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Impact Biomedicines Presents Analysis at the 2017 ASH Annual Meeting Suggesting that Fedratinib Did Not Increase Wernicke Encephalopathy Risk in Phase 2 and 3 Myelofibrosis Clinical Trials


Impact Biomedicines today presented a case review on fedratinib, a
selective oral small molecule JAK2 kinase inhibitor that is being
developed for the treatment of myelofibrosis (MF) and polycythemia vera
(PV), in a poster session at the 59th American Society of
Hematology (ASH) Annual Meeting, taking place on December 9-12, 2017 in
Atlanta, GA.

The poster titled "Case Series of Potential Wernicke Encephalopathy in
Patients treated with Fedratinib," demonstrated that patients treated
with fedratinib in clinical trials did not experience a decrease in
thiamine levels, and the prevalence of Wernicke Encephalopathy (WE) in
the trials was less than originally perceived for patients with
myeloproliferative neoplasms.

"Wernicke encephalopathy is a preventable and treatable condition that
can be associated with myeloproliferative neoplasms due to
splenomegaly-related malnutrition and neurological symptoms, and is
sometimes difficult to diagnose due to comorbidities in these patients,"
said Dr. Catriona Jamieson, Interim Chief Medical Officer of Impact
Biomedicines. "After in-depth analysis of the fedratinib data, we were
able to determine that there was only 1 clear case of WE and that
occurred in a significantly malnourished and debilitated patient."
Concurrently, Dr. Jamieson serves as Professor of Medicine and Chief of
Regenerative Medicine, Deputy Director of the Sanford Stem Cell Clinical
Center, Co-leader of the Hematologic Malignancies Program, and Director
of Stem Cell Research at the Moores UC San Diego Cancer Center.

Results presented in the poster included a retrospective analysis of
clinical reports showing that thiamine levels and MRI results from the 8
subjects suspected to have WE clearly supported a diagnosis of WE in
only 1 of 877 treated subjects. The diagnosed patient entered the
fedratinib clinical trial with >10% weight loss and had preceding
protracted nausea and vomiting, suggesting this as a contributing factor
to malnutrition and thiamine deficiency. This patient was treated with
IV thiamine and WE was considered resolved 2 months later.

"The retrospective identification of suspected Wernicke encephalopathy
was the major impediment to fedratinib clinical development in 2013,"
said Dr. John Hood, Chief Executive Officer of Impact Biomedicines. "Our
extensive case review has shown us that fedratinib does not inhibit
thiamine uptake. Furthermore, there are data to suggest WE is a
condition already associated with myeloproliferative neoplasms, and can
be treated with thiamine and prevented with proper nutrition. This
discovery enables us to move forward with getting fedratinib into the
hands of patients who need it."

In JAKARTA-1, a completed international Phase 3 pivotal trial for the
treatment of myelofibrosis, fedratinib met its primary and secondary
endpoints by reducing spleen size in 47% of patients by ≥35% at 24 weeks
(p<0.0001) and improving symptom score in 36% of patients by ≥50% at 24
weeks (p< 0.0001)1. Comparable responses were seen in
patients with normal or low platelet counts and thrombocytopenia was
similar between placebo and the target dose of 400mg. In JAKARTA-2, a
study in patients who were unresponsive to all other available
therapies, including patients who were either Jakafi® (ruxolitinib)
resistant or intolerant, fedratinib showed similar activity2.
In that study, 55% of patients who had failed or were intolerant to
ruxolitinib experienced a spleen size reduction of ≥35% with fedratinib.
Notably, responses were noted in 63% of patients intolerant to
ruxolitinib and 61% of patients who had lost ruxolitinib response.
Currently, ruxolitinib is the only drug approved by the FDA to treat
patients with MF and PV. The most common adverse events for fedratinib
were hematological (anemia) and gastrointestinal (nausea, diarrhea and
vomiting). The results of these trials have been published in leading
peer-reviewed journals.

The poster can be accessed via the "presentations and publications"
section of the Impact website.

About Impact Biomedicines
Impact Biomedicines is pioneering
the development of life changing treatments for patients with complex
cancers. The Company's pipeline is centered around fedratinib, a potent
and highly selective oral small molecule, JAK2 kinase inhibitor that is
being developed initially for the treatment of myelofibrosis (MF) and
polycythemia vera (PV).

1 Pardanani A, Harrison CN, Cortes JE, et al. Results of a
randomized, double-blind, placebo-controlled phase III study (JAKARTA)
of the JAK2-selective inhibitor fedratinib (SAR302503) in patients with
myelofibrosis (MF) Blood. 2013;122(21):393.

2 Harrison CN, Schaap N, Vannucchi AM, et al. Janus kinase-2
inhibitor fedratinib in patients with myelofibrosis previously treated
with ruxolitinib (JAKARTA-2): a single-arm, open-label, non-randomised,
phase 2, multicentre study. Lancet Haematol. 2017 Jul;4(7):e317-e324.

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