Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Supratek Pharma has announced that the FDA has granted orphan drug designation to SP1049C for the treatment of gastric cancer.
Subscribe to our email newsletter
Recently Supratek has also reached an agreement with the FDA for the design of SP1049C pivotal phase III study protocol under the special protocol assessment process.
Recently Supratek has also reached an agreement with the FDA for the design of SP1049C pivotal Phase III study protocol under the special protocol assessment process. A randomized Phase III pivotal clinical trial will compare SP1049C plus Best Supportive Care (BSC) versus BSC alone for the treatment of patients with metastatic adenocarcinoma of esophagus, gastroesophageal junction and stomach who have failed adjuvant or 1st or 2nd line chemotherapy. Supratek Pharma will direct the clinical development program.
Christopher Newman, vice-president and chief medical officer of Supratek, said: “Orphan drug designation provides multiple incentives for Supratek Pharma to continue its development of SP1049C for metastatic adenocarcinoma of the upper gastrointestinal tract. Our experience to date with SP1049C has been very encouraging and we look forward to the initiation of our Phase III pivotal clinical trial.”