Counting my change
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(Nasdaq: GTXI)GTX, Inc. saw its shares plunge in the after hours session. After the bell today the company announced top line results of the Phase III clinical trial evaluating toremifene 20 mg, a selective estrogen receptor modulator, for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia, or PIN, a premalignant lesion of the prostate. The company reported that the incidence of prostate cancer was lower in men receiving toremifene 20 mg compared to placebo but was not statistically significantly different.
"We designed the Phase III trial based upon the successful outcome of our Phase IIb clinical trial. Toremifene 20 mg did also reduce prostate cancer in our Phase III study but based on our review of the top line data, there is not a sufficient reduction in cancers compared to placebo over a three year period to demonstrate the statistical significance required for this study," said Dr. Mitchell S. Steiner, CEO of GTX. "We intend to review all data from the study this summer to better understand the trial results and the ability of toremifene 20 mg to reduce cancer among these high risk men.
The company said the outcome of this study will not affect its partnership with Ipsen, with whom the company is co-developing toremifene 80 mg, a drug that is supposed to reduce fractures in men with prostate cancer who are undergoing androgen deprivation therapy.
Shares of GTX fell 98 cents or more than 32% in the after hours session, closing at $2.04.
(Nasdaq: VRTX)Vertex Pharmaceuticals Incorporated soared in the extended session today after the company announced that 75% of people chronically infected with genotype 1 hepatitis C virus (HCV) who had not previously been treated achieved a sustained viral response (SVR or viral cure) after receiving a 12-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone, in the Phase 3 ADVANCE trial. 69% of people achieved SVR after receiving an 8-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone. 44% of people in the control arm achieved SVR after 48 weeks of treatment with the currently approved regimen of pegylated-interferon and ribavirin.
The safety and tolerability profile of telaprevir in the ADVANCE trial was consistent with the profile reported in Phase 2 studies, with an improvement in treatment discontinuation rates due to adverse events. Adverse events leading to discontinuation of all study drugs occurred in 6.9%, 7.7% and 3.6% of patients in the 12-week telaprevir-based arm, the 8-week telaprevir-based arm and the control arm, respectively.
"These first Phase 3 results are important for people with hepatitis C, as they represent a potential new era of therapy where doctors may be able to use direct acting antiviral medicines to improve treatment and help patients potentially avoid life-threatening liver-related consequences associated with chronic hepatitis C," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, and an Investigator for the ADVANCE trial. "The ADVANCE results confirm findings seen in earlier trials of telaprevir and highlight that telaprevir-based combination regimens may increase viral eradication rates and shorten treatment time for many patients."
"These groundbreaking data are the result of our more than decade-long commitment to improving care for people with hepatitis C and should provide new hope for patients with this disease," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "As fewer than half of people with genotype 1 hepatitis C achieve a viral cure with currently approved therapies, new and more effective medicines are urgently needed.
"These results for telaprevir show that 75 percent of patients in the 12-week telaprevir arm achieved a viral cure, with the majority receiving only 24 weeks of therapy, marking what we believe may be a potentially dramatic improvement in the future treatment of hepatitis C," concluded Dr. Kauffman.
Telaprevir is an investigational, oral inhibitor of HCV protease, an enzyme essential for viral replication, and is being developed by Vertex Pharmaceuticals in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration for telaprevir in the second half of 2010 for both treatment-naïve and treatment-failure patients.
Shares of Vertex surged more than 13% or $4.45 in the after hours session.
NBS..Neostem Will Step On To World Stage Today
Written by Staff and Wire Reports
Monday, 24 May 2010 23:12
Last week, investors and the media caught a small glimpse into NeoStem's (AMEX:NBS) upcoming press conference announcements when the company said it had formed a joint venture with the Vatican's Pontifical Council for Culture to expand research and raise awareness of adult stem-cell therapies.
On the day that news hit the wires, shares of the company which also sells pharmaceuticals in China, jumped 10.76% to $3.50 in premarket trading. Then, as soon as news spread that the company would also be raising money, shares of the stock began to sink as investors feared dilution. And who can blame them? In the past, investment bankers and financiers like Rodman & Renshaw have made fortunes shorting the very shares of companies they are raising money for in highly dilutive ways that damage the ownership percentage of current shareholders.
This time, however, NBS and their investors may have had the last laugh because the financing the company secured with the large investment fund, AQUA, will enable NBS to draw down at its own discretion up to $20 million at a slight discount to market without warrants as an equity investment. This firm commitment from an institution that rarely works in the small cap space but is looking to do more deals there provides NBS all the funding it needs, at the lowest possible dilution. Investors know that Neostem can call down the money at its discretion and that the fund has a no action letter with the Securities and Exchange Commission and that AQUA cannot short or sell in advance.
That is not only a "game changer" in the financing space for small cap biotech companies, but it's also a nod to the investment community that big things are underway for this relatively inexpensive stem cell play- which should easily be trading at double it's current share price.
Given the way the deal was structured, it's clear that the fund is willing earn its money with NBS as shares rise on fundamentals, earnings and news flow. Investors understood that message on Monday and shares traded as high as $3.17 after seeing lows of $2.65 the previous session.
Given the RSVP list from big and small media outlets who have confirmed their attendance at Tuesday's eagerly anticipated press conferences it's probably safe to assume that NBS and the Vatican will be grabbing quite a few headlines after today's announcements. Sources tell us that CNN and others are planning interviews and special segments on the historic alliance which will run in the days following today's news conferences.
Already NBS is a great play for investors given their vastly undervalued price as not only as an adult stem cell company, but as a multinational group actively working to expand its fast growing Chinese pharmaceutical business.
Until now, NeoStem's products have remained largely in the research phase. Now we are hearing that the marketing of NBS' proprietary and revolutionary stem cell treatments is about to make a big splash. Rumors indicate a cosmetic medicine application that may benefit from a much faster than usual "lab to market" development which is already being reviewed for approval by key regulatory agencies, including the FDA.
Unlike previous stem cell darlings like StemCells, Inc. (NASDAQ:STEM), since small cap analysts have been covering it during the past year, NBS stock has almost doubled, but it's becoming increasingly clear that support the Vatican is about to give the company and their technology will only help to advance scientific research and public awareness of the company. That isn't even taking into account the theological and ethical issues which will cause much discussion in circles outside Wall Street. Clearly, the Vatican has been very vocal in the past against use of embryonic stem cells for research, but news today of an investment of both cash or resources into NBS' platform could send shares much higher in the days and weeks ahead.
The presentation and road map plan by NeoStem's very bright Chairman and CEO, Dr. Robin L. Smith will be critical to how the stock reacts during and after the press conference. She plans to describe, in detail, this commitment milestone for not only the company, but for the field of regenerative medicine.
As part of the collaboration, NeoStem and the Pontifical Council will pursue the development of educational programs, publications and academic courses with an interdisciplinary approach for theological and philosophical faculties, including those of bioethics, around the world.
Investors may want to buy before today's press conferences and hold well beyond today's activities because this looks like a solid winner with great management and their fountain of youth technology; not to mention other pending developments which may significantly impact the share price from multiple points of interest.
UPDATE: To officially launch the initiative, the Vatican's Pontifical Council for Culture will co-host a media briefing with officials of NeoStem Tuesday, May 25th at 11:00 a.m. at the Regency Hotel in the Ballroom at 540 Park Avenue in New York, NY. The briefing will announce details of a joint initiative between their charitable organizations to expand research and raise awareness of the adult stem cell therapies to advance regenerative medicine breakthroughs. Reverend Tomasz Trafny and Dr. Smith will offer details about the planned collaborative activities that will be conducted to explore adult stem cells and their clinical application in the field of regenerative medicine. The two will also discuss the cultural relevance of such a fundamental shift in medical treatment options, particularly with regard to the impact on theological and ethical issues. Later in the day, at 1:00 p.m., Dr. Smith will provide corporate updates and discuss important advances in NeoStem's business at the NASDAQ MarketSite, 4 Times Square, New York, NY.
The delay was the Kosher seal.
CYTX Insider Buying Alert...5/24/2010 Director Paul W. Hawran purchased 5000 shares @ 4.65 $23,235 value Source:Form 4
CYTX Insider Buying Alert...5/24/2010 Director Paul W. Hawran purchased 5000 shares @ 4.65 $23,235 value Source:Form 4
Per CEO 1st consumer orders will be shipped out in less than 2 weeks,
also new website to be launched soon!
Not halted...
PDMI NEWS..Paradigm Announces Promotions in Management Team
marketwire
Press Release Source: Paradigm Medical Industries, Inc. On Monday May 24, 2010, 8:00 am
SALT LAKE CITY, UT--(Marketwire - 05/24/10) - Paradigm Medical Industries, Inc. (Pinksheets:PDMI - News) President and Chief Executive Officer Stephen Davis announced today the following promotions to the Company's management team: Julio Maximo has been named as Vice President of Operations. Mr. Maximo has over 10 years of engineering experience with Paradigm and was formerly the Director of Operations. Songyun You has been promoted to Manager of Finance. Ms. You has served the Company in the accounting department for six years and was formerly the accounting department manager. Jacob Matthews has been promoted to Manager of Marketing. Mr. Matthews has been with the Company for over two and a half years and formerly served as Sales Administrator and, more recently, as Sales and Marketing Coordinator.
Mr. Davis also announced that Jose Angelo has been named Information Technology Manager and International Sales Representative for South American countries. Mr. Angelo has been with Paradigm for over a year and previously worked in the same capacity for Medtronic Functional Diagnostics. Patrick Davis has been named Service Department Manager. Mr. Davis previously worked in sales and as a software applications engineer in the robotics industry. Angela Velasquez has been promoted to Sales Administrator. Ms. Velasquez joined Paradigm recently as a receptionist and administrative assistant.
"These promotions represent the nucleus of a growing team that will initiate development, implementation and expansion of the growth objectives that will drive Paradigm successfully into the future. Each of these talented individuals has exhibited the foresight, leadership and tenacity to recognize and overcome the obstacles and challenges that face Paradigm in the current marketplace," said Mr. Davis.
About Paradigm Medical Industries, Inc.
Paradigm Medical Industries, Inc. is a medical device company that develops, manufactures and distributes ophthalmic diagnostic instruments and related products for early detection of glaucoma and other eye disorders. The Company's primary objective is to capture a niche market within the glaucoma and ultrasound microscopy fields. The Company markets its products to ophthalmologists, optometrists, universities, and clinics throughout the United States and internationally.
This press release contains statements that, if not verifiable historic fact, may be viewed as forward-looking statements that could predict future events and outcomes with respect to Paradigm and its business. The predictions embodied in these statements will involve risk and uncertainties and, accordingly, actual results may differ significantly from the results discussed or implied in such forward-looking statements.
Contact:
Contact:
Stephen L. Davis
President and Chief Executive Officer
801-977-8970
www.paradigm-medical.com
SNSS News..Sunesis to Host Conference Call on June 8th to Discuss Voreloxin Data Presented at ASCO 2010 and Upcoming Phase 3 Trial in AML
Abstracts Discussing Voreloxin AML Data Also Accepted for Presentation at EHA
marketwire
Press Release Source: Sunesis Pharmaceuticals On Monday May 24, 2010, 7:30 am
SOUTH SAN FRANCISCO, CA--(Marketwire - 05/24/10) - Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS - News) today announced that it will host a conference call on Tuesday, June 8, 2010 at 9:00 a.m. Eastern time to review the data from the Phase 2 clinical trials of voreloxin in acute myeloid leukemia (AML) and ovarian cancer, scheduled to be presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting on June 7, 2010 in Chicago, Illinois. The Company will also discuss the plan for the Phase 3 trial of voreloxin in AML, which is expected to begin in the second half of 2010.
The Company also announced that the European Hematology Association (EHA) has published abstracts related to the presentation of data from the two Phase 2 trials of voreloxin in AML at the upcoming 15th Congress of the EHA, which will be held June 10 - 13 in Barcelona, Spain.
Conference Call and Webcast Slide Presentation
The company will host a conference call and webcast slide presentation Tuesday, June 8th at 9:00 a.m. Eastern time. Robert K. Stuart, M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina, will join the Sunesis senior management team in a discussion of the new Phase 2 data presented at ASCO and review the plans for the upcoming randomized, pivotal Phase 3 clinical trial evaluating the effect on overall survival of voreloxin in combination with cytarabine for the treatment of first relapsed or primary refractory AML. The call can be accessed by dialing (877) 303-9029 (U.S. and Canada) or (914) 495-8584 (international). To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company's website for two weeks.
Voreloxin Presentations at ASCO
Details on the ASCO presentations are included below.
Oral Podium Presentation: Final data from the Phase 2 study of voreloxin in women with platinum-resistant ovarian cancer will be presented on Monday, June 7, 2010 during the Gynecologic Cancer Clinical Science Symposium at 9:45 a.m. local time in the E Arie Crown Theater (Abstract #5002).
Poster Presentation and Discussion: Final results from the Phase 1b/2 combination study of voreloxin and cytarabine in patients with relapsed or refractory AML will be presented in Room E450a during the Leukemia, Myelodysplasia, and Transplantation Poster Session on Monday, June 7, 2010 from 2:00 to 6:00 p.m., with a discussion in Room E354a from 5:00 to 6:00 p.m. (Abstract #6526).
Poster Presentation and Discussion: Final results from the Phase 2 REVEAL-1 study of single agent voreloxin in newly diagnosed elderly patients will be presented in Room E450a during the Leukemia, Myelodysplasia, and Transplantation Poster Session on Monday, June 7, 2010 from 2:00 to 6:00 p.m., with a discussion in Room E354a from 5:00 to 6:00 p.m. (Abstract #6525).
EHA Presentations
Data from the Company's two Phase 2 trials in AML will be presented at the 15th Congress of the EHA during the Acute Myeloid Leukemia Clinical Poster Session on Friday, June 11, 2010 from 5:45 to 7:00 p.m. local time in Hall 6. The details of the abstracts are included below.
Abstract Number 0070: Final results from the Phase 2 REVEAL-1 study of single agent voreloxin in newly diagnosed elderly patients.
Abstract Number 0077: Final results from the Phase 1b/2 combination study of voreloxin and cytarabine in patients with relapsed or refractory AML.
About Voreloxin
Voreloxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a fully enrolled single agent Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a fully enrolled Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML. A Phase 2 single agent trial in platinum-resistant ovarian cancer has also completed enrollment. Sunesis anticipates initiating a Phase 3 trial of voreloxin in AML in the second half of 2010.
About the Pivotal Phase 3 Trial
Sunesis anticipates initiating a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or primary refractory AML in the second half of 2010. The trial is designed to evaluate approximately 450 patients, multi-nationally, including leading sites in the U.S. and Europe. Patients are expected to be randomized one to one to receive either voreloxin (90 mg/m2) on days one and four in combination with cytarabine (1 g/m2) daily for five days, or placebo in combination with cytarabine. The study's primary endpoint is overall survival.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The National Cancer Institute estimated that nearly 13,000 new cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. in 2009. Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
About Ovarian Cancer
In the United States, ovarian cancer remains the leading cause of death from gynecologic malignancies and is the fifth leading cause of cancer death overall in women behind lung, breast, colorectal and pancreatic cancers. According to the American Cancer Society, in 2009 there were an estimated 21,550 new cases and more than 14,000 deaths from ovarian cancer in the U.S. alone. Following frontline treatment, recurrence rates among ovarian cancer patients are high. Treatment options remain limited following relapse, and overall long-term survival has not changed significantly over the past 40 years in women with recurrent disease, with less than 30 percent of patients surviving for more than five years.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including without limitation statements related to the planned commencement of a pivotal trial of voreloxin and its timing. Words such as "anticipates," "upcoming" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Sunesis' need for additional funding to finance the voreloxin pivotal trial and to continue as a going concern, the risk that Sunesis' drug development activities for voreloxin could be halted or significantly delayed for various reasons, the risk that Sunesis' clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that preliminary data and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical trials may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of voreloxin, and the risk that Sunesis' proprietary rights may not adequately protect voreloxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Annual Report on Form 10-K for the year ended December 31, 2009 and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Contact:
Investor and Media Inquiries:
Andrea Rabney
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
SNSS News..Sunesis to Host Conference Call on June 8th to Discuss Voreloxin Data Presented at ASCO 2010 and Upcoming Phase 3 Trial in AML
Abstracts Discussing Voreloxin AML Data Also Accepted for Presentation at EHA
marketwire
Press Release Source: Sunesis Pharmaceuticals On Monday May 24, 2010, 7:30 am
SOUTH SAN FRANCISCO, CA--(Marketwire - 05/24/10) - Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS - News) today announced that it will host a conference call on Tuesday, June 8, 2010 at 9:00 a.m. Eastern time to review the data from the Phase 2 clinical trials of voreloxin in acute myeloid leukemia (AML) and ovarian cancer, scheduled to be presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting on June 7, 2010 in Chicago, Illinois. The Company will also discuss the plan for the Phase 3 trial of voreloxin in AML, which is expected to begin in the second half of 2010.
The Company also announced that the European Hematology Association (EHA) has published abstracts related to the presentation of data from the two Phase 2 trials of voreloxin in AML at the upcoming 15th Congress of the EHA, which will be held June 10 - 13 in Barcelona, Spain.
Conference Call and Webcast Slide Presentation
The company will host a conference call and webcast slide presentation Tuesday, June 8th at 9:00 a.m. Eastern time. Robert K. Stuart, M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina, will join the Sunesis senior management team in a discussion of the new Phase 2 data presented at ASCO and review the plans for the upcoming randomized, pivotal Phase 3 clinical trial evaluating the effect on overall survival of voreloxin in combination with cytarabine for the treatment of first relapsed or primary refractory AML. The call can be accessed by dialing (877) 303-9029 (U.S. and Canada) or (914) 495-8584 (international). To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company's website for two weeks.
Voreloxin Presentations at ASCO
Details on the ASCO presentations are included below.
Oral Podium Presentation: Final data from the Phase 2 study of voreloxin in women with platinum-resistant ovarian cancer will be presented on Monday, June 7, 2010 during the Gynecologic Cancer Clinical Science Symposium at 9:45 a.m. local time in the E Arie Crown Theater (Abstract #5002).
Poster Presentation and Discussion: Final results from the Phase 1b/2 combination study of voreloxin and cytarabine in patients with relapsed or refractory AML will be presented in Room E450a during the Leukemia, Myelodysplasia, and Transplantation Poster Session on Monday, June 7, 2010 from 2:00 to 6:00 p.m., with a discussion in Room E354a from 5:00 to 6:00 p.m. (Abstract #6526).
Poster Presentation and Discussion: Final results from the Phase 2 REVEAL-1 study of single agent voreloxin in newly diagnosed elderly patients will be presented in Room E450a during the Leukemia, Myelodysplasia, and Transplantation Poster Session on Monday, June 7, 2010 from 2:00 to 6:00 p.m., with a discussion in Room E354a from 5:00 to 6:00 p.m. (Abstract #6525).
EHA Presentations
Data from the Company's two Phase 2 trials in AML will be presented at the 15th Congress of the EHA during the Acute Myeloid Leukemia Clinical Poster Session on Friday, June 11, 2010 from 5:45 to 7:00 p.m. local time in Hall 6. The details of the abstracts are included below.
Abstract Number 0070: Final results from the Phase 2 REVEAL-1 study of single agent voreloxin in newly diagnosed elderly patients.
Abstract Number 0077: Final results from the Phase 1b/2 combination study of voreloxin and cytarabine in patients with relapsed or refractory AML.
About Voreloxin
Voreloxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a fully enrolled single agent Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a fully enrolled Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML. A Phase 2 single agent trial in platinum-resistant ovarian cancer has also completed enrollment. Sunesis anticipates initiating a Phase 3 trial of voreloxin in AML in the second half of 2010.
About the Pivotal Phase 3 Trial
Sunesis anticipates initiating a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or primary refractory AML in the second half of 2010. The trial is designed to evaluate approximately 450 patients, multi-nationally, including leading sites in the U.S. and Europe. Patients are expected to be randomized one to one to receive either voreloxin (90 mg/m2) on days one and four in combination with cytarabine (1 g/m2) daily for five days, or placebo in combination with cytarabine. The study's primary endpoint is overall survival.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The National Cancer Institute estimated that nearly 13,000 new cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. in 2009. Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
About Ovarian Cancer
In the United States, ovarian cancer remains the leading cause of death from gynecologic malignancies and is the fifth leading cause of cancer death overall in women behind lung, breast, colorectal and pancreatic cancers. According to the American Cancer Society, in 2009 there were an estimated 21,550 new cases and more than 14,000 deaths from ovarian cancer in the U.S. alone. Following frontline treatment, recurrence rates among ovarian cancer patients are high. Treatment options remain limited following relapse, and overall long-term survival has not changed significantly over the past 40 years in women with recurrent disease, with less than 30 percent of patients surviving for more than five years.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including without limitation statements related to the planned commencement of a pivotal trial of voreloxin and its timing. Words such as "anticipates," "upcoming" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Sunesis' need for additional funding to finance the voreloxin pivotal trial and to continue as a going concern, the risk that Sunesis' drug development activities for voreloxin could be halted or significantly delayed for various reasons, the risk that Sunesis' clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that preliminary data and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical trials may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of voreloxin, and the risk that Sunesis' proprietary rights may not adequately protect voreloxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Annual Report on Form 10-K for the year ended December 31, 2009 and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Contact:
Investor and Media Inquiries:
Andrea Rabney
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
Penny Stalker...I appreciate your opinion,but with stocks like this they take time to develop.This is a start up company.You either believe in what they are doing or you don't...Myself, thru my extensive DD believes in this company and the prospect of a large reward.I am willing to take the risk.This is my opinion, everyone has there own goals.
Delcath (DCTH): Market Share Estimate (Part 1/2)
http://www.gekkowire.com/?p=3537
POSC..Positron Sees Tenfold Increase in Quote Proposals
Written by Staff and Wire Reports
Saturday, 22 May 2010 11:22
Shares of Positron Corporation (OTCBB:POSC), the molecular imaging solutions company focused on Nuclear Cardiology, rose nearly 16% after they stated that over the first 4 months of 2010 that it has seen tremendous interest in their Attrius™ dedicated cardiac PET scanner. The Attrius™ was introduced in the 4th quarter of 2009 and has been met with critical acclaim throughout the molecular imaging industry.
Patrick G. Rooney, Positron Corporation’s CEO states, “The Nuclear Cardiology industry is experiencing a shift from SPECT to PET as a result of molly shortages combined with changes in reimbursement. Positron is in an ideal position to capitalize on this shift more so than any other imaging company. The Attrius™ is a state of the art, Frost & Sullivan New Product Innovation Award winning, device that was designed to be optimized for Cardiac imaging allowing physicians an easy transition to PET. Our pipeline for PET systems has had significant increases each month since we launched the Attrius™ late last year.
Our current pipeline has over 55 potential and/or pending sales with the second half on the year still too follow. We have done a very good job of positioning Positron to meet this new demand. Based on the current interest we believe we will meet or exceed our projected system sales moving forward. Positron’s objective is to be the leader in cardiac PET solutions. We believe we will continue to see substantial growth from both devices and radiopharmaceuticals."
That is a perfect play!!
CCCP...Good bottom call on IMGG up almost 9%
Alert...POSC on strong Accumulation
POSC NEWS! -Positron Sees Tenfold Increase in Attrius(TM) Quote Proposals
INDIANAPOLIS, May 21, 2010 (BUSINESS WIRE) -- Positron Corporation (OTCBB:POSC)
(the "Company") a molecular imaging solutions company focused on Nuclear
Cardiology, states that over the first 4 months of 2010 that it has seen
tremendous interest in its Attrius(TM) dedicated cardiac PET scanner. The
Attrius(TM) was introduced in the 4th quarter of 2009 and has been met with
critical acclaim throughout the molecular imaging industry.
Patrick G. Rooney, Positron Corporation's CEO states, "The Nuclear Cardiology
industry is experiencing a shift from SPECT to PET as a result of molly
shortages combined with changes in reimbursement. Positron is in an ideal
position to capitalize on this shift more so than any other imaging company. The
Attrius(TM) is a state of the art, Frost & Sullivan New Product Innovation Award
winning, device that was designed to be optimized for Cardiac imaging allowing
physicians an easy transition to PET. Our pipeline for PET systems has had
significant increases each month since we launched the Attrius(TM) late last
year. Our current pipeline has over 55 potential and/or pending sales with the
second half on the year still too follow. We have done a very good job of
positioning Positron to meet this new demand. Based on the current interest we
believe we will meet or exceed our projected system sales moving forward.
Positron's objective is to be the leader in cardiac PET solutions. We believe we
will continue to see substantial growth from both devices and
radiopharmaceuticals."
About Positron: Positron founded in 1983, is a molecular imaging company focused
on Nuclear Cardiology. Positron utilizes its proprietary product line to provide
unique solutions to the Nuclear Medicine community ranging from imaging systems
to radiopharmaceutical distribution. Positron products include: the Attrius(TM),
a PET imaging device; the Pulse(R), a SPECT imaging device; the Nuclear
Pharm-Assist(R), an automated radiopharmaceutical distribution device; and the
Tech-Assist(TM), a radiopharmaceutical injection shield. Positron is
headquartered in Indianapolis, Indiana. More information about Positron is
available at www.positron.com.
Forward Looking Statements: Statements in this document contain certain
forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933 and the Securities Exchange Act of 1934, as amended. These
statements are based on many assumptions and estimates and are not guarantees of
future performance and may involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance or achievements of
Positron Corporation to be materially different from future results, performance
or achievements expressed or implied by such forward-looking statements. Our
actual results may differ materially from the results anticipated in these
forward-looking statements due to a variety of factors, including, without
limitation those set forth as "Risk Factors" in our filings with the Securities
and Exchange Commission.
For further information, please contact Positron Corporation at (317) 576-0183.
SOURCE: Positron Corporation
CONTACT:
Positron Corporation
Patrick Rooney, (317) 576-0183
BIEL - Spittingfire I do not see a reverse split coming, I feel they are funded enough a this point to continue their growth. They have aligned themselves with distributors that will self fund BIEL's marketing efforts.Have a great day!
Great Pickup on IMGG!
PDMI News -- ARVO Meeting Yields Positive Results for Paradigm
Thursday, May 20, 2010 6:40 AM
News for 'PDMI' - (ARVO Meeting Yields Positive Results for Paradigm)
SALT LAKE CITY, UT, May 20, 2010 (MARKETWIRE via COMTEX) -- Paradigm Medical
Industries, Inc. (PINKSHEETS: PDMI) announced today that attendance at the
recent Association for Research in Vision and Ophthalmology (ARVO) meeting, held
in Ft. Lauderdale, Florida from May 2-5, 2010 exceeded expectations. "The ARVO
meeting was an excellent opportunity for Paradigm to continue to develop
cooperative professional relationships and introduce the Paramax, a new device
currently under FDA review pursuant to a 510(k) application. The meeting also
resulted in several new product development opportunities," said Stephen Davis,
the Company's President and CEO.
The ARVO Meeting was attended by Mr. Davis and Julio Maximo, the Company's Vice
President of Operations. Although the meeting format is not generally considered
a "selling" meeting, Paradigm actually sold over $125,000 of its equipment. The
Company also received many leads that might result in future sales of its
equipment.
During the time spent in Ft. Lauderdale, Mr. Davis met with new product
developers, development engineers, financial partners and many physicians who
represent leadership roles in the ophthalmic industry. "I am pleased with the
results of the time spent with companies and individuals at the meeting, but I
am more pleased with the renewed interest in our current and new products. This
meeting will definitely help put Paradigm Medical back on the map," added Mr.
Davis.
About Paradigm Medical Industries, Inc.
Paradigm Medical Industries, Inc. is a medical device company that develops,
manufactures and distributes ophthalmic diagnostic instruments and related
products for early detection of glaucoma and other eye disorders. The Company's
primary objective is to capture a niche market within the glaucoma and
ultrasound microscopy fields. The Company markets its products to
ophthalmologists, optometrists, universities, and clinics throughout the United
States and internationally.
This press release contains statements that, if not verifiable historic fact,
may be viewed as forward-looking statements that could predict future events and
outcomes with respect to Paradigm and its business. The predictions embodied in
these statements will involve risk and uncertainties and, accordingly, actual
results may differ significantly from the results discussed or implied in such
forward-looking statements.
Contact:
Stephen L. Davis
President and Chief Executive Officer
801-977-8970
www.paradigm-medical.com
SOURCE: Paradigm Medical Industries, Inc.
CONTACT: http://www.paradigm-medical.com
Copyright 2010 Marketwire, Inc., All rights reserved.
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AGEN..Encouraging Data Presented on Oncophage® Vaccine at International Conference on Brain Tumor Research and Therapy
Wednesday, 19 May 2010 22:30
TRAVEMUNDE, Germany--(BUSINESS WIRE)--Antigenics (NASDAQ: AGEN) today announced that data from a multi-center Phase 1/2 clinical trial of Oncophage (vitespen) for recurrent high-grade glioma (bra n cancer) was presented at the International Conference on Brain Tumor Research and Therapy. The study was conducted by the Brain Tumor Research Center at the University of California, San Francisco (UCSF).
“Furthermore, I am encouraged that recurrent glioma patients treated with Oncophage are experiencing longer than anticipated survival without treatment-related toxicities. These data could potentially justify advancement into late-stage trials.”
Data from 32 evaluable patients suggest that vaccination with Oncophage may improve overall survival in patients with recurrent high-grade glioma. An overall median survival of 44 weeks after tumor resection was observed. Approximately 70% of the evaluable patients survived beyond 36 weeks, and 41% survived up to or longer than one year. This is considered a significant achievement in the treatment of recurrent high-grade glioma. In addition, Oncophage was well tolerated, with no serious adverse events attributable to the vaccine.
All patients tested to date exhibited a significant innate immune response following vaccine administration. Furthermore, the majority of these patients showed an adaptive immune response, demonstrated by significant increases in CD8 and CD4 T cell responses. An innate immune response is defined as a generalized response, whereas the adaptive immune response is tumor antigen-specific. Taken together, these immune responses have the potential to kill tumor cells and may lead to patient benefit.
“The results from this trial suggest clear biological activity associated with Oncophage treatment as evidenced by stimulation of robust immune responses in the patients evaluated to date,†said Andrew T. Parsa, MD, PhD, associate professor in the department of neurological surgery at UCSF, and principal investigator of the trial, who presented the update. “Furthermore, I am encouraged that recurrent glioma patients treated with Oncophage are experiencing longer than anticipated survival without treatment-related toxicities. These data could potentially justify advancement into late-stage trials.â€
In a separate, more recently initiated Phase 2 trial enrolling patients with newly diagnosed glioma (n=8), there have been no significant toxicities associated with concurrent treatment of Oncophage and Temodar® (Merck: temozolomide), a chemotherapeutic that is the current standard of care. Clinical and immunologic evaluation is ongoing.
Study Details
The Phase 2 portion of the recurrent high-grade glioma trial is designed to enroll approximately 50 patients. The overall goal of this investigator-initiated, multi-center, single-arm, open-label study is to evaluate median overall survival, progression-free survival and immunologic response to vaccine treatment. Patients undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines. Patients receive four weekly doses of Oncophage and then bi-weekly doses thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion. To date, side effects observed in this study have been minor and have included injection-site reaction, fatigue, and headaches. The trial is supported in part through a grant from the National Institutes of Health. Last year, the trial was expanded to include New York-Presbyterian Hospital/Columbia University Medical Center and the Brain Tumor and Neuro-Oncology Center at University Hospitals Case Medical Center.
The Phase 2 newly diagnosed glioma trial is designed to enroll about 60 patients. This single-arm, open-label, investigator-initiated trial is designed to evaluate median overall survival, progression-free survival and immunologic response to vaccine treatment. Patients undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines. According to the protocol, patients receive Temodar concurrently with Oncophage once weekly for four consecutive weeks and monthly until vaccine depletion. The trial is supported through a grant from the American Brain Tumor Association and the National Cancer Institute Special Programs of Research Excellence.
Antigenics will assess data from the glioma trials as it matures and is currently assessing potential product registration strategies for Oncophage in this indication in the US and other territories.
About Oncophage
Nearly 800 patients in clinical trials throughout North America and Europe have been treated with Oncophage produced in Antigenics commercial facility located in Lexington, Massachusetts. Studies with Oncophage have demonstrated efficacy signals in multiple cancers, including melanoma, glioma, colorectal, pancreatic, renal cell carcinoma, gastric cancer and non-Hodgkins lymphoma.
Oncophage is approved for sale in Russia for the adjuvant treatment of kidney cancer patients at intermediate-risk for disease recurrence.
Derived from each individual tumor, Oncophage contains the antigenic fingerprint of the patients particular cancer and is designed to reprogram the bodys immune system to target only cancer cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy. Oncophage has been studied in Phase 3 clinical trials for the treatment of kidney cancer and metastatic melanoma and is currently being investigated in Phase 2 trials in recurrent and newly diagnosed glioma.
Oncophage has received fast track and orphan drug designations from the US Food and Drug Administration (FDA) for both kidney cancer and metastatic melanoma as well as orphan drug designation from the EMEA for kidney cancer. In 2009, Oncophage also received orphan drug designations from the FDA and EMEA for glioma.
In April 2009, the World Vaccine Congress named Oncophage as the best therapeutic vaccine.
About Brain and Spinal Cord Tumors
The American Cancer Society estimated that 22,070 malignant tumors of the brain or spinal cord would be diagnosed during 2009 in the United States, and that about 12,920 people would die from these tumors. Primary malignant brain tumors are uniformly fatal, and the five-year survival rate for the highest grade of malignant glial neoplasm, glioblastoma multiforme, is less than 2 percent. Brain and spinal cord tumors account for about 1 percent of all cancers and 2 percent of all cancer-related deaths.
About UCSF
UCSF is a leading university that consistently defines health care worldwide by conducting advanced biomedical research, educating graduate students in the life sciences, and providing complex patient care. For more information, please visit www.ucsf.edu.
Dr. Parsa has not received any financial support or travel expense reimbursement for this presentation or for consulting activities on behalf of Antigenics. Dr. Parsa does not have an equity interest in Antigenics or other financial relationship with the company.
About the American Brain Tumor Association
For more than 37 years, the American Brain Tumor Association has provided critical funding to researchers working toward breakthroughs in brain tumor diagnosis, treatment and care, with the ultimate goal of finding a cure. The ABTA is also the recognized resource for comprehensive information and compassionate support for the brain tumor patients, families and caregivers who are living with this disease.
About Antigenics
Antigenics (NASDAQ: AGEN) is a biotechnology company working to develop treatments for cancers and infectious diseases. For more information, please visit www.antigenics.com.
This press release contains forward-looking statements, including statements regarding trial enrollment expectations, availability of data and registrational strategies, the potential of Oncophage to improve overall survival and the potential advantage of Oncophage in effectively generating an immune response. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, that the results of the Phase 2 trials of Oncophage in glioma may be unfavorable; even if the results from these trials are positive, significant additional trials, the outcome of which are uncertain, would be required before submitting an application for marketing approval; decisions by physicians, patients, and regulatory agencies; and the factors described under the Risk Factors section of Antigenics Form 10-Q as filed with the Securities and Exchange Commission for the quarter ended March 31, 2010. Antigenics cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this document, and Antigenics undertakes no obligation to update or revise the statements. All forward- looking statements are expressly qualified in their entirety by this cautionary statement. Antigenics’ business is subject to substantial risks and uncertainties, including those identified above. When evaluating Antigenics’ business and securities, investors should give careful consideration to these risks and uncertainties.
BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read a
APPA..A.P. Pharma Receives Notice Related to Nasdaq Minimum Closing Bid Price Rule
Wednesday, 19 May 2010 22:00
REDWOOD CITY, Calif.--(BUSINESS WIRE)--A.P. Pharma, Inc. (Nasdaq: APPA), a specialty pharmaceutical company, today announced that, on May 18, 2010, the Company received a letter from The Nasdaq S ock Market (Nasdaq) indicating that the minimum closing bid price of its common stock had fallen below $1.00 for 30 consecutive trading days, and therefore, A.P. Pharma was not in compliance with Marketplace Rule 5550(a)(2). The Company has been provided 180 calendar days, or until November 15, 2010, to regain compliance with the minimum bid price requirement. This notice does not impact the Companys listing on Nasdaq at this time.
A.P. Pharma can regain compliance with the minimum closing bid price rule if the bid price of its common stock closes at $1.00 or higher for a minimum of ten consecutive business days during the initial 180-day compliance period.
If A.P. Pharma does not regain compliance within the initial 180-day period, but otherwise meets the listing standards for The Nasdaq Capital Market, Nasdaq will notify the Company that it has an additional 180 days to regain compliance. If A.P. Pharma is not eligible for an additional compliance period, or does not regain compliance during any additional compliance period, Nasdaq will provide written notice to the Company that its securities are subject to delisting. At such time, A.P. Pharma may appeal the delisting determination to a Nasdaq Listing Qualifications Panel.
About A.P. Pharma
A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer polymer-based drug delivery technology. The Companys primary focus is on its lead product, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV). A.P. Pharma received a Complete Response Letter on the APF530 NDA in March 2010 and is in the process of preparing a resubmission responsive to the deficiencies listed in the Complete Response Letter. The Company has additional clinical and preclinical stage programs in the area of pain management, all of which utilize its bioerodible injectable and implantable delivery systems. Further work on these programs has been deferred while the Company focuses on obtaining regulatory approval for APF530. For further information, visit the Company's web site at www.appharma.com.
A.P. Pharmas Forward-looking Statements
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including uncertainties associated with timely development, approval, launch and acceptance of new products, satisfactory completion of clinical studies, establishment of new corporate alliances, progress in research and development programs and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. We caution investors that forward-looking statements reflect our analysis only on their stated date. We do not intend to update them except as required by law.
Women with Hypoactive Sexual Desire Disorder (HSDD) Report That Flibanserin Increased Their Sexual Desire and Reduced Associated Distress
Tuesday, 18 May 2010 17:30
INGELHEIM, Germany--Significantly more pre-menopausal women with hypoactive sexual desire disorder (HSDD) reported a clinically meaningful improvement in their condition with flibanserin 100mg compared with placebo, according to new research announced today.
1 Flibanserin is an investigational, non-hormonal treatment being developed by Boehringer Ingelheim for pre-menopausal women with HSDD.
“In both of these study analyses, were seeing very positive outcomes with flibanserin, which is really quite exciting and could hold hope for those suffering with this distressing condition.”
More than 1,300 women were included in the pre-specified, pooled Phase III study analysis, presented at The American Congress of Obstetricians and Gynaecologists (ACOG) annual clinical meeting. All of the women had HSDD a medical condition characterised by a decrease in sexual desire associated with marked distress and/or interpersonal difficulties.2
We know that flibanserin is effective and well tolerated in a clinical setting, but its important to understand too whether patients themselves see a benefit from treatment,said John Thorp, study investigator and Professor of Obstetrics and Gynaecology at the University of North Carolina Medical School. These study results are very encouraging not only did women report an improvement in their HSDD symptoms, but they felt the improvement was meaningful to them and their overall well-being.
The patients perspective analysis builds on existing Phase III clinical trial data which demonstrate that flibanserin 100mg taken once daily at bedtime significantly increased sexual desire while significantly decreasing the distress associated with HSDD.3 This was reflected in a significant increase in the number of Satisfying Sexual Events (SSEs).
Significantly more women reported clinically meaningful improvements with flibanserin1
Study participants evaluated their treatment based on two measures overall improvement in their condition, and the question Do you believe you experienced a meaningful benefit from the study medication?
Of 1,338 participants questioned (flibanserin=659, placebo=679):
over 50% more women reported feeling˜very much improved™,˜much improved™ or minimally improved™ with flibanserin compared with placebo (318 vs. 206, p<0.0001)
Of 1,219 participants questioned (flibanserin=593, placebo=626):
over 50% more women reported a meaningful benefit from treatment with flibanserin compared with placebo (240 vs. 158, p<0.0001).
Flibanserin was shown to increase sexual desire and reduce associated distress4
A second pre-specified analysis of the Phase III study data presented at the meeting looked specifically at women who completed treatment to trial end.
Those who received flibanserin 100mg vs. placebo experienced statistically significantly:*
increased sexual desire, based on improvements in: e-diary sexual desire score (9.7 vs. 6.9, p<0.01) FSFI desire domain score (0.9 vs. 0.5, p<0.0001) reduced associated distress, based on improvements in: FSDS-R Item 13 score (-0.8 vs. -0.5, p<0.0001) FSDS-R total score (-9.3 vs. -5.0, p<0.0001) more satisfying sexual events (2.1 vs. 0.9, p<0.0001) improved overall sexual functioning, based on improvements in: FSFI total score (5.3 vs. 2.6, p<0.0001)
Although HSDD affects thousands of women, it is often misunderstood or overlooked, said Paula Hall, a sexual and relationship psychotherapist from the UK.In both of these study analyses, we’re seeing very positive outcomes with flibanserin, which is really quite exciting and could hold hope for those suffering with this distressing condition.
* see notes to the editors for an explanation of study measures
Notes to Editors:
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the USA.
Please be advised that further background information on the subject of this press release can be accessed via the Boehringer Ingelheim Corporate website following this link:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/19_may_2010.html
References
1. Jolly E, Thorp JM, Clayton AH, et al. Patients’ perspective of efficacy of flibanserin in pre-menopausal women with HSDD. Oral presentation at the 58th Annual Clinical Meeting of the American Congress of Obstetricians and Gynaecologists (ACOG), May 2010.
2. Sexual and gender identity disorders. In: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 2000:493-538.
3. Jolly E, Clayton AH, Thorp J, et al. Efficacy of flibanserin 100 mg qhs as a potential treatment for Hypoactive Sexual Desire Disorder in pre-menopausal women. Oral presentation at the European Society of Sexual Medicine Congress, November 2009.
4. Thorp JM, Clayton AH, Jolly E, et al. Efficacy of flibanserin in premonopausal women with HSDD who completed 24 weeks’ treatment. Oral presentation at the 58th Annual Clinical Meeting of the American College of Obstetricians and Gynaecologists (ACOG), May 2010.
5. Allers K, Dremencov E, Ceci A, et al. Acute and repeated flibanserin administration in female rats modulates monoamines differentially across brain areas: a microdialysis study. J Sexual Med 2010:7(5):1757-1767.
6. Shifren JL, Monz B, Russo P, et al. Sexual Problems and Distress in United States Women: Prevalence and Correlates. Obstet Gynecol 2008;112(5): 968-969.
SPPI..Spectrum Pharmaceuticals Started At Buy By Roth Capital
Way over sold,great long play
SPPI...Spectrum Pharmaceuticals Started At Buy By Roth Capital .
As I mentioned,SPPI is way under sold with a great future.
DCTH News...Delcath Systems, Inc. (Nasdaq: DCTH), NEW YORK, May 19 /PRNewswire-FirstCall/ --a development stage, specialty pharmaceutical and medical device company focused on oncology, reconfirmed today that the American Society of Clinical Oncology (ASCO) has accepted an oral presentation of Delcath's Phase III Trial Data comparing percutaneous hepatic perfusion with melphalan (PHP-mel) to the best alternative care for patients with hepatic metastases from ocular or cutaneous melanoma for ASCO's 2010 Annual Meeting, to be held June 4-8, 2010 at McCormick Place in Chicago.
James F. Pingpank, MD, FACS, Associate Professor of Surgery at the University of Pittsburgh School of Medicine and a lead Principal Investigator of the Phase III trial, will present the abstract on June 5 at 3:30 PM, during the Melanoma/Skin Cancer – Oral Abstract Session.
The abstract concerning Delcath's Phase III Clinical Trial is a late–breaking abstract. Per ASCO policy, all late-breaking abstracts will be publicly released on site at the Annual Meeting. According to ASCO, this process ensures that pivotal research accepted into ASCO's Annual Meeting is presented and discussed in a peer-review setting. These abstracts will also be made publicly available online for the first time over the duration of the Annual Meeting, June 4-8, 2010.
HNAB ... Up 10% !
ADDED-IMGG on fantastic trade play. Good call CCCP!
ADDED...SPPI and ALXA...Way way under valued!
Consider current downtrend of biotech stocks like a sale at Macy's. Good discounts to take advantage of.
Consider current downtrend of biotech stocks like a sale at Macy's. Good discounts to take advantage of.
Getting "Kosher" certified was recently holding up production. It is very hard to get this certification,but now,with this certification in place it will open up a larger market. This is moving perfectly in the right direction....
I totally agree..They have had nothing but good Pr's. They have to come up with a way to get the news out better.
Great PR...Remember Walgreen's may be right around the corner, since they bought Duanne Reed Stores. We also need more exposure,still no volume.
(CYTX)..News Cytori Therapeutics has sold its first StemSource Cell Bank in the United States
ALXA-Alexza Pharmaceuticals 2010 Annual Stockholders Meeting
Sunday, May 16, 2010
Event Reminder: Alexza Pharmaceuticals 2010 Annual Stockholders Meeting
Alexza's 2010 Annual Stockholders Meeting is on May 18, 2010 at 2:30 PM PST.
Items up for vote are the election of director nominees and to ratify the selection of an accounting firm.
I am right there with you...
BIEL..Spittingfire, The CEO stated that it should be OTC by the end of this month.All documents have been submitted. We shall see.
BIEL-Deniseann,I know how you feel,but start up companies have some controlled dilution in order to get dollars so that they can get product to market and/or grow.The key here is controlled dilution. I feel BIEL is controlling the dilution rate as best they can. The outcome is what we hope will happen getting FDA clearance and revenue.The PPS will then substantially rise.I am long on BIEL.