Category: Drug Development
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 ADDA partnership was launched as a unique collaboration between development teams at Southern Research and the University of Alabama at Birmingham. Leveraging the strengths of each organization, the ADDA provides the infrastructure and support to expedite the search for new insights and treatments for a number of diseases.
ADDA’s objective is to facilitate drug discovery and development utilizing the resources that exist at the two institutions. These resources include molecular target identification, high through-put screening, three dimensional structure of targets, and preclinical toxicology.
The ADDA funds pilot projects that are at different stages of the drug discovery and development process, and provides a suite of services tailored to the needs of each project.
The ADDA discovery pipeline includes possible therapies for Parkinson’s disease, diabetes, kidney disease, Alzheimer’s, and many types of cancers.
Minnesota-based Surmodics, which specialized in drug delivery technology, announced its deal for Brookwood Pharmaceuticals on Aug. 1, 2007. The deal, valued at $50 million, was the largest transaction in the history of Southern Research.
Surmodics’ plan called for Brookwood to operate as a distinct business unit, headed by Dr. Art Tipton and based in Birmingham.
“While we will miss having Brookwood as part of our extended organization, we are convinced that the combined companies will be much more successful than they would be apart,” Dr. Jack Secrist, Southern Research’s CEO, said about the deal. “Furthermore, the Birmingham community has benefited from Brookwood’s growth and presence, and we are very pleased that SurModics has decided to retain Brookwood in Birmingham.”
Brookwood was set up as a for-profit drug delivery company with all the resources needed to manufacture biomaterials and drug delivery formulations for clinical trials and for pharmaceutical companies. Dr. Art Tipton — a future leader of Southern Research — was tapped to head the new venture.
At the time of the launch, the Brookwood scientific team had amassed experience in virtually all drug delivery systems and was internationally recognized for its contributions to the drug-delivery field since the pioneering days of controlled release technology in the 1970s. While at Southern Research, the group created the first commercialized injectable microsphere product.
The new venture also included the external polymer manufacturing business of Alkermes, which it acquired. The business operated as a Brookwood subsidiary called Lakeshore Biomaterials.
“In spinning out Brookwood Pharmaceuticals, we are realizing an opportunity to expand one of Southern Research’s most successful commercial businesses, giving it room to grow and capitalize on the strength the team has long held in the drug delivery marketplace,” Robert C. Lonergan, Southern Research president and CEO, said at the time.
Photo shows Dr. Art Tipton
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
The U.S. Food and Drug Administration approved carmustine — marketed under the trade name BiCNU — in March 1977. This chemotherapy drug damages the DNA of cancer cells, preventing them from dividing and triggering their death.
Carmustine is used in the treatment of certain types of brain tumors, including glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
Its wafer formulation, the Gliadel wafer, is implanted into a surgical cavity after the removal of a brain tumor to release carmustine.
Other cancers treated with carmustine include multiple myeloma, Hodgkin’s disease, non-Hodgkin’s lymphomas, melanoma, lung cancer and colon cancer.
The drug was developed by Drs. John Montgomery and Tom Johnston, and synthesized in the lab by Shep McCaleb.
Lomustine is primarily used in the treatment of brain tumors, both primary (developed in the brain) and metastatic (spread from another source). It has also been used for Hodgkin’s disease and non-Hodgkin’s lymphoma, as well as in the treatment of melanoma, lung and colon cancer.
It was originally marketed under the name CeeNu but in 2014 was rebranded Gleostine.
Lomustine is a chemotherapy drug classified as an alkylating agent. Alkylation damages the DNA of cells, preventing them from dividing and triggering their death.
It is a nitrosurea compound, which unlike most chemotherapy drugs, can cross the blood-brain barrier, making it useful in treating brain tumors.