The world’s first commercially available gene therapy medication will soon be treating head and neck cancer in China.

Edison, New Jersey-based research equipment manufacturer New Brunswick Scientific announced that approval to produce the medication for treating head and neck squamous cell carcinoma has been granted to China’s Shenzhen SiBiono Gene Technologies.

“Our cell culture technology has been well received throughout the world and has been successfully used to produce a large variety of antibiotics, vaccines and other products within the pharmaceutical and immunology fields,” says David Freedman, New Brunswick Scientific’s chairman and CEO. “We are very proud that our equipment played a part in this latest, exciting medical breakthrough.”

Squamous cell carcinoma

Head and neck squamous cell carcinoma is a type of cancer involving squamous cells—cells that line the outside of the mouth, nose, throat and lungs.

These cells spread from their original site to the lymph nodes in the neck or around the collarbone.

The disease predominantly strikes men after age 50, and until this recent breakthrough in gene therapy, prognosis for survival has been poor.

Gene therapy

Gene therapy is a technique for replacing defective genes with working genes so that the body can make normal proteins.

It can also involve manipulating genes for the production of therapeutic proteins such as insulin.

In most gene therapies, a normal gene is inserted into the genome to replace an abnormal gene.

A carrier molecule called a vector is used to deliver therapeutic genes to target cells.

Applications for gene therapy are far-reaching, with the potential to eventually cure such illnesses as cancer and a litany of inherited conditions such as Huntington’s disease.

Regression with Gendicine

The gene therapy for which Shenzhen has received approval is an injectable medication marketed under the name Gendicine.

The treatment uses an adenoviral vector to deliver p53 tumor suppressor genes at the precise site of cancer.

Gendicine has been tested in clinical trials on patients with late-stage head and neck squamous cell carcinoma.

After eight weeks of therapy involving one injection per week, 64% of patients’ tumors went into complete regression and 32% experienced partial regression.

In combination with chemotherapy and radiotherapy, Gendicine improved treatment efficacy more than threefold.

Over more than three years, no patient relapsed.

Minimal side effects

Unlike gene therapies using retroviral vector delivery systems that can lead to complications, Gendicine’s adenoviral vector has far less serious side effects—low grade, self-limited fevers.

A license to market the drug was issued on October 16, 2003 by the State Food and Drug Administration of China after more than five years of clinical trials.

Gendicine is expected to become commercially available in January 2004.

With further testing, say its developers, it could prove effective for treating a range of cancers.
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