The U.S. Food and Drug Administration approved pralatrexate — also known by its brand name, Folotyn — as the first treatment for a form of cancer known as Peripheral T-cell Lymphoma (PTCL), an often aggressive type of non-Hodgkins lymphoma. Southern Research collaborated with the Sloan Kettering Memorial Cancer Center and SRI International on development of the drug.

“We prepared and tested many compounds before finally identifying a substance that gave favorable results,” Southern Research’s Dr. Robert Piper said about the FDA’s approval of pralatrexate.”We are very glad our compound will help alleviate human suffering and extend lives.”

Folotyn was approved under the FDA’s accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. It is approved for patients who have relapsed, or have not responded well to other forms of chemotherapy.

Lymphoma is a cancer of the lymphatic system, which is part of the immune system.

Pralatrexate belongs to the class of chemotherapy drugs called antimetabolites, which prevent cell division and cause cancer cells to die. Antimetabolities are substances that interfere with DNA or RNA synthesis, disrupting cell division the growth of tumors.

The U.S. Food and Drug Administration approved clofarabine for the treatment of pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL) after at least two prior regimens. The drug is marketed under the brand name Clolar.

Dr. John Montgomery, Dr. Jack Secrist and co-workers first synthesized clofarabine. It belongs to the class of chemotherapy drugs called antimetabolites, which prevent cell division and cause cancer cells to die.

At the time of its approval, Clolar was the first new leukemia treatment specifically for children in more than a decade.

Photo shows Dr. Jack Secrist, at whiteboard, speaking to members of Southern Research’s cancer team, including Dr. John Montgomery, second from left

In the 1960s, Southern Research scientists including Drs. Robert Piper and Tom Johnston conducted an extensive program to produce agents for the U.S. Army that would protect soldiers from radiation. One of these agents, amifostine, was later developed as a treatment to protect patients from harmful effects of radiation treatment and chemotherapy. The drug is marketed as Ethyol.

Amifostine works by promoting the repair of damaged tissue and binding to harmful free radicals released by cells after exposure to chemotherapy.

Photo shows Dr. Robert Piper

Fludarabine — also known under its brand name, Fludura — is used in the treatment of chronic lymphocytic leukemia (CLL), including CLL that has not responded to standard therapy, or recurred after therapy. It also is used as a salvage therapy for non-Hodgkin’s lymphoma and acute leukemias.

Fludarabine was first synthesized by Dr. John Montgomery and Kathleen Hewson of Southern Research in the late 1960s. U.S. Food and Drug Administration approval was granted in April 1991.

It belongs to the class of chemotherapy drugs called antimetabolites, which prevent cell division and cause cancer cells to die.

Fludarabine is on the World Health Organization’s Model List of Essential Medicines, the most important medications needed in a basic health system.

Photo shows Dr. John Montgomery

Triazene dacarbazine, developed by Dr. Fulmer Shealy and others in the early 1960s, became Southern Research’s first drug to achieve approval from the U.S. Food and Drug Administration, in May 1975. It was originally marketed by Bayer as DTIC-Dome.

Dacarbazine, a chemotherapy drug classified as an alkylating agent, is on the World Health Organization’s Model List of Essential Medicines.

It is used to treat metastatic malignant melanoma, Hodgkin’s disease, soft tissue sarcomas, neuroblastoma, fibrosarcomas, rhabdomyosarcoma, islet cell carcinoma, and medullary carcinoma of the thyroid.