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Yahoo
15-05-2025
- Business
- Yahoo
Shuttle Pharma Provides Corporate Update
GAITHERSBURG, Md., May 15, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ('Shuttle Pharma' or the 'Company'), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update. Shuttle Pharma's recent highlights: Phase 2 clinical trial of Ropidoxuridine for treatment of patients with glioblastoma highlights include: Patient enrollment nears milestone as nearly 50% enrollment has been achieved in the initial randomized portion of the trial. 84% of the enrolled patients have completed all seven cycles. Ropidoxuridine is being reported as well tolerated by treatment sites and toxicity is no greater than 2 on a scale of 1-5. Analyzing pharmacokinetic/pharmacodynamic samples to compare the relationship between dose and response in terms of the extent and duration of Ropidoxuridine's action has begun. Enrollment continues at nationally recognized cancer centers, including Georgetown University Medical Center, Allegheny Health Network (AHN) Cancer Institute, UNC Medical Center, the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, and Miami Cancer Institute, part of Baptist Health South Florida. Objective is to finalize enrollment later this year with follow up and data read out in 2026. Other key activities include: Continued advancement of the Company's Diagnostics subsidiary through the entry of a sponsored research agreement with the University of California, San Francisco (UCSF) to advance pre-clinical development of a ligand to the prostate-specific membrane antigen (PSMA) as a potential diagnostic and therapeutic, or theranostic, molecule. Theranostic molecules are suitable for diagnosis and therapy of cancers. Filed a key provisional patent application with the United States Patent and Trademark Office (USPTO) entitled 'PSMA-Targeted PARP Inhibitor Conjugates for Precision Cancer Therapy.' The filing comes through Shuttle Pharma's collaboration with internationally renowned medicinal chemist, Dr. Alan Kozikowski. Dr. Kozikowski's original medicinal chemistry research performed in collaboration with Professor Joseph Neale and conducted at Georgetown University Medical Center were a component in the creation of both Pylarify and Pluvitco. Appointed three new members to the Company's board of directors (George Scorsis, Oleh Nabyt and Joseph Tung), offering business and legal backgrounds to help guide the Company going forward. Strengthened the Company's balance sheet through the completion of an underwritten public offering. Cash and cash equivalents at March 31, 2025 were $4.5 million. 'We are thrilled with the progress of our Phase 2 clinical trial for Ropidoxuridine in treating glioblastoma, a devastating brain cancer,' commented Shuttle Pharma's interim Chief Executive Officer, Chris Cooper. 'With nearly 50% of patient enrollment achieved in the initial randomized portion and 84% of enrolled patients completing all seven cycles, the trial is advancing steadily at esteemed cancer centers. Ropidoxuridine has been well-tolerated and we have begun analyzing pharmacokinetic and pharmacodynamic samples to optimize dosing and response. Our goal is to complete enrollment later this year, with follow-up and data readouts anticipated in 2026.' "In parallel, Shuttle Pharma is making significant strides in our Diagnostics subsidiary through a sponsored research agreement with UCSF to develop a PSMA-targeted ligand for potential theranostic applications in prostate cancer. We've also filed a provisional patent for 'PSMA-Targeted PARP Inhibitor Conjugates for Precision Cancer Therapy,' in collaboration with Dr. Alan Kozikowski, an internationally renowned medicinal chemist. Additionally, we have enhanced our business focus through the addition of new board members and a strengthened balance sheet through our recent public offering. These actions help prepare us for the accelerated achievement of key milestones in the future.' On Friday, May 9, 2025, Dr. Anatoly Dritschilo announced his resignation from the Company's Board of Directors and as Chief Scientific Officer. Additionally, Michael Vander Hoek, the Company's Vice President, Regulatory, announced his retirement with an effective date of June 10, 2025. 'Finally, I want to thank Dr. Dritschilo and Michael Vander Hoek for their many contributions to Shuttle Pharma since its inception. We look forward to building off the work completed to date to bring us closer to offering hope for patients battling this aggressive disease," Mr. Cooper concluded. About Shuttle Pharmaceuticals Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharma is a discovery and development stage specialty pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination with surgery, chemotherapy and immunotherapy. For more information, please visit our website at Safe Harbor Statement Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements.' These statements include, but are not limited to, statements concerning the development of our company. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the 'Risk Factors' section of Shuttle Pharma's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 26, 2025, as well other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, Shuttle Pharmaceuticals specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Shuttle PharmaceuticalsChris CooperChief Executive Officerinfo@ Investor ContactsLytham Partners, LLCRobert Blum602-889-9700shph@
Boston Globe
30-01-2025
- Health
- Boston Globe
FDA approves Journavx, new non-opioid painkiller from Vertex: ‘An important public health milestone'
In two late-stage trials of patients who underwent tummy tuck surgery or removal of a bunion, Journavx led to a 50 percent reduction in pain, Vertex said. It acted faster than a placebo and with fewer side effects than a pill that combined acetaminophen and the opioid hydrocodone, the active ingredients in Vicodin. Advertisement Significantly, Journavx didn't provide better pain relief than the opioid combination in one of the trials and was inferior to the combination in the other trial. Nonetheless, Vertex executives say Journavx's ability to soothe pain without the risk of addiction will likely make it a blockbuster, a drug that generates sales of at least $1 billion a year. 'We think this is the sort of product that, frankly, physicians and patients have been waiting for,' said Stuart Arbuckle, Vertex's chief operating officer. The most common side effects in patients who received Journavx in the clinical trials included itching, muscle spasms, and rashes. The approval comes as the nation continues to grapple with a decades-old opioid crisis. More than 81,000 people died of opioid overdoses in the United States in 2023, according to the National Center for Health Statistics. Doctors prescribe opioids for acute pain to 40 million Americans a year, and about 85,000 of them develop opioid use disorder, according to Vertex. The company has also tested Journavx as a treatment for chronic pain, a bigger market than acute pain, but the results of clinical trials so far have been underwhelming. Advertisement Dr. Jessica McCoun, an Atlanta-based anesthesiologist and principal investigator in the trials, said she considers the new Vertex drug 'a very big tool in the toolbox' for treating pain. 'The more tools we have that we can combine together to treat a patient effectively ... That's the best we can do,' she said. A bottle of Journavx Courtesy of Vertex Among the patients who received Journavx in the clinical trials was a 50-year-old woman from the Atlanta area. She had a nose job in October 2023 and began taking the pill immediately afterward in a third Vertex trial for people who underwent a variety of surgeries. The woman, who only wanted to be identified by her first name, Samantha, because of the sensitivity of the subject, said she took Journavx for four days. She never felt any pain, she said, even though her operation was a 'pretty severe reconstruction.' 'For the level of pain I should have been in, this medicine was very, very effective,' she said. 'I think it's spectacular.' Some experts were more cautious in their assessments. Dr. Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University Medical Center, welcomed the FDA approval. But she contended it was premature to declare that Journavx posed no risk for addiction, saying it wasn't tested long enough in clinical trials. 'It's definitely a promising painkiller, but I haven't seen studies that lasted longer than a couple of weeks in humans,' said Fugh-Berman. Drugmakers, she went on, have made similar claims for other medicines and turned out to be wrong. She cited gabapentin, an anti-seizure medication used for nerve pain that experts say can lead to abuse and dependency. Advertisement Two market analysts had predicted the FDA would approve the drug based on the results of clinical trials, but they expressed different levels of enthusiasm. David Risinger, an analyst for the Boston investment bank Leerink Partners, called the clinical trial results 'compelling' and predicted that the medicine will generate peak annual sales of $4 billion in the 2030s. 'We think physicians and insurance companies would rather send patients home with a non-opioid pill prescription rather than an opioid pill prescription,' he said. 'It's a huge market opportunity.' Brian Skorney, an analyst with Baird, also said Journavx's approval was 'as close to a sure thing as one can get' because it reduced pain when compared to a placebo, the chief goal of the studies. But he said Vertex put its thumb on the scale for a secondary goal of the trials by comparing the drug to the equivalent of a low-dose Vicodin rather than to more potent opioids that doctors sometimes prescribe. He said it would have been more meaningful had Vertex simply compared Journavx to inexpensive over-the-counter painkillers that people have in their medicine cabinets, such as ibuprofen. 'I think people will be disappointed with, ultimately, how much it sells,' he said of Journavx. Vertex, however, seems to be confident and added 150 sales employees last year in anticipation of the FDA approval. The company has about 6,100 employees worldwide, including 4,200 in Massachusetts. Despite how common pain is, there hasn't been a significant innovation for treating it in decades. Aspirin dates to the late 19th century, while acetaminophen, ibuprofen, and naproxen sodium were invented generations ago. Advertisement Opioids date back thousands of years. But they have led to a devastating public health crisis, fueled in no small part by OxyContin, the opioid tablet made by Purdue Pharma. For years, multiple companies, including Cambridge-based Biogen, the South San Francisco biotech Genentech (which was later acquired by Roche), and the Swiss drug giant Novartis have tried unsuccessfully to develop a new class of painkillers. In 2022, Regeneron Pharmaceuticals, of Tarrytown, N.Y., shelved an experimental drug for osteoarthritis and chronic low back pain that it had long worked on after clinical trials raised safety concerns. Painkillers today fall into two major classes: anti-inflammatory analgesics, such as aspirin and ibuprofen, and opioids. Anti-inflammatories work by reducing swelling at the location of pain. Opioids change the brain's perception of pain, mimicking the natural pain-relieving chemicals known as endorphins produced in the brain. In contrast, Vertex's new drug interrupts pain signals before they reach the brain, blocking certain proteins called sodium channels that transmit pain in the peripheral nervous system. Because the non-opioid drug bypasses the central nervous system, the company says, it provides pain relief without the risk of addiction. Globe correspondent Stella Tannenbaum contributed to this report. Jonathan Saltzman can be reached at
