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Marking a first for Houston, Agennix, a private biotechnology company, is awaiting approvals from the Food and Drug Administration, for its revolutionary drug to treat lung cancer, according to the Houston Chronicle.
This drug, Talactoferrin Alfa, is based on the molecule talactoferrin, which is an immunomodulatory recombinant protein. Agennix researchers are relying on this protein for the treatment of nonsmall-cell lung cancer.
To Dr Bert O'Malley goes the credit for discovering and developing this protein in a laboratory in 1988.
Lung cancer is considered the second most widespread kind of tumour in the United States, preceded by prostate and breast cancer in men and women, respectively.
However, it is responsible for more deaths than the other two diseases. Talactoferrin molecule structure resembles that of lactoferrin, an ingredient found in mother's milk. Lactoferrin is known to establish the immune system in infants and one of the major reasons why breast feeding is highly recommended.
Talactoferrin can be produced in a laboratory in a fungus called Aspergillus niger. Since it structurally resembles lactoferrin, it is expected to stimulate the immune system and equip it to fight cancer.
Dr Atul Varadhachary, president, Agennix was quoted in the Houston Chronicle, as saying: "It helps in our gut. We started looking at this and wondered if it would be helpful to stimulate the immune system in this way so it could take care of the cancer."
As per pharmaceutical sector analysts, treatment of nonsmall-cell lung cancer is a $4 billion market in the US. If the drug gets a clean chit from FDA, Agennix will not only be the first company from Houston to own a federally approved drug, but will also stand to make high financial gains.
FDA is currently scanning the drug under Phase III of its clinical trials. The Houston Chronicle reported that earlier phases of testing showed Talactoferrin had low toxicity, making it ideal for combination with chemo-therapy and other drugs to battle treatment-resistant cancers.
"We're the first cancer drug developed in Houston to get this far and ours is distinct because it can be taken in combination with other therapies, because it's extremely well tolerated. Half the patient population can't take some of the recently approved drugs because of their toxicity. Ours would apply to the entire population," said Varadhachary.
Phase II trials by FDA showed a remarkable 62 per cent improvement in patients, with tumours shrinking by 30 per cent or more.
As Varadhachary explained to the Houston Chronicle, that more than 200 sites around the world will be dosing Talactoferrin in 1,100 "first line" patients who have not received any other kind of treatment. While another 700 "third line" patients who have failed with two or more standard cancer treatments, such as chemo-therapy, will also get the drug.
M.D. Anderson Cancer Center and Baylor College of Medicine will be participating in the Phase III trials.
With a Special Protocol Assessment from the FDA, Aggenix will embark on marketing the drug provided no public health concerns are raised after the final trials.
Agennix's Talactoferrin Alfa is a liquid to be taken orally in two 15-milliliter doses a day. This drug is likely to bring down the death toll of lung cancer in the US, which was a veritable 160,000 last year.
After the success of FDA Phase III trials, Agennix will implement its contract for commercial production of this drug in Capua, Italy.
Realising the extent of the disease's spread in Europe (300, 000 fresh cases diagnosed every year vis-à-vis 200, 000 new cases in the US), the European Medicines Agency has promised Agennix a marketing agreement in the European Union.
Apart from Agennix, other Houston-based biotech companies awaiting FDA Phase III approvals are: Encysive Pharmaceuticals for its drug Thelin to treat pulmonary hypertension and Repros Therapeutics for its Proellex to treat uterine fibroids.