|AVI BioPharma reports positive swine flu results. Celsion drug gets FDA Fast Track|
|By BioMedReports.com Staff|
|Tuesday, 24 August 2010 18:24|
These and other companies that made news in the healthcare sector on Tuesday, August 24, 2010 are listed below.AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based drugs, today announced positive results from two preclinical studies evaluating the therapeutic potential of AVI-7100 against a fully virulent pandemic H1N1 virus, also known as swine flu or swine origin influenza virus. An analysis of the data from the studies demonstrated statistically significant reductions in average viral titer versus a saline control and a control with Tamiflu®, a standard of care drug. The studies of AVI-7100, which used AVI's proprietary PMOplus chemistry, were supported by the Transformational Medical Technologies program (TMT) of the U.S. Department of Defense to identify RNA-based drug candidates against pandemic H1N1 virus. The studies were undertaken as part of a rapid response exercise demonstrating TMT's ability, in partnership with AVI, to rapidly respond to a real-world emerging viral threat.
"These H1N1 results build on the significant success we've had applying our RNA-based technologies and advanced proprietary chemistries, such as PMOplus, to anti-infective therapeutic candidates," said J. David Boyle II, interim President and CEO of AVI BioPharma. "Based on these results, TMT continues to support AVI-7100, funding an accelerated IND enabling program and Phase 1 study, as well as expanded preclinical evaluation that explores AVI-7100's potential as a broad spectrum influenza therapeutic. We look forward to continuing to work closely with TMT to support our national preparedness against biological threats."
Celsion Corporation (Nasdaq:CLSN), a leading oncology drug development company, today announced that the U.S. Food and Drug Administration has designated the HEAT Study of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), as a Fast Track Development Program. ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, is currently being evaluated under a Special Protocol Assessment (SPA) agreement with the FDA in a 600 patient global Phase III trial in patients with non-resectable hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. With nearly 70% of patients enrolled in the trial, Celsion is targeting to complete patient enrollment by year end 2010.
"We are very pleased to receive the Agency's Fast Track Designation for ThermoDox," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Fast Track Designation is an acknowledgement that HCC is a significant unmet medical need representing a life threatening disorder. It also recognizes the challenges facing pharmaceutical companies to develop effective new treatments for this difficult disease. Together with the FDA's SPA agreement, granting accelerated review for the HEAT Study, the Fast Track status provides Celsion with the shortest time to approval. Supported further by the National Cancer Institute's recent designation of the HEAT Study as a Priority Clinical Trial, it is clear that the major U.S. healthcare agencies and the liver cancer medical community recognize the potential of ThermoDox. We look forward to working with the FDA and other regulatory agencies around the world to make ThermoDox available to patients as soon as possible."
3SBio Inc. (Nasdaq:SSRX), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products and Isotechnika Pharma Inc. (TSX:ISA.to), a biopharmaceutical company focused on the discovery and development of immune modulating therapeutics, today announced the signing of a development and commercialization agreement for voclosporin, a next generation calcineurin inhibitor being developed for use in the prevention of organ rejection following transplantation and the treatment of autoimmune diseases.
Under the terms of the agreement, Isotechnika will grant 3SBio exclusive rights to all transplant and autoimmune indications of voclosporin in China, including Hong Kong and Taiwan, excluding ophthalmic indications and medical devices which were previously licensed to Lux Biosciences, Inc. and Atrium Medical Corporation, respectively. 3SBio will be responsible for the clinical development, registration and commercialization of voclosporin in China. Isotechnika will provide, under separate agreement, commercial supply to 3SBio on a cost-plus basis. Isotechnika will receive an upfront non-refundable licensing payment of US$1.5 million. Isotechnika will also receive ongoing royalties based on sales of voclosporin by 3SBio.
3SBio will invest the US$4.5 million in Isotechnika through a three-year convertible debenture which will pay interest of 7% payable semi-annually. Isotechnika has the option to pay interest in cash or to issue new shares at the prevailing price when the interest is payable. 3SBio has the right to convert the debenture at any time into common equity of Isotechnika at a conversion price of C$0.155 per share. At maturity, any remaining balance will be paid by the issuance of common shares at a price of C$0.155 per share. 3SBio will also nominate one member to Isotechnika's Board of Directors.
Advanced Cell Technology, Inc. ("ACT"; OTCBB:ACTC) commented today on yesterday’s federal court ruling, temporarily blocking federal funding for embryonic stem cell research involving the destruction of embryos. The company believes that this will add to the pressure on the NIH to find appropriate sources of human ES cells that can be funded in the context of this preliminary injunction. It is notable, then, that ACT’s proprietary "embryo-safe" Single Blastomere technique for deriving human embryonic stem cells (hESCs), documented in Nature and CELL Stem Cell magazines and elsewhere, does not require destruction of the embryo and as a consequence may not be directly affected by this ruling. ACT does not rely on government funding for any of its research or product development. Accordingly, there is no current impact on the company’s business.
AGA Medical Holdings, Inc. (Nasdaq: AGAM) today announced that it has filed a patent infringement lawsuit against W.L. Gore & Associates (Gore). AGA Medical is alleging that Gore is infringing AGA Medical’s U.S. Patent No. 5,994,738 which covers certain transcatheter occlusion products for the treatment of structural heart defects. AGA Medical is seeking damages against Gore and a permanent injunction prohibiting them from manufacturing and selling the Gore HELEX Septal Occluder both in the United States and abroad.
Cerus Corporation (NASDAQ: CERS) announced today that it has signed an agreement to acquire BioOne Corporation's commercialization rights for the INTERCEPT Blood System for platelets and plasma, subject to approval of the transaction by BioOne’s shareholders. In 2004 and 2005, Cerus and its partner at the time, Baxter International, licensed the commercialization rights for INTERCEPT platelets and plasma to BioOne for an Asian territory, which included China, Japan, Taiwan, Singapore, Korea, Thailand and Vietnam. Cerus holds the commercialization rights for the INTERCEPT red blood cell system for this region.
Under terms of the agreement, BioOne will receive approximately 1,170,000 shares of Cerus’ common stock valued at approximately $3.08 per share, and Cerus will relinquish its equity interest in BioOne.
"We believe there is great market potential for INTERCEPT in Asia and that regaining the platelet and plasma rights from BioOne will allow us to pursue a different business strategy and potential partnerships for all three programs," said Claes Glassell, Cerus' president and chief executive officer.
TomoTherapy Incorporated (NASDAQ:TOMO), maker of advanced, integrated radiation therapy solutions for cancer care, announced today that General Hospital of Guangzhou Military Command of PLA has purchased the first TomoTherapy® radiation therapy system to be installed in Southern China. The TomoTherapy treatment system will enable the hospital to provide advanced cancer care to a wide variety of patients, including those with head and neck cancers.
"In this area of Southern China, we see a large number of patients who suffer from head and neck cancers. But our aging linear accelerator technology has limited our ability to treat these patients, forcing us to refer them to other cancer centers," said Jian Liu, president of PLA Guangzhou Hospital, which treats more than 1 million patients annually. "The TomoTherapy platform will enable us to expand our care and deliver treatments for the most complicated cases very effectively and accurately with its integrated daily 3-D imaging."
Vyteris, Inc. (OTC.BB:VYTR), developer of the first FDA-approved active transdermal patch and a leader in alternative drug delivery technology, today announced an agreement with the Georgia Tech Research Corporation of the Georgia Institute of Technology (Georgia Tech) granting Vyteris the option to exclusively license Georgia Tech's patented thermal ablation and microdevice fabrication technologies for transdermal drug delivery.
The thermal ablation technology is designed to selectively enhance skin permeation to allow delivery of therapeutic drugs of high molecular weight, including peptides and proteins, through the skin, eliminating the need to inject or infuse such drugs with hypodermic needles. The microdevice fabrication technology provides a novel method to manufacture microstructures for drug delivery using mild conditions that do not harm encapsulated drugs. Vyteris plans to work closely with Georgia Tech to identify therapies that would be appropriate for the application of the new technologies.
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