MDRNA Inc: Key Developments
MDRNA, Inc. Receives Patent for Use of Nucleic Acids to Treat Cancer January 26, 2010 |
| MDRNA, Inc. announced that the State Intellectual Property Office of the People's Republic of China (PRC) has issued a Notification of Granting Patent Rights for PRC 200480018784 which includes the use of nucleic acids, e.g., an siRNA, for the treatment of cancer. The patent describes modulation of claudins, which are proteins implicated in tumor progression and metastasis. |
MDRNA, Inc. Announces Allowance Of European Patent Covering Formulations For Rapid Acting Insulin January 21, 2010 |
| MDRNA, Inc. announced that the European Patent Office intends to grant a patent for application EP06826368 covering formulations for the intranasal delivery of rapid acting insulin, and its use for the treatment of diabetes. |
MDRNA, Inc. Demonstrates Significantly Reduced Off-Target Activity for Proprietary RNAi-Based Compounds January 19, 2010 |
| MDRNA, Inc. announced the presentation of data highlighting the ability of the UsiRNA construct to significantly minimize off-target effects while maintaining potent RNA Interference (RNAi) activity. UsiRNAs are MDRNA's proprietary constructs in which Unlocked Nucleobase Analogs (UNA) strategically replace ribonucleobases. Placement of UNA in the passenger strand specifically blocks the activity of this strand to function in RNAi, thus decreasing off-target activity. Placement of UNA within the guide strand confers greater specificity upon RNAi by inhibiting micro-RNA-like effects. Using microarray analysis to simultaneously measure the expression levels of more than 30,000 genes, a UNA in the passenger strand reduced the off-target effects by greater than two-fold as compared to a standard siRNA. More importantly, a UsiRNA, with both passenger and guide strand UNA placements reduced the off-targets effects by more than 10-fold compared to a standard siRNA. MDRNA also reported delivery of UsiRNA against Survivin and PLK-1, by MDRNA's proprietary DiLA2-based liposome formulations via systemic (liver cancer) or local (bladder cancer) administration, and demonstrated potent and persistent target knock-down and inhibition of tumor growth. Significant knockdown in the expression level of a liver gene has also been described in non-human primates following intravenous (systemic) administration of a UsiRNA using DiLA2 liposomes. |
MDRNA, Inc. Raises $5.5 Million in Registered Direct Offering January 14, 2010 |
| MDRNA, Inc. announced that it has entered into a definitive agreement with investors to raise gross proceeds of $5.5 million through a registered direct offering. Under the terms of the agreement, the Company will sell 5,385,557 shares of its common stock at $1.02125 per share. As part of the transaction, the investors also will receive warrants, with a five year term, to purchase 3,500,612 shares of common stock at an exercise price of $1.00 per share. The transaction is expected to close on January 19, 2010. The Company plans to use the proceeds of this transaction for the satisfaction of all of the indebtedness owed pursuant to the secured promissory notes issued by the Company in December 2009, and as well to provide working capital and resources, in part with respect to the advancement of their RNAi drug discovery platform and preclinical oncology program. Canaccord Adams, Inc. served as the sole placement agent for the offering. |
MDRNA, Inc. Reports Potent Anti-Tumor Activity Against Multiple Targets In Liver And Bladder Cancer January 13, 2010 |
| MDRNA, Inc. reported today in vivo data for bladder and liver cancer demonstrating further advancement of the Company's oncology programs. The Company reported a reduction in tumor growth in both liver and bladder cancers by targeting genes key to tumor progression, via both systemic and local delivery with the Company's proprietary UsiRNAs delivered by its novel DiLA2 platform. In a presentation at the 2010 OneMedForum in San Francisco Mr. J. Michael French, President & CEO of MDRNA, stated that the Company has demonstrated potent anti-tumor activity with a UsiRNA targeting PLK1 (Polo-like Kinase 1), a protein involved in cell mitosis and tumor progression. Data from local (intravesical) application of a PLK1 UsiRNA in a DiLA2 liposome formulation in a mouse orthotopic bladder cancer model demonstrated a PLK1 UsiRNA dose-dependent decrease in bioluminescence in a mouse model of orthotopic bladder cancer, with greater than 90% reduction at a dose of 1 mg/kg. Decreased bioluminescence is generally considered to be a clear indication of reduced tumor growth. The additional early collaborative effort with a major international pharmaceutical company will utilize the broad capabilities of MDRNA's proprietary discovery engine for RNAi therapeutics and its world-class research team. The collaboration will focus on in vivo delivery of siRNAs using MDRNA's DILA2 liposome platform. |
MDRNA, Inc. Announces Closing Of $1 Million Bridge Loan December 24, 2009 |
| MDRNA, Inc. announced the closing of a bridge loan pursuant to a Note and Warrant Purchase Agreement. Under the terms of the loan, the Company sold promissory notes in the aggregate principal amount of $1.0 million and issued warrants to purchase an aggregate of approximately 1.1 million shares of the Company's common stock at $1.02 per share to certain accredited investors. The loan will become due and payable on February 1, 2010 with interest calculated at 12% per annum and payable on the due date. The loan is to be secured against the assets of MDRNA, Inc. and its subsidiaries. The warrants are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (No. 333-148771), which was declared effective by the Securities and Exchange Commission on February 4, 2008. |
MDRNA, Inc. Announces Patent Allowance Covering Methods for Targeted siRNA Delivery to the Lung December 17, 2009 |
| MDRNA, Inc. announced that the U.S. Patent and Trademark Office (USPTO) has allowed patent application U.S. 11/627,863 covering methods for the delivery of a broad array of compounds with pharmacological (biological) activity, including siRNAs, using targeting peptides that have preferential binding affinity for lung tissue. |
MDRNA, Inc. Announces Positive Efficacy And Tolerability Data In Non-Human Primates With Proprietary siRNA Compounds December 3, 2009 |
| MDRNA, Inc. announced data related to its non-human primate and oncology programs at the Informa Life Science 10th Annual Conference. The non-human primate program, which began four months ago, resulted in the significant knockdown of a primate liver gene following a single intravenous dose of 0.3 mg/kg. No increase in ALT and AST levels were observed at 24 or 48 hours post-dose nor was there elevation in other liver enzymes or kidney function markers. In addition, there were no alterations in hematology parameters and no apparent induction of cytokines. In models of liver and bladder cancer, UsiRNAs against Survivin and PLK-1, two genes considered to play critical roles in tumor growth, have demonstrated potent anti-tumor effects when delivered with the Company's proprietary DiLA2 liposome formulations via systemic and local administration. In orthotopic liver cancer, > 60% knockdown of survivin mRNA was found, and compared to negative controls a 65% decrease in tumor weights occurred in UsiRNA-treated mice. This was similar to the tumor growth inhibition in positive control Avastin (bevacizumab)-treated mice. Potent anti-cancer activity was also demonstrated for bladder cancer with up to 90% reduction in survivin mRNA. There was a dose-dependent decrease in bioluminescence of up to 90%, indicating significant reduction in tumor burden compared to vehicle and scrambled UsiRNA controls. Importantly, in each model, the mechanism was confirmed to be via RNA interference. |
MDRNA, Inc. Expands RNAi Bladder Cancer Program With Vancouver Prostate Centre November 24, 2009 |
| MDRNA, Inc. announced the extension and expansion of its collaboration with the Vancouver Prostate Centre (VPC), covering the discovery and development of RNAi-based therapeutics for the treatment of bladder cancer. Research conducted by scientists and surgeons from both institutions demonstrated that MDRNA's UsiRNA targeting human survivin and delivered via DiLA2 liposomes achieved up to 90% target knockdown in a mouse model of orthotopic bladder cancer. The effects of UsiRNA persisted for the duration of the three week study, and the level of survivin mRNA knockdown was associated with a significant reduction in tumor growth as measured by fluorescence from luciferase-expressing tumor cells. |
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