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NEWTOWN, Pa. and LUXEMBOURG, Dec. 06, 2019 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (ONTX) (“Onconova”), a Phase 3-stage biopharmaceutical aggregation advertent and developing atypical articles to amusement cancer, with an antecedent focus on myelodysplastic syndromes (MDS), and Inceptua Medicines Admission (a business assemblage of the Inceptua Group), a all-around biologic aggregation and account partner, today appear that they accept entered into a accord to accomplish accessible intravenous rigosertib via a Pre-approval Admission Affairs in called countries about the world.
Pre-approval Admission Programs (also accepted as broadcast access, aboriginal access, compassionate use, called accommodating supply) are regulatory-compliant processes allowing beginning agents in development to be fabricated accessible aloft the appeal of a physician or a accommodating for adapted patients for whom no another assay advantage exists in their country. Rigosertib is a baby atom that inhibits cellular signaling in blight beef by acting as a RAS mimetic. Current analytic development of rigosertib is centered aloft the ameliorative administration of MDS, a amalgamate accumulation of cartilage bottom disorders characterized by abortive hematopoiesis that generally advance into astute myeloid leukemia (AML). Rigosertib, in its intravenous formulation, is currently in Phase 3 analytic development for the assay of higher-risk MDS.
The rigosertib Pre-approval Admission Affairs is accepted to barrage in aboriginal bisected of 2020 and will acquiesce Inceptua to accumulation intravenous rigosertib aural appointed countries, primarily and initially concentrated in called countries in Europe, in acknowledgment to physician requests for patients with higher-risk MDS who accept beat all accessible assay options, and are not acceptable for or accept no admission to the INSPIRE study. Beneath the acceding of this agreement, Inceptua will abutment Onconova through the pre-approval accouterment of intravenous rigosertib initially into a cardinal of countries including: Australia, Denmark, Finland, France, Ireland, Italy, the Netherlands, Portugal, South Africa, Spain, and the UK.
“Inceptua Medicines Admission is captivated to be called as Onconova’s accomplice for the Pre-approval Admission Affairs for rigosertib. Higher-risk MDS is a ache with cogent unmet need, and we are admiring to be able to abutment healthcare professionals gluttonous admission to rigosertib, advanced of its bartering launch,” said Mark Corbett, EVP, Inceptua Medicines Access.
Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, said, “The rigosertib Pre-approval Admission Affairs is a key cardinal action for Onconova. We are admiring that intravenous rigosertib will be fabricated compliantly accessible to acceptable patients with higher-risk MDS through their physicians in appointed countries. The affairs will run alongside our advancing Phase 3 INSPIRE Trial, and is accepted to abide until bartering barrage in such countries. We are admiring to assignment with Inceptua, accustomed their able almanac of administering such programs successfully.”
Please note: Inceptua can alone acknowledge to unsolicited requests from bona fide healthcare professionals. Healthcare professionals can admission advice about the rigosertib Pre-approval Admission Affairs by contacting Inceptua either by blast 44 20 3910 7600 or by email: [email protected]
About Onconova Therapeutics, Inc.
Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical aggregation focused on advertent and developing atypical baby atom biologic candidates to amusement cancer, with an antecedent focus on Myelodysplastic Syndromes (MDS). Using a proprietary allure platform, Onconova has created a activity of targeted agents advised to assignment adjoin specific cellular pathways that are important in blight cells. Advanced analytic trials with the Company’s advance compound, rigosertib, are aimed at what the Aggregation believes are unmet medical needs of patients with MDS. Onconova has conducted trials with two added assay compounds and has a pre-clinical affairs with a CDK4/6 and Ark5 inhibitor, ON 123300.
For added information, amuse appointment http://www.onconova.com.
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are altitude that can action back the blood-forming beef in the cartilage bottom become abortive and appropriately aftermath an bare cardinal of circulating claret cells. It is frequently associated with the attendance of blasts or leukemic beef in the marrow. This leads to low numbers of one or added types of circulating claret cells, and to the charge for claret transfusions. In MDS, some of the beef in the cartilage bottom are aberrant (dysplastic) and may accept abiogenetic abnormalities associated with them. Altered corpuscle types can be affected, although the best accepted award in MDS is a curtailment of red claret beef (anemia). Patients with higher-risk MDS may advance to the development of astute leukemia.
Rigosertib, Onconova’s advance candidate, is a proprietary Phase 3 baby molecule. A key advertisement in a preclinical archetypal approved rigosertib’s adeptness to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: “A Baby Atom RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling.” Corpuscle 165, 643). Onconova is currently in the analytic development date with articulate and IV rigosertib, including analytic trials belief distinct abettor IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE trial) and articulate rigosertib added azacitidine in first-line and adverse higher-risk MDS patients (Phase 2). Patents accoutrement articulate and injectable rigosertib accept been issued in the US and are accepted to accommodate advantage until at atomic 2037.
About the INSPIRE Phase 3 Analytic Trial
The analytic balloon INternational Abstraction of Phase 3 IV RigosErtib, or INSPIRE, was accomplished afterward advice accustomed from the U.S. Food and Biologic Administration and European Medicines Agency. INSPIRE is a global, multi-center, randomized, controlled abstraction to appraise the adeptness and assurance of IV rigosertib in higher-risk MDS (HR-MDS) patients who had progressed on, bootless to acknowledge to, or relapsed afterwards antecedent assay with a hypomethylating abettor (HMA) aural nine cycles over the advance of one year afterwards admission of HMA treatment. This time anatomy optimizes the befalling to acknowledge to assay with an HMA above-mentioned to declaring assay failure, as per NCCN Guidelines. Patients are randomized at a 2:1 arrangement into two abstraction arms: IV rigosertib added Best Supportive Affliction against Physician’s Choice added Best Supportive Care. The primary endpoint of INSPIRE is all-embracing survival. The balloon connected above the pre-specified acting assay and is advancing its conclusion. Abounding capacity of the INSPIRE trial, such as admittance and exclusion criteria, as able-bodied as accessory endpoints, can be begin on clinicaltrials.gov (NCT02562443).
About IV Rigosertib
The intravenous anatomy of rigosertib has been advised in Phase 1, 2, and 3 analytic trials involving added than 1000 patients, and is currently actuality evaluated in a randomized Phase 3 all-embracing INSPIRE balloon for patients with HR-MDS after abortion of HMA therapy.
About Articulate Rigosertib
The articulate anatomy of rigosertib was developed to accommodate a potentially added acceptable dosage anatomy for use area the continuance of assay may extend to assorted years. This dosage anatomy may additionally abutment aggregate analysis modalities. To date, over 400 patients accept been dosed with the articulate conception of rigosertib in analytic trials. Aggregate analysis of articulate rigosertib with azacitidine, the accepted of affliction in HR-MDS, has additionally been studied. Currently, articulate rigosertib is actuality developed as a aggregate analysis calm with azacitidine for patients with higher-risk MDS who crave HMA therapy. A Phase 1/2 balloon of the aggregate analysis has been absolutely enrolled, and the basic adeptness and assurance abstracts was presented at The American Society of Hematology (ASH) Annual Meeting in December 2018. The abstracts will be adapted at the accessible 2019 ASH Annual Meeting abutting week.
Inceptua is a biologic aggregation and account accomplice spanning throughout the artefact lifecycle – from comparator sourcing for analytic trials, through aboriginal admission programs to licensing and commercialization for products.
We accomplice with activity science companies of all sizes, cartoon on over 20 years of industry experience. Our pharma and biotech alms includes allotment and commercialization of articles through in-licensing and adjustable partnerships. We accept arch adeptness in action and operational accomplishing of pre-approval admission programs authoritative biologic articles beneath analytic development accessible for patients and Inceptua’s analytic balloon casework business offers aerial affection analytic comparator sourcing and accomplishment casework with an active all-around accumulation alternation to ensure that articles are delivered absolutely back needed.
Inceptua Medicines Admission is a business assemblage of the Inceptua Group. It offers abounding admission solutions for the design, accomplishing and commitment of Pre-approval and Medicines Admission Programs on account of biopharmaceutical companies.
Inceptua has all-around operations with bounded offices beyond Europe, USA, and Asia.
Some of the statements in this absolution are advanced statements aural the acceptation of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and absorb risks and uncertainties. These statements chronicle to Onconova expectations apropos the INSPIRE Balloon and Onconova’s added development plans. Onconova has attempted to analyze advanced statements by analogue including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or added words that back ambiguity of approaching contest or outcomes. Although Onconova believes that the expectations reflected in such advanced statements are reasonable as of the date made, expectations may prove to accept been materially altered from the after-effects bidding or adumbrated by such advanced statements. These statements are alone predictions and absorb accepted and alien risks, uncertainties, and added factors, including Onconova’s adeptness to abide as a activity concern, advance its Nasdaq listing, the charge for added financing, the success and timing of Onconova’s analytic trials and authoritative approval of protocols, our collaborations, and those discussed beneath the branch “Risk Factors” in Onconova’s best contempo Annual Report on Anatomy 10-K and annual letters on Anatomy 10-Q. Any advanced statements independent in this absolution allege alone as of its date. Onconova undertakes no obligation to amend any advanced statements independent in this absolution to reflect contest or affairs occurring afterwards its date or to reflect the accident of hasty events.
General Contacts:Mark CorbettExecutive Vice PresidentInceptua Medicines Admission 44 20 3910 [email protected]
Avi OlerOnconova Therapeutics, Inc. [email protected]://www.onconova.com/contact/
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