Marina Biotech, Inc. (NASDAQ: MRNA), a leading RNAi-based drug discovery and development company, today announced interim results of a six month non-human primate toxicology study with clinical candidate CEQ508. CEQ508 was administered in an oral suspension once daily to non-human primates for over 180 consecutive days at a dose level of 10(11) colony forming units (cfu)/day. During this period of time, no toxicity or test article related adverse events were observed. To support the potential requirements of a Phase 2 clinical trial, the non-human primate study was extended for an additional three months. CEQ508 is Marina Biotech's clinical candidate for the treatment of Familial Adenomatous Polyposis (FAP), and is expected to begin dosing in patients in a Phase 1b/2a trial this quarter.
Marina Biotech announces interim safety results of long-term toxicology study
TYRX AIGISRx® antibacterial envelope shows low infection rate and high implantation success for CIED procedures
Patients undergoing CIED (Cardiac Implantable Electronic Device) implantation with TYRX, Inc.’s FDA-cleared AIGISRx Antibacterial Envelope enjoyed a 99.5% rate of successful implantation with an overall infection rate of 0.48% in the first 1.9 months following the procedure, as reported in newly published results of TYRX’s COMMAND Clinical Study. There were no infections in patients receiving initial implantations of pacemakers, implantable cardioverter-defibrillators, or cardiac resynchronization therapy devices. The infection rate within the highest risk cohort, ICD/CRT-D replacements/revisions, demonstrated 70% fewer infections than some previous studies.
Liquidia begins testing flu vaccine
Liquidia Technologies has started early clinical testing of its first vaccine developed using nanotechnology.
Gene test may improve heart disease detection
Researchers report a key step for the first gene test aimed at reducing unnecessary angiograms — expensive and somewhat risky procedures that hundreds of thousands of Americans have each year to check for clogged arteries. Most of these exams, done in hospital cardiac catheterization labs, turn out negative.
Marina Biotech announces first human use of its proprietary delivery technology
Marina Biotech, Inc. (NASDAQ: MRNA), a leading RNA-based drug discovery and development company, today announced that the first patient has received a novel cancer therapeutic candidate formulated in the Company's proprietary SMARTICLES(R) delivery technology. ProNAi Therapeutics Inc., a privately held biopharmaceutical company and licensee of the SMARTICLES technology, dosed their first patient in a Phase I clinical study of PNT2258 in patients with advanced solid tumors. PNT2258 is an oligonucleotide therapeutic encapsulated within a SMARTICLES formulation. The SMARTICLES delivery technology was developed by Novosom AG and acquired by Marina Biotech in July 2010. The SMARTICLES delivery technology is part of a broad and comprehensive patent estate surrounding amphoteric liposomal delivery now owned by Marina Biotech.
Anthera Pharmaceuticals announces pricing of $31.5 million PIPE financing
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), today announced that it has entered into definitive agreements with certain accredited investors in connection with a private placement, or PIPE, financing transaction pursuant to Section 4(2) of the Securities Act of 1933, as amended, and Regulation D promulgated thereunder. Upon the closing of the transaction, Anthera will receive gross proceeds of approximately $31.5 million in exchange for the issuance to such investors of 10,500,000 units, with each unit consisting of one share of Anthera common stock and one warrant to purchase 0.40 shares of Anthera common stock. The warrants will be exercisable for a period of five years from the date of their issuance at an exercise price of $3.30 per share. The closing of the transaction, which is subject to customary closing conditions, is scheduled to occur on or prior to September 24, 2010. Anthera intends to use the net proceeds of the transaction to fund the previously announced expansion of Anthera's A-623 Phase 2b study, known as PEARL-SC (A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A-623 AdministRation in Subjects with Systemic Lupus Erythematosus), the manufacture of Phase 3 material for A-623, and for general corporate purposes.
"Plexxikon - 2010 Fierce 15" - FierceBiotech
September 15, 2010
With pharma focused on new frontline therapies, developers are relying on new technology to advance a fresh series of best-in-class therapies--anything that looks like a me-too approach won't get pushed. And Plexxikon hit paydirt when it collected a $60 million upfront from Roche in early 2009 pact covering its PLX-5568, an experimental therapy for a rare genetic kidney disease as well as additional undisclosed programs. Altogether the developer has rounded up a whopping $185 million in non-dilutive partnership funding, a stellar record in an industry that thrives on that kind of cash.
Marina Biotech, Inc. announces significant knockdown of gene targets in tumors with a microRNA mimetic
Marina Biotech, Inc. (NASDAQ: MRNA), a leading RNA-based drug discovery and development company, today reported results from in vivo studies in rodent cancer models focused on effective delivery of a microRNA (miRNA) mimetic using Marina Biotech's proprietary Di-Alkylated Amino Acid (DiLA2) delivery system. Organ and tumor distribution studies demonstrated up to a 100-fold increase in miRNA copies per tumor cell as compared to baseline levels. Similar increases in the miRNA levels were noted in liver, lung, and heart after systemic administration of the mimetic formulated in DiLA2- based liposomes. Moreover, delivery of the miRNA mimetic in DiLA2 liposomes demonstrated approximately 60% knockdown of mRNA for two genes whose down-regulation is the intended target of the miRNA mimetic.
Plexxikon publishes PLX4032 Phase 1 data in the New England Journal of Medicine
Plexxikon today announced publication of data from the Phase 1 clinical trial of PLX4032 (RG7204), confirming that treatment of metastatic melanoma patients with the BRAF V600E mutation resulted in significant tumor shrinkage in the majority of patients. Specifically, in the melanoma extension cohort of the study, nearly all patients showed some response; 81 percent of patients had tumor shrinkage of at least 30 percent. The data were published in the August 26, 2010 issue of the New England Journal of Medicine, based on an analysis as of January 31, 2010. These results further support the current PLX4032 development strategy, which includes parallel and ongoing Phase 2 (BRIM2) and Phase 3 (BRIM3) studies to support registration. PLX4032 is a novel, orally administered, targeted agent that is selective for a key oncogenic driver in melanoma and other cancers.
Achillion Announces Private Placement of $50 Million
Achillion Pharmaceuticals, Inc., (Nasdaq:ACHN) a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that it has entered into definitive agreements for the purchase of $50.1 million of Achillion's common stock and warrants in a private placement financing with a select group of institutional and accredited investors, namely Domain Associates, Clarus Ventures, Quaker BioVentures and Pappas Ventures. The investment in Achillion consists of the sale and issuance of 19,755,101 shares of common stock at a price of $2.49 per share, the consolidated closing bid price reported by NASDAQ on August 17, 2010, as well as the sale and issuance of warrants to purchase 0.35 shares of common stock for each share of common stock at a price of $0.125 per warrant share. The warrants, which represent the right to acquire an aggregate of 6,921,285 shares of common stock, have a seven-year term from the date of issuance and will be exercisable at a price of $3.1125 per share. The transaction is expected to close on or about August 20, 2010, subject to the satisfaction of certain customary closing conditions.
