clinical trials bound

Houston biotech company gets green light from FDA to test coronavirus-fighting drug

Pulmotect is headed to clinical trials to verify how its drug fights against COVID-19. Getty Images

Houston biotech company Pulmotect Inc. has embarked on two clinical drug trials that could create weapons for the battle against the novel coronavirus.

Pulmotect gained permission from the U.S. Food and Drug Administration to test its inhaled drug, PUL-042, as a way to prevent coronavirus infections and to slow the early progression of COVID-19, the potentially fatal disease caused by the novel coronavirus. Pulmotect developed PUL-042 to activate the lungs' front-line defense against respiratory infections, and now it's being enlisted in the race to devise coronavirus treatments and cures.

"We have demonstrated PUL-042's unique ability to stimulate the immune system in the lungs to protect against a wide range of pathogens in multiple animal models," Dr. Colin Broom, CEO of Pulmotect, says in a May 7 release. "Pulmotect is optimistic that its immune-stimulating technology could be useful in mitigating the threats of [the coronavirus] and future emerging pathogens, and protecting vulnerable populations."

Unlike a vaccine, which typically takes 10 to 15 years to bring to the market, PUL-042 promises much faster deployment as scientists and health care workers wage war against COVID-19.

Each of the two clinical trials, both in the second phase, is being conducted at 10 sites across the U.S., including locations in Houston. In all, 20 sites are participating. Money for the trials came from the company's recently completed $12 million round of series B funding.

Pulmotect's partner in the trials is Covington, Kentucky-based CTI Clinical Trial and Consulting Services Inc. PARI Respiratory Equipment Inc., whose North American headquarters is in Midlothian, Virginia, is supplying medical equipment known as nebulizers to administer Pulmotect's inhaled drug.

"Both clinical trials are placebo-controlled to objectively evaluate safety and efficacy," Broom says in a May 5 release.

"In the first study, up to four doses of PUL-042 or placebo will be administered to 200 subjects by inhalation over a 10-day period to evaluate the prevention of infection and reduction in severity of COVID-19. In the second study, 100 patients with early symptoms of COVID-19 will receive the treatment administered up to three times over six days. In both trials, subjects will be followed up for 28 days to assess the effectiveness and tolerability of PUL-042."

Previous experiments conducted by Pulmotect indicate PUL-042 effectively protects mice against severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), which are caused by coronaviruses that differ from the COVID-19 virus. Researchers performed those tests at the University of Texas Medical Branch at Galveston.

PUL-042 initially was developed to fight respiratory problems in cancer patients undergoing chemotherapy, which weakens the immune system. But the drug offers the potential to prevent or treat an array of respiratory infections caused by viruses, bacteria, or fungi.

"We have always considered PUL-042 to have the potential for the prevention and treatment of emerging epidemics and pandemics like the one we currently face," Broom says.

A separate trial of PUL-042 is underway in London. There, the drug is being tested on patients with chronic obstructive pulmonary disease (COPD) who are susceptible to lung infections. COPD is an inflammatory disease that blocks airflow from the lungs. People with COPD face a heightened risk of conditions like heart disease and lung cancer, the Mayo Clinic says.

Researchers at MD Anderson Cancer Center and Texas A&M University invented Pulmotect's PUL-042, which holds patents in 10 countries. Pulmotect, founded in 2007, emerged from Houston's Fannin Innovation Studio, which fosters early stage companies in the life sciences sector.

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Building Houston

 
 

Here's your one-stop shop for innovation events in Houston this month. Photo via Getty Images

Houstonians are transitioning into a new summer month, and the city's business community is mixing in networking and conference events with family vacations and time off. Here's a rundown of what all to throw on your calendar for July when it comes to innovation-related events.

This article will be updated as more business and tech events are announced.

July 10 — Have a Nice Day Market at the Ion

Stop by for a one-of-a-kind vendor market - #HaveANiceDayHTX - taking place at the Ion, Houston's newest urban district and collaborative space that is designed to provide the city a place where entrepreneurial, corporate, and academic communities can come together. Free to attend and free parking onsite.

Have a Nice Day is a creative collective with a goal of celebrating BIPOC makers, creators, and causes.

The event is Sunday, July 10, 4 to 8 pm, at The Ion. Click here to register.

July 12 — One Houston Together Webinar Series

In the first installment of the Partnership's One Houston Together webinar series, we will discuss supplier diversity an often underutilized resource for business. What is it and why is it important? How can supplier diversity have long-term impact on your business, help strengthen your supply chain, and make a positive community impact?

The event is Tuesday, July 12, noon to 1 pm, online. Click here to register.

July 14 — Investor Speaker Series: Both Sides of the Coin

In the next installment of Greentown Labs' Investor Speaker Series, sit down with two Greentown founders and their investors as they talk about their experiences working together before, during, and after an equity investment was made in the company. Attendees will get a behind-the-scenes look at one of the most important relationships in a startup’s journey and what best practices both founders and investors can follow to keep things moving smoothly.

The event is Thursday, July 14, 1 to 2:30 pm, online. Click here to register.

July 15 — SBA Funding Fair

Mark Winchester, the Deputy District Director for the Houston District Office of the U.S. Small Business Administration, will give a short intro of the programs the mentors will discuss. There will be three government guaranteed loan mentors and two to three mentors co-mentoring with remote SBIR experts.

The event is Friday, July 15, 10:30 am to 1 pm, at The Cannon - West Houston. Click here to register.

July 16 — Bots and Bytes: Family STEAM Day

Join the Ion for a hands-on learning experience to learn about tech and robotics and gain insight into the professional skills and concepts needed to excel in a robotics or tech career. This event will be tailored for 9-14-year-olds for a fun STEM experience.

The event is Saturday, July 16, 10 am to 1 pm, at The Ion. Click here to register.

July 19 — How to Start a Startup

You have an idea...now what? Before you start looking for funding, it's important to make sure that your idea is both viable and valuable -- if it doesn't have a sound model and a market willing to pay for it, investors won't be interested anyway.

The event is Tuesday, July 19, 5:30 to 7:30 pm, at The Ion. Click here to register.

July 20 — Perfecting Your Pitch

Join the Ion for their series with DeckLaunch and Fresh Tech Solutionz as they discuss the importance and value of your pitch deck when reaching your target audience.

The event is Wednesday, July 20, 5:30 to 6:30 pm, at The Ion. Click here to register.

July 21 — Transition On Tap: Investor Readiness with Vinson & Elkins LLP

Attorneys from Greentown Labs’ Gigawatt Partner Vinson & Elkins LLP, a leading fund- and company-side advisor for clean energy financing, will present an overview of legal considerations in cleantech investing, geared especially toward early-stage companies and investors. The presentation will cover the types of investors and deals in the cleantech space and also provide background on negotiating valuation, term sheets, and preparing for diligence.

The event is Thursday, July 21, 5 to 7 pm, at Greentown Houston. Click here to register.

July 28 — The Cannon Community 2nd Annual Town Hall Event

Partner of The Cannon, Baker Tilly, has played an integral part in the success of Cannon member companies. Join the Cannon community for The Cannon's 5-year anniversary celebration!

The event is Thursday, July 28, 4 to 7 pm, at The Cannon - West Houston. Click here to register.

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