Hemiplegia

Rhenium (186Re) Obisbemeda delivered by convection enhanced delivery (CED) continues to show safety, response, and potential efficacy Mean Phase 2 absorbed dose was 300 Gy and 89% of patients exceeded the minimal dose threshold of 100 Gy ReSPECT-GBM Phase 1/2 trial has expanded to two new sites at leading U.S. academic medical centers in New York and Upper Midwest AUSTIN, Texas, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers presented an update on the ongoing ReSPECT-GBM Phase 1/2 clinical trial, evaluating the Company’s lead asset Rhenium (186Re) Obisbemeda for the treatment of recurrent glioblastoma. The data were presented at the 2024 Congress of Neurological Surgeons (CNS) Annual Meeting on September 30, 2024, in Houston, Texas. The presentation, titled “Treatment of Recurrent Glioblastoma (rGBM) via Convection Enhanced Delivery (CED) with Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL): ReSPECT-GBM Phase 1/2 Trial Update” was delivered by lead investigator and neurosurgeon John Floyd, M.D., Associate Professor and Chair of the Department of Neurosurgery at the University of Texas Health Science Center San Antonio. The data highlights the continued favorable safety profile and encouraging efficacy results of Rhenium (186Re) Obisbemeda in a patient population with historically poor prognosis. “The ReSPECT-GBM Phase 1/2 trial continues to reinforce the safety signal and potential efficacy of Rhenium (186Re) Obisbemeda in patients with recurrent glioblastoma,” said John Floyd, M.D. “These updated results, particularly the encouraging safety profile and overall survival rates, support the advancement of Rhenium (186Re) Obisbemeda as a promising therapeutic option for this aggressive cancer, and we are currently open and enrolling in our Phase 2 study.” ReSPECT-GBM is a first-in-human, open-label, Phase 1/2 study investigating feasibility, dose escalation, and critical convection enhanced delivery (CED) parameters to determine the maximum tolerated dose (MTD), maximum feasible dose (MFD), safety, and potential efficacy of Rhenium (186Re) Obisbemeda in recurrent adult glioma (IND 116117). Key Highlights from the ReSPECT-GBM Phase 1/2 Trial Update: 42 total patients have enrolled thus far at 3 sites and with 19/42 patients having been treated to date at the recommended Phase 2 dose (22.3 mCi in 8.8 mL) in tumors of approximately 20 cm3 or lessAll Phase 2 patients have recurrent, histologically confirmed glioblastoma; 1 recurrence, bevacizumab naïve, single tumor of approximately 20 cm3 or less (small-to-medium sized tumors)Average tumor size in Phase 2 was 7.5 mL (range 0.9-22.8 mL)Increases in absorbed dose correlated with specific drug delivery parameters such as infused dose and volume, maximal convection flow rate, and number of cathetersRhenium (186Re) Obisbemeda continues to show a favorable safety profile in the 42 enrolled patients; one dose-limiting toxicity (hemiplegia) has been reported, which was observed in Cohort 8 (41.5 mCi and 16.3 mL)In Phase 2, most adverse events (AEs) were mild (73.5%) or moderate (18.8%), and largely unrelated (37.7%), or unlikely related (27.1%) to the drug. Of the 9 severe adverse events (SAEs), only 2 were related to the study drugAverage absorbed radiation dose to the tumor in Phase 2 was 300 Gy (n=18, 1 patient still under analysis)To date, 88.9% of Phase 2 patients met key CED drug delivery parameters shown to correlate with overall survival, achieving a tumor absorbed dose >100 Gy and radiation coverage of >70%29/42 patients treated thus far participated in the Phase 1 dose escalation phase of the trial (Note: as per protocol, 6/42 patients were included in both the Phase 1 and Phase 2 trial arms and related analyses)Phase 1 dose-escalation increased administered doses from 1.0 mCi to 41.5 mCi and volumes from 0.66 mL to 16.3 mLIn terms of objective tumor response based on quantitative image analysis, a statistically significant reduction in tumor volume rate change was seen in tumors receiving > 100 Gy absorbed dose (n=11 patients analyzed to date, p<0.005). Sufficient tumor coverage correlated with tumor control, while regrowth occurred outside treated areas "As presented at CNS by Dr. Floyd, who has helped pioneer this therapy, the ReSPECT-GBM trial continues to show promising feasibility, safety, response, and potential efficacy," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Furthermore, the addition of new clinical trial sites, including North Shore University in New York and Ohio State University in the Upper Midwest, should help us complete both the Phase 1 and Phase 2 arms in the near term." Full details of the presentation can be found here. The ReSPECT-GBM trial is actively enrolling patients; additional information about the ReSPECT-GBM trial can be found here. About Glioblastoma (GBM) GBM affects approximately 15,000 patients annually in the U.S. and is the most common and lethal form of brain cancer. The average life expectancy with GBM is less than 24 months, with a one-year survival rate of 40% and a five-year survival rate of around 5%. There is no clear standard of care for recurrent GBM, and the few currently approved treatments provide only marginal survival benefit and are associated with significant side effects, which limit dosing and prolonged use. Approximately 90% of patients experience GBM tumor recurrence at or near the original tumor location, yet there are no FDA-approved treatments in the recurrent or progressive setting that can significantly extend a patient’s life. About Rhenium (186Re) Obisbemeda Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) Obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) Obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). About Convection Enhanced Delivery Convection Enhanced Delivery (CED) is a therapeutic strategy that was developed to facilitate targeted delivery of pharmaceuticals to the brain. The CED procedure involves a minimally invasive surgical exposure of the brain, followed by placement of small diameter catheters directly into the brain tumor. About Plus TherapeuticsPlus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/. Cautionary Statement Regarding Forward-Looking StatementsThis presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of Rhenium (186Re) Obisbemeda including the ability of Rhenium (186Re) Obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC, clinical trials; possible negative effects of Rhenium (186Re) Obisbemeda; the continued evaluation of Rhenium (186Re) Obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so. Investor ContactCharles Y. Huang, MBADirector of Capital Markets and Investor RelationsOffice: (202)-209-5751 | Direct (301)-728-7222chuang@plustherapeutics.com

The collaboration will allow for a more rapid and efficient approach to the identification and pre-clinical evaluation of potential drug candidates across multiple diseases to advance into clinical testing. BOSTON and BAR HARBOR, Maine, Sept. 17, 2024 /PRNewswire/ -- Unravel Biosciences, Inc., ("Unravel"), an AI-enabled therapeutics company spun out of Harvard University to advance drugs for complex diseases and The Jackson Laboratory (JAX), a pioneer in the discovery of precise genomic solutions for disease, today announced the initiation of a collaboration to expedite and efficiently identify promising drug candidates for clinical development. Unravel will utilize their proprietary BioNAV™ drug discovery platform and JAX's extensive expertise in pre-clinical disease modeling to identify potential drugs and novel drug targets across multiple diseases. The collaboration will prioritize already approved drugs that have the potential to be repurposed for other diseases, facilitating rapid clinical translation and near-term beneficial impact to patients. "We are thrilled to collaborate with JAX on this key multi-program effort to efficiently tackle multiple rare disorders," said Richard Novak, Ph.D., Unravel Co-Founder and CEO. "By seamlessly iterating between preclinical models and advanced computational analyses of multimodal datasets, we are revolutionizing the time, cost, and risk of drug discovery to enable rapid clinical translation and derisking for patients in need." The first disease to be studied in the collaboration will be Alternating Hemiplegia of Childhood (AHC), a rare neurodevelopmental disorder characterized by repeated episodes of weakness or paralysis leading to hemiplegia or quadriplegia. AHC is estimated to occur in approximately 1 in 1,000,000 births and is caused by mutations in the ATP1A3 gene. Unravel will generate RNASeq data from JAX's ATP1A3 disease relevant mouse models and analyze the data using Unravel's BioNAV™ platform to generate in silico hits of promising therapeutic candidates. These drug candidates will then be evaluated in JAX's pre-clinical models for efficacy as well as to inform dose selection for clinical testing. "Our collaboration with Unravel Biosciences is deeply meaningful for the patients and foundations we serve," said Cat Lutz, Ph.D., MBA, vice president of the Rare Disease Translational Center at JAX. "Validating Unravel's leads in our patient-specific mouse models has the potential to provide immediate benefits to patients and pave the way for future targeted genetic therapies. We also believe linking our scientific resources creates more seamless navigation for patients and families." While it is expected that rare disease foundations will drive much of the initial demand for research under the collaboration, this innovative drug discovery work is also anticipated to generate interest by biotechnology and pharmaceutical companies to support their drug development programs, as well as for use by Unravel and JAX to accelerate development of their own proprietary assets. About Unravel Biosciences Unravel Biosciences is the first rapid prototyping therapeutics company, integrating AI systems biology computation with rapid in vivo screening and clinical validation of discovered targets with unprecedented efficiency. Unravel leverages its proprietary BioNAV™ platform combining target and drug discovery, preclinical screening and patient stratification to find treatments for complex diseases. Unravel's platform has led to four clinical trials starting in 2024. Unravel's platform developed RVL002, a first-in-class new small molecule targeting mitochondrial metabolism, and RVL027, a molecule targeting a novel mechanism to treat dystonias. The rareSHIFT™ program provides platform access to foundation and biotech partners to accelerate and clinically derisk therapeutics. and About The Jackson Laboratory The Jackson Laboratory is an independent, nonprofit biomedical research institution with a National Cancer Institute-designated Cancer Center and more than 3,000 employees in locations across the United States, Japan and China. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health. For more information, please visit . SOURCE Unravel Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ADA, Okla., May 20, 2024 /PRNewswire/ -- Dillion Kirkland is a 31-year-old Mercy emergency medical technician who works with life-threatening injuries and illnesses every day. Last October, he found himself on the receiving end of care when he was taken to the emergency department by his own co-workers after he experienced a stroke. May is American Stroke Month and this week is National EMS Week, making Kirkland's story important and reinforcing stroke awareness and treatment through in-person and virtual care. For his complete story and video, click here. Continue Reading "I'm 31, I can't be having a stroke. Even with all my training and experience, I couldn't process what was happening." Post this Kirkland was in the driver's seat of an ambulance after a routine patient transfer when he started feeling strange. He asked his partner, Brian Ridgway, to take the wheel. But after arriving back in Ada, Oklahoma, his symptoms continued to worsen. Kirkland's paramedic partner recognized something was seriously wrong and loaded him up in his own ambulance and took him straight to the ER. "Brian told me, 'I think you're having a stroke,' but I thought, 'I'm 31, I can't be having a stroke,'" said Kirkland. "Even with all my training and experience, I couldn't process what was happening. It progressed to where I couldn't speak, I couldn't formulate a sentence, everything was garbled and delayed. What I wanted to say in my brain just wouldn't come out of my mouth." According to the Centers for Disease Control and Prevention, someone experiences a stroke every 40 seconds in the United States, and stroke remains one of the leading causes of death and long-term disability. While stroke risk increases with age, a stroke can occur at any age. After Kirkland arrived in the Mercy Hospital Ada emergency department, he was evaluated and connected with a Mercy Virtual neurologist. Sensing the urgency of the situation, the virtual neurologist rushed the local team to administer a beta-blocker to lower blood pressure and a clot-dissolving stroke medication called Tenecteplase (TNK). "Our team quickly evaluated Dillion and gave him the medication he needed," said Dr. Advait Mahulikar, a member of Kirkland's virtual neurology team. "The quick actions and assessment of our team combined with clot-busting medication helped prevent the worsening of symptoms that could have potentially become disabling, especially at such a young age." Mercy Virtual has a team of neurologists who provide care 24/7 to 31 Mercy facilities across four states. Depending on a hospital's needs, Mercy Virtual supplements in-person neurology care or provides full neurology coverage for many rural hospitals unable to staff full-time physicians. This allows the local team to work collaboratively at a patient's bedside without spending extra time transporting them to larger trauma centers. "Virtual care has literally changed the lives of thousands of patients by providing access to a neurologist when it matters most during a time-sensitive diagnosis like stroke," said Dr. Meghan Rodden, physician lead of Mercy Virtual stroke care. "Time is brain, and a typical patient can lose 1.9 million neurons each minute a stroke is untreated. That is why it's essential that our virtual neurologists do a combination of bedside and virtual work so some of our smaller facilities can get access to the specialized care they need faster." With the help of his in-person and virtual care team, Kirkland's story has a happy ending. "After the TNK medication was administered, my symptoms were resolved within 30 minutes, and I've fully recovered with no deficits to this day," he said. "TNK was actually a relatively new standard of stroke care. It was something we had recently discussed as an EMS team, but I had yet to see it in action, so it was scary to try it myself firsthand. I'm a firm believer in TNK now." While Kirkland didn't have the typical stroke symptoms of one-sided weakness, he had overall coordination loss, garbled speech and an extremely elevated blood pressure. Mercy recommends the acronym B.E.F.A.S.T. if someone is believed to be having a stroke. B – Balance: Does the person complain of sudden dizziness or difficulty walking? E – Eyes: Does the person complain of blurred vision, seeing dark or bright spots? F – Face: Ask the person to smile. Is the smile even or lop-sided? A – Arms: Ask the person to raise both arms. Does one arm drift downward? S – Speech: Ask the person to repeat a simple phrase. Is the speech slurred or strange? T – Time: If you see any of these signs, call 9-1-1 right away and note the time. Observers should record the time when any symptoms first appear to help health professionals plan the best treatment and minimize long-term stroke damage. Kirkland is back at work saving lives, but he hopes sharing his story will help spread awareness. "Knowing the signs is important for everyone and can make a big difference in recovery or even between life and death," Kirkland said. "When in doubt, call 9-1-1 and seek medical attention." About Mercy Mercy, one of the 20 largest U.S. health systems and named the top large system in the U.S. for excellent patient experience by NRC Health, serves millions annually with nationally recognized care and one of the nation's largest and highest performing Accountable Care Organizations in quality and cost. Mercy is a highly integrated, multi-state health care system including more than 50 acute care and specialty (heart, children's, orthopedic and rehab) hospitals, convenient and urgent care locations, imaging centers and pharmacies. Mercy has over 900 physician practice locations and outpatient facilities, more than 4,500 physicians and advanced practitioners and 50,000 co-workers serving patients and families across Arkansas, Kansas, Missouri and Oklahoma. Mercy also has clinics, outpatient services and outreach ministries in Arkansas, Louisiana, Mississippi and Texas. In fiscal year 2023 alone, Mercy provided more than half a billion dollars of free care and other community benefits, including traditional charity care and unreimbursed Medicaid. SOURCE Mercy