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Thursday, September 29, 2011

Biotech Stock Alert; Aethlon Medical (OTCBB: AEMD), ImmunoGen (Nasdaq:IMGN) Report on HER2+ Breast Cancer Developments

Point Roberts, WA - September 29, 2011- Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks reports recent news and developments in HER2+ Breast Cancer treatment from Aethlon Medical (OTCBB:AEMD) and ImmunoGen (Nasdaq:IMGN).
Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced this week , the introduction of HER2osome™, a novel medical device strategy to inhibit the progression of HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. Breast cancer represents the most common form of invasive cancer in women. HER2+ breast cancer accounts for approximately 25% of new breast cancer diagnosis.
A white paper entitled: "A Medical Device Strategy to Inhibit HER2+ Breast Cancer Progression can be accessed online at: www.slideshare.net/Aethlon/a-medical-device-to-inhibit-her2-breast-cancer
The goal of HER2osome™ therapy is to simultaneously reduce the circulatory presence of HER2 protein and breast cancer exosomes, which have increasingly become recognized as playing pivotal role in the development and progression of breast cancer. Researchers report that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin (trastuzumab), a leading monoclonal antibody treatment against the HER2+ breast cancer. As an adjunct therapeutic candidate, HER2osome™ offers to address an unmet medical need and enhance the benefit of Herceptin and standard of care chemotherapies without adding drug toxicity or interaction risks.
On September 24 th, ImmunoGen, Inc. (Nasdaq:IMGN ), a biotechnology company that develops targeted anticancer products using its TAP technology, reported findings from the first randomized clinical trial conducted with trastuzumab emtansine (also known as T-DM1). Trastuzumab emtansine consists of ImmunoGen's DM1 cancer cell-killing agent attached to the HER2-targeting antibody, trastuzumab, developed by Genentech, a member of the Roche Group, and is in global development by Roche. The study findings are being presented (abstract #5001; presentation at 9:10 am CET on Sept. 25) at the 2011 European Multidisciplinary Cancer Congress taking place in Stockholm, Sweden.
The results are from a 137-patient, randomized Phase II trial conducted by Roche comparing trastuzumab emtansine, used as a single agent, against Herceptin(R) (trastuzumab) plus chemotherapy (docetaxel) for first-line treatment of HER2-positive metastatic breast cancer. Herceptin plus chemotherapy is standard of care for this cancer. The primary endpoints of the study were progression-free survival (PFS) and assessment of safety.
The Company noted, "It is noteworthy that single-agent therapy with trastuzumab emtansine demonstrated both efficacy and tolerability advantages over Herceptin given with separate chemotherapy," commented Daniel Junius, President and CEO. "These findings further demonstrate the power of our TAP technology. We expect the body of impressive clinical results to grow substantially as the number of later-stage trials underway with TAP compounds continues to increase."
Trastuzumab emtansine is in Phase III testing for first-, second-, and third-line treatment of HER2-positive metastatic breast cancer (the MARIANNE, EMILIA, and TH3RESA trials, respectively) and in Phase II testing for adjuvant/neoadjuvant use for earlier-stage disease. Roche expects to report results from the second-line, EMILIA trial in 2012 and to use these results to support a global regulatory submission for trastuzumab emtansine in 2012. Three other compounds utilizing ImmunoGen's TAP technology -- IMGN901, SAR3419, and BT-062 -- are expected to be in Phase II clinical testing by mid-2012, with as many as seven other TAP compounds in early stage clinical testing.
About Aethlon Medical
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Aethlon's ADAPT™ platform provides the technology foundation for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Hemopurifier®, a first-in-class medical device with broad-spectrum capabilities against exosomes that contribute to the progression of cancer and infectious viral pathogens such as HIV and Hepatitis C. For more information, please visit www.aethlonmedical.com.]
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Certain of the statements herein may be forward-looking and involve risks and uncertainties.
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD) Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
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Tuesday, September 27, 2011

Biotech/Medical Stock News Alert; "A Medical Device Strategy To Inhibit HER2+ Breast Cancer Progression" Released by Aethlon Medical, Inc. (OTCBB: AEMD)

SAN DIEGO � September 27, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, disclosed today that it has released a white paper entitled: "A Medical Device Strategy To Inhibit HER2+ Breast Cancer Progression." The paper is available on the company's website at:
http://www.aethlonmedical.com/assets/ 001/5080.pdf
Or on SlideShare at:
http://www.slideshare.net/Aethlon/ a-medical-device-to-inhibit-her2-breast-cancer
About Aethlon Medical
The Aethlon Medical mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. The Aethlon ADAPT™ system is an expansive technology platform that converges affinity drug agents and plasma membrane technology to create therapeutic filtration devices that selectively target the removal of harmful particles from the entire circulatory system. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a device with broad-spectrum capabilities against viral pathogens and immunosuppressive cancer exosomes. In human studies, Hemopurifier® therapy has provided significant viral load reductions in HIV and hepatitis C virus infected individuals without the administration of antiviral drugs. We are now focused on advancing our Hemopurifier® as an adjunct strategy to improve the benefit of established infectious disease and cancer treatment regimens. Based on studies conducted by government and non-government research organizations, the Hemopurifier® is also a leading broad-spectrum treatment candidate to address bioterror and pandemic threats. For more information, please visit www.aethlonmedical.com.
Certain of the statements herein 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 ability to demonstrate ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients, future therapeutic trials in cancer patients, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier's® ability to capture exosomes and the impact it 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 either internally or through outside companies 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:
James A. Joyce
Chairman, CEO
            858.459.7800       x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
            310.691.7100      
jcain@lhai.com
Jim Frakes
Chief Financial Officer
            858.459.7800       x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
            858.459.7800       x307
jps@aethlonmedical.com
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com
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Friday, September 23, 2011

Pharma and Biotech Stocks Reporting on Breast Cancer Treatments; (OTC: AEMD), (NASDAQ: SPPI), (NASDAQ:RXII), (OTCBB: GNBT)

Point Roberts, WA - September 23, 2011- Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks, issues an update and recent news from Biotech, Pharma and Medical Technology stocks reporting on developments in the treatment of breast cancer.
Aethlon Medical (OTCBB: AEMD ), a pioneer in developing therapeutic filtration devices, announced this week, HER2osome™, a novel medical device strategy to inhibit the progression of HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. Breast cancer represents the most common form of invasive cancer in women. HER2+ breast cancer accounts for approximately 25% of new breast cancer diagnosis.
The goal of HER2osome™ therapy is to simultaneously reduce the circulatory presence of HER2 protein and breast cancer exosomes, which have increasingly become recognized as playing pivotal role in the development and progression of breast cancer. Researchers report that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin (trastuzumab), a leading monoclonal antibody treatment against the HER2+ breast cancer. As an adjunct therapeutic candidate, HER2osome™ offers to address an unmet medical need and enhance the benefit of Herceptin and standard of care chemotherapies without adding drug toxicity or interaction risks.
Spectrum Pharmaceuticals, Inc.(NasdaqGS: SPPI ) announced Monday announced that top-line data from part one of a two-part Phase 1 study of SPI-1620 in combination with docetaxel was presented in an oral presentation at the 12th International Conference on Endothelin, held in Cambridge, United Kingdom, from September 11-14, 2011. Part one of the study has been completed, while part two is ongoing.
The primary objective of this Phase 1 study was to assess the safety and tolerability of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy. Secondary objectives of the study include assessing the pharmacokinetic and pharmacodynamic profiles of SPI-1620 and identifying the optimum dose of SPI-1620 to be used in future Phase 2 studies.
A total of 30 patients were enrolled in this study. Patients ranged in age from 41 to 77 years (median 61), and had prostate cancer (9/30), breast cancer (3/30), female reproductive malignancies (4/30), gastrointestinal cancer (3/30), and pancreatic cancer (2/30), among other types.
Roxy Pharmaceuticals Corporation (Nasdaq:RXII ) reported in a press release on Wednesday announced today that it licensed worldwide rights to develop and commercialize a Folate Binding Protein-E39 (FBP) targeted vaccine to prevent recurrence in gynecological cancers such as ovarian and endometrial adenocarcinomas.
It also said it is pursuing development of a cancer vaccine for breast cancer. NeuVax consists of the E75 peptide derived from HER2 combined with the immune adjuvant granulocyte macrophage-colony stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2. NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease free survival (DFS), the FDA granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax(TM) Treatment) study. The Phase 3 trial is expected to commence in the first half of 2012.
Generex Biotechnology Corporation's (OTCBB:GNBT) (www.generex.com) wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), today announced that its lead drug candidate AE37, a novel HER-2/neu-targeted vaccine currently in Phase II development for the treatment of breast cancer, is featured in the October 2011 issue of Scientific American, in a story titled "A New Ally Against Cancer" by Eric von Hofe, Ph.D., President of Antigen Express.
Biotech Investor Snapshot for Aethlon Medical (OTCBB: AEMD)
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Aethlon's ADAPT™ platform provides the technology foundation for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Hemopurifier®, a first-in-class medical device with broad-spectrum capabilities against exosomes that contribute to the progression of cancer and infectious viral pathogens such as HIV and Hepatitis C. For more information, please visit www.aethlonmedical.com.
Visit the AEMD showcase page on Investorideas.com
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Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech,  biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411
Source: www.Investorideas.com
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com
Visit the AETHLON MEDICAL INC (OTC BB: AEMD) showcase profile page
Disclosure/Disclaimer: AETHLON MEDICAL INC (OTC BB: AEMD) is a paid advertising client ($one thousand five hundred per month, $five thousand per month in 144 stock)

Wednesday, September 21, 2011

Biotech/Medical Technology Stock News; Aethlon Medical (OTCBB: AEMD) Introduces HER2osome™, A Novel Therapeutic Device Strategy to Address Breast Cancer

SAN DIEGO � September 21, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today the introduction of HER2osome™, a novel medical device strategy to inhibit the progression of HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. Breast cancer represents the most common form of invasive cancer in women. HER2+ breast cancer accounts for approximately 25% of new breast cancer diagnosis.
Investorideas.com Newswire The goal of HER2osome™ therapy is to simultaneously reduce the circulatory presence of HER2 protein and breast cancer exosomes, which have increasingly become recognized as playing pivotal role in the development and progression of breast cancer. Researchers report that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin (trastuzumab), a leading monoclonal antibody treatment against the HER2+ breast cancer. As an adjunct therapeutic candidate, HER2osome™ offers to address an unmet medical need and enhance the benefit of Herceptin and standard of care chemotherapies without adding drug toxicity or interaction risks.
To support the pre-clinical and clinical advancement of HER2osome™, Aethlon has submitted a funding proposal entitled, "An Innovative Device Strategy to Eliminate HER2 Breast Cancer Progression" to the Breast Cancer Research Program (BCRP) offered through the Assistant Secretary of Defense for Health Affairs, Defense Health Program. The BCRP was established in fiscal year 1992 (FY92) to support innovative research focused on eradicating breast cancer. Appropriations for the BCRP from FY92 through FY10 totaled over $2.5 billion. The FY11 appropriation is $150 million. Principal investigators underlying the Aethlon BCRP funding proposal are Dr. CS Chen, Chief, Division of Hematology and Oncology and Medical Director of the Loma Linda Cancer Center, and Dr. Douglas Taylor, Professor, Department of Obstetrics & Gynecology at University of Louisville School of Medicine.
The evolution of HER2osome™ therapy is based upon an adaptable dialysis-like affinity platform technology known as the Aethlon ADAPT™ system. Therapies evolved from the Aethlon ADAPT™ system target the selective clearance of harmful agents from the entire blood volume within clinically relevant time frames and without the loss of essential blood components. Thus, overcoming the historic limitation of extracorporeal strategies that indiscriminately adsorb or remove particles solely by molecule size. In function, the device platform allows the immobilization of single or multiple affinity agents in the outer-capillary space of plasma filtration membrane technology as a means to provide rapid real-time clearance of corresponding targets. In the case of HER2osome™, the immobilization of a HER2 antibody and an exosome targeted affinity agent provides a mechanism to clear both targets from the circulatory system of HER2+ breast cancer patients. Like all ADAPT™ derived therapies, HER2osome™ will operate dialysate free, will not require replacement fluids, and can be utilized on dialysis machines or CRRT systems already located in hospitals and clinics worldwide.
Aethlon has previously leveraged its ADAPT™ system through a proposal chosen for funding through a DOD contract award under DARPA-BAA-11-30 entitled "Dialysis-Like Therapeutics". The proposed program, which is pending completion of a contracting phase, would support the development of a therapeutic device that reduces the incidence of sepsis in wounded warfighters through the selective clearance of circulating septic precursors.
The genesis of the ADAPT™ system is the Hemopurifier®, a device that immobilizes a single lectin affinity agent to provide broad-spectrum capabilities against viral pathogens and immunosuppressive proteins. Human studies have demonstrated the Hemopurifier® to be safe and provide average viral load reductions of greater than 50% during four-hour treatment periods in both hepatitis-C (HCV) and HIV infected individuals without the administration of antiviral drugs. The device is currently the subject of a human clinical study to evaluate its ability to accelerate viral load depletion when utilized in combination with HCV standard of care drug therapy. An investigational device exemption (IDE) to initiate clinical studies in the United States has been submitted to The Food and Drug Administration (FDA).
In vitro studies recently documented that the Hemopurifier® also captures exosomes underlying cancer, including colorectal, lymphoma, melanoma, ovarian, and breast cancer. On August 24th, Aethlon expanded its exosome research programs through a collaborative agreement with the Sarcoma Oncology Center (SOC), based in Santa Monica, California. The SOC collaboration will study the ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients. The study will evaluate 25 patients, five patients with metastatic cancer of the following types; non-small cell lung cancer, prostate cancer, melanoma, head and neck cancer, and sarcoma. Exosomes released by cancers have emerged to become an important therapeutic target in cancer care, as they are implicated in cancer survival, growth, and metastasis. Researchers have also identified that cancer-released exosomes may assist tumors in evading the response of the immune system.
About Aethlon Medical
The Aethlon Medical mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. The Aethlon ADAPT™ system is an expansive technology platform that converges affinity drug agents and plasma membrane technology to create therapeutic filtration devices that selectively target the removal of harmful particles from the entire circulatory system. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a device with broad-spectrum capabilities against viral pathogens and immunosuppressive cancer exosomes. In human studies, Hemopurifier® therapy has provided significant viral load reductions in HIV and hepatitis C virus infected individuals without the administration of antiviral drugs. We are now focused on advancing our Hemopurifier® as an adjunct strategy to improve the benefit of established infectious disease and cancer treatment regimens. Based on studies conducted by government and non-government research organizations, the Hemopurifier® is also a leading broad-spectrum treatment candidate to address bioterror and pandemic threats. For more information, please visit www.aethlonmedical.com.
Certain of the statements herein 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 ability to demonstrate ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients, future therapeutic trials in cancer patients, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier's® ability to capture exosomes and the impact it 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 either internally or through outside companies 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:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com
Visit the AETHLON MEDICAL INC (OTC BB: AEMD) showcase profile page
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Tuesday, September 13, 2011

Biotech/Pharma Stocks to Watch; (BPAX, RXII, DNDN, CPRX)

POINT ROBERTS - September 13, 2001 - www.InvestorIdeas.com, a global investor research portal for independent investors issues a report for biotech and pharma stocks to watch based on trading and news for 12th September.
U.S. markets ended higher after falling sharply earlier in the trading session boosted by some reports that China could rescue European debt markets. Bitotechnology stocks were among the top per performers with the NASDAQ Biotechnology Index climbing 6.6 or 0.71% to $982.57, near the day's high of 982.84.
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) shares ended higher by 0.73% to $2.77 after hitting a day's high of $2.90. On Monday, the company announced successful completion of its principal LibiGel (testosterone gel) pharmacokinetic (PK) study. The top-line results indicate that LibiGel increases levels of free testosterone, bioavailable testosterone and total testosterone in the serum of postmenopausal women to within the normal ranges for younger, premenopausal women.
RXi Pharmaceuticals Corporation (NASDAQ:RXII) was one of the top biggest gainers and moved 14 cents or 14% to $1.14, off day's high of $1.28. The company announced that the FDA has expanded a partial clinical hold on the company's NeuVax, which had been earlier delaying a late-stage study.
Dendreon Corporation (NASDAQ:DNDN) shares rose 29 cents or 2.54% to $11.69, recovering from day's low of $10.89. Analyst at Roth Capital has downgraded the stock to Neutral from Buy. Also, an analyst at ThinkEquity reduced its price target on the stock to $21 with a buy rating.
Catalyst Pharmaceutical Partners, Inc. (NASDAQ:CPRX) jumped 17 cents or 13.46% to close at day's high of $1.45. More than 70.5K shares traded hands, compared to its average volume 31.13K shares. The stock moved following an article from Seekingalpha, which listed the stock as a top ceap biotech stocks that could double or triple by next year.
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Showcase Biotech/Pharma stock at Investorideas.com:
BioSante Pharmaceuticals, Inc.
http://www.biosantepharma.com/
Read the August 2011 Fact Sheet in Full
http://www.biosantepharma.com/downloads/BioSante-Fact-Sheet.pdf
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "continue," "could," "believe," "intends," "continue," "expects," "anticipates," "estimates," "may," other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
312-506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
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Monday, September 12, 2011

Biotech and Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Successfully Completes LibiGel® Pharmacokinetic Study

LINCOLNSHIRE, Ill. - September 12, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), today announced successful completion of its principal LibiGel (testosterone gel) pharmacokinetic (PK) study. The top-line results indicate that LibiGel increases levels of free testosterone, bioavailable testosterone and total testosterone in the serum of postmenopausal women to within the normal ranges for younger, premenopausal women. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.
The LibiGel PK study was conducted as part of the required studies to be submitted in the LibiGel new drug application (NDA), which is anticipated by the fourth quarter of 2012. The PK study was conducted in 24 postmenopausal subjects for a total of 63 days, in the absence of estrogen therapy, as well as in the same women when treated with a transdermal estradiol patch and subsequently oral estrogen. There were no differences in blood levels of testosterone regardless of the absence or presence of estrogen therapy, whether transdermal or oral.
The data from the PK study showed that testosterone blood levels were similar on days 14, 21, 42 and 63 of the study, indicating that there was no buildup of testosterone blood levels with daily LibiGel treatment. Additionally, free and bioavailable testosterone returned to baseline levels within 36-48 hours after the last dose of LibiGel, indicating effective elimination after dosing is discontinued. The testosterone blood levels produced in this study were very similar to those seen in the BioSante LibiGel Phase II efficacy trial reported previously, and they were very similar to blood levels observed in transdermal testosterone patch studies, which also demonstrated efficacy in the treatment of HSDD. Importantly, in the LibiGel PK study, there were no measurable increases in blood levels of the most active estrogen, estradiol, which could have occurred as a result of the conversion of testosterone to estradiol. BioSante plans to present the full PK study results at an upcoming medical meeting.
"Significantly, none of the subjects in the LibiGel PK study had average testosterone concentrations above the normal range for younger, premenopausal women, a finding that may be a key component in the safety evaluation of LibiGel by FDA," noted Michael C. Snabes, M.D., Ph.D., senior vice president of medical affairs at BioSante. "This finding adds to our confidence that the results of our ongoing, long-term safety study of LibiGel will be favorable."
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). The two on-going Phase III efficacy trials are double-blind, placebo-controlled trials that have each enrolled over 500 surgically menopausal women for a six-month clinical trial. The efficacy trials, which completed enrollment in the first quarter 2011, are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily, pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from HSDD by 238 percent versus baseline (p <0.0001); this increase also was significant versus placebo (p <0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
In addition, BioSante is conducting a Phase III LibiGel safety study, which is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that completed enrollment of 3,656 women on June 2, 2011 and has accrued over 4,500 women-years of exposure. The safety study will continue for a total of five years, however, BioSante will use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women. The NDA submission is targeted for the fourth quarter of 2012.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "continue," "could," "believe," "intends," "continue," "expects," "anticipates," "estimates," "may," other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp  
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Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com

Friday, September 9, 2011

Biotech Investor Stock News Alert; BioSante (NASDAQ: BPAX) Trading its Way Back to $3.00

Point Roberts, WA, LINCOLNSHIRE, Ill –September 9, 2011,– Investorideas.com, a leader in sector stock research for independent investors , issues a trading alert for specialty biotech/pharma stock, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) for  the week of September 9th.

The stock has bounced back as high as $2.82 in today’s trading, and was up 9.9% yesterday at $2.89.

In recent commentary on Motley Fool,3 Biotechs Ready to Move, the author noted, "Despite the future risks, though, there's no doubt BioSante will rise on positive efficacy data. With a market cap under $300 million, there are very little sales baked into the price."



News Excerpt: Pharma News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present at Three September Healthcare Conferences
“LINCOLNSHIRE, Ill. - September 1, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced that BioSante will present at three healthcare conferences in September. The three presentations are as follows: on Wednesday, September 7, 2011 at 9:45 am EDT at the Stifel Nicolaus Healthcare Conference in Boston; on Monday, September 12, 2011 at 1:35 pm EDT at the Rodman & Renshaw Healthcare Conference in New York; and on September 27, 2011 at 2:00 pm EDT at the JMP Securities Healthcare Conference in New York.

BioSante will provide a company overview at each conference, as well as an update on the LibiGel® (testosterone gel) Phase III clinical development program and planned new drug application (NDA) submission.

A live audio webcast of remarks by Phillip Donenberg, senior vice president & CFO of BioSante, at the Stifel Nicolaus Conference may be accessed at http://www.veracast.com/webcasts/stifel/healthcare 2011/ 07104418.cfm:  the webcast will be archived for 30 days. A live audio webcast of remarks by Stephen M. Simes, president & CEO of BioSante, at the Rodman Conference may be accessed at http://www.wsw.com/webcast/ rrshq20/bpax: the webcast will be archived for 90 days. A live audio webcast of Mr. Simes’ remarks at the JMP Conference can be accessed at http://www.wsw.com/webcast/ jmp14/bpa/: the webcast will be archived for 90 days.”
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/09011.asp


About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology.  BioSante’s lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA).  BioSante’s first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante’s licensee.  BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials.  Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology.  Additional information is available online at: www.biosantepharma.com.

To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions  and other statements identified by words such as “will,” “continue,” “could,”  “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words or the use of future dates.  Forward-looking statements by their nature address matters that are, to different degrees, uncertain.  Uncertainties and risks may cause BioSante’s actual results to be materially different than those expressed in or implied by BioSante’s forward-looking statements.  For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante’s licensees or sublicensees; the success of clinical testing; and BioSante’s need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante’s actual results are described in BioSante’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q.  All forward-looking statements in this news release speak only as of the date of this news release.  BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.


Contact BioSante:
For info about BioSante Pharmaceuticals, Inc

For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com

For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com

BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com

Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp

Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp

About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks. Investorideas.com is known for its comprehensive stock directories in each sector and sector specific newswires.

Disclaimer: The following news/content is paid for as part of the  BPAX showcase program  (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp  
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp  

Source: Investorideas.com, BioSante, Investorideas.com
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cvanzant@investorideas.com

Thursday, September 8, 2011

Wednesday’s Biotech Stocks Trading; LGND, CTIC, AVII, DNDN, OTC: AEMD

Point Roberts, WA- September 08, 2011- Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for September 07, 2011.

Aethlon Medical, Inc. (OTC:AEMD) closed lower by 3.03% to $0.0640 on volume of 164K shares and is now trading higher in the morning session, up OVER 15%. The Company recently reported it has entered into an agreement with the Sarcoma Oncology Center to study the ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients.

Top gaining stocks in the sector yesterday included Ligand Pharmaceuticals Inc. (NASDAQ:LGND) traded higher by 1.92 (13.68%) and closed at new multi-year high of $15.95. Yesterday’s rally was followed by sharp fall of 10% in the past one week. So far this year, the stock has jumped over 79%.

Cell Therapeutics, Inc. (NASDAQ:CTIC) continued to move higher and rose another 8.85% to $1.23. The stock has been showing strong support at $1 mark and has jumped about 20% in the past one month. The stock has 52-week range of $1-$3.33.

AVI BioPharma, Inc. (NASDAQ:AVII) shares also climbed 0.08 (7.41%) to $1.16 bouncing back from its recent fall of about 8% in the past one week. The stock had made its new 52-week low of $1.02 earlier during this week. The stock has 52-week range of $1.02-$2.74.

Dendreon Corporation   (NASDAQ:DNDN) gained 0.80 (7.40%) to $11.61 on high volume. The company’s management will host a conference call on Thursday, September 8, 2011 at 4:30 p.m. ET to provide a structural and business update on the company.


Biotech Medical Company Snapshot for Aethlon Medical (OTCBB: AEMD)

Visit the AEMD showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
or www.aethlonmedical.com
The Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.

Contacts:  
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com

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