Singapore has launched a one-stop digital portal to streamline and consolidate information and research studies on the safety and efficacy of trial drugs, treatments and medical devices.
The portal, Clinical Trials Singapore (CTSG) is managed by the Singapore Clinical Research Institute (SCRI). It is designed to allow individuals easier access and options, as well as information needed by physicians before deciding on a patient’s suitability for medical trials.
Currently, the portal includes 338 trials, each one including a short description of the study, and the criteria that must be met by potential participants.
Prior to the launch of the new portal, information on clinical trials was generally customized for research professionals and principal investigators. Now, with the new portal, the public has access to medial trial information independent of their physician.
Speaking on the launch of the portal, Deputy Prime Minister Heng Swee Keat noted to The Straits Times that “Singapore must invest more in trials centered on upstream disease prevention. The Republic should also leverage new health-tech innovations and tap clinical trials to advance more sustainable healthcare systems.”
Dr. Wee Kiat Tan, co-CEO of Singapore-based Cytomed Therapeutics (NASDAQ: GDTC) said, “The new portal developed by the SRCI could very well lead to a boon in new drug development. Before the portal was created, it was actually not a simple process to find qualified trial candidates.
Now, with the portal, new drugs, therapies and devices that are in trial can be rather easily seen by people who are actively searching. Because of this, it is my belief that Singapore is on the forefront of new drug and therapy development.
“By streamlining the process of candidate discovery and qualification, it is possible we could see the entire trials system become far more efficient.”
Read more about Singapore’s new trials portal HERE
Or see CytoMed Therapeutics’ latest investor presentations HERE
In an effort to help mitigate the financial burden put upon patients requiring cell, tissue and gene therapies, the government of Singapore has announced it will offer substantial subsidies to help cover patient costs.
As of August 1, based on means-testing and household income, Singapore citizens are eligible for a subsidy of up to 75% of the cost of their treatment, capped at $150,000. Permanent residents may be eligible for up to a 22.5% subsidy, capped at $45,000.
The initial subsidies are currently offered for a single product to patients suffering from blood cancers, specifically refractory B-cell acute lymphoblastic leukemia, as well as relapsed or refractory diffuse large B-cell lymphoma.
The initial product to be subsidized, a chimeric antigen receptor (CAR) T-cell therapy, currently costs around $475,000 before subsidies. Additional cell, tissue and gene therapy products (CTGTPs) will likely be added to the subsidy list based on clinical need, clinical effectiveness, cost and budget impact.
Dr. Wee Kiat Tan, co-CEO of CytoMed Therapeutics (NASDAQ: GDTC) said of the subsidies, “The Singapore government has taken a significant step towards not only offering financial assistance to patients in need, but has signaled, in my opinion, its steadfast endorsement of chimeric antigen receptor T-cell therapies.
“However, while subsides to patients are important and very much needed, we believe CytoMed’s cancer therapy products could greatly reduce the cost of CAR T-cell therapies, as we plan to create an “off the shelf” solution targeting not only blood cancers, but solid tumors as well.
“Production of our drug could be quickly scaled, bringing costs down significantly. This would allow for far more patient access to life-saving CAR T-cell therapies, potentially without the need for government subsidies.”
Read more about Singapore’s CTGTPs subsidies HERE
Or see CytoMed Therapeutics’ latest investor presentations HERE
Dr. Carl June, the “Father of CAR T-Cell Therapy”, believes 2024 will be marked as a breakthrough year for brain cancer treatment, specifically for patients with glioblastoma, a highly aggressive form of brain cancer.
As Dr. June recently told Forbes, glioblastoma is a death sentence, with the average glioblastoma patient having just 15-18 months survival time, and a survival rate of just 5% after five years.
However, recent studies conducted by several research groups, including a group lead Dr. June, involving CAR T-Cell infusions have shown promise for glioblastoma patients.
“We published six patients just about a month and a half ago in an ongoing trial with a dual CAR given into the brain.
“And all six patients had really quite remarkable imaging changes very rapidly. I think about five years down the line, we’re going to have FDA-approved CARs for glioblastoma,” said Dr. June.
As the “Father of CAR T-Cell Therapy”, Dr. June treated the first patients with CAR T-cell therapy back in 2010. And, as reported in Forbes, the results were “astonishing.”
By 2017, the FDA approved the first T Cell therapy drug, with six approved for market today.
Dr. Wee Kiat Tan, co-CEO of CytoMed Therapeutics (NASDAQ: GDTC) said, “While 2024 has indeed represented a year of breakthrough for cancer therapies and we are very heartened by the glioblastoma treatment showing promise, we believe that next year, 2025 could offer even grander advancement in the cancer therapeutics field.
“With the anticipation of our clinical trials slated to begin later this year, unlike conventional CAR-T therapy, which is limited to hematological disorders, our “off-the-shelf” gamma delta T cells can target both hematological disorders and solid tumors as well.
“Hence, 2025 can be a true breakthrough for cancer therapies as well as for CytoMed as well.”
Read the full article HERE
Or watch CytoMed Therapeutics’ (NASDAQ:GDTC) latest investor presentation, HERE
In late July, the US FDA accepted a Biologics License Application (BLA) from Mesoblast Limited. The BLA was resubmitted for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
If approved, Mesoblast’s “RYONCIL” will be the first allogenic, off-the-shelf cellular medicine in the US, as well as the first cell therapy for children up to 18 years old with the condition.
Mesoblast CEO, Dr. Silviu Itescu said, “We are pleased that FDA has accepted our BLA resubmission for review and look forward to the potential approval of RYONCIL for children with SR-aGVHD.”
Of the application’s acceptance, Dr. Wee Kiat Tan, co-CEO of CytoMed Therapeutics (NASDAQ: GDTC), a pre-clinical biotechnology company focusing on developing off-the-shelf, cell-based immunotherapy cancer treatments, said…
“This is a great advancement for allogeneic cell based therapy as once the approval is obtained, this means that the regulatory and approval pathway has been trailblazed.
“All other allogeneic cell based therapy, including CytoMed’s allogeneic gamma delta T cell cancer therapy can follow this regulatory pathway to bring potentially affordable cell therapy to the masses.”
The FDA has considered Mesoblast’s resubmission to be a complete response to prior inquiries arising from its last submission, and Mesoblast anticipates a decision on or before the FDA’s Prescription Drug User Fee Act (PDUFA) goal date of January 7, 2025.
Read the full article, HERE
Or watch CytoMed Therapeutics’ (NASDAQ:GDTC) latest investor presentation, HERE