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Ziopharm Oncology Announces Publication of Positive Results of a Controlled IL-12 Phase 1 Monotherapy Trial in Recurrent Glioblastoma Patients in Scientific Translation Medicine

– Advert-RTS-hIL-12 and 20 mg veledimex (IL-12 Controlled Medium) Decided to be the Most popular Dose
for the Remedy of Adult Glioblastoma Repeated Low Dose Steroids –
– Median General Survival 12 in patients receiving low-dose steroids had 17.eight months –
– Increased tumor-absorbed lymphocytes and PD-1 (programmed cell demise protein 1) help the immunological antitumor impact of
managed IL-12 – [19659] BOSTON, Aug. 14, 2019 (GLOBE NEWSWIRE) – Ziopharm Oncology, Inc. ("Ziopharm" or "Company") (Nasdaq: ZIOP), at the moment announced controlled IL-12 in sufferers with recurrent glioma, in the journal Science Translational Medicine. Publication, entitled "Adjustable interleukin-12 gene therapy on recurrent high-grade glioma: results of the Phase 1 study," is out there at https://stm.sciencemag.org/.[19659002^NoinkuinIL-12tunnetaanvoimakkaanaimmuuniaktivaattorinajokalaukaiseeT-solutkohdistamaansyöpäähistoriallisettutkimuksetjotkasystemaattisestiinfusoivatIL-12-proteiiniaovatepäonnistuneetsietämättömäntoksisuudentakiaSitävastointämätutkimusosoittiettäligandillaindusoitugeenikytkinsääteleeILExpressionof-12CentralNervousSystemandMainlyEnhancedPresenceofCytokineandT-CellActivityinaTumorEnviromentwhilemaintainingafavorablesafetyprofile

Glioblastoma is an aggressive, largely incurable most cancers. Patients receive surgery, radiation, and chemotherapy, however in virtually all instances the tumors recuperate inside months. When this mind cancer recurs, the median general survival time is six to nine months.1,2

The article accommodates knowledge from 31 sufferers with recurrent glioblastoma (rGBM) treated with controlled IL-12 (Ad-RTS-hIL-12). plus veledime), Advert + V). The incidence and severity of antagonistic occasions, together with cytokine launch syndrome, correlated with dose of veledimex (ligand), reversible upon discontinuation. The 20 mg dose of veledimex achieved better treatment readiness and showed a median follow-up of 12.7 months with a median general survival (mOS) of 13.1 months. Concomitant corticosteroids adversely affected survival and sufferers continued to have an improved MOS of 17.eight months, with the cumulative dexamethasone quantity being restricted to lower than 20 mg during lively veledimex administration.

“I want to thank the site teams and researchers, as well as all the patients who participated in this study,” stated Ziopharm CEO, Ph.D. Laurence Cooper, “This research confirmed that our monotherapy-controlled IL-12 platform offers speedy immune activation and is associated with basic enchancment. survival in rGBM sufferers with a favorable safety profile. In addition, the rise in PD-1 expression observed in repeated biopsies in this research helps the choice to proceed our ongoing experiments combining controlled IL-12 inhibitors with programmed death-1 (PD-1). "

" In Phase 1, we are trying to show that the new drug candidate is primarily safe for patients, while trying to prove the original evidence of efficacy, "stated Antonio Chiocca, MD, PhD, senior writer and chair of Neurosurgery and Brigham and Ladies's Hospital Neuroscience Professor of Neurosurgery at Harvard Medical Faculty and director of surgical procedure on the Dana-Farber Cancer Institute Neuroconcology Middle. “We consider these outcomes show that it’s now attainable to manage immunotherapy by means of genes. Controlled IL-12 is nicely tolerated in patients with glioblastoma and has encouraging proof that the drug has the meant impact. "

" Repeated glioblastoma is a devastating cancer, and few treatments have been shown to be successful. This updated data demonstrates a promising continuation of patient survival and demonstrates how the control of potent cytokine IL-12 can bind to the body's own immune system to produce an anti-tumor response to rGBM, "says assistant Rimas V. Lukas, MD. Assistant Professor of Neurology (Neurooncology), Feinberg Medical Faculty of Medicine, and Department of Neurology, University of Chicago. Gene therapy designed to induce and management the production of human interleukin 12 (hIL-12) as the primary regulator of the immune system have to be investigated for the -12 substrate. The corporate has handled greater than 100 patients, together with more than 75 rGBM sufferers, with Advert-RTS-hIL-12 and velimix and administered more than 1,300 doses of veledimex in three varieties of strong tumors, building a vital safety profile, mechanical knowledge and evidence of antitumor effects.

Earlier this yr, the company introduced the completion of its enrollment in an enlargement statistics research (Clinicaltrials.gov NCT03679754), which prolonged the first-phase research to a different 36 patients with Ad-RTS-hIL-12 plus 20 mg / day veledimex for up to 14 days. In that cohort, 75% of patients (27/36) acquired low dose steroids.

Info on Controlled IL-12 with PD-1 Inhibitors
Ziopharm also promotes Ad-RTS-hIL-12 plus veledimex. for remedy of rGBM in combination with immune checkpoint inhibitors. The corporate announced in June 2019 that it had enrolled in three dose teams in a Phase 1 research of grownup sufferers with rGBM to guage a single dose of Ad-RTS-hIL-12 plus every day Velimex in combination with OPDIVO (nivolumab). an immune checkpoint inhibitor towards PD-1 (Clinicaltrials.gov NCT03636477). Based mostly on a good security profile, researchers in this multi-center trial confirmed interest in increasing the research, and the corporate now expects to report up to 12 further sufferers at the highest dosage degree.

In June 2019, the company announced the launch of a Phase 2 research evaluating the mixture of Ad-RTS-hIL-12 and veledimex with PD-1 antibody Libtayo® (cemiplimab – rwlc) for the remedy of recurrent or progressive glioblastoma (rGBM) in adults . The multi-center examination is carried out in about 10 hospitals specializing in mind cancer in the USA. The open-label, single-arm, part 2 trial enrolls roughly 30 rGBM sufferers with safety and efficacy endpoints.

Fast and Orphan Designation
In April 2019, Ziopharm announced that the FDA had granted a speedy designation to the company's dominant IL-12 program for the remedy of rGBM in adults. The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) issued a favorable opinion in August 2019 recommending that controlled IL-12 be designated an orphan medicinal product for the remedy of glioma.

Study more about Controlled IL-12. on-line at https://ziopharm.com/controlled-il-12[194590066CKamiya-MatsuokaMRGilbertRepeatedGangloblastomaTreatment:UpdateCNSOncol491-104(2015)
2. M.M. Mrugala, Progress and Challenges in Glioblastoma Remedy: Medical Imaginative and prescient. Discov Med 15, 221–230 (2013).

About Ziopharm Oncology, Inc.
Ziopharm Oncology is an immuno-oncology company that focuses on creating cost-effective solutions to comprehensive cost-effective solutions utilizing its viral-free sleeping magnificence. beginning with TCR and CAR-T cell therapies and immune system stimulating gene therapy with controlled interleukin 12 (IL-12). Sleeping Beauty medium genetically modifies T cells with DNA plasmids to precise T cell receptors (TCRs) to target neo-antigens inside and out of doors of strong tumor loading points and chimeric antigen receptors (CAR) to focus on CD19 of blood cancers using the company's “quick personalized CAR” T inside two days of gene switch. The Sleeping Beauty platform is being developed in collaboration with the National Most cancers Institute, MD Anderson Most cancers Middle on the University of Texas and Eden BioCell. The company can also be creating its managed IL-12 platform or Advert-RTS-hIL-12 plus veledimex as monotherapy and in mixture with immune checkpoint inhibitors in the remedy of brain most cancers, additionally in cooperation with Regeneron Prescription drugs.

Ahead-Wanting Statements Disclaimer of Disclaimer
This press release incorporates forward-looking statements as outlined in the Personal Securities Litigation of 1995, as amended. Forward-looking statements are statements that are not historical details and in some instances could also be recognized by phrases corresponding to "may", "will", "could", "expect", "plans", "anticipate" and "believe" consists of, however is just not restricted to, statements relating to the Company's enterprise and strategic plans and the progress and timing of the Firm's research and improvement packages, together with affected person enrollment expectations. Whereas Ziopharm's management believes that the expectations mirrored in such forward-looking statements are affordable, buyers are warned that forward-looking info and statements carry a variety of risks and uncertainties, many of that are troublesome to foretell and are usually in the control of Ziopharm. , which can trigger precise outcomes and performance to differ materially from what is disclosed or implied in the forward-looking statements and statements. These dangers and uncertainties embrace, however aren’t limited to, modifications in policies which will affect our cash outlay, uncertainty associated to analysis and improvement, future medical information and analysis, together with any of Ziopharm's product candidates in the preclinical research or the obtaining approval from regulatory businesses to conduct medical trials, and whether or not and for what objective, to acquire ultimate approval from the US FDA or comparable overseas regulatory businesses; The power and enforceability of Ziopharm's mental property rights; competition from other pharmaceutical and biotechnology corporations, and the danger elements mentioned or identified in Ziopharm's public purposes to the Securities and Change Commission, together with the dangers and uncertainties listed in the Ziopharm Interim Report on Type 10-Q, offered by and the Trade Commission. We provide this info as of the date of this press release, and Ziopharm is underneath no obligation to replace or revise the knowledge contained in this press release as a end result of new info, future occasions, or some other purpose.

Ziopharm Contact:
Chris Taylor
Director, Investor Relations and Company Communications
617.502.1881
ctaylor@ziopharm.com

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