Copernicus Receives Milestone Payment from Cystic Fibrosis Foundation Therapeutics to Further Development of its Non-Viral Gene Therapy for Cystic Fibrosis -- Cleveland, OH - December 11, 2007
Therapeutics, Inc. announced today that it received a milestone payment from Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), a non-profit affiliate of the Cystic Fibrosis Foundation. This milestone payment is part of a research, development, and commercialization agreement between CFFT and Copernicus to develop gene therapy to treat cystic fibrosis. Copernicus earned the milestone payment by demonstrating a significant improvement in the level of CFTR gene activity in an animal model. This increased improvement in the level and duration of CFTR gene activity represents an important step in the path to developing a clinically relevant therapy.

Copernicus' Nanoparticle Technology Applied to siRNA -- Cleveland, OH - June 5, 2007
Copernicus Therapeutics, Inc. announced today that at the American Society of Gene Therapy (ASGT) Meeting held in Seattle, Washington, Copernicus showed that the methods used to produce DNA nanoparticles were also very effective when applied to siRNA. Both DNA nanoparticles as well as nanoparticles made with siRNA are highly resistant to degradative processes that would destroy the therapeutic benefit of the nanoparticles. These findings are significant because siRNAs can be designed to block the expression of specific genes and have the potential to treat numerous human diseases, including viral infections. A 2006 Nobel Prize was awarded to the scientists that discovered siRNA.

Vision Deficit in Retinitis Pigmentosa Mice Corrected with DNA -- Cleveland, OH - June 4, 2007
Copernicus Therapeutics, Inc. announced today that a research team at University of Oklahoma Health Sciences Center, led by Dr. Muna Naash, Professor of Cell Biology, demonstrated that Copernicus' DNA nanoparticles corrected vision defects in a mouse model of retinitis pigmentosa (RP). These findings were presented at the American Society of Gene Therapy meeting in Seattle, WA. Mutations in genes important in the biology of vision cause RP, a common genetic form of visual impairment affecting nearly 70,000 patients in the United States.

Copernicus to Receive Increased Support from Cystic Fibrosis Foundation Therapeutics to Further Development of its Non-Viral Gene Therapy for Cystic Fibrosis -- Cleveland, OH - February 15, 2007
Copernicus Therapeutics, Inc., announced today it will receive up to $5.2 million from Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) to support continued development of a potential gene therapy for cystic fibrosis. This continued funding is a result of satisfactory progress shown in 2006 and represents a significant increase in funding over that received in 2006.

Manuscript Demonstrates Remarkable DNA Delivery and Expression in the Mouse Retina -- Cleveland, OH – January 9, 2007
Copernicus Therapeutics, Inc. announced today that a research team at University of Oklahoma Health Sciences Center, led by Dr. Muna Naash, professor of Cell Biology, demonstrated that Copernicus’ DNA nanoparticles safely and effectively deliver and express DNA in the rods and cones of the mouse retina. According to Dr. Naash’s team, current data indicate that greater than 95% of these retinal cells expressed the DNA nanoparticle and there was no evidence of toxicity. These findings, published on December 20, 2006 in the journal PLoS ONE, have significant implications for the development of DNA-based therapeutics for various eye disorders, including retinitis pigmentosa and macular degeneration company officials said.

Copernicus Demonstrates Ability of Its Non-Viral Delivery System to Efficiently Transfer Large Sizes of Nucleic Acid into Lung Cells -- Cleveland, OH – July 6, 2006
Copernicus Therapeutics, Inc. announced that its non-viral based DNA nanoparticles technology can efficiently deliver even very large sizes of nucleic acid, up to at least 20,000 base pairs in size, to the lung cells of mice. Thus, Copernicus has again demonstrated the robust nature of its proprietary non-viral delivery system by successfully surmounting a significant limiting factor of competitive delivery technologies. These data were published in the July issue of the journal Gene Therapy.

Copernicus to Receive Continued Support from Cystic Fibrosis Foundation Therapeutics to Further Develop Non-Viral Gene Therapy for Cystic Fibrosis -- Cleveland, OH - February 14, 2006
Copernicus Therapeutics, Inc. announced today it had reached an agreement with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) whereby CFFT will continue to fund development of Copernicus' potential gene therapy for cystic fibrosis (CF). The agreement provides $1.5 million for 2006 with the potential for $4.6 million in additional funding for 2007 if satisfactory progress continues.

Copernicus Announces Efficient DNA Drug Delivery for Brain & Eye Diseases -- Cleveland, OH - June 7, 2005
Copernicus Therapeutics, Inc. announced today that collaborators Dr. David Yurek at the University of Kentucky and Dr. Muna Naash at the University of Oklahoma presented results at the American Society of Gene Therapy Meeting in St. Louis, Missouri. Using the company's efficient and effective non-viral nucleic acid nanoparticle technology, Dr. Yurek showed that DNA nanoparticles were very effective and non-toxic in introducing DNA into brain cells. Dr. Naash showed that DNA nanoparticles were more than ten-fold more efficient than any competing gene transfer system in effectively introducing DNA into the cells of the retina.

Highly Efficient DNA Drug Delivery for Eye Diseases -- Cleveland, OH - May 5, 2005
Treating important causes of blindness, including retinitis pigmentosa, macular degeneration, diabetic retinopathy, and various viral infections may be possible due to a new proprietary non-viral nucleic acid nanoparticle technology that efficiently introduces DNA into cells of the retina and other optic tissues, Copernicus Therapeutics, Inc. officials announced today. In collaborative studies with Dr. Muna Naash at University of Oklahoma Health Sciences Center, gene transfer efficiencies of up to 99 percent were achieved according to findings reported at the 2005 Association for Research in Vision and Ophthalmology meeting in Ft. Lauderdale, Florida.

Copernicus Receives Orphan Drug Designation for Treatment of Cystic Fibrosis -- Cleveland, OH - May 2, 2005
Copernicus Therapeutics, Inc. announced today that it was granted Orphan Drug Designation from the Food and Drug Administration Office of Orphan Products Development for its DNA drug intended to treat cystic fibrosis (CF). Orphan drug status is a category of drug products that are indicated for rare diseases or conditions (affecting less than 200,000 persons in the U.S.). The designation gives Copernicus access to tax credits for clinical research undertaken to generate required data for marketing approval of its drug and seven years of marketing exclusivity for the designated drug following approval by the FDA.

Copernicus Receives $1M from Cystic Fibrosis Foundation Therapeutics To Advance Development of a Non-Viral Gene Therapy for Cystic Fibrosis -- Cleveland, OH - January 20, 2005
Copernicus Therapeutics, Inc. today announced that it has received an extension to its therapeutics development award from Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT). This award in the amount of $750,000 was coupled with a $280,000 outstanding payment from the original therapeutics development award to bring the total payment to $1.03 million. The award extension is intended to support the Phase II advancement of Copernicus' potential genetic therapy for cystic fibrosis (CF). Copernicus' unique non-viral nanoparticle formulation is intended to deliver a normal copy of the CF gene to the affected airway cells of people with CF, and may eventually provide a long-term treatment for this disease.

Copernicus Presents Progress in the Development of its Non-Viral Gene Transfer Aerosol Product for Treating Patients with Cystic Fibrosis -- Minneapolis, MN - June 8, 2004
Copernicus Therapeutics, Inc. presented data at the 7th Annual Meeting of the American Society of Gene Therapy showing that compacted DNA nanoparticles can be successfully formulated as aerosol mists suitable for treating the lungs of cystic fibrosis (CF) patients, that compacted DNA can be repetitively dosed in animals without any fall off in effectiveness, and that there is no significant size limitation to the DNA drug payload its nanoparticle technology can deliver.

Copernicus Therapeutics, Inc. Receives Emerging Technology Award -- Cleveland, OH - October 22, 2003
Copernicus Therapeutics, Inc., a Cleveland company initially focused upon bringing a therapeutic to market for treating the root cause of cystic fibrosis, has been selected to receive the 2003 Emerging Technology Award, presented annually by the Ohio Department of Development (ODOD) through the office of Bob Taft, Governor and Bruce Johnson, Director. Copernicus is developing novel targeting and gene delivery systems with broad applications in human therapeutics and vaccines.

Use of Ubiquitin Promoter in Copernicus' Compacted DNA Nanoparticles Provides Prolonged, High Level Gene Expression after Intrapulmonary Administration -- Cleveland, OH - June 11, 2003
Copernicus Therapeutics, Inc. presented data at the 6th Annual Meeting of the American Society of Gene Therapy showing that incorporation of a ubiquitin promoter in the compacted DNA construct can generate sustained gene expression, superior to that of analogous compositions containing the CMV promoter. As determined by monitoring expression of a reporter gene in the lungs of animals, ubiquitin-controlled compacted DNA was expressed for many weeks longer than CMV-controlled compacted DNA. Prolonged DNA drug expression is preferred in order to maximize the efficiency of therapeutics for chronic lung disorders such as Cystic Fibrosis (CF).

Phase I/II Clinical Trial Shows Encouraging Results Using Copernicus' Non-Viral Gene Transfer System to Correct the Underlying Gene Defect in Cystic Fibrosis Subjects -- Cleveland, OH - June 11, 2003
Copernicus Therapeutics, Inc. presented data at the 6th Annual Meeting of the American Society of Gene Therapy showing that their compacted DNA formulation partially restored chloride channel function in the nasal epithelial cells of human subjects with cystic fibrosis (CF). No serious adverse events occurred in the trial demonstrating that the compacted DNA nanoparticles could be safely administered to the nares of CF subjects.

Cystic Fibrosis Gene Therapy Trial Results Encouraging -- Cleveland, OH - April 29, 2003
Scientists and physicians in Cleveland have announced encouraging results from the first-of-its-kind gene therapy trial involving cystic fibrosis (CF) patients and a new compacted DNA technology. The Phase I trial involving 12 patients was launched one year ago by University Hospitals of Cleveland (UHC), Case Western Reserve University (CWRU) School of Medicine, Children's Hospital of Denver, and Cystic Fibrosis Foundation Therapeutics, Inc., the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation.

Copernicus Receives Issued U.S. Patent for Methods to Formulate Highly Efficient Non-viral Gene Therapy Vectors
-- Cleveland, OH - January 17, 2003
Copernicus Therapeutics, Inc. announced that the United States Patent Office has issued US patent 6,506,890 entitled "Method of Nucleic Acid Compaction". Mark J. Cooper, M.D., Senior Vice President of Science and Medical Affairs said, "This highly reproducible method of formulating non-viral expression vectors results in stable compacted DNA nanoparticles that can be concentrated and stored for long periods of time. These non-viral DNA nanoparticles are able to transfect even non-dividing cells at high efficiency. Our recently completed Phase I/II clinical trial involving subjects with cystic fibrosis utilized DNA nanoparticles that were manufactured at Copernicus using this formulation method."

Copernicus Receives $2+ Million Financing -- Cleveland, OH - November 18, 2002
Copernicus Therapeutics, Inc. a Cleveland company developing novel targeting and gene delivery systems with broad applications in human therapeutics and vaccines, announced today that it has completed a first close of $2 million toward a private placement financing round of $2.5 million.

State of Ohio Awards Copernicus $1.08 Million Technology Action Fund Grant --Cleveland, OH - June 20, 2002
Copernicus Therapeutics, Inc. has received a grant from the State of Ohio to fund optimization of aerosols of its non-viral compacted DNA nanoparticles for intrapulmonary delivery. Mark J. Cooper, M.D., Senior Vice President of Science and Medical Affairs said, “We are very pleased to be recognized by the State of Ohio for our recent advances in formulating safe and effective DNA drugs for intrapulmonary delivery. Based on data in animals demonstrating that our DNA formulation was both safe and effective, we have recently initiated our first human clinical trial in subjects with cystic fibrosis.

Copernicus Non-Viral Gene Transfer System Corrects Chloride Channel Defect in Cystic Fibrosis (CF) Mice --Boston, MA - June 9, 2002
Copernicus Therapeutics, Inc. presented data at the American Society of Gene Therapy meeting showing that their compacted DNA formulation can successfully reconstitute the faulty chloride channel in airway epithelial cells in CF mice. Mark J. Cooper, M.D., Senior Vice President of Science and Medical Affairs said, “CF is a devastating disease of children and young adults that results in irreversible lung damage and ultimate respiratory failure. This disease, which affects more than 60,000 people in North America and Europe, is due to mutations in a gene that regulates salt transport in airway epithelial cells.

Copernicus Announces Breakthrough in Non-Viral Gene Transfer to the Lung --Boston, MA - June 9, 2002
Copernicus Therapeutics, Inc. presented data at the American Society of Gene Therapy meeting showing that their compacted DNA formulation can effectively transfect murine lung, establishing a robust DNA drug delivery platform for pulmonary and systemic diseases. Mark J. Cooper, M.D., Senior Vice President of Science and Medical Affairs said, “Our compacted DNA nanoparticles have been optimized to effectively deliver genes to pulmonary epithelial cells. Our pharmaceutical preparation of compacted DNA is extremely stable in serum and other biological fluids, and has an extended shelf-life at either 4oC or room temperature. The small size of our DNA particles facilitates transfer of the DNA payload into the nucleus of pulmonary epithelial cells.

Copernicus Non-Viral Gene Transfer System is Non-Toxic and Non-Immunogenic - Chronic Administration of DNA Drugs Is Feasible --Boston, MA - June 9, 2002
Copernicus Therapeutics, Inc. presented data at the American Society of Gene Therapy meeting showing that their compacted DNA formulation is non-toxic and non-inflammatory in mice following an intrapulmonary dose. Mark J. Cooper, M.D., Senior Vice President of Science and Medical Affairs said, “As part of our IND-directed studies, Copernicus has extensively evaluated our formulation of compacted DNA nanoparticles for safety and efficacy following an intrapulmonary dose. As also presented at the meeting, compacted DNA nanoparticles efficiently introduce DNA into airway epithelial cells. We now report that compacted DNA is non-toxic in out-sourced GLP toxicity studies.

Cystic Fibrosis Patient Receives First-of-its-Kind Gene Transfer - Trial Tackles Root of Gene Defect --Cleveland, OH - April 3, 2002
Copernicus Therapeutics, Inc., University Hospitals of Cleveland (UHC), Case Western Reserve University (CWRU) School of Medicine, and Cystic Fibrosis Foundation Therapeutics Inc. (CFFTI), a nonprofit affiliate of the Cystic Fibrosis Foundation, today announced that the first person in a 12 patient study has received a first-of-its-kind non-viral gene transfer vector in an effort to develop gene therapy for cystic fibrosis (CF). This study, being led by Dr. Michael Konstan, aims to use gene transfer technologies to provide a normal copy of the CF gene to correct the underlying defect. The mutations of this gene are the root cause of the disease. This trial is the first step in a long process toward developing a more effective therapy for individuals with CF.

Copernicus to Receive Nearly $1M from Cystic Fibrosis Foundation --Cleveland, OH - March 12, 2002
Money to Support Clinical Trials of Non-Viral Gene Transfer in Subjects with Cystic Fibrosis -- Copernicus Therapeutics, Inc. to receive up to $937,000 from the Cystic Fibrosis Foundation to advance the development of therapeutic treatments for Cystic Fibrosis (CF). Copernicus’ unique, non-viral approach to deliver the Cystic Fibrosis Transmembrane Regulator gene (CFTR) to the affected airway cells of CF patients may eventually provide a long-term treatment for this disease. To initiate the trials, the first subjects will receive Copernicus’ non-viral gene therapy in the next few weeks.

Copernicus Receives Issued U.S. Patent for In Vivo Use of High Efficiency Gene Therapy Vector in Humans --Cleveland, OH - January 17, 2002
Copernicus Therapeutics, Inc. announced that the United States Patent Office has issued Episomal Vector for Human Gene Therapy, US Patent Number 6,339,065. Mark J. Cooper, M.D., Senior Vice President of Science and Medical Affairs said, “This non-viral expression vector was designed to express therapeutic genes at very high levels in cancer patients. Since inadequate levels of gene expression likely limit the success of cancer gene therapy clinical trials, this vector may significantly improve the modest results generally observed.

Copernicus Reports Targeting of Liver Cells by Non-Viral Compacted DNA Complexes --Cleveland, OH - November 2, 2001
Copernicus Therapeutics, Inc. announced that the size and shape of compacted DNA particles markedly influences the efficiency of targeted gene transfer to liver cells. As reported in Journal of Biological Chemistry (276:34379-34387, 2001), “Biological Properties of Poly-L-lysine-DNA Complexes Generated by Cooperative Binding of the Polycation,” receptor-mediated uptake in hepatoma cells only occurs when compacted DNA particles are spherical and are smaller than 30 nm. Mark J. Cooper, M.D., Senior Vice President of Science and Medical Affairs said, “This manuscript provides a detailed correlation between the size and shape of compacted DNA complexes and successful targeting of liver cells expressing the asialoglycoprotein receptor.

Copernicus Receives Issued U.S. Patent For Peptide Therapeutics Targeted To Epithelial Cells --Cleveland, OH - October 10, 2001
Copernicus Therapeutics, Inc. announced that the United States Patent Office has issued Fusion Proteins for Protein Delivery, US Patent Number 6,287,817, to Case Western Reserve University. Copernicus has an exclusive license to this and other technology from CWRU scientist Dr. Pamela Davis. Mark J. Cooper, M.D., Senior Vice President of Science and Medical Affairs said, “This patent broadly covers a novel fusion protein technology that delivers proteins to the luminal surface of epithelial cells. The fusion protein consists of a single chain antibody fragment that targets any transcytotic receptor (including the polymeric immunoglobulin receptor) and any protein payload.

Copernicus Awarded PHASE I SBIR Grant From NIH to Support Development of a Needleless Treatment for Hemophilia B --Cleveland, OH - September 28, 2001
Copernicus Therapeutics, Inc. announced today that it has been awarded a Phase I SBIR grant from the National Heart, Lung, and Blood Institute to develop a novel therapeutic to treat patients with factor IX deficiency, or hemophilia B. Using Copernicus' non-viral gene transfer formulation, nanoparticles of DNA encoding human factor IX will be administered to animals as an inhaled mist.

Copernicus Receives Issued U.S. Patent For Automated Device That Produces Non-Viral Gene Therapy Vectors --Cleveland, OH - August 28, 2001
Copernicus Therapeutics, Inc. announced that the United States Patent Office has issued Automated Nucleic Acid Compaction Device, US Patent Number 6,281,005. Mark J. Cooper, M.D., Senior Vice President of Science and Medical Affairs said, “This patent provides very broad coverage for scale-up manufacture of compacted nucleic acids for gene therapy. Our non-viral formulation consists of single molecules of nucleic acid that are condensed to their minimal possible size using polycationic carriers. These compacted nucleic acid complexes have a diameter of approximately18-25 nm as visualized in electron micrographs, and are especially effective in transfecting post-mitotic, differentiated cells.

Copernicus Receives Issued U.S. Patent That Targets Small Molecules to Epithelial Cells --Cleveland, OH - July 26, 2001
Copernicus Therapeutics, Inc. announced that the United States Patent Office has issued Bifunctional Molecules for Delivery of Therapeutics, US Patent Number 6,261,787 to Case Western Reserve University (CWRU). Copernicus has an exclusive license to this and other related technologies from CWRU scientist Dr. Pamela Davis. Mark J. Cooper, M.D., Senior Vice President of Science and Medical Affairs said, “This patent broadly covers novel drug compositions that deliver therapeutic molecules to the luminal surface of epithelial cells.

Copernicus Announces Breakthrough in Non-Viral Gene Therapy --Seattle, WA - May 31, 2001
Copernicus Therapeutics, Inc. presented data at the American Society of Gene Therapy meeting showing that their compacted DNA formulation can effectively transfect non-dividing human cells, solving the problem of restricted access of plasmid DNA to the nucleus.

Copernicus Announces Issuance of Gene Targeting Patent --Cleveland, OH - December 19, 2000
Copernicus Therapeutics, Inc. announced that the United States Patent Office has issued Serpin Enzyme Complex Receptor (SECR)-Mediated Gene Transfer, US Patent Number 6,200,801. Mark Cooper, M.D., Senior Vice President of Science and Medical Affairs said, “This patent, issued to Case Western Reserve University and licensed exclusively by Copernicus, further expands our ability to target various tissues for DNA transfer by reciting composition claims for fusion proteins that consist of SECR targeting ligands and polycations capable of binding to DNA.

Copernicus Therapeutics, Inc. Announces the Signing of a Collaborative Research and Development Agreement with the Navy to Develop a Malaria DNA Vaccine Using Copernicus
PLASmin™ Complexes --Cleveland, OH - December 19, 2000
Copernicus Therapeutics, Inc. and the U.S. Naval Medical Research Center (NMRC) announced they have signed a Collaborative Research and Development Agreement (CRADA) to explore uses of Copernicus’ PLASmin™ Complexes in the development of a malaria DNA vaccine.

Copernicus Receives Milestone Payment from Cystic Fibrosis Foundation --Cleveland, OH - November 1, 2000
Copernicus Therapeutics, Inc. has received a milestone payment as part of a $1.5 million Phase II grant from the Cystic Fibrosis Foundation to advance the development of therapeutic treatments for Cystic Fibrosis (CF). Copernicus demonstrated in vitro the development of a non-viral gene delivery system (i) that contains a functional CFTR gene, and; (ii) that targets a receptor protein found on airway cells.

Copernicus Awarded Phase I SBIR Grant from CDC --Cleveland, OH - September 22, 2000
Copernicus Therapeutics, Inc. announced today that it has been awarded a Phase I SBIR grant from the Centers for Disease Control & Prevention to advance the development of DNA vaccines that can be applied topically, thus avoiding the need for painful injections. PLASmin™ Complexes will be formulated as an ointment or cream and will be applied topically to the skin.

Copernicus Awarded Phase I SBIR Grant from National Cancer Institute --Cleveland, OH - August 15, 2000
Copernicus Therapeutics, Inc. has been awarded a Phase I SBIR grant from the National Cancer Institute to advance the development of therapeutic gene therapy treatments for breast cancer, the Company announced today. The grant will support preclinical development of Copernicus’ REPLIsome™ Vectors that enable the delivery of therapeutic genes to target cells with subsequent amplification of transgene copy number, therefore increasing the magnitude and duration of transgene expression.

Copernicus Issued US Patent for Use of Compacted DNA in Humans --Cleveland, OH - June 27, 2000
Copernicus Therapeutics, Inc. announced that the United States Patent Office has issued Compacted Nucleic Acids and Their Delivery to Cells, US Patent Number 6,077,835, to Case Western Reserve University (CWRU). Copernicus has an exclusive license from CWRU to this and other technologies developed in the laboratory of CWRU scientist Dr. Richard Hanson.

Copernicus Issued US Patent Targets Proteins to Epithelial Cells --Cleveland, OH - June 16, 2000
Copernicus Therapeutics, Inc. announced that the United States Patent Office has issued Fusion Proteins for Protein Delivery, US Patent Number 6,072,041 to Case Western Reserve University (CWRU). Copernicus has an exclusive license to this and other technology from CWRU scientist Dr. Pamela Davis.

Copernicus Raises $3M in Series A-1 Financing --Cleveland, OH - April 13, 2000
Copernicus Therapeutics, Inc. announced that it has completed the private placement of $3,000,000 in new equity. The oversubscribed offering was accompanied by a restructuring of its debt. Robert C. Moen, M.D., Ph.D., President and COO of Copernicus, stated: “This debt restructuring and additional influx of funds presents the Company with the financial framework necessary to develop its technology further. The equity raised will enable the Company to develop corporate partnerships and prepare the Company to enter the clinic.” The equity was raised from existing investors, including the Edison Biotechnology Center Foundation.

Copernicus Announces Issuance of Gene Transfer Patent --Cleveland, OH - January 4, 2000
Copernicus Therapeutics, Inc. announced that the United States Patent Office has issued Patent Number 6,008,336: Compacted Nucleic Acids and Their Delivery to Cells. Mark J. Cooper, M.D., Senior Vice President of Science and Medical Affairs said, “This patent further expands our gene transfer technology by granting composition of matter claims for non-targeted complexes consisting of any nucleic acid and any carrier molecule that result in a compacted particle.