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"With each of our approvals it becomes clearer that the time for
life-saving stem cell therapies in the practice of medicine has arrived,
and we are humbled to have a leading role," said
Osiris submitted a New Medicine Application (NMA) to Medsafe (
"The incidence of GvHD is likely to rise as the demographic profile of
our transplant population evolves," said
Clinical trials have shown that Prochymal is able to induce an objective, clinically meaningful response in 61-64 percent of children with GvHD that is otherwise refractory to treatment. Furthermore, treatment response with Prochymal resulted in a statistically significant improvement in survival.
"As a mother who watched my son Christian suffer and die from the
horrifying effects of GvHD, while waiting for the regulatory approvals
necessary to allow him access to Prochymal, words cannot express how
happy I am that significant progress is finally being made," said
Prochymal is now approved in
About GvHD
GvHD represents a major unmet medical need with no approved treatment until Prochymal. GvHD is the leading cause of transplant related mortality, in which immune cells contained within the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Severe GvHD can cause blistering of the skin, intestinal hemorrhage and liver failure. Severe GvHD is extremely painful and fatal in up to 80 percent of cases. Currently, steroids are used as first-line therapy with a success rate of only 30-50 percent. When steroids fail, treatment options are limited to immunosuppressive agents used off-label with little benefit and significant toxicities.
About Prochymal (remestemcel-L)
Prochymal is the world's first approved drug with a stem cell as its
active ingredient. Developed by
About
Osiris, Prochymal, Grafix and Ovation are registered trademarks of
About
At only 13-years-old, Christian was diagnosed with a rare form of leukemia. The treatment for this cancer required a bone marrow transplant. However, due to the aggressive nature of the cancer, Christian relapsed and a second transplant was conducted. The treatment regimen consisted of extreme chemotherapy, radiation, and multiple surgeries. Despite the negative side effects from those treatments, nothing compared to the brutal suffering which occurred after he contracted graft-vs.-host disease, which painfully destroyed every part of Christian's body. The disease caused Christian's skin to peel off, and he vomited several liters of blood daily due to the destruction of his gastro intestinal tract. To make matters even worse, Christian experienced liver failure and suffered daily with extreme pain from head to toe. This condition was prevalent for the four months, and eventually lead to his death. No child should have to suffer like this, and watching Christian's body being destroyed by the disease was as horrifying for him as it was for our family and his caregivers.
After Christian died in
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking
statements include statements about our expectations, beliefs, plans,
objectives, intentions, assumptions and other statements that are not
historical facts. Words or phrases such as "anticipate," "believe,"
"continue," "ongoing," "estimate," "expect," "intend," "may," "plan,"
"potential," "predict," "project" or similar words or phrases, or the
negatives of those words or phrases, may identify forward-looking
statements, but the absence of these words does not necessarily mean
that a statement is not forward-looking. Examples of forward-looking
statements include, but are not limited to, statements regarding the
following: our product development efforts; our clinical trials and
anticipated regulatory requirements and the ability to successfully
navigate these requirements; the success of our product candidates in
development; status of the regulatory process for our biologic drug
candidates; implementation of our corporate strategy; our financial
performance; our product research and development activities and
projected expenditures, including our anticipated timeline and clinical
strategy for Prochymal, Chondrogen and our other MSC and biologic drug
candidates; our cash needs; patents and proprietary rights; the safety
and ability of our potential products to treat disease and the results
of our scientific research; our plans for sales and marketing; our plans
regarding our facilities; types of regulatory frameworks we expect will
be applicable to our potential products; and results of our scientific
research. Forward-looking statements are subject to known and unknown
risks and uncertainties and are based on potentially inaccurate
assumptions that could cause actual results to differ materially from
those expected or implied by the forward-looking statements. Our actual
results could differ materially from those anticipated in
forward-looking statements for many reasons, including the factors
described in the section entitled "Risk Factors" in our Annual Report on
Form 10-K and other Periodic Reports filed on Form 10-Q, with the
OsirisPR@Osiris.com
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