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Fifth graph, first sentence of release dated July 13, 2009, should read: The phase III study involves 1,050 patients randomized in a one-to-one ratio to two treatment arms: patients in Arm A (n=525) receive ABRAXANE 100 mg/m2 weekly plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle; and patients in Arm B (n=525) receive Taxol 200 mg/m2 plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle (sted xxx and patients in Arm B (n=525) receive Taxol 200 mg/m2 weekly plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle).
The corrected release reads:
ABRAXIS BIOSCIENCE COMPLETES ENROLLMENT OF PIVOTAL PHASE III ADVANCED LUNG CANCER STUDY EVALUATING ABRAXANE® VS. TAXOL®
- Study Compares ABRAXANE and Taxol in Combination with Carboplatin, in the First-Line Treatment of 1,050 Patients with Metastatic Non-Small Cell Lung Cancer -
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, announced today that the company has completed patient enrollment of a pivotal, phase III clinical study comparing the company’s chemotherapy agent ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) with Taxol® (paclitaxel) injection, both in combination with carboplatin, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). The study, which is being conducted at 111 sites globally, includes 1,050 patients and is being led by principal investigator Dr. Mark Socinski at the University of North Carolina Lineberger Comprehensive Cancer Center. It is one of the largest NSCLC clinical studies to complete enrollment.
“The completion of enrollment of this phase III study marks a significant milestone in our efforts to evaluate ABRAXANE for the treatment of patients with metastatic lung cancer,” said Lonnie Moulder, President and Chief Executive Officer of Abraxis BioScience, Inc. “We anticipate filing a supplemental new drug application (sNDA) with the FDA in the first half of 2010 for what will be the second indication for ABRAXANE.”
ABRAXANE is currently approved for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
NSCLC comprises 85 to 90 percent of lung cancers. Lung cancer is the leading cause of cancer death, and treatment options for patients are limited.i
Study Design
The phase III study involves 1,050 patients randomized in a one-to-one ratio to two treatment arms: patients in Arm A (n=525) receive ABRAXANE 100 mg/m2 weekly plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle; and patients in Arm B (n=525) receive Taxol 200 mg/m2 plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle. The primary study endpoint is disease response, measured as complete and partial responses as defined by RECIST (Response Evaluation Criteria in Solid Tumors). Secondary study endpoints include: safety and tolerability; disease control rate and duration of response; progression-free survival (PFS); patient survival; and assessments of ABRAXANE efficacy correlated with specific tumor biomarkers, including secreted protein acidic and rich in cysteine (SPARC).
About ABRAXANE®
ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Abraxis BioScience’s proprietary nab® technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel. ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma, pancreatic and gastric.
The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. For the full prescribing information for ABRAXANE please visit www.abraxane.com.
IMPORTANT SAFETY INFORMATION
The use of ABRAXANE has not been studied in patients with hepatic or renal dysfunction. In the randomized controlled trial, patients were excluded for baseline serum bilirubin >1.5 mg/dL or baseline serum creatinine >2 mg/dL.
ABRAXANE can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ABRAXANE.
Men should be advised to not father a child while receiving treatment with ABRAXANE. It is recommended that nursing be discontinued when receiving ABRAXANE therapy. ABRAXANE contains albumin (human), a derivative of human blood.
Caution should be exercised when administering ABRAXANE concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4.
ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. It is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE. Patients should not be retreated with subsequent cycles of ABRAXANE until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3. In the case of severe neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, a dose reduction for subsequent courses is recommended. Sensory neuropathy occurs frequently with ABRAXANE.
If grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE. Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients in the randomized trial. These events included chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary embolism, and hypertension.
In the randomized metastatic breast cancer study, the most important adverse events included alopecia (90%), neutropenia (all cases 80%; severe 9%), sensory neuropathy (any symptoms 71%; severe 10%), asthenia (any 47%; severe 8%), myalgia/arthralgia (any 44%; severe 8%), anemia (all 33%; severe 1%), infections (24%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any 27%; severe <1%), and mucositis (any 7%; severe <1%).
Other adverse reactions have included ocular/visual disturbances (any 13%; severe 1%), fluid retention (any 10%; severe 0%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST [SGOT] 39%), renal dysfunction (any 11%; severe 1%), thrombocytopenia (any 2%; severe <1%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe 3%), and injection site reactions (<1%). During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have been reported with ABRAXANE.
About Abraxis BioScience, Inc.
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company’s portfolio includes the world’s first and only protein-bound nanoparticle chemotherapeutic compound (ABRAXANE®), which is based on the company’s proprietary tumor targeting technology known as the nab® platform. The first FDA approved product to use this nab platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer and is now approved in 36 countries. The company continues to expand the nab platform through a robust clinical program and deep product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.
FORWARD-LOOKING STATEMENTS
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the clinical development plan, and the timing and scope of clinical studies and trials, for ABRAXANE and the global commercialization of ABRAXANE. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the fact that results from pre-clinical studies may not be predictive of results to be obtained in other pre-clinical studies or future clinical trials; delays in commencement and completion of clinical studies or trials, including slower than anticipated patient enrollment and adverse events occurring during the clinical trials; decisions by regulatory authorities regarding whether and when to approve ABRAXANE or product candidates for various indications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of ABRAXANE and other products and product candidates; unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE or product candidates; the need for additional data or clinical studies for ABRAXANE or product candidates; regulatory developments (domestic or foreign) involving the company’s manufacturing facilities; the market adoption and demand of ABRAXANE and other products, the costs associated with the ongoing launch of ABRAXANE; research and development associated with the nab® technology platform; the impact of pharmaceutical industry regulation; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; the ability to successfully manufacture products in a time-sensitive and cost effective manner; the acceptance and demand of new pharmaceutical products; and the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2008 and in other documents it has filed with the Securities and Exchange Commission.
The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
TAXOL® is a registered trademark of Bristol-Myers Squibb Company.
i Detailed Guide: Lung Cancer – Non-Small Cell. American Cancer Society Web site. 2009. http://www.cancer.org/docroot/CRI/CRI_2_3x.asp?rnav=cridg&dt=15. Accesses July 9, 2009.
Applied Nanotech Holdings, Inc. (OTCBB: APNT) announced that it has entered into an exclusive worldwide license agreement with a leading industrial chemical products company in Japan for manufacturing and commercializing nano-copper inks and pastes. Applied Nanotech will receive an upfront payment of $1.5 million, of which $500,000 is payable immediately, and $1.0 million is payable in June 2010. In addition, Applied Nanotech will receive a royalty of 4% of sales of the copper inks and pastes by its partner. The parties are also beginning discussions for a new research and development contract beginning October 1, 2009 to transition to the fourth phase of the project, which began in 2006.
“This is a giant step toward implementing our Technical Inks Printing Solution (’TIPS’) strategy based on five important modules: nanoparticles manufacturing, inks development and manufacturing, technical printing applications development, processing development, and adequate hardware. Securing a trusted, high quality technology partner with a broad base of products used in electronic applications plays a vital role in our approach,” said Dr. ZviYaniv, Chief Executive Officer of Applied Nanotech, Inc.
“We are pleased to have reached this milestone,” said Doug Baker, CEO of APNT. “We look forward to a long and beneficial relationship with our partner in this area and the opportunities that this relationship provides.”
Dr. Robert Ronstadt, Chairman of APNT, added, “I believe we will look back on this license, which provides strong support for the viability of our business model, as a seminal event in our company’s history.”
ABOUT APPLIED NANOTECH HOLDINGS, INC.
Applied Nanotech Holdings, Inc. is a premier research and commercialization organization focused on solving problems at the molecular level. Its team of PhD level scientists and engineers work with companies and other organizations to solve technical impasses and create innovations that will create a competitive advantage. The business model is to license patents and technology to partners that will manufacture and distribute products using the technology. Applied Nanotech has over 250 patents or patents pending. APNT also possesses investments related to electronic digitized sign technology. Applied Nanotech’s website is www.appliednanotech.net.
SAFE HARBOR STATEMENT
This press release contains forward-looking statements that involve risks and uncertainties concerning our business, products, and financial results. Actual results may differ materially from the results predicted. More information about potential risk factors that could affect our business, products, and financial results are included in our annual report on Form 10-K for the fiscal year ended December 31, 2008, and in reports subsequently filed by us with the Securities and Exchange Commission (”SEC”). All documents are available through the SEC’s Electronic Data Gathering Analysis and Retrieval System (EDGAR) at www.sec.gov or from our website listed above. We hereby disclaim any obligation to publicly update the information provided above, including forward-looking statements, to reflect subsequent events or circumstances.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has entered into a licensing partnership with Korea Research Institute of Chemical Technology (“KRICT”) regarding the development of a synthetic process for Quinoxalines compounds. Research has demonstrated that Quinoxalines provide selective toxicity towards hypoxic cells – cells found in solid tumors and that are resistant to anticancer drugs and radiation therapy. This makes Quinoxaline-based drugs a potential potent treatment for solid tumors.
Dr. Chang Ahn, Rexahn’s Chairman and CEO, commented, “KRICT is a world-class research institute and partnership with KRICT will further enrich our growing pre-clinical drug pipeline devoted to new therapies that change treatment paradigms in cancer and CNS.” Dr.Ahn added, “The Quinoxaline family of compounds is very promising, and we expect to bring Quinoxaline-based drugs into the clinical trial process and ultimately to market.”
Under the terms of the agreement, Rexahn will acquire all intellectual properties related to Quinoxaline-Piperazine derivatives that were synthesized under a previous Joint Research Agreement, by exercising its option to receive an exclusive license to use, develop and commercially exploit the intellectual properties.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals is a clinical stage pharmaceutical company dedicated to commercializing first in class and market leading therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. Rexahn currently has three drug candidates in Phase II clinical trials – Archexin™, Serdaxin™, and Zoraxel™ – all potential best in class therapeutics, and a robust pipeline of preclinical compounds to treat multiple cancers and CNS disorders. Rexahn also has key R&D programs in cancer nano-medicines and multi-target aimed ligands drug discovery technologies. For more information, please visit www.rexahn.com
About Korea Research Institute of Chemical Technology (“KRICT”)
KRICT is the government-supported research institution in chemical technology of Korea. Since the establishment in 1976 for research and development of chemical technology, KRICT has contributed to the growth of the chemical industry and recently endeavors to develop key chemical technologies. For more information, please visit http://www.krict.re.kr/english/about/about_01.html
Safe Harbor
This press release contains forward-looking statements. Rexahn’s actual results may differ materially from anticipated results, and expectations expressed in these forward-looking statements, as a result of certain risks and uncertainties, including Rexahn’s lack of profitability, and the need for additional capital to operate its business to develop its product candidates; the risk that Rexahn’s development efforts relating to its product candidates may not be successful; the possibility of being unable to obtain regulatory approval of Rexahn’s product candidates; the risk that the results of clinical trials may not be completed on time or support Rexahn’s claims; demand for and market acceptance of Rexahn’s drug candidates; Rexahn’s reliance on third party researchers and manufacturers to develop its product candidates; Rexahn’s ability to develop and obtain protection of its intellectual property; and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission. Rexahn assumes no obligation to update these forward-looking statements.
Stem Cell Therapy International, Inc. (OTCBB: SCII), through its wholly owned subsidiary AmStem International, Inc., announced today that it has started the process to enable the Company to distribute Histostem and other stem cell related products.
In anticipation of the finalization of the merger between Stem Cell Therapy International, Inc. and Histostem, David Stark, SCTI President and CEO, has been working closely with Histostem management to prepare the supply channels and to network with various retailers to enable AmStem International, Inc. to begin US distribution and immediately bolster the company’s cash flow. Details about the manufacturing and shipping of the Stem Cell Facial Cream, for example, have been worked out and are ready for implementation.
“The response to our Stem Cell Facial Cream has been extremely positive,” informs Mr. Stark, “and because we have a proven market presence in Asia, proprietary supply chain, GMP-approved manufacturing facility, and some very promising study results, we are ready to partner with a major distributor right now.”
AmStem International is also seeking investigators for a clinical study of the highest caliber, to compare its Stem Cell Facial Cream with others on the market. “Our experience with clinical trials is crucial,” claims Mr. Stark. “We will be conducting a scientifically and statistically valid study, IRB-approved, and ethically sound. It will be conducted with GCP standards set by FDA, ICH, and other regulatory agencies. This study will compare our Stem Cell Facial Cream vs. inactive placebo and 3 competing products in a controlled, randomized protocol.” He adds, “This is attracting leaders in the field as investigators, and we are confident that our study results will be phenomenal.”
Stem Cell Therapy International, Inc. continues to work on the necessary steps to finalize the merger, and both sides are working diligently to manage its many details. “We will continue to collaborate closely with Histostem to ensure the greatest benefit for our stockholders and investors,” adds Mr. Stark.
About Stem Cell Therapy International, Inc.
Stem Cell Therapy International, Inc. (OTCBB: SCII) is in the field of regenerative medicine. SCII is a company devoted to the treatment of patients with stem cell transplantation therapy as well as providing the supplies of biological solutions containing new lines of stem cell products. Further information about Stem Cell Therapy International, Inc. can be found by contacting David Stark, President, at the email posted below.
About AmStem International, Inc.
AmStem International, Inc. is a new biotechnology company based in Northern California, in the watershed of stem cell innovation fueled by President Obama’s recent announcement to lift Federal funding limitations for stem cell research. AmStem provides biotherapeutic and cosmetic stem cell products, stem cell collection and storage know-how, and access to nanotechnology vital to cutting edge stem cell research. Further information about AmStem International, Inc. can be found by contacting David Stark, SCTI President, at the email posted below.
About Histostem Corporation, Ltd:
Histostem Co., Ltd. started in Seoul, Korea in 2000. To date it has treated more than 500 patients with stem cells and currently has 56 full-time employees and 28 part-time employees. Histostem’s intellectual property portfolio consists of five patents that have been granted and six patents pending. To its knowledge Histostem is one of the very few stem cell companies in the world currently earning several million dollars in income from its products and technology. Further information about Histostem Corporation, Ltd. can be found by contacting David Stark, SCTI President, at the email posted below.
Forward-Looking Statements
Some of the statements included in this press release, particularly those anticipating future clinical and business prospects for Stem Cell Therapy International, Inc., may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to obtain necessary capital, our ability to successfully complete the merger, successfully complete clinical trials; our ability to meet anticipated development timelines, our ability to establish global market for the cord blood cells, clinical trial results, successfully consummate future acquisitions, manufacturing capabilities or other factors; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
NanoTecNexus (NTN) formerly NanoBioNexus, a leading nanotech education organization and the University of California, San Diego NanoTumor Center (NTC) have received the 2009 Bronze Telly Award for the production of a video on approaches to fighting cancer using nanotechnology. The 30th Annual Telly Awards honors outstanding local, regional, and cable television commercials and programs, as well as the finest video and film productions, and work created for the web. The video entitled “Fighting Cancer with Nanotechnology” was produced in collaboration with Mindeliver Media, a San Diego-based media company specializing in pharmaceutical, biotechnology, and science industries.
The NanoTumor Center, a public-private consortium funded by the National Cancer Institute Alliance for Nanotechnology and led by UCSD, is dedicated to the fight against cancer. Its primary focus is on potential uses of nanotechnology in detecting, imaging and treating cancer through a “smart” multifunctional platform capable of targeting tumors and delivering payloads of therapeutics. One of its core missions is also education.
“Education in the new field of cancer nanotechnology for the scientific and clinical communities as well as the general public is an integral part of our center,” said NTC Director Sadik Esener, PhD, professor of electrical and computer engineering at the UCSD Jacobs School of Engineering. “The public needs to be aware of and informed about progress in cancer research in key fields such as nanotechnology,” noted Dennis Carson, MD, director of the Moores UCSD Cancer Center, an NTC member. “These types of educational projects are vital to its continued support and success.”
The Telly Awards receives over 13,000 entries annually from all 50 states and countries around the world and showcases the best work of the most respected advertising agencies, production companies, television stations, cable operators, interactive agencies, and corporate video departments in the world. “We are proud to have this recognition for our educational efforts,” said Adriana Vela, Founder and CEO of NanoTecNexus. “I credit a strong vision from the NanoTumor Center, support from the NCI Alliance, and a high caliber production team for the success of this project.” The video can be viewed at NanoTumor Center and NanoTecNexus websites as well as YouTube and other public sites.
The Telly Award follows several highly successful outreach projects held in March and April in collaboration with and in support of the inaugural San Diego Science Festival, a month-long celebration that promoted the sciences to students and the public. More than 200,000 people attended, far exceeding the first year’s goal. NTN and the NanoTumor Center offered programs such as the Nanotech Mashup event, a NanoArt Exhibit, and Nanopalooza, an interactive booth at the Festival’s Expo held at San Diego’s Balboa Park. More than 50,000 people attended the Expo.
The Nanotech Mashup event featured a talk by Josh Wolfe, co-Founder and Managing Partner of Lux Capital and the Nanopalooza booth featured fun activities, games, and displays focused on educating visitors about nanotechnology. The NanoArt exhibit, hosted by Mission Valley Library, offered nano-landscapes by Cris Orfescu who brings science and technology to the creation of unique works of art. Each program offered something for everyone and supported the educational and outreach mission of the NanoTumor Center and NanoTecNexus.
Future partnerships with the NanoTumor Center include an upcoming International Symposium focusing on “Automated Virus Detection and Analysis for Applications from Oncology to Bio-Weapon,” scheduled for July 28th, 2009 in San Diego, CA. The symposium gathers experts from France, Mexico and the United States to discuss pioneering approaches employing high-resolution DMA (Differential Mobility Analyzer), a physical method that can be applied to the detection of many virus species, particles, and ions found in the environment or cancer in humans and at-risk populations. For event details and registration visit www.nanotecnexus.org .
About NanoTecNexus
NanoTecNexus (NTN), formerly known as NanoBioNexus, is a leading non-profit organization headquartered in San Diego with offices in Tucson AZ, San Jose, CA and Vancouver, WA. NTN is dedicated to catalyzing collaboration and knowledge exchange in the nanotech field by connecting people, technology, industry and investment. NanoTecNexus enables constituents worldwide to keep up-to-date on the developments of cutting-edge nanotechnologies. Nanotechnology involves manipulating matter on an atomic or molecular scale smaller than 100 nanometers (1 nm=1 billionths of a meter) and taking advantage of properties that are present at that scale. Nanotechnology is used in thousands of applications in medicine and health, energy and water, defense and many others. On the Net: www.nanotecnexus.org
About Moores UCSD Cancer Center and NanoTumor Center
The Moores UCSD Cancer Center is one of the nation’s 41 National Cancer Institute-designated Comprehensive Cancer Centers, combining research, clinical care and community outreach to advance the prevention, treatment and cure of cancer. For more information, visit www.cancer.ucsd.edu.
The NTC is a five-year, $20-million National Cancer Institute (NCI)-funded public-private consortium and one of only eight such NCI-backed programs in the nation. UCSD physicians, engineers, chemists and biologists collaborate with colleagues at the Burnham Institute for Medical Research and University of California campuses at Irvine, Riverside, and Santa Barbara, in addition to various industry partners, to examine the potential uses of nanotechnology in cancer detection, imaging and treatment. For more information, visit http://nano.cancer.gov/programs/ucsd/.
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NanoTecNexus specializes in the field of nanotechnology and its impact on industry, academia and society. Our mission is to catalyze collaboration and knowledge exchange across these seemingly disparate entities with a variety of programs and services.
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