myTomorrows and Omeros Corporation Collaborate to Provide an Expanded Access Program for Narsoplimab
“Through our Medical Team, we engage with physicians looking for treatment options for their patients with high unmet needs and who cannot access an existing clinical trial,” said
“We are pleased to partner with myTomorrows to broaden our expanded access program,” said
Narsoplimab has been granted Breakthrough Therapy designation by the
About Expanded Access Programs
An Expanded Access Program (sometimes called “compassionate use”) supports in a compliant and controlled way the treatment with a medicine currently not licensed in a patient’s country of residence. Such treatment can be an option for patients who have high unmet medical need and have exhausted all registered treatment options and cannot participate in a clinical trial.
Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplants. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, GvHD, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In
myTomorrows operates as a two-sided platform. It serves the interests of both patients and healthcare providers, as well as drug development. On one side, the company provides information on all treatment options to patients and physicians when registered treatments have been exhausted. Requests may come in to myTomorrows by phone, email, or through an online portal. After which physicians and patients will be directed to a member of our Medical Team for more information regarding treatment options. And on the other side, myTomorrows specializes in expanded access regulations and administration and real-world data collection, evolving scientific clinical development. myTomorrows has gained experience in running over 25 EAPs over the past 5 years, in more than 40 countries across 5 continents. For more information, please visit www.mytomorrows.com.
For specific questions regarding the Omeros’ expanded access program, please contact myTomorrows at firstname.lastname@example.org.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely”, “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “prospects,” “should,” “slated,” “targeting,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements, including statements regarding Omeros’ research and development programs and the therapeutic application of Omeros’ research findings, are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unproven preclinical and clinical development activities, availability and timing of data from preclinical or clinical studies and the results of such studies, risks associated with product commercialization and commercial operations, regulatory actions and oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K filed with the
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations