Non-chemo cancer drug trial in state

KOLKATA: Indian American researchers and Calcutta University alumni Ananda Mohan Chakrabarty and Tapas Das Gupta have urged the state government to start clinical trial of their protein-based cancer drug p28. Once patented, it can then be administered to terminally ill patients in India. p28 is currently undergoing clinical trials in the US.
"We do understand how significant this research is and what it will mean to Bengal.The proposal will be cleared after the Budget," said state science and technology and biotechnology minister Rabiranjan Chattapadhyay.
The anti-cancer drug, once gets through, can replace chemotherapy. It has proven to be non-toxic but with significant cancer regressing effect in initial trials in the US. Talking to TOI from Chicago, Chakrabarty described the drug as a peptide of 28 amino acids. Termed p28, it is part of bacterial protein azurin.
In December, Chakraborty had visited Delhi and Kathmandu, seeking approval from governmental regulatory agencies and cancer hospitals to start a phase II clinical trial with p28.
Nearly 12 years ago, Das Gupta and Chakrabarty had set up their company CDG Therapeutics with approval from the US Food & Drug Administration (FDA) to conduct a clinical trial in 15 stage-IV cancer patients living in Chicago. Before the trial, the patients with tumours such as melanoma, sarcoma, prostate and colon were not responding to any drug. When administered through intra-venous injections, p28 not only exhibited its non-toxic (very unlike the chemotherapeutic drugs) quality but also stabilized the tumour growth. It allowed partial or even complete regression of the tumours in four patients, allowing three of them to survive beyond two years after the trial ended.
Encouraged by the results, the US government's National Cancer Institute (NCI) initiated a second trial in the US on 18 pediatric brain tumour patients (aged 3 to 21 years).
"Because brain tumours are highly invasive and difficult to treat, the NCI wanted to take a chance with p28. However, when NCI and a consortium - PBTC (pediatric brain tumour consortium) -started this trial in October 2013, they made it clear that if p28, used in adult dosages, proved to be toxic to these children or not very effective, they would stop the trial," the scientist said.
Since p28 has been proven to be non-toxic, unlike the highly toxic chemotherapeutic drugs, terminally ill patients in India may take a chance. The drug has been patented by UIC and exclusively licensed to CDG Therapeutics. Indian companies could start manufacturing and marketing it in India and its neighboring countries.
"In clinical trials in the US, p28 has not shown any of the side-effects prevalent in chemotherapy (nausea, vomiting, diarrhea, skin rash, anemia, hypertension and many other toxic symptoms). Learning this, relatives of cancer patients, both from India and abroad, have been writing to me to treat their loved ones. That's when I feel frustrated. I have to tell them p28 is not approved to treat patients unless such they are part of an approved clinical trial," Chakrabarty rued.
How expensive p28 will be if marketed in India? Chakrabarty admitted that because of the high quality of the peptide drug, which needs to be chemically synthesized to be administered to the patients, the price is likely to be relatively high. "But it's nowhere near the currently available anticancer drugs used in chemotherapy," he added.
Chakraborty and his colleagues in Mexico and Portugal are already working in producing p28's parent drug azurin as parts of plants so that in the future, patients all over the world would get their cancer therapy through food.
"Azurin and p28 have not only cancer therapeutic activity but both appear to have cancer preventive activity as well. Its consumption may be particularly useful to those genetically vulnerable to certain cancers (breast and ovarian)," Chakrabarty said.
Once the trial is over and the government gives its approval, p28 will be one the very few can drugs patented by India.
In India, drug companies play it safe by copying patented drugs and manufacture them once the patent period (of 20 years) expires. "Though India is the second largest exporter of patent-expired drugs, it only produces generics, which are copies of the original drugs patented by developed nations," the professor said.