Written by 9:00 am Soft Tissue Sarcoma Views: 16

Written by Jessica Lynn Soft Tissue Sarcoma

Tigilanol Tiglate Granted Orphan Drug Designation for Soft Tissue Sarcoma (STS)

There are over 80 separate subtypes of soft tissue sarcoma (STS), a rare cancer that manifests in soft tissues in the body. Soft tissues include muscle, fat, joint linings, tendons, nerves, and blood vessels. While these cancers can grow anywhere in the body, they most often occur in the abdomen, arms, and legs. Angiosarcoma, liposarcoma, and synovial sarcoma are all subtypes of STS. Symptoms vary based on specific subtype. However, common symptoms of STS include pain (if the tumor is pressing on nerves) and a noticeable lump or mass in the affected area. The risk of developing soft tissue sarcoma increases with age.

While there are existing treatment options for soft tissue sarcoma, including chemotherapy, radiation, and surgery, researchers continue to explore options that could improve patient outcomes and heighten the overall survival rate. One such option being explored in clinical studies is tigilanol tiglate. Developed by life sciences company QBiotics Group Limited, tigilanol tiglate is a novel small-molecule treatment. Tigilanol tiglate improves wound healing and causes cancerous cells to die through oncosis (cell swelling). In the ongoing Phase 2 QB46C-H07 study, researchers are exploring how safe and effective tigilanol tiglate is for people with advanced and/or metastatic soft tissue sarcoma. Trial endpoints include how many patients see their tumor size fall by at least 30%, the pharmacokinetic profile, the rate of tumor recurrence after six months, and what adverse reactions occur.

Read more about soft tissue sarcoma here.

Orphan Drug Designation for a STS Treatment

In mid-February 2024, QBiotics Group Limited reported that the US FDA granted Orphan Drug designation to tigilanol tiglate for soft tissue sarcoma. Orphan Drug designation is granted to drugs or biologics intended to treat, diagnose, or prevent rare conditions. Rare conditions are those affecting fewer than 200,000 people nationwide. Benefits earned by QBiotics include fee waivers, tax credits, increased regulatory assistance, and up to seven years of market exclusivity if/when the drug is approved.

You can read the original press release from QBiotics Group here.

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Last modified: March 6, 2024

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