Benign Prostate Hypertrophy (BPH) as It Continues to Prioritize Its Portfolio Strategy
* Estimated Savings of $40+ Million for Clinical Trials and Other Related Costs to Help Advance Other Portfolio Programs
* Spectrum Continues Major Effort to Prioritize Product Portfolio
businesswire
Companies:
o Spectrum Pharmaceuticals, Inc.
Press Release Source: Spectrum Pharmaceuticals On Wednesday January 27, 2010, 7:03 am
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGM: SPPI - News), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it is discontinuing development of ozarelix in benign prostatic hypertrophy (BPH).
“While ozarelix is a potent GnRH antagonist, low-dose intermittent therapy has been disappointing in the treatment of lower urinary tract symptoms in men with BPH. As a result, we have made the strategic decision to discontinue the ozarelix BPH program,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “By discontinuing the ozarelix program, the savings of more than $40 Million we had budgeted for the clinical trials and other related costs will help us advance other programs that have the greatest likelihood of commercial success in providing patients with more effective treatment options. This is part of a concerted effort at streamlining and prioritizing our portfolio.”
Ozarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, was in late stage trials for the treatment of benign prostatic hypertrophy. However, the mixed results of the Company’s earlier Phase 2b study and the recently announced failure of AEterna Zentaris’s large, Phase 3, registrational trial of cetrorelix (another LHRH antagonist) in BPH does not support continued development in this indication.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in 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 continues to build a team that has the necessary education, experience, skills, and passion for success. 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.
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 to Spectrum’s 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, advancing programs that have the greatest likelihood of commercial success in providing patients with more effective treatment options, streamlining and prioritizing our portfolio 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 Spectrum’s existing and new drug candidates may not prove safe or effective, the possibility that Spectrum’s 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 Spectrum’s existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that Spectrum’s efforts to acquire or in-license and develop additional drug candidates may fail, Spectrum’s lack of significant revenues, limited marketing experience, dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum’s reports filed with the Securities and Exchange Commission. Spectrum does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ® is a registered trademark of Spectrum, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact:
Spectrum Pharmaceuticals
Paul Arndt
Senior Manager, Investor Relations
949-788-6700, x216
Robert said a PR is coming soon
Have a great weekend and remember we are on the same team.
They are...A quote from a recent e-mail I got from EVRN "We are working on our E-News portion of our website and will inform you when it is complete. Fresh product samples should be ready for shipment in early March, 2010."
and from Robert that a PR will be out soon.
I am not saying web sales are not important.But if you had so much initial financing and production right now,who would you give the product to:
The already large chain orders which will bring in a ton of money or the beginning of small individual internet sales orders?
They simply cannot do everything all at once...it is impossible!
They must go after big money first,then broaden their sales using other avenues.
With all due respect.I have a very heavy marketing background and what they are doing is perfect. The real money right now is the major chains,where they can fill large orders.They need to do this first with the initial financing and production. This is much bigger than you or I buying 1 or 2 jars on the internet.I am not saying that internet sales are not important,but they must follow this process first.The Balancing Act segments are strictly for Brand Awareness (building demand).EVRN has full intentions to have heavy internet sales in the very near future.
One more thing..Their marketing message is genius ie....an alternative for mayo,how to get your kids to eat their veggies and the multiple uses of their product.From the earlier discussions demand is in place and growing fast.
Interesting...A response on a web order I placed earlier.They are gearing up!!:
Thank you for your interest in Nature’s Peak Company and products. We appreciate your patience with us in responding to your requests/inquiries.
We are working on our E-News portion of our website and will inform you when it is complete. Fresh product samples should be ready for shipment in early March, 2010. Could you please verify your shipping address for us again, we did not receive the city, state and zip code information previously.
To also help us better serve you better, please tell us if you are a distributor/retail store, direct consumer, or just interested in obtaining information on our company.
Also, please let us know if you are already a stockholder in our company.
Thank you again for your interest,
Jeri Tjon
Customer Service
Nature’s Peak
343 Soquel Ave.
Santa Cruz, CA. 95062
800-628-7325
"The Balancing Acts" segment main purpose,according to Robert, is to get the word out(Brand Awareness).The first production is mainly for back orders and to start filling the bigger chains,that were named in previous PRS.Web sales will also start very soon,but is not a first priority.Robert did state that we will hear about the production schedule very soon in form of a PR.
Thank you. I love how the company is moving.Everything is thought out and calculated to be a real company.These guys are working their tails off.
Update - I just got off the phone with Robert.
The Lifetime Slots are all go and the schedule is accurate.They are very professional. side note...I love the How to get your kids to eat veggies part...Fantastic approach. They will all be the same segment that runs.
The Production Schedule is almost done and will be announced shortly.
The first production will be for back orders and also working on filling the bigger chains...Not the Super Stores like Walmart yet.The channel into Walmart is there,but they want to take care of the big chains first then into the super stores.
Web sales should start during the first production schedule also.
He stated financing all looks good going forward for 2010.
The T/A is not gagged....their was a admin error that was corrected.He said if you find there is still a problem call him.
The share structure to date has not changed.
Remember,Paul Robert and Dick all have a lot of there own personal money in this. Approx. 1.2 million..they what to win.And their shares are restricted.They cannot sell them.
Robert and Paul are at a major food show in California as we speak.The response has been excellent for the product. All the big boy distributors,suppliers,chains are there.Paul is working the booth.
Robert said we will here more details in the form of PRs soon. A lot is going on. The motion has started.
*** Please do your own DD. Robert will talk to anyone.
All comments are strictly my opinion.
Will do!
I talked to Robert everything is looking very good. He is going to call me back tonight to discuss...What questions do you guys want me to ask him?
Cell Therapeutics Inc. (NASDAQ : CTIC), $1.34 , +0.17, 14.53%, traded in the range of 1..18 and 1.40 closing the day on gains of 14.53%. Cell Therapeutics just announced that it has entered into an agreement to sell $30 million of shares of its Series 3 Preferred Stock
and warrants to purchase shares of its common stock in a registered offering. Each share of Series 3 Preferred Stock is convertible into approximately 823 shares of common stock at a conversion price of $1.21375 per share of common stock, for a total of approximately 24,690,000 common shares. Cell Therapeutics is a biopharmaceutical industry leader with a focus on oncology drugs
It is real simple LLBO has a great product that has the ability to change how breast cancer is detected.Everything is falling in place perfectly.
They have delivered on the news.Don't shoot the messenger!Everything I have brought up has come directly from Robert.I understand you are frustrated,so am I.I think everyone thought bring this product to market was going to be quicker.I still stand confident that we will win at the end. I like the idea these guys have their own personal money in the game.
How is sharing DD shady? We are all here for the same reason. Why would you tear into someone who is taking their own personal time to get answers and help the board a terrible thing?
RedChip Visibility Issues Research Update on Aethlon Medical
globenewswire
Companies:
o Aethlon Medical Inc.
Press Release Source: RedChip Companies Inc. On Wednesday January 13, 2010, 1:23 pm
ORLANDO, Fla., Jan. 13, 2010 (GLOBE NEWSWIRE) -- RedChip Visibility, a division of RedChip Companies, Inc., has issued a research update on Aethlon Medical, Inc. (OTCBB:AEMD - News), a company developing a therapeutic device to treat acute and chronic viral infections, biological warfare pathogens, and other conditions by filtering virus particles and immunosuppressive agents from the blood.
David Webber, RedChip Research Analyst, reported:
"During the final months of 2009, Aethlon continued to seek to build value with the initiation of a pilot production run of Hemopurifier cartridges using Good Manufacturing Practices, the start of work on less expensive production of the Hemopurifier's affinity agent in plants, and the establishment of a subsidiary to develop a non-core, potential use of the device in cancer."
"Based on the clinical data reported, Aethlon has made development of the Hemopurifier for the treatment of chronic hepatitis C its core program. During the final months of the year, the bulk of visible progress took place in improving manufacturing processes in ways necessary for broad commercialization."
Webber continued "We continue to rate Aethlon Medical a Speculative Buy with a 12-month price target of $1.00 per share. According to management, talks continue with potential partners. As it is not clear when to expect the next substantial increment of clinical data, we consider news of a partnership, should that occur, the potential event with the best chance of moving the stock towards our price target during 2010."
To receive a complimentary copy of the RedChip Visibility Research Update for AEMD, please visit: http://www.redchip.com/about/aboutmain.asp?rid=214
To learn more about Aethlon, visit http://www.redchip.com/visibility/investor.asp?symbol=AEMD.
About Aethlon Medical
Aethlon Medical creates diagnostic and therapeutic filtration devices to improve the health of individuals afflicted with infectious disease and cancer. Aethlon's lead product, the Hemopurifier(R), is a first-in-class artificial adjunct to the immune system proven to capture infectious viruses and immunosuppressive particles from the human circulatory system. The device targets to inhibit disease progression of Hepatitis-C Virus (HCV) and Human Immunodeficiency Virus (HIV), and serves as a broad-spectrum treatment countermeasure against bioterror and emerging pandemic threats. The Hemopurifier(R) also holds promise in cancer care, as research studies verify the Hemopurifier(R) effectively captures immunosuppressive exosomes that are secreted by tumors to kill-off immune cells. At present, over 65 Hemopurifier(R) treatments (representing approximately 260 hours of treatment time) have been conducted in multi-site studies at the Apollo Hospital, Fortis Hospital, and Sigma New-Life Hospital in India. The studies enrolled end-stage renal disease (ESRD) patients infected with either HCV or HIV. In addition to establishing treatment safety, robust viral load reductions have been reported in both HCV and HIV infected individuals. Research studies have also demonstrated the Hemopurifier(R) is effective in capturing a broad-spectrum of viruses untreatable with drug therapy, including several of world's deadliest bioterror and pandemic threats. Beyond therapeutic market opportunities, Aethlon is leveraging principles underlying the Hemopurifier(R) technology platform to establish a pipeline of clinical and research diagnostic products and services. Additional information regarding Aethlon Medical can be accessed online at http://www.aethlonmedical.com.
About RedChip Companies, Inc.
RedChip Companies is an international, small-cap research and financial public relations firm headquartered in Orlando, Florida; with affiliate offices in Qingdao, China; Paris, and San Diego. RedChip delivers concrete, measurable results for its clients through its extensive national and international network of small-cap institutional and retail investors. RedChip has developed the most comprehensive platform of products and services for small-cap companies, including: RedChip Research(TM), Traditional Investor Relations, Digital Investor Relations, Institutional and Retail Conferences, RedChip Small-Cap TV(TM), Shareholder Intelligence, Social Media and Blogging Services, Webcasts, and RedChip Radio(TM). To learn more about RedChip's products and services please visit: http://www.redchip.com/visibility/productsandservices.asp.
"Discovering Tomorrow's Blue Chips Today"(TM)
The RedChip Companies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=2761
Disclosure
The analysts contributing to this report do not hold any shares of Aethlon Medical, Inc. (AEMD). RedChip certifies that no part of the analysts' compensation was, is, or will be, directly or indirectly, related to the specific recommendation or views expressed by the analyst in the report. The equity research report(s) are not a recommendation of a solicitation to purchase or sell any security, nor do they constitute investment advice. AEMD is a client of RedChip Companies, Inc. and of RedChip Visibility, a division of RedChip Companies. AEMD paid RedChip Visibility, a division of RedChip Companies, Inc., one hundred thousand shares of Rule 144 common stock for RedChip Visibility Program services, which includes the preparation of the equity research report(s). The equity research report(s) are prepared for informational purposes only and are paid for by the company portrayed in the report. Information contained in the equity research report(s) is obtained from sources believed to be reliable, but their accuracy and completeness are not guaranteed. RedChip Companies, Inc., is currently engaged by this company to provide investor awareness services. Investor awareness services and programs are designed to help small-cap companies communicate their investment characteristics. These services may include investor conferences, digital and print distribution of AEMD investor-related materials, investor road shows and radio programming. AEMD agreed to pay RedChip Companies, Inc. three hundred thousand shares of Rule 144 common stock for six months of these investor relations services. RedChip Companies, Inc., employees and affiliates may have positions and affect transactions in the securities or options of the issuers mentioned herein.
Contact:
RedChip Companies Inc.
1-800-RED-CHIP (733-2447, Ext. 106)
research@redchip.com
http://www.RedChip.com