NEW YORK--(BUSINESS WIRE)--Cytovia, Inc. (“Cytovia”) the oncology subsidiary of Immune Pharmaceuticals Inc. (NASDAQ:IMNP) ("Immune" or the “Company”), a clinical stage biopharmaceutical company, announced the filing of a patent protecting the use of Ceplene® (histamine dihydrochloride) in hematologic cancers. The new patent is based on favorable clinical results in patients with acute myeloid leukemia (AML) who had persistent cancer cells in their bone marrow. The patent aims to protect the use of Ceplene® in forms of cancer where malignant cells may harbor a mutated oncogene, NPM1mut(mutated nucleophosmin gene). These forms of cancer include AML, non-Hodgkin lymphoma, acute promyelocytic leukemia and myelodysplastic syndrome.
A mutated NPM1 gene (NPM1mut) is found in cancer cells in approximately 25-30% of patients with AML. The presence of NPM1mut cancer cells in bone marrow after the completion of chemotherapy (i.e. persistence of leukemic cells or “minimal residual disease”) is associated with high relapse risk and poor overall survival. In a recent clinical study in the New England Journal of Medicine only 19% of adult AML patients in complete remission with persistence of NPM1mut cancer cells remained relapse-free, and only 40 % survived for more than 2 years (Ivey et al., 2016).
In Cytovia’s proprietary Re:Mission phase IV trial in AML, adult patients in complete remission received Ceplene® and low-dose IL-2 to prevent relapse. At onset of treatment with Ceplene®/IL-2, nine patients (51-76 years old) had persistent NPM1mut cancer cells in bone marrow. Five of these 9 patients (58%) remained relapse-free, and 6/9 patients (78%) survived for more than 2 years.
“The persistence of NPM1mut leukemic cells after the completion of chemotherapy heralds poor prognosis in AML, and no targeted therapy is available for these patients,” said Dr. Anna Martner at the Sahlgrenska Cancer Center, University of Gothenburg. “Our results merit an extended clinical trial aiming to clarify to what extent treatment with Ceplene®/IL-2 may eradicate persistent leukemia.”
“We are encouraged by these new results,” said Dr. Daniel Teper, of Cytovia. “The Company is in discussion with leading hematologists to pursue larger studies aiming to confirm the clinical benefit of Ceplene®/IL-2 in multiple hematological cancers with overexpression of NPM1mut .”
The Re:Mission phase IV trial studied 84 AML adult patients who received Ceplene and low-dose IL-2 to prevent relapses. For details of the trial design, please visit https://clinicaltrials.gov/ct2/show/NCT01347996?term=ceplene&rank=1.
Most Patients with AML initially achieve complete remission from leukemia after receiving chemotherapy. However, the majority of adult patients will experience relapse of AML with poor prospects of long-term survival. Ceplene®, used in conjunction with low-dose IL-2, has been developed to prevent relapses in the post-chemotherapy phase of AML. A previous phase III trial in 320 patients confirmed the efficacy of Ceplene®/IL-2 in preventing relapse of AML.
Ceplene, in combination with low-dose Proleukin (interleukin-2 (IL-2)), has been approved in over 30 countries in Europe and in Israel for the treatment of AML for maintenance of remission and prevention of relapse of leukemia. For the vast majority of AML patients there is currently no other approved therapy to prevent relapse post first remission.
Ceplene (histamine dihydrochloride) is an immunostimulant that is administered in conjunction with low-dose interleukin-2 (IL-2), for maintenance of first remission in patients with AML. Ceplene has been shown in an international phase III clinical study to prevent relapse of leukemia in AML patients in first remission while maintaining good quality of life during treatment. Ceplene acts by countering dysfunction and apoptosis of T and NK cells, thereby inducing immune-mediated killing of leukemic cells, providing a strong pharmacological rationale for the combination therapy. A recent Phase IV study presented at the meeting of the American Association for Cancer Research in 2016 supported the safety and efficacy of Ceplene demonstrated in the international phase III study. Following Cytovia’s recent acquisition of Ceplene from Mylan, the Company now holds worldwide rights for Ceplene.
AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis, and typically become free of detectable leukemia, achieving "complete remission". However, within 1-2 years the majority of adult patients will experience a relapse of leukemia, of which the prognosis for survival is 33% in younger patients and 15-20% in patients over 60 years of age. According to the American Cancer Society, there will be approximately 21,380 new cases of AML and 10,590 deaths from AML in the US in 2017. AML represents an orphan indication with particularly high unmet need.
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. (NASDAQ:IMNP) is dedicated to alleviating the burden of patients suffering from autoimmune diseases by developing novel immunotherapeutic agents. Immune's lead product candidate, bertilimumab, is in Phase 2 clinical development for bullous pemphigoid, an orphan autoimmune dermatological condition, and for ulcerative colitis. Other potential relevant indications for bertilimumab include atopic dermatitis, Crohn's disease, severe asthma and Non-Alcoholic Steato-Hepatitis (NASH). Also, Immune's pipeline includes topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis and AmiKet™ and AmiKet™ Nano™ for the treatment of neuropathic pain.
Immune's oncology subsidiary, Cytovia, plans to develop Ceplene for maintenance remission in AML in combination with IL-2. Additional oncology pipeline products include Azixa® and crolibulin, which are clinical stage vascular disrupting agents, and bispecific antibodies and NanomAbs™, which are novel technology platforms.
For more information, please visit Immune's website at www.immunepharma.com, the content of which is not a part of this press release.
This news release, and any oral statements made with respect to the information contained in this news release, may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal" or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. Forward-looking statements include, among others, statements regarding the Company's ability to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.
There can be no assurance that the Company will ever successfully complete its anticipated corporate restructuring, or that the Company will be able to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. Factors that may cause actual results or developments to differ materially include, but are not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that ongoing or future clinical trials will not be successful; the risk that our compounds under development will not receive regulatory approval or achieve significant commercial success; the risk that we will not be able to find a partner to help conduct future trials or commercialize our product candidates on attractive terms, on a timely basis or at all; the risk that our product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later-stage clinical trials; the risk that we will not obtain approval to market any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property. There is no certainty that Cytovia or its commercial partners will achieve a certain market share of the addressable market in AML. There is also uncertainty that the reimbursement price will be maintained in Europe or that it will accepted in Latin America. In addition, among other risks, there can be no guarantee that concomitant investment by Pint will be completed, or if it is completed, that it will close within the anticipated time period or that the expected benefits of the licensing and investment agreements will be realized.
These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and our other filings with the U.S. Securities and Exchange Commission.
You are urged to carefully review and consider the disclosures found in our filings, which are available at www.sec.gov or at www.immunepharma.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors. We expressly disclaim any obligation to publicly update any forward-looking statements contained herein (including those relating to the corporate reorganization and exploration of strategic alternatives), whether as a result of new information, future events or otherwise, except as required by law.