Houston-based clinical stage biotech company, Pulmotect, has announced that they have successfully completed a phase I clinical trial for PUL-042, their experimental drug for the prevention and treatment of respiratory infections. The completion of the trial also means that the company will now receive the last $3.5 million dollar tranche of funding granted by the Cancer Prevention Research Institute of Texas (CPRIT), and is now ready to begin the next phase of development of the drug.
The phase 1 study was a randomized, double-blind, placebo-controlled, single ascending dose clinical trial, which was conducted on healthy individuals at the ICON plc clinical site in San Antonio, Texas, and in collaboration with the Texas A&M Health Science Center and the University of Texas MD Anderson Cancer Center. The purpose of the study was to evaluate the safety and tolerability of the drug, in order to support further developments of PUL-042.
“We are very excited to see this technology advancing into the next phase of development and getting closer to helping those that receive sub-optimal cancer treatment due to the risk of pneumonia due to myleosuppression,” said the President of Pulmotect, Inc., Brenton Scott. “Overall there is a significant need to reduce the incidence of respiratory infections in cancer patients, asthmatics and the general population. PUL-042 has tremendous potential to impact the effects of respiratory infections in multiple circumstances.”
Pulmotect’s research and development project has received funding from the state through CPRIT in recognition of the company consistently reaching key milestones on time and within the established budget. The last tranche of the grants from CPRIT will be used in the further development of the drug, as well as in the search for new market partners. In addition, the company has recently been awarded a $1M Small Business Innovative Research (SBIR) grant for its phase II study to examine the use of the drug in preventing asthma attacks, as well as a $250K Phase I SBIR award to optimize treating influenza.
“We are very pleased by not only the clinical results but also the position the Company is now in to execute on its long-term objectives as we drive PUL-042, our immune modulation drug, through the clinical trial process,” said Leo Linbeck III, Chairman of the Board.
The inhalation therapy is expected to stimulate the lungs and its immune system, improving the body’s defenses against respiratory infections. Even though PUL-042 is recommended mainly for the prevention of opportunistic pneumonia in cancer patients who have been immunocompromised by their chemotherapy treatment, it may also be able to help in biodefense, prevention and treatment of seasonal and pandemic influenza, and other respiratory infections, like asthma, COPD, and Cystic Fibrosis.
The company is now planning on continuing the trials, including conducting a repeat dosing study to assess use of the inhalation drug with patients who suffered from cancer and are at risk of developing pneumonia due to the cancer treatments.