AsianScientist (May 7, 2015) – Stempeutics Research, a group company of Manipal Education and Medical Group and a Joint Venture with Cipla Group, announced that the State Intellectual Property Office of China (SIPO) has granted a process patent for its novel stem-cell based drug Stempeucel®.
Stempeucel® will initially be used for the treatment of critical limb ischemia (CLI), a progressive form of peripheral arterial disease, which blocks the arteries in the lower extremities, resulting in the reduction of blood flow. It is a debilitating disease which affects patients with severe pain in the feet or toes.
Insufficient supply of blood flow results into the development of sores and wounds in legs and feet. If left untreated, patients may ultimately have to undergo amputation of the affected limb as the last treatment option.
In China, the most common current treatments for CLI are characterized by high rates of primary amputations, multiple procedures and high rates of procedure-related complications. In such cases, the disease not only affects the quality of life but also increases the economic burden of patients.
Stempeucel® is derived from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy, adult voluntary donors. Unlike existing drugs which deal with the symptoms of the disease, Stempeucel® is expected to address the root cause by stimulating the regrowth of blood vessels.
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. This approach also allows more than one million patient doses from a single set of master cell banks, which is unique in regenerative medicine. The proprietary technology allows Stempeucel® to extend the therapeutic potential of the drug across multiple disease categories.
“Stempeutics has taken an aggressive, focused and well thought-out scientific approach to understand the biology of human adult stem cells and to harness the potential of these cells for the treatment of CLI,” said Mr. B. N. Manohar, CEO of Stempeutic.
“The efforts are realized through innovative technologies and ideas, cutting edge R&D, patentable process development, large scale manufacturing and effective clinical trial design. We believe that the Stempeucel® product is a game-changer offering an advanced therapeutic treatment to millions of patients suffering from this dreadful disease.”
Mr. Chandru Chawla, head Cipla New Ventures said,
“China has a high prevalence of diabetes and consequently many suffer from ischaemic limb condition. The patent grant in China is yet another important milestone after the grant of the patent in the United States.”
Stempeutics has already submitted its application to the Drug Controller General of India (DCGI) to obtain marketing authorization approval for Stempeucel®. The availability of the product in the market is subjected to DCGI approvals.
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Source: Stempeutics Research.
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