MONMOUTH JUNCTION, N.J. USA-September 23, 2009– MicroDose Therapeutx Inc. (formerly MicroDose Technologies) today announced that it has initiated a Phase I study at the University of Pittsburgh Medical Center with atropine sulfate delivered from the MicroDose proprietary dry powder inhaler (DPI). The study is a further step in the development program for an atropine inhaler to treat nerve agent poisoning in military and civil defense applications.  The program is being congressionally funded and managed through the Chemical Biological Medical Systems Joint Project Management Office to treat the symptoms, including bronchopulmonary, of mild to moderate organophosphorus poisoning after adequate amounts of injectable atropine have been administered.

The Phase 1 clinical trial is an open-label, active-controlled, crossover, safety study investigating the pharmacokinetics of atropine dry powder inhalation in 18 adult healthy subjects.  The trial compares multiple inhalations of an atropine dry powder with one dose of a commercially marketed atropine intramuscular injection.  The primary endpoint of the trial is the pharmacokinetic comparison between inhaled and intramuscular atropine over 12 hours.

This study represents the third U.S. clinical trial involving the MicroDose DPI to be initiated within the last 14 months.  The study is being conducted through a majority-owned subsidiary, MicroDose Defense Products, LLC.

“We are pleased to announce first patient dosing has taken place at the University of Pittsburgh with our advanced dry powder inhaler,” said Robert O. Cook, Ph.D., Senior Director, Product Commercialization Group, at MicroDose.  “While intramuscular injection of atropine is a recognized treatment for acute poisoning, the inhaled route offers a non-invasive alternative by delivering atropine directly to the lungs where local complications present, which may be more convenient when repeated dosings are required.”

Commenting from the University of Pittsburgh, Tim Corcoran, Ph.D., Principal Investigator of the project said, “We’re proud to partner with MicroDose to provide the Army with this technology.  It’s rare for us to work on medicines that we hope never get used, but it’s crucial that these tools be available if they are ever needed.”  Dr. Corcoran is Assistant Professor of Medicine and Bioengineering, Division of Pulmonary, Allergy, and Critical Care Medicine and an expert on inhaled medications and aerosols.

Chemical and biological agents pose a considerable threat to the warfighter and potentially to other military personnel and civilians.  The development of new antidote delivery systems is a crucial step in protecting personnel from these threats.  Dry powder drug delivery through inhalation provides a means of delivering drugs to the site of entry for aerosol agents but also offers access to the bloodstream that rivals the speed of injection.  The development of an inhaled atropine, a specific antidote for the treatment of poisoning from organophosphorus nerve agents, offers a new means for defending against the ominous threat of chemical weapons. If successfully clinically tested and approved, the MicroDose system is expected to allow more efficient administration of atropine than is available with existing drug-delivery technologies.

Additional study details are provided on the clinicaltrials.gov website: http://www.clinicaltrials.gov/ct2/show/NCT00947596?term=NCT00947596&rank=1

About MicroDose Therapeutx
MicroDose Therapeutx is dedicated to improving the quality of life for people suffering from serious diseases by creating improved pharmaceutical products.  The company is a leader in the application of proprietary drug delivery technologies, developing advanced pulmonary, combination oral dosage, and other technologies and products for the pharmaceutical and biotechnology industries.  More can be found at our website; www.mdtx.com.
About the MicroDose Dry Powder Inhaler (DPI)

The MicroDose DPI is among a number of key proprietary drug delivery technologies developed by MicroDose.  By employing piezo electronics, the MicroDose DPI has the potential to deliver enhanced performance as compared to other inhalers, offering efficient and reproducible delivery independent of patient coordination, inhalation rate and posture.  MicroDose believes that the flexibility of the inhaler makes it a true platform technology, able to support a broad pipeline of products across the spectrum of patient populations and therapeutic categories.

Contact: Scott Fleming, Senior V.P., Sales & Marketing at 732-355-2114 or sfleming@mdtx.com

Judith Fleischer, Ex Machina D x M, 908-469-0554 or jfleischer@exmachinadxm.com

PITTSBURGH, Oct. 13, 2003 – American troops may soon have a better line of defense against chemical weapons as a result of research beginning at the University of Pittsburgh School of Medicine.

The Division of Pulmonary, Allergy and Critical Care Medicine at the University of Pittsburgh School of Medicine has received a $1.52 million grant from the U.S. Department of Defense to co-develop a dry powder inhaler (DPI), which would administer an antidote for nerve agent poisoning. The system will allow more efficient self-administration of the drug atropine by American forces while under the care of military healthcare professionals.

The research will be conducted in collaboration with MicroDose Technologies, Inc., of Monmouth Junction, N.J., and will use MicroDose’s proprietary pulmonary delivery technology.

“Chemical and biological agents pose a considerable threat to American forces and potentially to other military personnel and civilians. The development of a new antidote delivery system is a crucial step in protecting personnel from these threats,” said Augustine Choi, M.D., chief of the Division of Pulmonary, Allergy and Critical Care Medicine at the University of Pittsburgh and principal investigator of the project.

“This grant will allow us to develop and test a new and improved method of protection from the effects of chemical warfare agents.”

The Army’s current inhaler technology depends on chlorofluorocarbons (CFCs), which are being phased out due to environmental concerns. The new drug delivery system contains no propellant and is based on  DPI technology developed by MicroDose.

“Our objective is to demonstrate that this new technology can improve the effectiveness of these antidotes by significantly reducing the time for the treatment to reach its peak concentration in the blood and by improving the reliability of the dose delivered to the soldier,” said Aldo Iacono, M.D., associate professor of medicine and surgery at the University of Pittsburgh School of Medicine, who has over ten years of experience in developing aerosol immunosuppressants for lung transplant recipients.

The MicroDose DPI technology uses a piezo vibrator, which converts electrical energy to mechanical motion that is then transferred into the dry powder. This vibration de-aggregates the powder forming an aerosol that directly deposits in the lungs when inhaled, where it dissolves and is absorbed into the bloodstream. By controlling the amplitude and frequency of the vibration, the DPI can be used for various compounds.

Atropine is a drug that has, among other uses, an ability to treat the effects of certain poisons and nerve agents such as tabun, sarin, soman, cyclosarin and VX. The current standard treatment for exposure to one of these agents includes intramuscular injection of atropine sulfate followed by an oxime using an autoinjector syringe. The initial research will focus on the development of a dry powder form of atropine including micronization, stability testing and development of a radioisotope-labeled form of the medication for use during studies.

“We believe that the use of a dry powder inhaler will result in more efficient delivery of the medication compared to the device the Army is using now. This should mean faster relief from the symptoms,” said Tim Corcoran, Ph.D., research assistant professor of medicine and bioengineering at the University of Pittsburgh. Dr. Corcoran is co-investigator in the project and a biomedical engineer with extensive experience in the development of aerosol drugs and aerosol drug delivery devices.

Inhaled medications have a long history of use in the treatment of respiratory diseases and the administration of medications to the bloodstream through the lungs has been successfully demonstrated in recent years. The surface area on the inside of the lungs is approximately 143 square-meters, approximately the same surface area as a tennis court, providing considerable access to the bloodstream. The blood interacts with the air spaces in the lungs through a boundary that is only 2 cell layers thick, allowing for the quick passage of inhaled medications into the bloodstream, according to Dr. Corcoran.

Also participating in the study is Frank Torok, M.D., an assistant professor of radiology at Pitt and a nuclear medicine physician. Dr. Torok’s duties include the administration of radioisotope medications and the interpretation of images generated by gamma cameras. “Gamma camera technology can be used along with radioactive forms of some medications to create a picture of where an inhaled aerosol deposits in the lungs. University of Pittsburgh investigators have previously used this technique to evaluate the effectiveness of inhaled medications,” Dr. Torok said. Recovery from nerve agent intoxication is a prolonged process requiring an extended period of hospitalization and therapy, which may include additional atropine administrated via an inhalation route under the supervision of medical professionals.

MicroDose Technologies, Inc., based in Monmouth Junction, N.J., is a privately held drug delivery company developing advanced pulmonary, solid oral dosage and needle-free transdermal products for the pharmaceutical industry. The MicroDose DPI is a handheld, low cost, breath-activated device, which makes novel use of piezo electronics to efficiently deliver a broad range of compounds independent of inhalation effort. The device is the first totally electronic DPI and represents the next generation in inhaler technology both in performance and ease of use.