Aminolevulinic Acid Hydrochloride

Alpheus put forward first-in-human data late last year, pushing median overall survival to 15.7 months compared to historical averages for glioblastoma of about 6 to 8 months. \n After publishing early clinical results of its ultrasound-activated brain tumor therapy this year, Alpheus Medical has raised $52 million in venture capital funding to support a new randomized trial.The company’s sonodynamic treatment starts with the patient drinking a drug that’s already been approved by the FDA for use in fluorescence-guided brain surgery. Known as 5-aminolevulinic acid, or 5-ALA, it accumulates within tumor cells to help them stand out from healthy tissue during a procedure.Alpheus takes a non-invasive approach that does not even require sedation, by applying diffuse, low-intensity ultrasound that causes the drug to release oxygen molecules that then destroy the tumor. With the latest proceeds, the company plans to enroll patients with newly diagnosed glioblastoma into a phase 2b trial. “This investment is a key inflection point for Alpheus and the glioblastoma community—advancing sonodynamic therapy from promise to clinical validation,” the company’s president and CEO, Vijay Agarwal, said in a statement. “With this support, we are poised to generate pivotal evidence that could help establish a new standard of care for newly diagnosed brain tumors.”Alpheus’ series B round was co-led by HealthQuest Capital and Samsara BioCapital, with participation from returning investors OrbiMed and Action Potential Venture Capital. Other backers included BrightEdge, the investment arm of the American Cancer Society, the Brain Tumor Investment Fund, a subsidiary of the National Brain Tumor Society and the Sontag Innovation Fund.“The complex and diffuse nature of glioblastomas has long hindered therapeutic innovation,” said Conrad Wang, a partner at HealthQuest Capital. “Alpheus\' sonodynamic therapy represents a novel, non-invasive whole brain approach with compelling early data.”In February, the company had a study published in the Journal of Neuro-Oncology that followed three patients with glioblastomas who were not candidates for removing the whole tumor via brain surgery. Following a single dose of the ultrasound-powered therapy before trying other treatments, early imaging results confirmed signs of cancer cell death and no adverse effects or impacts to healthy tissue.Alpheus put forward first-in-human data late last year, from a phase 1/2 open-label trial that demonstrated an improvement in median overall survival to about 15.7 months, compared to historical averages for the aggressive disease of about 6 to 8 months. Progression-free survival also increased to 5.5 months, versus the typical 1.8 months.

The BLU-U Model 4170E offers a compact, easy-to-use option with the same BLU-U safety and efficacy healthcare professionals have trusted for years. MUMBAI, India, PRINCETON, N.J. and BILLERICA, Mass., May 16, 2025 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries and/or associates referred as "Sun Pharma") today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval application (PMA) approval of the next generation of BLU-U® Blue Light Photodynamic Therapy (PDT) Illuminator which features light emitting diode light (LED) panels as a replacement for the previous model's fluorescent tubes. The new model (LED BLU-U) in combination with LEVULAN® KERASTICK® (aminolevulinic acid HCl) Topical Solution, 20%, is indicated for the treatment of minimally to moderately thick actinic keratoses (AK) of the face, scalp, or upper extremities. The new LED BLU-U is approved for the same indications as the previous model but takes up less space in a dermatologist's office, and has a more flexible five-panel shape, improved LED arrangement, lighter weight, and other updated functions that may increase patient comfort and ease of use. "We are pleased to receive the FDA's approval of LED BLU-U and look forward to seeing the positive impact this next generation device will have for those living with actinic keratosis," said Abhay Gandhi, Sun Pharma North America CEO. "As a company committed to innovation, we are confident that this new LED BLU-U model will provide improved efficiency and reliability while maintaining the safety and efficacy that healthcare professionals and people with AKs have come to trust from Sun Pharma." The approval of LED BLU-U was granted under FDA's Real-Time Review Program, reflecting the robustness of the submission and Sun Pharma's continued collaboration with the Agency. The LED BLU-U will be available for delivery in the near future. For details regarding availability, ordering, or implementation, please direct inquiries to your Sun Pharma Specialty Dermatology representative. For more information, healthcare professionals are encouraged to visit . About Actinic Keratosis (AK) AK is a chronic condition that can lead to skin cancer. AKs are rough, dry, and scaly patches on the skin resulting from extended sun exposure. These spots can vary in size from a tiny pinhead to a quarter and are commonly found on sun-exposed areas such as the face, scalp, arms and hands. About LEVULAN KERASTICK + BLU-U LEVULAN KERASTICK + BLU-U blue light is the only FDA-approved photodynamic therapy (PDT) that effectively targets and clears actinic keratosis (AK) on the face, scalp, arms and hands. LEVULAN KERASTICK (a topical 20% ALA [aminolevulinic acid] solution) + BLU-U blue light photodynamic therapy (PDT) has earned the trust of dermatologists for more than 20 years, offering a proven safe and effective treatment that can eliminate actinic keratoses (AKs) in one or two in-office visits. About Sun Pharmaceutical Industries Limited. (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Sun Pharma Media Contact (USA): James Freeman Head of Communications Sun Pharmaceutical Industries, Inc. [email protected] Mobile: (978) 808-6956 SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED