|RxNews Recap for Monday 03-22-10. Arrowhead Research Subsidiary, Calando Pharmaceuticals surges on RNAi breakthrough.|
|By BioMedReports.com Staff|
|Monday, 22 March 2010 20:59|
Arrowhead Research Corporation (NASDAQ: ARWR) saw its shares soar today after the company announced that the clinical trial being conducted by majority-owned subsidiary, Calando Pharmaceuticals, Inc., has demonstrated systemic delivery of siRNA and the successful "silencing" of a widely recognized cancer gene via RNA interference (RNAi) in humans. This represents a breakthrough for Calando, its proprietary RONDEL™ delivery system, and the field of RNAi. It is thought to be the first ever demonstration in humans of targeted siRNA-containing nanoparticle delivery to tumors using systemic administration, delivery of functional siRNAs, and achievement of specific mRNA and protein reductions via RNAi. Thus far in the trial, no significant drug-related toxicities, known as serious adverse events (SAEs), have been observed that may limit use. Data based on Calando’s study were published in the prestigious journal, Nature, on March 21, 2010 in an advance online edition."These important proof-of-concept data position us well as we look to the next phase of Calando’s development. Effective systemic delivery of siRNA has been referred to as the Holy Grail of RNAi therapeutics, and we have now shown that we can accomplish this in humans. We have always believed that great value would be created by the first company to demonstrate the following in humans: (1) siRNA delivery vehicles inside tumor cells; (2) target mRNA knockdown; (3) target protein knockdown; and (4) evidence that effects were mediated by the RNAi mechanism. We have now shown these, so we continue to see Calando as an attractive candidate for partnering and licensing opportunities both with respect to CALAA-01 as a specific drug candidate, as well as with RONDEL as a broad, flexible siRNA delivery system for delivering virtually any other oncology-related siRNA sequence. We are now focused on treating more patients at both UCLA and START. Importantly, we are not seeing drug-related SAEs, so while we have entered a dose range capable of triggering RNAi, we believe we are still far from a maximum tolerated dose (MTD). We intend to continue to escalate doses in search of that MTD," Dr. Anzalone concluded.
Shares shot up a whopping 92.59% or 50 cents to close the day at $1.04 after hitting a high of $1.28. Shares moved higher in the after hours session, moving up another 6 cents to $1.10.
News released after the bell:
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and its co-plaintiffs announced today that the U.S. Court of Appeals for the Federal Circuit (the "Federal Circuit") has ruled in favor of Eli Lilly & Co. following an en banc rehearing last December. The rehearing concerned a 2007 judgment that held Lilly liable for infringement of four claims of U.S. Patent No. 6,410,516 (the ‘516 patent). The Federal Circuit held that the four patent claims are invalid due to inadequate written description.
The co-plaintiffs include Harvard University, the Massachusetts Institute of Technology and the Whitehead Institute for Biomedical Research. Together with ARIAD, they had sued Lilly for infringing their pioneering U.S. patent covering methods of treating human disease by regulating NF-B cell-signaling activity and had prevailed at trial.
"We are reviewing the ruling issued today by the Federal Circuit to assess our options in the case," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.
In May of 2006, a district court awarded $62.5 million to Ariad and its co-plaintiffs, charging Lilly with infringement on the patents which cover medical treatment targeting a specific molecular pathway. Some of Lilly's drugs, such as Evista for osteoporosis, do target that pathway.
The federal appeals court reversed the decision in April. Ariad then appealed to have the case reheard by the entire panel of federal appeals court judges in what is known as an en banc hearing.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that a subsidiary of the Company won a patent infringement suit against Applied Medical Resources Corporation relating to certain of Applied Medical’s Kii™ and Universal® laparoscopic trocars
"We are pleased that the jury found that Applied Medical infringed our patent. We will continue to vigorously protect our innovations and intellectual property," said Ralph Corradi, Vice President, Endomechanical Franchise, Covidien.
Meridian Bioscience, Inc. (NASDAQ: VIVO) announced after the bell that it has submitted a 510(k) application to the United States Food and Drug Administration for marketing clearance of its new, simple molecular diagnostic test, illumigene™ C. difficile. illumigene is a simplified new technology platform, based upon loop amplification (LAMP) that makes molecular diagnostic testing possible for any size laboratory. The technology is isothermal and therefore requires no costly capital equipment. Clostridium difficile is a major cause of antibiotic associated diarrhea and it is the primary cause of pseudomembranous colitis.
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) shares dropped after the bell as the company announced that it is offering to sell up to 4,000,000 shares of its common stock in an underwritten public offering. Jefferies & Company, Inc. is acting as sole book-running manager in the offering. The co-manager in the offering is Oppenheimer & Co. Inc. Somaxon expects to grant the underwriters an option to purchase up to an additional 600,000 shares of common stock to cover overallotments of shares, if any. Somaxon’s product Silenor® (doxepin) was approved last week by the FDA for the treatment of insomnia characterized by difficulty with sleep maintenance.
In news from earlier in the day:
Abbott (NYSE:ABT) announced today that it has completed its $123 million acquisition of STARLIMS Technologies Ltd., a leader in laboratory information management systems. The acquisition provides Abbott with leading products and expertise to build its position in laboratory informatics, an emerging and rapidly growing field focused on helping to manage the increasing amount of data generated in laboratories.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the Company has submitted applications to extend patent protection for AMPYRA™ (dalfampridine) Extended Release Tablets, 10 mg to the United States Patent and Trademark Office (USPTO). AMPYRA was approved by the U.S. Food and Drug Administration (FDA) on January 22, 2010 and has seven years of exclusivity in multiple sclerosis (MS) based on orphan drug status, which has been confirmed by the FDA. Acorda has applied to extend two AMPYRA patents listed in the FDA Orange Book based on provisions in the Hatch Waxman Act that allow for up to five additional years of patent protection based on the development timeline of a drug. These patents currently expire on December 6, 2011 and July 30, 2013. If both are granted, the Company will need to select one patent for extension.
Advaxis, Inc., (OTCBB: ADXS), reported that the ongoing follow up of the surviving patients from the phase I study of ADXS11-001 for the treatment of cervix cancer failures has shown that two (2) of fifteen (15) treated patients or 13.3% are still alive 1,248 and 1,128 days after receiving their initial dose. This result of 13.3% of treated patients alive at over three (3) years, post dosing, exceeds the-established historical finding that the one-year survival for these patients is approximately 5% irrespective of the treatment regimen administered. The one-year survival in the Advaxis trial was 53%. Similarly, once progression begins following a failure of prior cytotoxic treatment the median survival for these patients is 180 days as compared with 347 days in the Advaxis study.
ATS Medical, Inc. (Nasdaq:ATSI), shares moved higher today after the manufacturer and marketer of state-of-the-art cardiac surgery products and services today announced that Health Canada-Medical Device Bureau, Therapeutic Products Programme has approved commercialization of the ATS Simulus® Annuloplasty Product Line for valve repair.
BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced the positive outcome of a meeting with the FDA on the development program for BEMA Granisetron, the company’s potential treatment for the prevention of nausea and vomiting associated with cancer therapy. FDA concurred with BDSI’s plans to pursue a development program based on clinical pharmacokinetic data for a 505(b)(2) New Drug Application (NDA). If the development program proceeds as anticipated, a BEMA Granisetron NDA could be submitted to the FDA by the end of next year and without the need for clinical efficacy studies.
Biogen Idec (NASDAQ: BIIB) today announced that Dr. Eric K. Rowinsky and Dr. Stephen A. Sherwin have been appointed to its Board of Directors pursuant to an agreement with Icahn Partners. Dr. Rowinsky was proposed as a nominee to the Board by Icahn Partners and Dr. Sherwin was selected by the Company as part of its process to identify new directors.
Under the terms of the agreement, Icahn Partners has agreed to vote its shares at the 2010 Annual Meeting for Biogen Idec’s nominees, who will include current directors Nancy L. Leaming and Brian S. Posner as well as Drs. Rowinsky and Sherwin. In addition, under the terms of the agreement, Icahn Partners will withdraw its notice of nomination of persons for election as directors and its proposal to amend Biogen Idec’s Bylaws to limit the size of the Board.
BSD Medical Corporation (NASDAQ: BSDM) today announced that a study titled "BSD2000 Deep Hyperthermia Combined with Chemotherapy of PT regimen in Patients with Non-small Cell Lung Cancer" has been published in the current issue of The Chinese Journal of Lung Cancer. The clinical study, conducted at a prestigious hospital in China, involved 60 patients with non-small cell lung cancer (NSCLC) who were randomized to receive either chemotherapy (cisplatin and paclitaxel) combined with hyperthermia (delivered using the BSD-2000 Hyperthermia System) or chemotherapy without hyperthermia.
Cambrex Corporation (NYSE:CBM) announced it has acquired IEP GmbH ("IEP"), a privately held company that is a leader in the field of industrial biocatalysis. IEP is located in Wiesbaden, Germany and offers cost effective customized biocatalytic process development and sales of enzymes to the pharmaceutical industry, with the ability to utilize its tool box of over 100 proprietary biocatalytic enzymes. IEP "bioreduction" technologies have been successfully used in numerous commercialized processes.
Cellceutix Corporation (OTC.BB:CTIX), a bio-pharmaceutical company that develops small molecules to treat cancer and inflammatory disease, today announced that it has concluded an agreement with Formatech, Inc. of Andover, Massachusetts, to formulate Kevetrin for a Phase 1 study. The terms of the agreement were not disclosed. Kevetrin will be presented as a lyophilized powder for reconstitution in saline solution at the time of use. "This agreement allows us to stay on track for our IND filing," said George Evans, CEO of Cellceutix.
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) as reported earlier today on BioMedReports, the company announced that the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee panel voted unanimously (9-0) that clinical trial data was not adequate to support approval of pixantrone for patients with relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL"). Shares dropped 44 cents or 48.34% to close the day at 47 cents.
Insmed Inc. (Nasdaq:INSM) today announced that Nicholas A. LaBella Jr., MS, RPh, has joined Insmed, effective immediately, as Chief Scientific Officer, a newly-created position on the executive team. Mr. LaBella's primary responsibility will be to oversee the scientific and regulatory analysis related to the Company's ongoing strategic review. He will report directly to Dr. Melvin Sharoky, Insmed's Chairman. Mr. LaBella, 54, has approximately 30 years of pharmaceutical industry experience in various functions, including drug development, clinical operations and regulatory affairs.
Molecular Insight Pharmaceuticals, Inc. (NASDAQ:MIPI) today announced the initiation of a Phase 1 clinical trial of Solazed™ (Ioflubenzamide I-131), the Company's targeted radiotherapeutic drug candidate for treatment of malignant metastatic melanoma. The Phase 1 proof-of-concept study is being conducted with the University of Pennsylvania and is funded by a two-year grant from the National Cancer Institute that could total as much as $1.5 million to support this stage of development of Solazed.
PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that in addition to its year end results, it will provide an update on the contract modification suspension it received on Friday, March 19, 2010. PharmAthene is pursuing various options to move forward under the contract modification announced on February 23, 2010 to its existing contract with BARDA for the research and development of SparVax™ pending a final ruling under the protest. The Company is confident that the protest is without merit and that the contract modification will be upheld. While the protest is being resolved, all work under the current contract for the development of SparVax™, including prior modifications, will continue uninterrupted.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN) saw its shares move significantly higher today.The company announced the formation of its Parkinson’s Disease Scientific Advisory Board (SAB), featuring some of the leading medical researchers in neurology. The SAB actively will collaborate with Rexahn on the clinical development strategy for its CNS drug candidate, Serdaxin®. Chairing the SAB is Dr. William Weiner, Director of the Maryland Parkinson’s Disease and Movement Disorders Center, and Professor and Chair of the Department of Neurology at the University of Maryland School of Medicine. Dr. Weiner is a recognized pioneer and key opinion leader in Neurology. He has been involved in Parkinson’s disease clinical research for over 40 years and has been involved in the development of all the major therapeutic agents used to treat this disease. Dr. Weiner has also published over 200 peer reviewed articles and 20 textbooks related to Parkinson’s disease and related disorders.
Dr. Weiner commented, "With Serdaxin, Rexahn is developing a promising therapeutic for Parkinson’s disease, a condition in great need of effective treatment options. I am excited to help contribute to the design of Serdaxin’s clinical trials and ultimately to help guide this promising drug into the clinic, where it may one day help treat patients suffering from this debilitating illness."
Shares of Rexahn closed up 13.47% or 19 cents on 5 times the average daily volume.
Simcere Pharmaceutical Group (NYSE:SCR), a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the patented anti-cancer biotech product Endostar (also known as Endu) in China, announced today the successful completion of Endostar Phase IV clinical study at a conference in Beijing dedicated to this study. Professor Sun Yan, Member of the Chinese Academy of Engineering, commented at today's conference: "This Phase IV clinical study is the first of its kind to be completed in China and houses a huge amount of data which we can tap into to help patients suffering from advanced stages of Non-Small-Cell Lung Cancer. These are very encouraging results and with its re-registration, Endostar will bring relief to patients across China for many years to come."
Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), today announced that the first patient has been dosed in a National Cancer Institute (NCI)-sponsored Phase 1/2 trial of belinostat in combination with cisplatin, doxorubicin and cyclophosphamide in the first line treatment of advanced or recurrent thymic malignancies. The trial is designed to determine what drug doses can be safely administered together in patients, and to make dose recommendations for future clinical trials. This trial is among the first to test the feasibility of simultaneously administering a histone deacetylase (HDAC) inhibitor, such as belinostat, with common chemotherapy agents such as cisplatin, doxorubicin, and cyclophosphamide, in the first line treatment of advanced or recurrent thymic malignancies..
Vical Incorporated (Nasdaq:VICL) announced today that the U.S. Navy, through the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., has awarded Vical a contract to conduct a Phase 1 clinical trial of the company's Vaxfectin(R)-formulated DNA vaccine against A/H1N1 pandemic influenza (swine flu). Vical had previously been awarded a contract by the U.S. Navy, in collaboration with the Transformational Medical Technologies Initiative (TMTI) of the Department of Defense (DoD), to support large-scale cGMP vaccine manufacturing and related clinical and regulatory preparations for the trial, bringing total U.S. government funding for this project to approximately $2 million. The Investigational New Drug (IND) application describing the trial design had been allowed by the U.S. Food and Drug Administration (FDA) in 2009, so the new funding clears the path for the trial to begin.
China Sky One Medical, Inc. (Nasdaq: CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced the pending commercial launch of 13 new SFDA approved products over the next few quarters.
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