Orphan Drug Status Has Been Awarded to an Investigational Drug For the Treatment of Stomach Cancer

An investigational drug called ALT-P7 is being developed as a potential medicine for certain forms of cancer. The drug has received Orphan Drug Designation for the treatment of gastric cancer from the US FDA. The source press release can be read here, at Business Wire.

About Gastric Cancer

Gastric cancer, also known as stomach cancer, is estimated to affect almost 100,000 people in the United States. The first symptoms of stomach cancer are often vague and non-specific, such as indigestion, heartburn, trapped wind, bloating, and stomach pain.

Most forms of gastric cancer develop in stomach lining cells, but it can also affect lymphatic, muscle, or connective tissue of the stomach.

About ALT-P7

ALT-P7 is an experimental drug that is being investigated by Alteogen as a possible treatment for gastric cancer. It is an antibody-drug conjugate that uses ‘NexMabTM’ technology.

ALT-P7 is also currently being researched as a potential treatment for breast cancer in a Phase 1 clinical trial taking place in Korea. There are plans to begin a Phase 2 clinical study of the drug, also for the treatment of breast cancer, in 2019. Alteogen has said that they intend to extend the clinical development of ALT-P7 for gastric cancer as well after the on-going study in patients with breast cancer is completed.

Orphan Drug Designation

The US Food and Drug Administration’s Orphan Drug Designation (also known as ‘Orphan status’) may be awarded to drugs that meet certain criteria. Orphan designation is granted to drugs that are intended for use for the treatment, diagnosis, or prevention of a rare condition. This is defined as a condition that affects under 200,000 people in the United States. Orphan designation is intended to encourage and support drug developers, and so confers certain benefits to the developing company, such as a period of marketing exclusivity, tax benefits for clinical trials, scientific advice from the FDA as the drug is researched, and in some cases, reductions to some fees.

Anna Hewitt

Anna Hewitt

Anna is from England and recently finished her undergraduate degree. She has an interest in medicine and enjoys writing. In her spare time she likes to cook, hike, and hang out with cats.

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