Mackay Memorial Hospital

TAIPEI and BARCELONA, Spain, Sept. 16, 2024 /PRNewswire/ -- A groundbreaking study conducted by PhytoHealth Corporation, a leading provider of botanical medicine, has revealed that combining Astragalus Polysaccharides (PG2®Lyo. Injection) with standard concurrent chemoradiotherapy (CCRT) significantly improves survival rates for patients with advanced esophageal cancer. The study enrolled 38 patients with stage IIb to IIIb esophageal cancer. Participants were randomly assigned to receive either CCRT alone or CCRT combined with PG2, a proprietary extract of Astragalus membranaceus roots developed by PhytoHealth Corporation. Results showed that patients who received PG2 in addition to CCRT experienced significantly longer overall survival compared to those who received CCRT alone. Furthermore, the combination therapy resulted in a higher tumor objective response rate. The study also found that PG2 helped strengthen the immune system by modulating the tumor immune microenvironment (TIME) and enhancing the suppression of tumor growth. 'These findings offer a new hope for patients with esophageal cancer,'' said Dr. Wen-Chieh Huang, Chief of Division of Thoracic Surgery at Mackay Memorial Hospital, Taiwan and the Principal Investigator of the clinical trial for PG2, a drug for cancer-related fatigue (CRF) relief developed by PhytoHealth Corporation, Taiwan. "PG2 has the potential to become a valuable addition to the standard treatment regimen, and can achieve improved patient outcomes.'' The data will be presented as a poster at the prestigious 2024 ESMO Congress. [ESMO abstract link]. Dr. Huang noted that treatment options for esophageal cancer patients are relatively limited compared to those for other cancers. However, this study has shown that PG2 combination therapy can reduce inflammation markers in the blood, decrease the differentiation of macrophages towards the M2 type, and even help shrink tumors while improving survival rates. This represents a significant breakthrough in the treatment of esophageal cancer. Dr. Huang further added that esophageal cancer patients often face tremendous challenges during treatment, with many unable to complete their therapy. However, by incorporating CRF medication, most patients were able to regain their strength, complete the full courses of cancer treatment, and achieve the expected therapeutic effects. Esophageal cancer is a challenging disease with high recurrence rates and poor survival outcomes. PG2, previously established as a treatment for cancer-related fatigue (already approved by Taiwan Food and Drug Administration) has shown promise as a potential treatment enhancer. This latest discovery marks a significant advancement in the ongoing battle against this challenging cancer. About PhytoHealth Corporation PhytoHealth Corporation is a leader in the development and manufacturing of botanical medicine and natural health products based in Taiwan. With a focus on scientific research and innovation, PhytoHealth is committed to providing safe, effective, and high-quality products that support overall health and well-being. Contact: Alison [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Courtesy of Getty Images AVROBIO is planning a 2023 Phase II/III registrational trial for its Gaucher Disease Type 3 (GD3) gene therapy candidate, AVR-RD-02. The plans are based on “compelling” evidence seen in the first pediatric patient to receive the treatment, said Chief Medical Officer Essra Ridha, M.D., in a call with investors Wednesday. Gaucher Disease is one of the most common lysosomal disorders, a collection of rare diseases characterized by the accumulation of fatty substances in cells in the spleen, liver and bone marrow. The inherited disease is caused by an improperly-working enzyme that breaks down the fatty substances. Gaucher Disease Type 1 (GD1) is the most common form of the disease. GD3 is a progressive form of the lysosomal storage disorder that has more widespread systemic manifestations, including neurological symptoms. Ridha said GD3 patients are typically refractory to standard-of-care treatment. Fifteen months after infusion of the company’s experimental hematopoietic stem cell (HSC) gene therapy, an 11-year-old patient treated with AVR-RD-02 has what the company called a “complete biochemical correction.” The patient, who was refractory to multiple therapeutic approaches, has seen a 33% increase in albumin levels. This indicates marked improvements in lymphadenopathy and enteropathy, AVROBIO reported. The company also noted the patient has no clinically detectable change in neurological status or new neurological manifestations following treatment. “This pharmacodynamic efficacy equates with improvements in major refractory elements of disease for this patient, something the child has never experienced on current standard of care,” Ridha said. AVROBIO officials said there have been no noted safety concerns associated with the therapy 15 months after infusion. The data prompted regulatory agencies in the U.S. and Europe to greenlight plans for the late-stage study trial that could lay the groundwork for potential approval. The Phase II/III trial, a first for a gene therapy aimed at this indication, will assess the safety and efficacy of AVR-RD-02, compared to current enzyme replacement therapy standard of care, Ridha said. The company expects the trial will include 40 patients to be randomized 1:1 to receive AVR-RD-02 or standard of care. Ridha said the trial design for the Phase II/III offers a high probability of success based on existing data the company has accrued in earlier studies, as well as in its ongoing Phase I/II trial in Gaucher Disease Type 1. Data shared from the single GD3 patient who received AVR-DR-02 showed the gene therapy demonstrated stabilization or improvement of multiple clinically meaningful measures, according to the company. AVROBIO Chief Executive Officer Geoff MacKay also touted the data seen in the pediatric patient, during the Wednesday call. Positive Data for Four GD1 Patients He pointed to promising data in the company’s ongoing Phase I/II trial in GD1. The trial is also assessing AVR-RD-02 in this disease subtype, which MacKay said has the same underlying pathology of other forms of Gaucher disease. Data from the Phase I/II Guard1 Gaucher disease study shows the gene therapy demonstrated clinically meaningful reduction in organ size and reductions in toxic metabolites. During its presentation, the company highlighted the positive data seen in four patients. The patients have reductions in the accumulation of fatty tissues. Three of the four patients dosed demonstrated a reduction in liver and spleen volume below the baseline established on enzyme replacement therapy. The fourth patient was not far enough out following infusion to be scanned for liver or spleen volume, Ridha said. If AVR-RD-02 demonstrates significant efficacy and safety data in the registrational study, MacKay said the treatment could present a “substantial commercial opportunity” for the company. One-time gene therapies have a significant price tag totaling about 15 years of current care. We are transitioning to a late-stage clinical company,” MacKay said. “The clinical path forward is clear. Throughout 2023 we expect a steady cadence of regulatory milestone updates. 2023 is setting up to be a big year with important catalysts across the pipeline.”

Rallybio and AbCellera will jointly choose targets in their new partnership. Rallybio has become the latest company to hitch its antibody drug development efforts to AbCellera. The partners will co-develop up to five rare disease therapeutic targets in a risk-sharing pact, starting with a metabolic disease program. AbCellera, a biotech perhaps best known for its work on Eli Lilly’s COVID-19 antibodies, has signed up a string of drug developers as partners in recent years on the strength of its discovery platform. Rallybio has now added its name to that list by forming a multiyear, multitarget collaboration that could provide a stream of new programs for its pipeline. Rallybio CEO Martin Mackay, Ph.D., said the partnership covers rare hematology, immuno-inflammation, maternal fetal health and metabolic disorders, with the latter therapeutic area topping the companies’ list of priorities. The partners will jointly choose targets. That meritocratic approach to target selection reflects the fact both companies have skin in the game. Mackay framed the alliance as “a true risk and reward sharing partnership,” adding that the publicly undisclosed financial terms “reflect the contribution of each company in discovering, developing and commercializing the new antibody-based medicines that are created.” Both parties have an option to make additional investments at progressive stages of clinical development to maintain a 50% stake in each program. If a partner opts out, their contribution will be rewarded with royalties that run from low- to mid-double-digits, depending on how deep into development it supported the program. AbCellera has an option to conduct process development and clinical manufacturing. If the collaboration delivers candidates, they will slot into a Rallybio pipeline currently led by anti-HPA-1a antibodies that are in early-phase development as treatments for maternal fetal blood disorders. The biotech is also working on C5 inhibitors and an antibody against MTP-2.