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Stempeutics Research has received a process patent from the United States Patent and Trademarks Office for its novel stem cell-based drug Stempeucel.
The company is part of the Manipal Education and Medical Group and drugmaker Cipla entered into a joint alliance with it in 2009.
The drug will initially be used for the treatment of Critical Limb Ischemia (CLI), the companies said in a joint note, adding that the treatment option directly addresses the root cause of the disease, unlike others that treat the symptoms and not the disease.
CLI is a progressive form of peripheral arterial disease that blocks arteries in the lower extremities of the body, resulting in reduced blood flow.
It is a debilitating disease which affects patients with severe pain in the feet or toes, besides the development of sores and wounds, the note said.
If left untreated, patients may have to undergo amputation of the affected limb, it added.
Stempeutics has also submitted its applications to the regulatory Drug Controller General of India (DCGI) to obtain marketing authorisation for Stempeucel.
The availability of the product in the local market is subject to DCGI approvals.
In the US, the most common current treatments for CLI are characterised by high rates of primary amputations, multiple procedures and high rates of procedure-related complications, the note said.
And this not only affects the quality of life but also increases the economic burden of patients.
Manufacture plans Stempeucel is derived from specific cells extracted from the bone marrow of healthy, adult voluntary donors.
The company’s proprietary pooling approach allows an efficient manufacturing process with minimum wastage of resources in order to provide the product at an affordable cost to patients, it said.
This approach allows more than one million patient doses from a single set of master cell banks, which is unique in regenerative medicine, it added.
The proprietary technology allows Stempeucel® to extend the therapeutic potential of the drug across multiple disease categories, the companies said.
B N Manohar, Chief Executive of Stempeutics, said that the product was a game-changer offering advanced therapeutic treatment for millions of patients suffering with the disease.
Cipla’s head of New Ventures, Chandru Chawla, added that its investment in Stempeutics demonstrated the company’s commitment to bring in next generation biologics to address unmet medical needs.
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