MELBOURNE, Australia--(BUSINESS WIRE)--Aug 21, 2025--
SMSbiotech, a San Diego–based leader in regenerative medicine, today announced the initiation of its first-in-human Phase 1 clinical trial for Chronic Obstructive Pulmonary Disease (COPD). This milestone marks the transition of years of dedicated research into clinical development, with the goal of delivering a transformative therapy for millions living with this debilitating lung condition.
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On July 11, 2025, at Veritus Research in Melbourne, Australia, the first dose of SMSbiotech’s novel therapeutic candidate was administered to the inaugural patient. The Phase 1 study, titled “A study to investigate small mobile stem cells (SMS cells) in participants aged 39 to 69 years with chronic obstructive pulmonary disease,” will enroll 18 COPD patients. The trial is designed to evaluate the safety and preliminary efficacy of SMSbiotech’s Small Mobile Stem (SMS) cells —a unique, healthy, adult blood-derived cell population discovered and named by SMSbiotech.
Unlike traditional treatments, SMS cells are designed to regenerate damaged lung tissue. The off-the-shelf, non-invasive therapy is administered directly to the lungs through a nebulizer. Preclinical studies demonstrated significant restoration of lung function in as little as 10 days. The study duration is expected to be 15 months.
“The initiation of our Phase 1 trial for COPD is a profound moment for SMSbiotech and, more importantly, for the millions of patients yearning for better treatment options,” said Dr. Abdulkader Rahmo, President of SMSbiotech. “We are also encouraged to report that the first two sentinel patients have been dosed, initial safety data has been received, and the trial can now move forward—an important validation step as we continue this study. We are immensely optimistic about the potential of our Small Mobile Stem cell therapy to not only manage COPD symptoms but to fundamentally alter the disease’s progression and potentially reverse its devastating effects. We believe this represents a new dawn for respiratory medicine, offering the promise of a future where patients can breathe easier and live fuller lives.”
The trial received regulatory approval from the Therapeutic Goods Administration (TGA), Australia’s regulatory authority equivalent to the U.S. Food and Drug Administration (FDA).
SMSbiotech has filed 16 patents and received 7 granted patents for its technology. Pending sufficient safety data from this trial, the company plans to evaluate compassionate use applications. Encouraged by promising preclinical data, SMSbiotech is also investigating applications in orthopedics and other therapeutic areas.
For more information about this clinical trial, please visit the Australian New Zealand Clinical Trials Registry at: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12624001140549p.
Inquiries about study participation:
Veritus Research
Phone: +61 03 8736 1750
Email: info@veritusresearch.com
About SMSbiotech
SMSbiotech is a regenerative medicine company dedicated to advancing breakthrough therapies that restore tissue function and transform patient care. Leveraging its proprietary Small Mobile Stem (SMS) cell technology, SMSbiotech is focused on developing novel treatments for COPD and other debilitating diseases.
Dr. Abdulkader Rahmo
WASHINGTON (AP) — Venezuelan opposition leader María Corina Machado discussed her country's future with President Donald Trump at the White House on Thursday, even though he has dismissed her credibility to take over after an audacious U.S. military raid captured then-President Nicolás Maduro.
Trump has raised doubts about his stated commitment to backing democratic rule in Venezuela and signaled his willingness to work with acting President Delcy Rodríguez, who was Maduro’s No. 2. Along with others in the deposed leader’s inner circle, Rodríguez remains in charge of day-to-day government operations and was set to deliver her first state of the union speech Thursday.
In endorsing Rodríguez so far, Trump has sidelined Machado, who has long been a face of resistance in Venezuela. She also had sought to cultivate relationships with Trump and key administration voices like Secretary of State Marco Rubio among the American right wing in a gamble to ally herself with the U.S. government.
White House press secretary Karoline Leavitt said Trump had been looking forward to the lunchtime meeting with Machado and called her “a remarkable and brave voice” for the people of Venezuela. But Leavitt also said Trump's opinion of Machado had not changed, calling it "a realistic assessment."
Trump has said it would be difficult for Machado to lead because she “doesn’t have the support within or the respect within the country.” Her party is widely believed to have won 2024 elections rejected by Maduro.
Leavitt went on to say that Trump supported new Venezuelan elections “when the time is right” but did not say when he thought that might be.
Leavitt said Machado sought the face-to-face meeting without setting expectations for what would occur. Machado previously offered to share with Trump the Nobel Peace Prize she won last year, an honor he has coveted.
“I don’t think he needs to hear anything from Ms. Machado," the press secretary said, other than to have a ”frank and positive discussion about what’s taking place in Venezuela.”
Machado spent about two and a half hours at the White House but left without answering questions on whether she'd offered to give her Nobel prize to Trump, saying only “gracias."
After her White House stop, Machado plans to have a meeting at the Senate. Her Washington visit began after U.S. forces in the Caribbean Sea seized another sanctioned oil tanker that the Trump administration says had ties to Venezuela.
It is part of a broader U.S. effort to take control of the South American country’s oil after U.S. forces seized Maduro and his wife at a heavily guarded compound in the Venezuelan capital of Caracas and brought them to New York to stand trial on drug trafficking charges.
Leavitt said Venezuela's interim authorities have been fully cooperating with the Trump administration and that Rodríguez's government said it planned to release more prisoners detained under Maduro. Among those released were five Americans this week.
Rodríguez has adopted a less strident position toward Trump then she did immediately after Maduro's ouster, suggesting that she can make the Republican administration's “America First” policies toward the Western Hemisphere, work for Venezuela — at least for now.
Trump said Wednesday that he had a “great conversation” with Rodríguez, their first since Maduro was ousted.
“We had a call, a long call. We discussed a lot of things,” Trump said during an Oval Office bill signing. “And I think we’re getting along very well with Venezuela.”
Even before indicating the willingness to work with Venezuela's interim government, Trump was quick to snub Machado. Just hours after Maduro's capture, Trump said of Machado that “it would be very tough for her to be the leader.”
Machado has steered a careful course to avoid offending Trump, notably after winning the peace prize. She has since thanked Trump, though her offer to share the honor with him was rejected by the Nobel Institute.
Machado’s whereabouts have been largely unknown since she went into hiding early last year after being briefly detained in Caracas. She briefly reappeared in Oslo, Norway, in December after her daughter received the Nobel Peace Prize on her behalf.
The industrial engineer and daughter of a steel magnate began challenging the ruling party in 2004, when the nongovernmental organization she co-founded, Súmate, promoted a referendum to recall then-President Hugo Chávez. The initiative failed, and Machado and other Súmate executives were charged with conspiracy.
A year later, she drew the anger of Chávez and his allies again for traveling to Washington to meet President George W. Bush. A photo showing her shaking hands with Bush in the Oval Office lives in the collective memory. Chávez considered Bush an adversary.
Almost two decades later, she marshaled millions of Venezuelans to reject Chávez’s successor, Maduro, for another term in the 2024 election. But ruling party-loyal electoral authorities declared him the winner despite ample credible evidence to the contrary. Ensuing anti-government protests ended in a brutal crackdown by state security forces.
Garcia Cano reported from Caracas, Venezuela, and Janetsky from Mexico City. AP Diplomatic Writer Matthew Lee in Washington contributed to this report.
Venezuelan opposition leader María Corina Machado gestures to supporters on Pennsylvania Avenue as she leaves the White House after meeting with President Donald Trump Thursday, Jan. 15, 2026, in Washington. (AP Photo/Pablo Martinez Monsivais)
Venezuelan opposition leader María Corina Machado waves to supporters on Pennsylvania Avenue as she leaves the White House after meeting with President Donald Trump Thursday, Jan. 15, 2026, in Washington. (AP Photo/Pablo Martinez Monsivais)
Venezuelan opposition leader María Corina Machado smiles on Pennsylvania Avenue as she leaves the White House after meeting with President Donald Trump Thursday, Jan. 15, 2026, in Washington. (AP Photo/Pablo Martinez Monsivais)
Venezuelan opposition leader María Corina Machado waves to supporters on Pennsylvania Avenue as she leaves the White House after meeting with President Donald Trump Thursday, Jan. 15, 2026, in Washington. (AP Photo/Pablo Martinez Monsivais)
FILE - U.S. President George Bush, right, meets with Maria Corina Machado, executive director of Sumate, a non-governmental organization that defends Venezuelan citizens' political rights, in the Oval Office of the White House, Washington, May 31, 2005. (AP Photo/Charles Dharapak, File)
FILE - Opposition leader Maria Corina Machado gestures to supporters during a protest against President Nicolas Maduro the day before his inauguration for a third term, in Caracas, Venezuela, Thursday, Jan. 9, 2025. (AP Photo/Ariana Cubillos, file)
