Children are born with underdeveloped immune systems; lactoferrin, a compound found in mother's milk, helps them develop it.
A slight variation of lactoferrin, known as talactoferrin alfa, helps fight lung cancer, according to research by Dr Atul Varadhachary, president and chief operating officer of the Houston-based Agennix.
The researcher is now in the final stages of fashioning a drug based on his discovery.
The Food and Drug Administration has approved the design of a single, pivotal, Phase 3 trial to see if talactoferrin alfa can indeed fight the most common form of lung cancer in combination with chemotherapy, as a first line of treatment.
The European Medicines Agency also said that this single trial would support a marketing authorisation application in the European Union for the drug.
The new drug could be in the market by 2010, said Varadhachary, a physician who went on to become a businessman and social activist.
Agennix has already spent $101million to develop the drug, and Varadhachary expects to spend another $100 million before it reaches the market.
The treatment of this form of lung cancer (called nonsmall cell lung cancer) is a $4 billion-a-year industry in the US alone, making the prospects bright for the company.
After breast cancer in women and prostate cancer in men, lung cancer is the most common type of cancer.
But it is more damaging than other forms of cancer because it kills more Americans than breast, prostate and colorectal cancers combined -- more than 160,000 people last year.
Another 300,000 are diagnosed as having the cancer annually in Europe, and 520,000 are diagnosed annually in the rest of the world.
For patients diagnosed with advanced NSCLC, the expected survival is only about 8.5 months, even after multiple doses of toxic chemotherapy.
Varadhachary says he is hopeful that talactoferrin will prove to be an important tool in the treatment of this cancer, pointing out that lung cancer is usually detected only when it is in very advanced stage.
Talactoferrin alfa comes in liquid form, and is to be taken in two 15-milliliter doses a day.
It can be used by any patient as it has almost no toxicity, he claimed.
"Half the patient population can't take some of the recently approved drugs because of their toxicity. Ours would apply to the entire population," he said.
The Phase 3 trial will be conducted at more than 200 sites around the world and will involve several thousand patients, Dr Varadhachary said.
If no new public health concerns surface in relation to the drug, then the FDA could grant marketing approval.
The discovery of talactoferrin occurred in 1988 when Baylor College of Medicine scientist Dr Bert O'Malley produced the protein in his laboratory from a fungus called Aspergillus niger.
Structurally, it is almost identical to human lactoferrin, which is found in mother's milk.
Breast-fed babies fight infections better, in part, because of lactoferrin, Dr Varadhachary said.
"It helps in our gut. We started looking at it and wondered if it would be helpful to stimulate the immune system... and thus fight cancer," he said.
Lactoferrin, the most abundant non-whey
Babies are born with an underdeveloped immune system, and lactoferrin found in milk helps strengthen their immunity.
But strengthening the immune system can be important in cancer patients as well.
Talactoferrin has been tested in several cancer trials, with promising results.
Two of the larger trials -- placebo controlled trials in patients with lung cancer -- were conducted at 11 major cancer centers in India, including sites in Bangalore, Chennai, Delhi, Hyderabad, Mumbai, and Pune.
These trials suggested that talactoferrin could fight cancer.
In fact, in both trials, the patients receiving talactoferrin had fewer severe adverse events than those receiving the placebo, Dr Varadhachary said.
Agennix has a contract with Capua, Italy, to produce Talactoferrin on a commercial scale.
A Netherlands company is already producing it in a large quantity for the trial. The company is also trying to see if the drug can fight diabetes and other forms of cancer, too.
Dr Varadhachary, who studied medicine in Mumbai, joined Agennix in 2001, and helped refocus the company, among other things pushing it into the fight against cancer.
Excitement at Agennix has increased steadily over the last six years after they saw encouraging anti-cancer results, first in animal experiments, then in early patient trials and finally in larger Phase II trials, Dr Varadhachary said.
"Talactoferrin has the potential to be an important advance in the treatment of NSCLC," said Dr Waun Ki Hong, head of the Division of Cancer Medicine at M D Anderson Cancer Center and a member of Agennix's Scientific Advisory Board.
Dr Varadhachary who came to the US in 1987, earned a PhD in physiology and did a postdoctoral fellowship in biochemistry at the Johns Hopkins University School of Medicine in Baltimore.
While at Hopkins, he was also the founding president of the Johns Hopkins Postdoctoral Association. Soon he joined the global management consulting firm, McKinsey & Co.
His wife Gauri is an associate professor at MD Anderson Cancer Center in Houston.
In 1998-99, while on leave from McKinsey, he worked for a year with Pratham, in Mumbai.
Atul and Gauri started Pratham Health, a preventive health and micronutrient program that reaches over 50,000 pre-school children each year.
Their work was honoured by Children's Hope India, which presented them with a 'Making a Difference' award in 2001.
Pratham Health was later spun out as a separate organisation -- the Niramaya Health Foundation.
Dr Varadachary serves as the president of the Indo-American Chamber of Commerce of Greater Houston.
His academic affiliations include adjunct professorships at the Baylor College of Medicine and at the Jesse Jones School of Management at Rice University, where he teaches a course on entrepreneurship in biotechnology.
Agennix, a privately held company, was founded in 1993 based on technology from the Baylor College of Medicine in Houston.
Starting in 2001, the company changed its focus to its current lead indications, including the treatment of cancer.
