Plant-based psoriasis drug Tinefcon safe in human trials, says Piramal Life Sciences

Piramal Life Sciences Limited, a leading life sciences company from India, has reported clinical trial data on psoriasis drug Tinefcon suggesting that the experimental phytopharmaceutical product is safe.

As a partially purified extract of a plant, Tinefcon, sphaeranthus indicus (East Indian Globe Thistle), is categorised as a phytopharmaceutical in India and an herbal supplement in the USA.

Tinefcon safety data was in treating severe psoriasis presented at the 68th scientific session of American Academy of Dermatology held at Miami Beach, Florida, USA, from 5th to 9th, March 2010.

Tinefcon has been found quite effective and safe in patients with moderate to severe psoriasis, according to Dr Somesh Sharma, managing director, Piramal Life Sciences, who presented details of the clinical trial data.

Last year, Piramal Life Sciences carried out clinical trials for psoriasis in which the drug has shown good efficacy, and excellent safety profile, announced the company.

Piramal Life Sciences scientists discovered the efficacy of Tinefcon against psoriasis from as part of its ongoing phytopharmaceutical and NCE development programme.

In September 2009, Piramal Life Sciences presented the preclinical pharmacological data pertaining to a novel and injectable antibiotic PM181104 discovered and developed in-house.

In-house screening of the natural product library resulted in the discovery of this peptide molecule from a marine sponge-associated microorganism. This particular marine sponge was obtained from National Institute of Oceanography (NIO) under an ongoing collaboration between Piramal Life Sciences, and NIO.

Piramal Life Sciences Limited has embarked upon a research programme to discover and develop new chemical entities (NCEs) and Novel Drug Delivery Systems (NDDSs) in select therapeutic areas, including cancer, inflammation, diabetes / metabolic disorders and infectious diseases with a research pipeline of 14 molecules in different phases of development.

Piramal Life has completed phase I trials with a new molecule for type II diabetes in Europe, recently.

Its new molecule for diabetes – metabolic syndrome is currently undergoing phase 1 studies in Canada.

Piramal Life has a diverse collection of natural product extracts from microbes and plants from rare habitats in India. Discovery efforts are also directed towards evaluating and investigating medicinal extracts and preparations from herbs and plants used by tribals and cited in ancient ayurvedic texts.

Piramal Life’s lead chemical compound, a Cdk-4 inhibitor, has completed two phase studies and is being tested in another phase I/II trials for multiple myeloma.

Piramal Life’s cancer molecule P276 for pancreatic, and head and neck cancer has recently received regulatory approval by Drug Controller General of India (DCGI) for the initiation of two phase-I/II combination studies.

P276 is an inhibitor of key enzymes involved in the uncontrolled division and multiplication of cancer cells. It is being developed for the treatment of cancers for which there are inadequate treatment options. Multiple phase II, and Phase I/II trials are ongoing in USA, and India.

Piramal life started phase II trial of P 276 in USA in January to treat Mantle cell Lymphoma (MCL) and it is the second IND approved by the US FDA for this compound.

P-1446A-05, another cancer compound from Piramal Life Sciences Limited is currently in phase-I study in India. P-1446A-05 is an orally active molecule being developed for the treatment of cancer. P-1446A-05 is an inhibitor of key enzymes involved in the uncontrolled division and multiplication of cancer cells.

In August Piramal Life Sciences announced the completion of a phase I study of a new, orally active glucoselowering compound, P1736, in The Netherlands. P1736 is a non-PPARgamma insulin sensitizing compound and is being developed for the treatment of Type II diabetes. In the phase I trial single and multiple ascending dose studies were conducted in 30 and 22 healthy volunteers respectively, in The Netherlands.

Piramal Lifesciences, the recently spun off drug research arm of India’s leading generic company Piramal Healthcare, has plans to invest an additional Rs 200 crore in the in the next two years for discovery and development of new drugs.

Piramal Lifesciences, which was formed in 2008, posted a loss of Rs 31 crore for the quarter ended September 30 against a revenue of Rs 3 crore.

Piramal Healthcare plans to raise about 90% of the proposed investment of Rs 200 for the next two years through debt.

“Annually, we invest about Rs 100 crore. About 90% of the Rs 200 funding for the next two years will be raised through debt, ” Dr Swati Piramal, director at the Piramal Group was quoted as saying.

Costs developing new drugs are estimated to be over $1 billion and a new molecule could would require around 10-12 years to reach markets from the time of discovery.

However, cost of developing new drugs are rather low in India compared to western countries due to the abundance of patient population and cheaper but skilled workforce.

Piramal Lifesciences’s strategy is to develop upto proof-of-concept studies and then licence out to interested global pharma companies.

Piramal Life has drug discovery and developments agreements with Eli Lilly & Company and Merck & Company.
Psoriasis is a common and chronic inflammatory disease of the skin, and affects approximately 2 per cent of the world’s population.

In India, approximately 21 million people are believed to suffer from psoriasis. People with psoriasis typically have sharply demarcated chronic erythematous plaques covered by silvery white scales.

These commonly appear on the elbows, knees, scalp, umbilicus and lumbar area.

Current standard of care includes topical treatment with corticosteroids, vitamin D3 analogues (calcipotriol, calcitriol and tacalcitol) and retinoids (tazarotene), use of narrow band photo-therapy and use of biological agents.