South Korean bio names CrystalGenomics and GemVax & Kael gained clearance from U.S. and domestic authorities to proceed with clinical trials for pancreatic cancer treatment and Alzheimer’s disease, respectively.

CrystalGenomics received a Federal Drug Association (FDA) nod for a Phase 2 clinical trial evaluating Ivaltinostat, an HDAC (histone deacetylase) antagonist coded CG-745, in the treatment for pancreatic cancer.

GemVax & Kael gained approval from the Ministry of Food and Drug Safety to conduct Phase 3 clinical trial for GV1001, a telomerase-derived peptide consisting of 16 amino acids, for Alzheimer’s disease treatment after modifying its application from original design for pancreatic cancer treatment.

CrystalGenomics will conduct Phase 2 clinical trial on 70 patients with progressive or metastatic pancreatic cancer patients who have received standard treatment. One experimental group will be administered a combination therapy of Ivaltinostat and Roche’s Capecitabine (Xeloda), an anticancer drug used for colon cancer, breast cancer, and stomach cancer. The other group will receive a monotherapy of just the Capecitabine.

One of the two current standard treatments for pancreatic cancer is Folfirinox therapy, which uses a combination of four drugs, folinic acid, fluorouracil (5FU), irinotecan, and oxaliplatin. Folfirinox therapy, however, cannot be administrated for more than 4 to 6 months because it is a potentially highly toxic combination of drugs with serious side effects.

Pancreatic cancer is projected to become the second leading cause of cancer-related deaths before 2030.

“We are planning to conduct experiments in up to 25 hospitals to recruit patients more quickly and easily,” said an official from CrystalGenomics. Based on the results from the trials, CrystalGenomics will also be open to pharmaceutical technology transfers to other global pharmaceutical companies.

GemVax’s GV1001 was originally developed and tested to also treat pancreatic cancer under the name “Riavax”. It received conditional approval in 2014 but had its license revoked by the ministry after it failed to submit a clinical result report before the expiration of the conditional approval period.

Since then, drug developers at drug developers at GemVax found that GV1001 induced anti-inflammatory effects in brain cells and may work as a treatment for Alzheimer’s disease.

GV1001 is a peptide derived from the reverse transcriptase of human telomerase (hTERT). Telomerase can be used in cancer therapy and acts as an antioxidant, anti-aging and stem cell activation agent.

GV1001 demonstrates neuroprotective effects by improving cognitive-behavior symptoms of Alzheimer’s disease by restoring the apoptosis and damage of neural stem cells induced by amyloid beta and tau protein.

GemVax previously confirmed the efficacy and safety of GV1001 in Phase 2 clinical trials conducted in patients with moderate and severe Alzheimer`s disease at 12 hospitals in Korea from August 2017 to September 2019. Based on these results, GemVax applied for a Phase 3 clinical trial approval in January last year, but the application was rejected due to insufficient data. After conducting further tests, GemVex applied for Phase 3 clinical trial approval once again in June last year.

GemVax plans to confirm the possibility of treating Alzheimer’s disease with GV1001 during the Phase 3 clinical trials. Afterwards, based on the results, GemVax will apply for drug licenses to treat patients with moderate to severe symptoms.

Phase 3 clinical trials for GV1001 will be conducted in more than 50 hospitals on 936 patients, according to GemVax on Monday. The clinical trials will be evaluated for efficacy and safety.

By Chung Seul-gi and Susan Lee

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