- Accelerated development by approval of MFDS's third-line treatment for
colorectal cancer phase 1b/2 clinical trial
Elevar Therapeutics announced that they
received an Investment New Drug (IND) approval from the Korean Registry of Food
and Drug Safety (MFDS) for phase 1b/2 of clinical trials of combination therapy
with Rivoceranib and Lonsurf (Taiho Pharmaceutical, Japan) for the development
of a third-line treatment for colorectal cancer.
As appropriate dosage determination was
completed in the ongoing global clinical trials of Rivoceranib and Lonsurf,
clinical trials were also approved in Korea to prepare for the second phase.
The safety and drug resistance are evaluated to determine the dose without side
effects on the patient through Phase I and the treatment effect is confirmed
with the dose determined in Phase II clinical trials.
This clinical trial will be conducted at Washington
University School of Medicine, Vanderbilt University, and Florida Cancer
Specialists, along with Asan Medical Center, Samsung Medical Center, Seoul
National University Bundang Hospital, Seoul National University Hospital, and
Severence Hospital in Korea.
The combined therapy of Rivoceranib and
Lonsurf can effectively block recurrence and metastasis by Lonsurf acting
directly on cancer cells to induce apoptosis, and Rivoceranib inhibiting the
production of neoplasms needed for tumor growth, normalizing abnormal cancer
vascular structures and activating immune cells. In addition, Rivoceranib and
Lonsurf are expected to be the best combination because they do not overlap
with side effects and are both easy to take as oral medicines.
An official from HLB said, " In addition to the U.S., IND will be approved in Korea and the recruitment of patients will be accelerated," adding, "We will do our best to give hope to patients with terminal colorectal cancer through rapid clinical progress through global collaboration."