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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
Alert - LLBO NEWS Lifeline Biotechnologies Reports on FDA Filing Status Business Wire "US Press Releases "
RENO, Nev. --(BUSINESS WIRE)-- Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today reported on the results of the FDA submission of its First Warning System(TM), filed in July 2009 .
Jim Holmes , Lifeline's CEO, said, "This past July we filed with the FDA to determine if our technology and testing of over 600 patients would meet the requirements for a 510(k). The FDA recently responded issuing a non-binding opinion as to the potential classification of the First Warning System(TM). The letter's author noted that a number of classification possibilities are available for the System, including a potential 510(k)."
Subsequent to this response, management has begun a relationship with a consulting firm to help develop, design and implement a regulatory strategy and path for commercialization in the U.S. as well as a potential CE mark for international distribution. Strategy development and planning should take between one and three months to complete, including the preparation of the FDA application. Efforts for regulatory approval will commence subsequently.
Provided no additional clinical testing is required and according to our best estimate at this time, a 510(k) filing could take approximately four to six months or possibly longer for the FDA to clear our application. Once cleared by the FDA the First Warning System(TM) could immediately commence commercialization.
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, 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.
Source: Lifeline Biotechnologies, Inc.
LLBO NEWS Lifeline Biotechnologies Reports on FDA Filing Status Business Wire "US Press Releases "
RENO, Nev. --(BUSINESS WIRE)-- Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today reported on the results of the FDA submission of its First Warning System(TM), filed in July 2009 .
Jim Holmes , Lifeline's CEO, said, "This past July we filed with the FDA to determine if our technology and testing of over 600 patients would meet the requirements for a 510(k). The FDA recently responded issuing a non-binding opinion as to the potential classification of the First Warning System(TM). The letter's author noted that a number of classification possibilities are available for the System, including a potential 510(k)."
Subsequent to this response, management has begun a relationship with a consulting firm to help develop, design and implement a regulatory strategy and path for commercialization in the U.S. as well as a potential CE mark for international distribution. Strategy development and planning should take between one and three months to complete, including the preparation of the FDA application. Efforts for regulatory approval will commence subsequently.
Provided no additional clinical testing is required and according to our best estimate at this time, a 510(k) filing could take approximately four to six months or possibly longer for the FDA to clear our application. Once cleared by the FDA the First Warning System(TM) could immediately commence commercialization.
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, 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.
Source: Lifeline Biotechnologies, Inc.
Genta comeback?
Two New Studies Show Gallium-Containing Compounds Significantly Increase Bone Strength in Standard Models of Osteoporosis
businesswire
Companies:
o Genta Incorporated
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Symbol Price Change
GETA.OB 0.09 0.00
Chart for GENTA INC
{"s" : "geta.ob","k" : "c10,l10,p20,t10","o" : "","j" : ""}
Press Release Source: Genta Incorporated On Tuesday January 12, 2010, 8:04 am
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA - News) today announced publication of two scientific studies that test the active ingredient in Genta’s program to develop orally available gallium-containing compounds and the Company’s marketed product, Ganite® (gallium nitrate for injection). In these studies, a compound containing the active ingredient was tested in a widely accepted animal model of established osteoporosis. The new data show that extended treatment with the active ingredient significantly increased bone volume and calcium content in animals with induced osteoporosis. In addition, the increase in new bone formation was associated with a significant restoration of bone strength back to normal levels.
Previous studies have shown that extended in vivo treatment with low-dose gallium in normal animals was associated with increased bone content of calcium and phosphorous, a decrease in bone resorption, a possible increase in new bone formation, and no deleterious effects upon bone biomechanical strength. Moreover, preliminary clinical studies in patients with bone involvement from myeloma, breast cancer, and other malignant diseases had shown biochemical evidence of decreased resorption and increased bone density. Decreased bone resorption has also been reported in patients with advanced Paget’s disease, a metabolic bone disorder. However, no studies have previously examined whether these effects could be replicated in osteoporosis, the most prevalent metabolic bone disease.
In the new studies, a model that simulates post-menopausal osteoporosis was used to induce bone loss. The active ingredient was administered for 8 weeks in an inorganic form (similar to Ganite®) and also in an organic form (comparable to the Company’s orally available gallium-containing compounds). Micro-CT scanning showed that treatment significantly increased both trabecular and cortical bone volume by 49% and 32%, respectively. These findings were confirmed by histomorphometry. Additional analysis revealed a significant increase in bone calcium content. Since some drugs used for clinical treatment of osteoporosis (including certain bisphosphonates) are associated with a decrease in bone strength, biomechanical studies were performed in order to assess the quality of the newly formed bone. These studies showed that bone from treated animals had been restored to levels that were both fully comparable to normal controls and significantly superior to untreated osteoporotic controls.
Together, these new data confirm that – in osteoporotic bone – gallium treatment is associated with significant increases in bone mineral content, bone volume, and new bone formation that is biomechanically normal – findings that had been previously described only in bone that was normal at baseline. These data strongly suggest that gallium-containing compounds exert anti-resorptive and anabolic effects on bone metabolism, and that such compounds may be broadly useful for a wide spectrum of bone-losing disorders.
Abstracts of these reports can be accessed at the following links:
http://www.ncbi.nlm.nih.gov/pubmed/19578822?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=2;
http://www.ncbi.nlm.nih.gov/pubmed/19652924?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=1.
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 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 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® 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, the Company’s ability to obtain sufficient financing to fund the AGENDA trial, 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 Incorporated
908-286-3980
info@genta.com
Genta Come-Back?
Two New Studies Show Gallium-Containing Compounds Significantly Increase Bone Strength in Standard Models of Osteoporosis
businesswire
Companies:
o Genta Incorporated
Related Quotes
Symbol Price Change
GETA.OB 0.09 0.00
Chart for GENTA INC
{"s" : "geta.ob","k" : "c10,l10,p20,t10","o" : "","j" : ""}
Press Release Source: Genta Incorporated On Tuesday January 12, 2010, 8:04 am
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA - News) today announced publication of two scientific studies that test the active ingredient in Genta’s program to develop orally available gallium-containing compounds and the Company’s marketed product, Ganite® (gallium nitrate for injection). In these studies, a compound containing the active ingredient was tested in a widely accepted animal model of established osteoporosis. The new data show that extended treatment with the active ingredient significantly increased bone volume and calcium content in animals with induced osteoporosis. In addition, the increase in new bone formation was associated with a significant restoration of bone strength back to normal levels.
Previous studies have shown that extended in vivo treatment with low-dose gallium in normal animals was associated with increased bone content of calcium and phosphorous, a decrease in bone resorption, a possible increase in new bone formation, and no deleterious effects upon bone biomechanical strength. Moreover, preliminary clinical studies in patients with bone involvement from myeloma, breast cancer, and other malignant diseases had shown biochemical evidence of decreased resorption and increased bone density. Decreased bone resorption has also been reported in patients with advanced Paget’s disease, a metabolic bone disorder. However, no studies have previously examined whether these effects could be replicated in osteoporosis, the most prevalent metabolic bone disease.
In the new studies, a model that simulates post-menopausal osteoporosis was used to induce bone loss. The active ingredient was administered for 8 weeks in an inorganic form (similar to Ganite®) and also in an organic form (comparable to the Company’s orally available gallium-containing compounds). Micro-CT scanning showed that treatment significantly increased both trabecular and cortical bone volume by 49% and 32%, respectively. These findings were confirmed by histomorphometry. Additional analysis revealed a significant increase in bone calcium content. Since some drugs used for clinical treatment of osteoporosis (including certain bisphosphonates) are associated with a decrease in bone strength, biomechanical studies were performed in order to assess the quality of the newly formed bone. These studies showed that bone from treated animals had been restored to levels that were both fully comparable to normal controls and significantly superior to untreated osteoporotic controls.
Together, these new data confirm that – in osteoporotic bone – gallium treatment is associated with significant increases in bone mineral content, bone volume, and new bone formation that is biomechanically normal – findings that had been previously described only in bone that was normal at baseline. These data strongly suggest that gallium-containing compounds exert anti-resorptive and anabolic effects on bone metabolism, and that such compounds may be broadly useful for a wide spectrum of bone-losing disorders.
Abstracts of these reports can be accessed at the following links:
http://www.ncbi.nlm.nih.gov/pubmed/19578822?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=2;
http://www.ncbi.nlm.nih.gov/pubmed/19652924?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=1.
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 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 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® 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, the Company’s ability to obtain sufficient financing to fund the AGENDA trial, 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 Incorporated
908-286-3980
info@genta.com
Spectrum Pharmaceuticals Completes Enrollment in Second of Two Phase 3 Pivotal Trials for Apaziquone in Non-Muscle Invasive Bladder Cancer
* Enrollment Completed In Both Phase 3 Registration Trials Per a Special Protocol Assessment with the FDA
* Scientific Advice Procedure with EMEA Indicated That The Two Phase 3 Studies Should Be Sufficient for a Regulatory Decision in Europe
* Apaziquone Trials Received Fast Track Designation By FDA in July 2009
* Primary Endpoint is Rate of Tumor Recurrence at Year Two
* Triggers $1.5M Milestone Payment to Spectrum Pharmaceuticals by Allergan
businesswire
Companies:
o Spectrum Pharmaceuticals, Inc.
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SPPI 4.61 0.00
Chart for Spectrum Pharmaceuticals, Inc.
{"s" : "sppi","k" : "c10,l10,p20,t10","o" : "","j" : ""}
Press Release Source: Spectrum Pharmaceuticals On Tuesday January 12, 2010, 7:00 am
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGM: SPPI - News) today announced that the second of two Phase 3 pivotal clinical trials of apaziquone has achieved its enrollment target. The two trials enrolled more than 1600 patients with non-muscle invasive bladder cancer. As per the collaboration agreement with Allergan, a $1.5 million milestone payment will be paid to Spectrum Pharmaceuticals.
“We are delighted to have achieved our enrollment objectives in both clinical trials on target,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “Currently, there are no FDA approved drugs for immediate instillation following trans-urethral resection of bladder tumor (TUR-BT). If apaziquone meets its primary endpoint and is ultimately approved by the FDA, apaziquone would be the first FDA approved drug for immediate installation following TUR-BT. In due course, we look forward to evaluating the safety and efficacy of apaziquone in bladder cancer, and the ‘fast-track’ designation should help expedite the drug’s review process with the FDA.”
“Enrolling more than 1,600 bladder cancer patients in 30 months is a clear demonstration of our clinical capabilities with respect to managing global trials and represents a remarkable achievement for our clinical team,” added Andrew Sandler, MD, Chief Medical Officer of Spectrum Pharmaceuticals, Inc.
The apaziquone registration plan, which the U.S. Food and Drug Administration (FDA) concurred with under a Special Protocol Assessment, calls for two double blind, placebo-controlled, randomized Phase 3 clinical studies, each with 562 evaluable patients with Ta G1 or G2 low risk non-invasive bladder cancer. Patients are randomized in a one-to-one ratio to apaziquone or placebo. Under the protocol, the patients are given a single 4 mg dose following surgical removal of the tumors. The primary endpoint is the rate of tumor recurrence between the two treatment groups at year two. Spectrum also received scientific advice from the European Medicines Agency (EMEA) whereby the EMEA agreed that the two Phase 3 studies as designed should be sufficient for a regulatory decision regarding European registration.
Fast Track designation is designed to facilitate drug development and expedite the review of drugs intended to treat serious conditions and demonstrate the potential to address unmet medical needs. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication facilitates the sponsor’s ability to expeditiously address questions and issues. A drug that receives Fast Track designation is eligible for a Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Company’s strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it 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, establishing a commercial organization for Spectrum’s approved drugs, continuing to build Spectrum’s team, leveraging the expertise of partners around the world to assist Spectrum in the execution of its strategy, that “fast-track” designation should further help expedite the drug’s review process with the FDA, 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 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.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact:
Spectrum Pharmaceuticals
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x216
New EVRN Report Coming!
I have been calling Robert,he called me back today and left me a message to call him.He is with Paul on EVRN business in New York. He said he had some very interesting news to share with me. As soon as I talk to him I will get details and share them with all of you.The excitement is still building.
Alert - Aethlon Medical Releases Shareholder Update
prnewswire
Companies:
o Aethlon Medical Inc.
Press Release Source: Aethlon Medical, Inc. On Thursday January 7, 2010, 7:30 am
SAN DIEGO, Jan. 7 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc., (OTC Bulletin Board: AEMD) disclosed today that its Chairman and CEO, James A. Joyce has issued the following letter to shareholders.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b)
To our Shareholders:
The scientific accomplishments of your Aethlon Medical team in 2009 have set the stage for the initial commercialization of our Hemopurifier® as an adjunct therapy targeted to improve Hepatitis-C virus (HCV) cure rates. In addition, we strategically cultivated principles underlying our core Hemopurifier® platform technology to create an expansive yet cohesive medical product pipeline beyond infectious disease. In this regard, we positioned ourselves to advance new therapeutic and diagnostic paradigms in cancer, and also executed a collaboration that allowed us to enter the biomarker discovery marketplace. Among our reported events in 2009, we:
1. Initiated a collaborative biomarker discovery program with the Center for the Study of Traumatic Encephalopathy (CSTE) at the Boston University School of Medicine and the Sports Legacy Institute (SLI). The goal of this collaboration is to apply our proprietary techniques for selectively capturing viruses and other particles as a means to discover biomarkers that could identify athletes likely to have an increased susceptibility to Chronic Traumatic Encephalopathy (CTE) and related issues resulting from repetitive head trauma. The identification of such biomarkers could provide the basis for a test to distinguish those individuals who should be precluded from participating in football and other activities with a high risk for head trauma. CTE has recently been identified in ten deceased National Football League (NFL) players, of which most died before the age of 50. Since the announcement of our research collaboration, the NFL has established a formal relationship with the CSTE and will provide $1 million to support research. The NFL is also encouraging current and retired players to participate in CSTE brain research programs. We have subsequently received brain samples of former players identified with CTE during autopsy and have initiated our testing program. It is possible that our research becomes the story behind a story now being played out before congress and covered by major media outlets. Click here for a recent New York Times article on the topic.
2. Established Exosome Sciences, Inc. (ESI) as a wholly owned subsidiary of Aethlon Medical to leverage the discovery that our Hemopurifier® captures exosomes known to suppress the immune system in cancer patients. Inhibiting the destructive immunosuppressive activity caused by exosomes is an unmet medical need that could improve the lives of cancer patients worldwide. Addressing this need may increase patient responsiveness to chemotherapy and other treatment strategies. From a business perspective, it provides us the potential to enter the $43+ billion market for cancer therapies. While there is still much research and clinical work to be accomplished, our established collection of human Hemopurifier® data provides an advantage that could accelerate our therapeutic objectives. ESI also has the prospect of advancing exosome diagnostic and research services, and exploring recently discovered opportunities to address exosomes in disease conditions beyond cancer. Scientific publications reveal that exosomes may also have implications in inflammatory conditions including Sepsis, bacterial infections including Tuberculosis (TB), autoimmune conditions such as Rheumatoid Arthritis, and neurological and neurodegenerative diseases such as Alzheimer's disease. Regardless, the formation of ESI allows us to leverage value from a previously unrecognized asset into an entity not burdened with the status of being a publicly traded organization.
3. Completed and reported on the "first-in-man" study of a medical device to treat the Human Immunodeficiency Virus (HIV), which demonstrated a 92% reduction of viral load and improved immune function resulting from short-term intermittent application of our Hemopurifier® in the absence of any antiviral drug therapy. Similar to our treatment strategy in HCV, we believe the Hemopurifier® could significantly enhance and extend the benefit of both established and candidate drug therapies. The Hemopurifier® also offers a potential new treatment strategy for HIV-infected individuals that become fully resistant to antiviral drug regimens.
4. Entered into an agreement that extends studies of our Hemopurifier® with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) under a cooperative research and development agreement. The objectives of the USAMRIID agreement include determining the therapeutic efficacy of our Hemopurifier(R) in non-human primate studies against hemorrhagic fever viruses, including the highly virulent Zaire strain of Ebola (ZEBOV). We also disclosed that studies previously conducted by USAMRIID documented our Hemopurifier® captured approximately 50% of both wild type and mutant strains of ZEBOV from fluids during one hour in vitro studies. ZEBOV, which is untreatable with drug therapies, has the highest known virus fatality rate, up to 90% in some epidemics, with an average case fatality rate of approximately 83% in outbreaks.
5. Documented our Hemopurifier® effectively captures the current pandemic strain of the H1N1 Swine Flu Virus. During invitro studies, the Hemopurifier® removed 68% of H1N1 virus from blood plasma in 30 minutes, 80% of the virus in two hours, and a 96% reduction of H1N1 was observed at six hours. The studies were performed by third party researchers approved by the United States Department of Health and Human Services (HHS) to house and conduct research with pandemic strains of H1N1 virus. Beyond the H1N1 Swine Flu Virus data, third party researchers have now validated the ability of our Hemopurifier® to capture Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection. In addition to being the first-in-class medical device to selectively capture infectious viruses, the breadth of our collected data reinforces my belief that our Hemopurifier® is the leading and perhaps only true broad-spectrum countermeasure against drug resistant bioterror and pandemic threats.
6. Reported compelling human clinical outcomes against Hepatitis-C virus (HCV) infection; then disclosed a data supported strategy to improve HCV cure rates; and subsequently discovered a clinical validation by Asahi Kasei Kuraray Medical (Asahi) that confirms moderate levels of viral filtration at the outset of standard of care (SOC) therapy can dramatically impact HCV cure rates. Asahi reported 71.4% cure rates in patients who previously failed SOC, by applying their V-RAD filtration system (Click Here for V-RAD Website) once daily for three consecutive days at the outset of the 48-week SOC drug regimen. Cure rates of HCV patients who previously fail and then reinitiate SOC are generally reported below 20%. Viral load reductions of 26.1% were documented during each V-RAD treatment period, which averaged 3 1/4 hours in duration. These results do not bode well for drug candidates vying to become a component of SOC therapy. Especially if viral filtration achieves such results without needing to be administered during the remaining 47-weeks of SOC therapy and without stacking additional drug toxicity on top of the known toxicity of SOC therapy. However, this is good news for 180 million individuals infected with HCV worldwide. Regardless, we believe the viral filtration capabilities of our Hemopurifier® will provide even better treatment outcomes. This sentiment is reflected in the following paragraph extracted from my December 8th shareholder letter:
On October 30th, we reported HCV treatment outcomes at the 42nd Annual American Society of Nephrology (ASN) Conference. When analyzing Hemopurifier® treatment data from all of our HCV human studies, we documented average per-treatment viral load reductions of 29-42%. While the length of each Hemopurifier® treatment was similar in duration to V-RAD, the Hemopurifier® did not benefit from SOC associated viral load reductions as our results were achieved in the absence of SOC therapy. We acknowledge and appreciate that V-RAD has indeed documented that viral filtration improves HCV treatment outcomes. However, we believe the Hemopurifier® delivers the necessary capabilities to establish broad-market acceptance of a medical device in infectious disease care. Foremost of these capabilities is our ability to selectively capture infectious viruses and immunosuppressive proteins not addressed by V-RAD. The selective capture of deleterious agents from circulation establishes an environment that permits continuous or aggressive intermittent treatment strategies that can truly optimize patient outcomes. Whereas historic therapeutic filtration approaches, including V-RAD, are restricted in scope as they indiscriminately remove particles from blood by molecule size. As a result, the safe application of such treatments remains limited as beneficial blood components required for health are removed along with the deleterious target.
7. Initiated a relationship with Kentucky Bioprocessing LLC (KBP) to establish the processes necessary to support large-scale production of the active affinity agents we immobilize inside our Hemopurifier®. Such affinity agents allow our Hemopurifier® to selectively capture viruses and immunosuppressive proteins from blood and other fluids. The KBP relationship represents an important step towards establishing the long-term commercial feasibility of our Hemopurifier® in the marketplace.
8. Executed a non-exclusive agreement with NextPharma Technologies (Click Here for Website) to establish manufacturing of our Hemopurifier® under good manufacturing practice (GMP) requirements set forth in quality system (QS) regulations for medical device commercialization. As the result of a lengthy and dedicated effort, we established our GMP manufacturing processes and initiated our first Hemopurifier® production run. Consequently, we are primed to initiate commercialization in India and have established a manufacturing standard that exceeds the requirements for human clinical studies in the United States and the European Union. For a complete news summary of our activities in 2009, please "click here".
The productivity of our team, as referenced by our scientific advances and achievements last year are a source of great pride. I also note that in the face of one of the most challenging capital markets on record, we didn't need to put our hands out to Wall Street as both established and new shareholders stepped forth to provide sufficient investment to fund our operations. As a result, we were able to invest meaningful time into advancing potential strategic relationships that could accelerate the pace of our efforts and maximize long-term economic value for Aethlon Medical shareholders. However, until definitive agreements underlying such relationships are executed, we will continue our adherence to minimizing operating expenses.
I am challenged when authoring a shareholder letter as my passion for our endeavors often becomes muffled by the many regulatory implications of being a publicly traded company that creates medical products. However, I will confess frustration with the value assigned to our organization by the public markets. In the therapeutic world, the perception of value is often steeped in the redundancies of known and accepted treatment strategies, which in many cases are nothing more than me-too drug mechanisms that largely duplicate the action of existing drugs. These redundancies, while not scientifically meaningful, can be economically rewarding as they provide analysts and investors with a comparable guideline to judge public market value based on previously awarded values to like organizations. As we are pioneering a therapeutic device strategy to address infectious disease and potentially cancer, we don't have the collective benefit of comparable organizations as a basis for our value to be judged. However, I do believe our scientific advances will blossom into medical products that save lives.
In the HCV treatment world, considerable value is placed upon promising drug candidates. At present, there are a reported 65 drug candidates competing to become a component of standard of care (SOC) drug therapy. Yet, we are uniquely positioned to enhance the benefit of SOC therapy even if the drug combination underlying SOC becomes redefined. Thus, we have an enduring market opportunity that positions us to be an ally with drug developers, not a competitor. The most advanced HCV drug candidate is Telaprevir, which represents a significant value component of the $7+ Billion market valuation enjoyed by Vertex Pharmaceuticals (VRTX). Among the deep pipeline of HCV drug candidates, I am not aware that any has proven to reduce viral load in an HIV-infected individual. Nor am I aware that any candidate has established broad-spectrum activity against bioterror and pandemic threats. Certainly, none of these candidates represent a platform technology that can be leveraged to participate in the cancer marketplace. On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements in the above Shareholder Letter may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
RedChip Companies, Inc.
Jon Cunningham
1-800-733-2447, Ext. 107
Jon@redchip.com
Jim Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Senior VP Finance
858.459.7800 x300
jfrakes@aethlonmedical.com
Hot Bio Alert - Aethlon Medical Releases Shareholder Update
prnewswire
Companies:
o Aethlon Medical Inc.
Press Release Source: Aethlon Medical, Inc. On Thursday January 7, 2010, 7:30 am
SAN DIEGO, Jan. 7 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc., (OTC Bulletin Board: AEMD) disclosed today that its Chairman and CEO, James A. Joyce has issued the following letter to shareholders.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b)
To our Shareholders:
The scientific accomplishments of your Aethlon Medical team in 2009 have set the stage for the initial commercialization of our Hemopurifier® as an adjunct therapy targeted to improve Hepatitis-C virus (HCV) cure rates. In addition, we strategically cultivated principles underlying our core Hemopurifier® platform technology to create an expansive yet cohesive medical product pipeline beyond infectious disease. In this regard, we positioned ourselves to advance new therapeutic and diagnostic paradigms in cancer, and also executed a collaboration that allowed us to enter the biomarker discovery marketplace. Among our reported events in 2009, we:
1. Initiated a collaborative biomarker discovery program with the Center for the Study of Traumatic Encephalopathy (CSTE) at the Boston University School of Medicine and the Sports Legacy Institute (SLI). The goal of this collaboration is to apply our proprietary techniques for selectively capturing viruses and other particles as a means to discover biomarkers that could identify athletes likely to have an increased susceptibility to Chronic Traumatic Encephalopathy (CTE) and related issues resulting from repetitive head trauma. The identification of such biomarkers could provide the basis for a test to distinguish those individuals who should be precluded from participating in football and other activities with a high risk for head trauma. CTE has recently been identified in ten deceased National Football League (NFL) players, of which most died before the age of 50. Since the announcement of our research collaboration, the NFL has established a formal relationship with the CSTE and will provide $1 million to support research. The NFL is also encouraging current and retired players to participate in CSTE brain research programs. We have subsequently received brain samples of former players identified with CTE during autopsy and have initiated our testing program. It is possible that our research becomes the story behind a story now being played out before congress and covered by major media outlets. Click here for a recent New York Times article on the topic.
2. Established Exosome Sciences, Inc. (ESI) as a wholly owned subsidiary of Aethlon Medical to leverage the discovery that our Hemopurifier® captures exosomes known to suppress the immune system in cancer patients. Inhibiting the destructive immunosuppressive activity caused by exosomes is an unmet medical need that could improve the lives of cancer patients worldwide. Addressing this need may increase patient responsiveness to chemotherapy and other treatment strategies. From a business perspective, it provides us the potential to enter the $43+ billion market for cancer therapies. While there is still much research and clinical work to be accomplished, our established collection of human Hemopurifier® data provides an advantage that could accelerate our therapeutic objectives. ESI also has the prospect of advancing exosome diagnostic and research services, and exploring recently discovered opportunities to address exosomes in disease conditions beyond cancer. Scientific publications reveal that exosomes may also have implications in inflammatory conditions including Sepsis, bacterial infections including Tuberculosis (TB), autoimmune conditions such as Rheumatoid Arthritis, and neurological and neurodegenerative diseases such as Alzheimer's disease. Regardless, the formation of ESI allows us to leverage value from a previously unrecognized asset into an entity not burdened with the status of being a publicly traded organization.
3. Completed and reported on the "first-in-man" study of a medical device to treat the Human Immunodeficiency Virus (HIV), which demonstrated a 92% reduction of viral load and improved immune function resulting from short-term intermittent application of our Hemopurifier® in the absence of any antiviral drug therapy. Similar to our treatment strategy in HCV, we believe the Hemopurifier® could significantly enhance and extend the benefit of both established and candidate drug therapies. The Hemopurifier® also offers a potential new treatment strategy for HIV-infected individuals that become fully resistant to antiviral drug regimens.
4. Entered into an agreement that extends studies of our Hemopurifier® with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) under a cooperative research and development agreement. The objectives of the USAMRIID agreement include determining the therapeutic efficacy of our Hemopurifier(R) in non-human primate studies against hemorrhagic fever viruses, including the highly virulent Zaire strain of Ebola (ZEBOV). We also disclosed that studies previously conducted by USAMRIID documented our Hemopurifier® captured approximately 50% of both wild type and mutant strains of ZEBOV from fluids during one hour in vitro studies. ZEBOV, which is untreatable with drug therapies, has the highest known virus fatality rate, up to 90% in some epidemics, with an average case fatality rate of approximately 83% in outbreaks.
5. Documented our Hemopurifier® effectively captures the current pandemic strain of the H1N1 Swine Flu Virus. During invitro studies, the Hemopurifier® removed 68% of H1N1 virus from blood plasma in 30 minutes, 80% of the virus in two hours, and a 96% reduction of H1N1 was observed at six hours. The studies were performed by third party researchers approved by the United States Department of Health and Human Services (HHS) to house and conduct research with pandemic strains of H1N1 virus. Beyond the H1N1 Swine Flu Virus data, third party researchers have now validated the ability of our Hemopurifier® to capture Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection. In addition to being the first-in-class medical device to selectively capture infectious viruses, the breadth of our collected data reinforces my belief that our Hemopurifier® is the leading and perhaps only true broad-spectrum countermeasure against drug resistant bioterror and pandemic threats.
6. Reported compelling human clinical outcomes against Hepatitis-C virus (HCV) infection; then disclosed a data supported strategy to improve HCV cure rates; and subsequently discovered a clinical validation by Asahi Kasei Kuraray Medical (Asahi) that confirms moderate levels of viral filtration at the outset of standard of care (SOC) therapy can dramatically impact HCV cure rates. Asahi reported 71.4% cure rates in patients who previously failed SOC, by applying their V-RAD filtration system (Click Here for V-RAD Website) once daily for three consecutive days at the outset of the 48-week SOC drug regimen. Cure rates of HCV patients who previously fail and then reinitiate SOC are generally reported below 20%. Viral load reductions of 26.1% were documented during each V-RAD treatment period, which averaged 3 1/4 hours in duration. These results do not bode well for drug candidates vying to become a component of SOC therapy. Especially if viral filtration achieves such results without needing to be administered during the remaining 47-weeks of SOC therapy and without stacking additional drug toxicity on top of the known toxicity of SOC therapy. However, this is good news for 180 million individuals infected with HCV worldwide. Regardless, we believe the viral filtration capabilities of our Hemopurifier® will provide even better treatment outcomes. This sentiment is reflected in the following paragraph extracted from my December 8th shareholder letter:
On October 30th, we reported HCV treatment outcomes at the 42nd Annual American Society of Nephrology (ASN) Conference. When analyzing Hemopurifier® treatment data from all of our HCV human studies, we documented average per-treatment viral load reductions of 29-42%. While the length of each Hemopurifier® treatment was similar in duration to V-RAD, the Hemopurifier® did not benefit from SOC associated viral load reductions as our results were achieved in the absence of SOC therapy. We acknowledge and appreciate that V-RAD has indeed documented that viral filtration improves HCV treatment outcomes. However, we believe the Hemopurifier® delivers the necessary capabilities to establish broad-market acceptance of a medical device in infectious disease care. Foremost of these capabilities is our ability to selectively capture infectious viruses and immunosuppressive proteins not addressed by V-RAD. The selective capture of deleterious agents from circulation establishes an environment that permits continuous or aggressive intermittent treatment strategies that can truly optimize patient outcomes. Whereas historic therapeutic filtration approaches, including V-RAD, are restricted in scope as they indiscriminately remove particles from blood by molecule size. As a result, the safe application of such treatments remains limited as beneficial blood components required for health are removed along with the deleterious target.
7. Initiated a relationship with Kentucky Bioprocessing LLC (KBP) to establish the processes necessary to support large-scale production of the active affinity agents we immobilize inside our Hemopurifier®. Such affinity agents allow our Hemopurifier® to selectively capture viruses and immunosuppressive proteins from blood and other fluids. The KBP relationship represents an important step towards establishing the long-term commercial feasibility of our Hemopurifier® in the marketplace.
8. Executed a non-exclusive agreement with NextPharma Technologies (Click Here for Website) to establish manufacturing of our Hemopurifier® under good manufacturing practice (GMP) requirements set forth in quality system (QS) regulations for medical device commercialization. As the result of a lengthy and dedicated effort, we established our GMP manufacturing processes and initiated our first Hemopurifier® production run. Consequently, we are primed to initiate commercialization in India and have established a manufacturing standard that exceeds the requirements for human clinical studies in the United States and the European Union. For a complete news summary of our activities in 2009, please "click here".
The productivity of our team, as referenced by our scientific advances and achievements last year are a source of great pride. I also note that in the face of one of the most challenging capital markets on record, we didn't need to put our hands out to Wall Street as both established and new shareholders stepped forth to provide sufficient investment to fund our operations. As a result, we were able to invest meaningful time into advancing potential strategic relationships that could accelerate the pace of our efforts and maximize long-term economic value for Aethlon Medical shareholders. However, until definitive agreements underlying such relationships are executed, we will continue our adherence to minimizing operating expenses.
I am challenged when authoring a shareholder letter as my passion for our endeavors often becomes muffled by the many regulatory implications of being a publicly traded company that creates medical products. However, I will confess frustration with the value assigned to our organization by the public markets. In the therapeutic world, the perception of value is often steeped in the redundancies of known and accepted treatment strategies, which in many cases are nothing more than me-too drug mechanisms that largely duplicate the action of existing drugs. These redundancies, while not scientifically meaningful, can be economically rewarding as they provide analysts and investors with a comparable guideline to judge public market value based on previously awarded values to like organizations. As we are pioneering a therapeutic device strategy to address infectious disease and potentially cancer, we don't have the collective benefit of comparable organizations as a basis for our value to be judged. However, I do believe our scientific advances will blossom into medical products that save lives.
In the HCV treatment world, considerable value is placed upon promising drug candidates. At present, there are a reported 65 drug candidates competing to become a component of standard of care (SOC) drug therapy. Yet, we are uniquely positioned to enhance the benefit of SOC therapy even if the drug combination underlying SOC becomes redefined. Thus, we have an enduring market opportunity that positions us to be an ally with drug developers, not a competitor. The most advanced HCV drug candidate is Telaprevir, which represents a significant value component of the $7+ Billion market valuation enjoyed by Vertex Pharmaceuticals (VRTX). Among the deep pipeline of HCV drug candidates, I am not aware that any has proven to reduce viral load in an HIV-infected individual. Nor am I aware that any candidate has established broad-spectrum activity against bioterror and pandemic threats. Certainly, none of these candidates represent a platform technology that can be leveraged to participate in the cancer marketplace. On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements in the above Shareholder Letter may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
RedChip Companies, Inc.
Jon Cunningham
1-800-733-2447, Ext. 107
Jon@redchip.com
Jim Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Senior VP Finance
858.459.7800 x300
jfrakes@aethlonmedical.com
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HESG - Healing Center has a budding business in Kalispell
Medical Marijuana Takes Root
Michael J. Smith, executive director of The Healing Center, plans to open medical marijuana collectives in Kalispell, Polson and Whitefish. – Lido Vizzutti/Flathead Beacon
By Myers Reece , 01-05-10
With distribution locations across the state, Michael Smith claims to have the largest medical marijuana collective in Montana, at least in terms of geographical range. But there is one obvious missing link in his network: Northwest Montana. That’s about to change.
Sometime this month, a branch of The Healing Center, Smith’s Bozeman-based collective, will open in Kalispell. Polson and Whitefish are next, though Whitefish has imposed a temporary moratorium on all medical marijuana businesses.
Smith said he hopes to work with city officials in Whitefish to change the language of its urgency ordinance to take away the limit of three patients per caregiver. As written now, caregivers with three patients or fewer operate under a “home occupation” designation, rather than a business, and are not included in the moratorium. But Smith argues that it’s illegal to assign any patient limit, three or otherwise.
It’s unclear whether the urgency ordinance will be a moot point by the time Smith and the city work out their differences. If Smith sues, the litigation could extend past the urgency ordinance’s life span. At that point, the permanent law’s language will be different than the temporary ordinance, perhaps to Smith’s liking.
In the event of a lawsuit, Whitefish City Attorney John Phelps believes the city is on sturdy ground. He said state law allows urgency ordinances to impose outright moratoriums on lawful endeavors for up to six months while officials establish a permanent law.
Billings considered a similar temporary ordinance in November, but voted to table it after medical marijuana proponents spoke at a public meeting. Smith sent an attorney who threatened to sue if the law was passed.
Whitefish has implemented urgency ordinances twice before, for casinos and a storm water drainage law called the critical areas ordinance. Both times the city was challenged in court. Both times, Phelps said, the city won. The city lost a case over how the critical areas ordinance was administered, but not whether the law was valid.
“If they sue us, it won’t accomplish anything for them, but that’s their choice,” Phelps said. “That’s why this interim zoning ordinance exists. If something wants to open in your town that the zoning ordinances aren’t prepared for, it allows you to maintain the status quo until a permanent zoning ordinance can be enacted.”
Smith has met with two attorneys. He points to a recent ruling in Centennial, Colo., in which a judge ruled that it’s illegal for cities to ban medical marijuana dispensaries if allowed by state law. Referring to Phelps, if a lawsuit does occur, Smith said: “He will lose.”
The Healing Center, registered as a nonprofit with the state, has seven “brick and mortar” collectives already open, with another operating in Billings without a fixed location. Three more in Northwest Montana would give The Healing Center 11 total. All of the collectives combined serve about 400 patients and counting, Smith said. His Web site is http://www.thehealingcentermt.com.
Each collective operates independently, Smith said, though each uses The Healing Center name and marketing potential. Smith helps the collectives get off their feet, charges an initial fee and then an annual renewal fee, but he doesn’t collect royalties. Smith already has someone selected to run the Kalispell branch and, as of last week, believed he would find a building to lease soon.
Smith said he wants to be in town, but he doesn’t plan on being overtly conspicuous.
“I don’t intend to be on Main Street so when the tourists show up in the summer their kids say, ‘Look there’s a pot store,’” Smith said.
Caused by years in the construction industry, Smith said he has 50 percent nerve damage in one arm. He said the best medicine for his aches is cannabis – Smith prefers the word “cannabis” instead of marijuana.
Perhaps the biggest inspiration for Smith’s foray into the medical marijuana business is his son, who was badly injured in a motorcycle accident and became one of the first minors in Colorado to get a medical marijuana card, he said. His son, like Smith, uses cannabis for pain instead of pharmaceuticals. Smith also has a collective in Colorado and is looking to open more there.
One of Smith’s patients, who asked not to be named, is a 59-year-old retired ironworker who used to be on a steady diet of opiates such as oxycodone to ease his chronic back pain. Now he rarely uses pharmaceuticals, instead opting for cannabis.
He lives in Kalispell with his wife, who is also looking into getting a prescription for her arthritis and other conditions. His wife says cannabis has an unfair stigma, but believes it’s a much better alternative than “the hard stuff.”
Smith recently finalized a licensing agreement to sell the rights of his Livingston collective to Los Angeles-based Health Sciences Group, Inc. He said it’s the first public partnership collective in Montana.
The Montana Medical Marijuana Act passed in 2004 as a voter initiative with 62 percent approval. Under the law, patients must obtain a written certification from a doctor and then register with the state’s Department of Public Health and Human Services.
Through November, there were 5,440 patients registered in the state, and another 495 with expired cards. Flathead County had the second most active patients with 753, trailing only Gallatin County’s 837.
Smith disputes the requirement to register with the state. In his interpretation of the law, a patient is legal to obtain medical marijuana without registering with DPHHS. Smith and Tom Daubert, one of the 2004 law’s architects, have publicly disagreed over this matter.
Medical marijuana collectives are essentially private clubs serving as intermediaries between registered patients and caregivers, rather than for-profit businesses. The Healing Center’s collective in Kalispell will likely have a receptionist up front, along with legal hemp-based products such as shirts and informational packets on the laws and benefits of medical marijuana.
In the back, card-carrying patients will have access to marijuana, in raw form to be smoked and in products, such as baked goods, to be eaten. Tinctures are also available. All of Smith’s marijuana is organically grown. Smith said, since smoking anything harms the lungs, he encourages patients to ingest the medicine.
“We’re really trying to get people away from smoking it,” he said.
As an entrepreneur, Smith sees financial potential in his business, though he doesn’t plan to get wealthy off of it: “I’m not poor, but I’m not rich.” He does plan, however, to use the profit to promote industrial hemp. He is an advocate of the organization Montana Hemp Farmers.
“Anyone who’s an entrepreneur and starts out with a grassroots effort stands to gain some financial gain, but it’s what they do with it that’s important,” Smith said. “Hemp – that’s where we’re going next. This thing is way bigger than medical marijuana.”
Biel- a message from the CEO
Answering questions from the yh board
Question on patient protection in China
Our intellectual property protection is threefold:
1.Constant innovation;
2.Aggressive patent protection - Fish & Richardson, major law firm; and,
3.Disruptive market pricing.
China has 200 million people with western style incomes, which makes it a market that cannot be ignored. We need the first to market position.
The price of a press release is a function of the number of words and what distribution you request. We limit our distribution request in most incidences to Maryland and assume the release is picked up by the national wire services. Our cost per release is generally in the $200.
We have a new PR group, Crosby - Volmer to focus on product awareness and to handle the press releases.
1)Will the audited financials be released to the public soon (within the next few weeks) and do you think they will help resolve the issues with trading restrictions amongst several brokers?
We are trying to finish the audit this week. We will post the reports and work diligently to get the SEC filings done. I have not done a 10k or Q in years and I am out traveling the last 2 weeks of the month. Sherri and Kelly are getting up to speed.
2)Can you tell me when BIEL will be submitting the newest filings with the FDA. You had mentioned that a meeting was to occur with the FDA. Can you elaborate?
I am the culprit on the delay in filing the reclassification. I have been through three different consultant groups to optimize our strategy. We now have our plan defined and are making the final changes to the submission. We do not want to have the device incorrectly classified and open Pandora's Box. We are not using cookbook technology so we need to be very precise in our explanations and requests.
3)Will television ads begin in any markets this month?
Latin America, Canada and possibly Australia will run this month.
Regards,
Andy
Andrew J. Whelan
BioElectronics Corporation
4539 Metropolitan Court
Frederick MD 21704
(301) 874-4890 office
(301) 874-6935 fax
Word out news coming soon!!Going to be strong!
CSLI News!
White Door, Inc. Looks Ahead to 2010 as Breakout Year in the Global Renewable Energy Industry
globenewswire
*
Companies:
o Critical Solutions, Inc.
Press Release Source: Critical Solutions, Inc. On Wednesday January 6, 2010, 12:00 pm
ASHBURN, Va., Jan. 6, 2010 (GLOBE NEWSWIRE) -- Critical Solutions Inc. (Pink Sheets:CSLI - News)'s sales and marketing subsidiary, White Door, Inc., has announced the Company is very optimistic that growth predictions of the use of clean, renewable energy worldwide will help facilitate and increase sales of its renewable energy tower systems in 2010.
According to the Cleantech Group, a leading authority and research provider, clean economies will become the new space race in 2010. In an article put out in late November 2009, Nicholas Parker, Executive Chairman of the Cleantech Group, is quoted, "Fueled by unprecedented quantities of 'green and clean' stimulus money, cities, states, provinces and countries are now competing to grow cleantech businesses, to bring innovation to market, to attract inward investment and to brand themselves as hubs of cleantech growth. It's no longer about trading our way out of the carbon crisis, it's about inventing new industries."
Jeff Sirianni, President of White Door, Inc., commented, "We are very excited for 2010 as we believe this will be the year where the global economy sees a breakout in the funding, implementation and infrastructure of clean and renewable energy sources. We believe that our Titan and Mojo renewable energy trailers can fill the critical need for nations worldwide to have a secure, mobile source of renewable energy. The versatility of our products provides a cost-effective and eco-friendly solution to military operations, national disaster sites, and chemical and nuclear plant security worldwide and we plan to develop new clean technology based on the success of our existing products and needs that are dictated by the global market for renewable energy moving forward."
About Critical Solutions, Inc.
Critical Solutions, Inc., through its wholly owned subsidiary, White Door, Inc., markets and sells a line of self-powered trailer systems that can be rapidly deployed to power physical security and communication requirements. The company utilizes non-traditional power sources such as solar, wind, and hydrogen to provide efficient recovery, backup, and primary power systems. The company's alternative energy trailer systems have been chosen by a top defense contractor to secure a nuclear power plant, by the Federal Bureau of Prisons for Emergency Response Teams, and to the Marines for emergency communications.
Please visit www.criticalsolutions.net for more information.
Safe Harbor Statement
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties including, but not limited to, the impact of competitive products, the ability to meet customer demand, the ability to manage growth, acquisitions of technology, equipment, or human resources, the effect of economic and business conditions, and the ability to attract and retain skilled personnel. The Company is not obligated to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.
Contact:
Seal Point Consulting, LLC
Investor & Media Contact
pressreleases@sealpointconsulting.com
BIEL - Allay Patch is already listed on project asia website.
http://www.projectasia.com/index.htm
BIEL-Allay Patch is already listed on project asia website.
http://www.projectasia.com/index.htm
Health Sciences Enters Into Negotiations for Colorado Medical Marijuana License
marketwire
Companies:
o Health Sciences Gr
Press Release Source: Health Sciences Group, Inc On Tuesday January 5, 2010, 1:20 pm
INDIAN HARBOR BEACH, FL--(Marketwire - 01/05/10) - Health Sciences Group, Inc. (Pinksheets:HESG - News) would like to announce that it has engaged in negotiations with The Healing Center to assist with the acquisition of a Medical Marijuana license in the State of Colorado. "We believe that we will obtain the same sort of licensing agreement with The Healing Center as we did in Montana," said Health Sciences Group CEO Tom Gaffney.
Gaffney continues, "Our goal is to obtain proper and legal licenses in each of the legalized medical marijuana states during 2010. Once licensing is obtained we intend on raising capital to procure business in each of our licensed locations."
ABOUT HEALTH SCIENCES GROUP, INC.
Health Sciences Group, Inc. is a provider of health and wellness services to consumers, physicians and other healthcare professionals through its website, www.igohealthy.org, and health focused publications. The Health Sciences network consists of its public website, www.igohealthy.org, and iGoHealthy Magazine. The Company operates in three segments: Online Services, Publishing and Other Services. The Company is recently exploring options of corporate growth within the Legal Medical Marijuana Industry.
FORWARD-LOOKING DISCLAIMER
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Health Sciences Group, Inc. to be materially different from the statements made herein. Investors are highly advised to seek professional advice and conduct a complete due diligence regarding this, or any other company being considered for investment purposes. Investing in securities, particularly in issues priced at less than $1 per share, involves substantial risk and may result in a partial or complete loss of investment capital. Health Sciences Group, Inc., its subsidiaries, officers and employees cannot guarantee the completeness or accuracy of the information contained in company press releases or other company communications. Press releases and communications issued by the company should not be interpreted as an offer to sell or a solicitation to buy company stock. Investors are highly advised to seek professional advice and conduct a complete due diligence regarding this, or any other company being considered for investment purposes. Investing in securities, particularly in issues priced at less than $1 per share, involves substantial risk and may result in a partial or complete loss of investment capital. Health Sciences Group, Inc., its subsidiaries, officers and employees cannot guarantee the completeness or accuracy of the information contained in company press releases or other company communications. Press releases and communications issued by the company should not be interpreted as an offer to sell or a solicitation to buy company stock.
Contact:
CONTACT:
Health Sciences Group, Inc.
Investor Relations
Health Sciences Group, Inc.
Frank Godleski
IR Representative
Email Contact: Email Contact
Lifeline Biotechnologies Updates Pink Sheets
businesswire
Companies:
o Lifeline Biotechnologies, Inc.
Press Release Source: Lifeline Biotechnologies, Inc. On Monday January 4, 2010, 3:09 pm
RENO, Nev.--(BUSINESS WIRE)--Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO - News) today announced that it has completed the updating of the Company's information on Pink Sheets.
Jim Holmes, Lifeline's CEO, said, "The information submitted includes a Balance Sheet, Statement of Operations and Footnotes to Financial Statements as of September 30, 2009. This information can be seen on Lifeline's Pink Sheets site at www.pinksheets.com. Then enter Lifeline's trading symbol, LLBO, then click on 'FILINGS.'"
Holmes went on to say, “We are preparing for Lifeline’s 2009 year end closing and expect to issue annual financial statements as soon as practical and possible. Additionally, we are nearing the completion of a major revision of Lifeline’s website, which is expected to contain more information, both historical and current.
"The Company has received many questions concerning the prospect of a reverse split of the common stock. Though the outstanding common stock is increased from time to time, there are no plans for a reverse split. We have issued several hundred million shares during the fourth quarter; these shares have been issued to secure funding for operations. We expect to issue several hundred million additional shares during the first quarter of 2010. These shares are expected to be issued for various services agreements and to exchange for convertible debt.”
Lifeline competes in the money markets for funds to continue the development of its products as well as supporting operating and administrative expenses. The cost of funds for companies such as Lifeline is expensive, and the terms have been and may continue to be dilutive. The Company continues to seek alternative sources of financing in an effort to reduce the dilutive aspects.
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
Lifeline Biotechnologies Updates Pink Sheets
businesswire
Companies:
o Lifeline Biotechnologies, Inc.
Press Release Source: Lifeline Biotechnologies, Inc. On Monday January 4, 2010, 3:09 pm
RENO, Nev.--(BUSINESS WIRE)--Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO - News) today announced that it has completed the updating of the Company's information on Pink Sheets.
Jim Holmes, Lifeline's CEO, said, "The information submitted includes a Balance Sheet, Statement of Operations and Footnotes to Financial Statements as of September 30, 2009. This information can be seen on Lifeline's Pink Sheets site at www.pinksheets.com. Then enter Lifeline's trading symbol, LLBO, then click on 'FILINGS.'"
Holmes went on to say, “We are preparing for Lifeline’s 2009 year end closing and expect to issue annual financial statements as soon as practical and possible. Additionally, we are nearing the completion of a major revision of Lifeline’s website, which is expected to contain more information, both historical and current.
"The Company has received many questions concerning the prospect of a reverse split of the common stock. Though the outstanding common stock is increased from time to time, there are no plans for a reverse split. We have issued several hundred million shares during the fourth quarter; these shares have been issued to secure funding for operations. We expect to issue several hundred million additional shares during the first quarter of 2010. These shares are expected to be issued for various services agreements and to exchange for convertible debt.”
Lifeline competes in the money markets for funds to continue the development of its products as well as supporting operating and administrative expenses. The cost of funds for companies such as Lifeline is expensive, and the terms have been and may continue to be dilutive. The Company continues to seek alternative sources of financing in an effort to reduce the dilutive aspects.
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
60 Page DD on BIEL (a must read)
http://www.obex.co.nz/Shared/Documents/Physics-ActiPatch.pdf
60 page DD on BIEL (A must read)
http://www.obex.co.nz/Shared/Documents/Physics-ActiPatch.pdf
If you believe medical marijuana is the next gold rush then you are with the right stock.HESG and MJNA have definite ties to each other and in my opinion and DD they are planning to be the dominate players in this industry together.
Now that is great DD! Thanks
You are being beaten up because of the lack your creditability.You can be anyone playing games.We cannot confirm your employment and even if you were employed,how do we know your negative emotional feelings for being asked to leave gives any solid merit to what you say?Plus, why do you feel compelled after being let go in August to come around now and save the day?
DD research is solid creditable data that can be verified.
Are you a comedian?Why are you posting nonsense?
Exactly!!!!Come on! We are going to take advise from someone who is claiming to be an ex-employee with no way to verify his employment?
Even if he is, how do we know what he is saying is true?He could be pissed. If I was fired I would not be pro company!
From my DD that I got from the listing agent the leasing of the Connecticut office is nothing but pure consolidation.They are trying to consolidate to save money. Makes sense to me.The company is trying to run lean.They already said that was one of their goals.
Why would he show up now to be our guardian angel?What is it in it for him.Guys you know nothing of this guy.He may be real or not. There are paid pumpers and bashers on all boards.If he is real and was let go he could be pissed. Just a nice guy? Do your own DD.Stop looking for insider information.
(BIEL)BioElectronics Ends 2009 with International Product and Partner Gains
PPS:.0446
FREDERICK, Md.--(BUSINESS WIRE)--BioElectronics Corp. (PINKSHEETS: BIEL - News), the maker of inexpensive, disposable, drug-free anti-inflammatory devices, today announces product gains in the international market as well as new international distributor and marketing partnerships. As a result, BioElectronics is expecting significant gains in international markets throughout 2010.
Mr. Andrew Whelan, CEO of BioElectronics provides the following update to investors and other stakeholders:
“Earlier in 2009, we had stated that our corporate priorities were the completion of clinical studies, United States Food and Drug Administration (FDA) filings and the building of our brands. I am pleased to say this management team has helped BioElectronics make excellent strides in these areas. This year we completed several major studies, which we filed in support of our FDA applications. Over the past two months our staff has worked diligently on additional applications
seeking reclassification of our products from Class III to Class II. We believe this application contains compelling evidence that our products are not only effective, but are also safe. We remain confident that FDA clearance will be granted for our products. We believe our meeting, which is scheduled with the FDA for January, will allow us to make significant progress towards that goal. In the meantime, our international marketing efforts are moving into high gear with significant progress already being realized.
“Today, we are announcing several significant international orders and partnerships. Our new distributor in Columbia, Health Tools S.A., has placed an order for both Allay, ActiPatch, and HealFast in support of the Latin American direct response TV campaign and its direct sales operations. We are also anticipating additional orders from our other Latin American partners. Additionally, our Turkey distributor has made a substantial commitment for product in support of direct response TV marketing campaigns in that region.
“The management team has also been spending a considerable amount of time fostering relationships to drive sales in Asia. We recently finished our television advertising spots targeting China and those will be tested during the first quarter of 2010. Over the next several months members of the team will visit our Chinese marketing partner, Chinese government officials and television station executives in China. We view this as a very exciting revenue generation opportunity. We are also happy to announce we have completed negotiations with a well financed public company that will act as our marketing partner in Japan. Over the next few days we are expecting this partner to place a significant pre-order for product. We have long been excited about the Japanese market and believe it could ultimately be our largest market outside the United States.
“The significant revenues we expect from these efforts will allow us to further strengthen our year-end balance sheet and position us well for substantial revenue growth in 2010 and beyond.”
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch® Therapy, RecoveryRx(TM) Devices, HealFast(TM) Therapy (www.healfasttherapy.com) and the Allay(TM) family of inexpensive, disposable drug-free anti-inflammatory devices.
For more information please see http://www.BioElectronicsCorp.com.
Contact:
Media
Crosby~Volmer International Communications
Jason Schneider, 202-236-8583
jschneider@cvic.com
or
Investors
Joe Noel, 925-922-2560
http://finance.yahoo.com/news/BioElectronics-Ends-2009-with-bw-958134910.html?x=0&.v=1
Guys you know nothing of this guy.He may be real or not. There are paid pumpers and bashers on all boards.If he is real and was let go he could be pissed. Why would he show up now to be our guardian angel?What is it in it for him. Just a nice guy? Do your own DD.Stop looking for insider information.
VION Bankruptcy Filing- Is there life after death?
http://www.delclaims.com/pdf/09-14429_Vion_30_notice%20of%20motion%20(12-22-091).pdf
Short but Sweet EVRN Update.
Per Robert...We will be getting another PR update soon...laying out the production schedule.Also, we will hear more on the extremely high built up product demand.Walmart and Costco have been wanting their product ,but they have to be able to deliver.This will come soon.
PS I am still waiting for more information on the website questions and "the Seller" update.Robert was in New York for a meeting and could not talk much. He will call me back.
Happy New Year to Everyone on this board! Lets make some money. I love the way EVRN is building their business.
Level 2
2x.0004
5x.0005
Great BIEL Overview Wednesday, December 23, 2009
BioElectronics
Have you ever heard of a fully recording penny stock? Well exempt from Citigroup, Freddie Mac, Fannie Mae, Sirius Satellite Radio, it is pretty hard. Believe it or not, I have found two companies that are fully recording. This blog is about BioElectronics (BIEL.PK) and the next will be about the other company. BioElectronics company is a fully reporting company. I have many shares with them.
Here are some reasons why I like this company:
In 2000, BioElectronics gained rights to the technology and patents supporting the development of the current product line. Prior to that time the previous owners of the technology and patents had invested over $4.65 million in electronic engineering prototypes, production runs, and in confirming clinical studies. BioElectronics subsequently filed with the US Food and Drug Administration for market clearance in April 2000.
The Company was granted its first approval from the FDA under a 510k in August 2002. Prior to FDA approval and the establishment of its research and development group, PAW, LLC (Andrew Whelan's wife and children) paid and expensed the cost of development.
In 2003, BioElectronics redesigned the ActiPatch product to reduce its size and costs to manufacture and developed several new products. In March 2004, the Company sold 5,020,000 shares of common stock and the Company's stock was listed on the Pink Sheets.
In December 2004 the Company received ISO and CE (European Common Market) certification. In 2005 Health Canada, (Canada's FDA) approved ActiPatch Therapy: for the relief of pain in muscosketal complaints.
In April 2005, the Company established an Orthopedic Group, a direct response sales organization, and its design and manufacturing operations in Westlake Village, California. In 2007 the Company shut down theOrthopedic Group, moved all operations to the home office and transferred manufacturing offshore.
In early 2008 the Company redesigned its product, manufacturing and established new disease specific products and distinct medical and retail product lines. It also shifted its attention to international sales.
About the products:
There are 5 products the company offers. All of them are listed and described on their website:
http://www.bielcorp.com/products.html
Some more infomation:
In 2006, the Company and the Lahey Clinic jointly announced a three-year program to study the effects of ActiPatch Therapy on a variety of soft tissue injuries and related medical conditions. The internationally renowned Lahey Clinic of Boston, whose faculty is affiliated with the Medical Schools of Harvard and Tufts, has committed to initiating a number of double-blind clinical studies on ActiPatch Therapy in the areas of plastic surgery, orthopedics and chronic wound care. Results from these clinical trials will be submitted to the United States Food and Drug Administration (the FDA) for expanded indications for the use of ActiPatch Therapy.
The company also commenced a series of double-blind clinical trials to be conducted in conjunction with leading schools of podiatry and selected clinics to document the effects of ActiPatch on treating plantar fasciitis [heel pain]. The studies in started in March 2006. The Principal Investigator for the study is Dr. William Van der Reis, a Board Certified Orthopedic Surgeon and sports medicine specialist.
The primary motivation for continued clinical trials is to obtain additional FDA approved therapeutic indications for existing and future products and to facilitate faster diffusion of the Companies medicalproduct line by the medical community. Securing FDA approval is central to market entry and product acceptance. Below are listed currently planned clinical studies.
Ankle Sprains: This study will use Grade I and II ankle sprains (no gross instability) as the entry criteria. The patients will be randomly assigned to two treatment groups after initial biometric measurement of inversion and eversion power, (swelling around the injury) and recorded photographic documentation of the injury. Five data points, including the first visit point, will monitor the rate of recovery. The monitoring will include swelling circumferential measurements at the level of injury, photography, and repeated inversion and eversion power measurements. Digital scales will assess total weight bearing capability. The targeted claim will document an accelerated return to normal power and weight bearing capability on the actively treated ankle injury as compared to the uninjured ankle.
Heel Pain: Chief Investigator, Joel Brook, D.P.M. - The Heel Pain study is a randomized study with both a placebo and control study group. Each patient will be asked to rate morning pain prior to treatment on a severity scale of 1 to 10 (10 being intolerable and 1 being absence of pain). Patients will also be evaluated to determine weight bearing tolerance on the affected heal, and the approximate percentage of the total weight borne. The daily therapeutic treatment regime of 8 hours will be conducted on each patient during
normal sleep.
C-Sections: Chief Investigator, Chad Simmons, M.D. Dr. Simmons is chief of obstetrics and gynecology at the Methodist Hospital in Dallas. The hospital has a large residency program, which will facilitate completion of the 120 patient study within 4 months. The overall hypothesis of the study is that pulsed electromagnetic therapy will ameliorate the inflammatory effects of edema and pain without the adverse effects typically experience by standard pharmacological therapy.
Breast Augmentations: Dr. David Genecov will be the chief investigator Dr. Genecov with 11 other plastic surgical sites will each treat 10 patients with either an active or placebo device. The goal is to obtain results prior to an October meeting where Dr. Genecov is scheduled to present the results. The hypothesis of the study is the measure the comparative reduction of pain and edema between the active and placebo devices.
Blepharoplasty: This new blepharoplasty study is to test the new eye devices. The goal of the study is to compare the efficacy of the device to placebo devices in decreasing the edema, erythema, ecchymosis, and discomfort associated with the surgical recovery. The physician and the patient will evaluate efficacy in one week. The lead investigators are Dr. Jill Foster, Clinical Assistant Professor and Dr. Craig Czyz, Chief Resident at The Ohio State University Medical Center, Department of Ophthalmology.
BioElectronics Distributer's:
http://www.bielcorp.com/distributors.html
Contacting BioElectronics:
4539 Metropolitan Ct.
Frederick, MD 21704
866-757-2284 Toll Free
301-874-4890 Phone
301-874-6935 Fax
Office Hours:
9 A.M. - 5 P.M. EST
E-mail: info@bielcorp.com
Summing it up:
Why do I like them? They have potential. They are selling their product now on Amazon (http://www.amazon.com/s/ref=nb_ss?url=search-alias%3Daps&field-keywords=BioElectronics&x=0&y=0). They are awaiting FDA approval. Their Anti-Patch is better than Tylenol (http://finance.yahoo.com/news/BioElectronics-Technology-iw-3088384703.html?x=0&.v=1). Their products are selling overseas. Now the question is, why wouldn't it be approved by the FDA even if it is selling overseas?
They are awaiting OTCBB approval.
FDA approval will proballly in January. OTCBB listing should be within a couple of weeks.
The company is currently trading at $0.0499 (on 12/23/09).This is your choice to invest, not mine. I will not be responsible for any losses.
Posted by Zach Wilson at 9:32 PM
Interesting Article on BIEL Four Actipatches per patient 14-Dec-09 12:14 pm
ActiPatch is a non-drug, anti-inflammatory device that has been used for multiple medical conditions from facial surgery recovery to plantar fasciitis. It helps reduce swelling and inflammation through the use of pulsed electromagnetic fields contained in either a patch design or a loop configuration. The patch or loop devices contain a tiny circuit which is operated by a small low-voltage battery. Beneath the geometry of the circuit, a penetrating electromagnetic field or zone is created which penetrates into the tissues under the skin. The frequency of the generated signal works by decreasing intercellular fluid and inflammation in the injured site. As a result, the amount of swelling and associated pain around a surgery site is reduced and recovery is accelerated.
I first starting using ActiPatch for my own back and shoulder pains from years of long hours of surgery. It worked as well as any non-steroidal anti-inflammatory medication and I began to use it on my breast augmentation patients. By positioning a crescent patch over the upper medial pole of the breast (where the raised pectoralis major muscle exists) and another patch over the lateral pole of the breast (4 patches per patient), I have been equally impressed with the results. My past 25 breast augmentation patients have used it with good success. It is now part of my routine post op breast augmentation protocol and I have each patient wear them around the clock for the first 48 hours after surgery. In most cases, patients are off pain medications within 24 hours.
While I aggressively place them on an arm exercise program after surgery, which makes a big contribution to their recovery as well, the use of the ActiPatch is a simple and easy adjunct to this recovery protocol. Breast augmentation patients are extremely appreciative of any efforts made to decrease any potential pain, which is their biggest fear about breast augmentation surgery. Based on my experience with it in the breast implant patient, I can see no reason why it would not be of benefit for all kinds of breast surgery as well. I now consider it as essential to the patient's after care as the wearing of a bra.
Dr Barry Eppley is a board-certified plastic surgeon in private practice in Indianapolis, Indiana at Clarian Health Systems. (http://www.eppleyplasticsurgery.com) He writes a daily blog on plastic surgery, spa therapies, and medical skin care at http://www.exploreplasticsurgery.com
Article Source: http://EzineArticles.com/?expert=Dr_Barr...
Health Sciences Completes Licensing Agreement With The Healing Center of Montana
marketwire
Companies:
o Health Sciences Gr
Related Quotes
Symbol Price Change
HESG.PK 0.0006 0.0000
Chart for HEALTH SCIENCES GR
{"s" : "hesg.pk","k" : "c10,l10,p20,t10","o" : "","j" : ""}
Press Release Source: Health Sciences Group, Inc. On Monday December 28, 2009, 1:37 pm EST
INDIAN HARBOR BEACH, FL--(Marketwire - 12/28/09) - Health Sciences Group, Inc. (Pinksheets:HESG - News) would like to announce that it has completed a licensing agreement with The Healing Center of Montana for the territory of Livingston County, Montana for purposes of operating a medical marijuana collective and distribution center for medical marijuana patients as pertains to Montana state and Livingston County law.
"Health Sciences Group is enthusiastic about this license," said Thomas Gaffney, Health Sciences Group, Inc., CEO & Chairman. "It is only with support of industry leaders like The Healing Center that we can help create market-driven solutions to medical marijuana patients so Health Sciences can form a collective with the guidance and knowledge of The Healing Center so that patients can get the medicine they need and want from legitimate sources. The Healing Center of Montana has been a leader in medical marijuana in the State of Montana since the legalization of medical marijuana in Montana."
Under the terms of the licensing agreement Health Sciences Group will operate under the Healing Center-Livingston.
ABOUT HEALTH SCIENCES GROUP, INC.
Health Sciences Group, Inc. is a provider of health and wellness services to consumers, physicians and other healthcare professionals through its website, www.igohealthy.org, and health focused publications. The Health Sciences network consists of its public website, www.igohealthy.org, and iGoHealthy Magazine. The Company operates in three segments: Online Services, Publishing and Other Services. The Company is recently exploring options of corporate growth within the Legal Medical Marijuana Industry.
FORWARD-LOOKING DISCLAIMER
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Health Sciences Group, Inc. to be materially different from the statements made herein. Investors are highly advised to seek professional advice and conduct a complete due diligence regarding this, or any other company being considered for investment purposes. Investing in securities, particularly in issues priced at less than $1 per share, involves substantial risk and may result in a partial or complete loss of investment capital. Health Sciences Group, Inc., its subsidiaries, officers and employees cannot guarantee the completeness or accuracy of the information contained in company press releases or other company communications. Press releases and communications issued by the company should not be interpreted as an offer to sell or a solicitation to buy company stock. Investors are highly advised to seek professional advice and conduct a complete due diligence regarding this, or any other company being considered for investment purposes. Investing in securities, particularly in issues priced at less than $1 per share, involves substantial risk and may result in a partial or complete loss of investment capital. Health Sciences Group, Inc., its subsidiaries, officers and employees cannot guarantee the completeness or accuracy of the information contained in company press releases or other company communications. Press releases and communications issued by the company should not be interpreted as an offer to sell or a solicitation to buy company stock.
Contact:
CONTACT:
Health Sciences Group, Inc.
Investor Relations
Health Sciences Group, Inc.
Frank Godleski
IR Representative
Email Contact: Email Contact
BIEL Update - Why this patent is so important
25-Jun-09 12:26 pm
Hi everyone:
This is really big news for BIEL. They have been working on this patent for five years. It will prevent anyone from marketing a portable, wearable PEMF device. The FDA is currently reviewing acetaminophen looking at pulling some forms of packaging off the shelves. Acetaminophen is the number one cause of liver failure in the the US and UK and its potential dangers are being well covered by the media. PEMF offers a viable alternative for many types of pain, but the older version of the tech are not marketable because of size and cost - you can't strap a big machine on your knee and go for a run - you can with BIEL's technology. This patent ensures that if PEMF goes mainstream it will be BIEL who controls it. Great news for the company. This combined with the FDA applications on file, the coming clinicals we will announce soon and the additional FDA filings planned should make this stock move much higher. Joe Noel - good luck to all and thanks for all your support. It's a very exciting time for all of us at the company.
I have a call in ...I will find out about the website issue more and the "Seller" Happy Holidays
What know one understands is you can't take internet orders when you have large demand that needs to filled first,then you can focus on the internet orders.Take care of the big orders first!
You are 100% right!!!!!!!!!!