On October 03, 2017 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported final clinical and translational research data from its OVATION Study, a Phase Ib dose escalating clinical trial combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced Stage III/IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery (Press release, Celsion, OCT 3, 2017, View Source [SID1234520758]). GEN-1 is an IL-12 DNA plasmid vector formulated as a nanoparticle in a non-viral delivery system to cause the sustained local production and secretion of the Interleukin-12 (IL-12) protein loco-regionally to the tumor site.

The Company updated the translational data from the OVATION Study in a poster presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Special Conference entitled “Addressing Critical Questions in Ovarian Cancer Research and Treatment” at the Wyndham Grand Pittsburgh Downtown in Pittsburgh, PA. The poster entitled “Immunological changes following intraperitoneal administration of a formulated IL-12 plasmid in combination with neoadjuvant chemotherapy in newly diagnosed advanced ovarian cancer patients,” was presented by Dr. Khursheed Anwer, Celsion’s executive vice president and chief scientific officer in a poster session on Monday, October 2, 2017 from 6:00 PM to 8:30 PM.

The Company also held an Advisory Board Meeting on September 27, 2017 with the clinical investigators and scientific experts including those from Roswell Park Cancer Institute, Vanderbilt University Medical School, and M.D. Anderson Cancer Center to review and finalize clinical, translational research and safety data from the OVATION Study in order to determine the next steps forward for this exciting new immunotherapy. With the endorsement and recommendations from the Advisory Board, the Company expects to file a next phase protocol with FDA later this year.

Translational Research Data

Key translational research findings from all evaluable patients are consistent with the earlier reports from partial analysis of the data and are summarized below:

The intraperitoneal treatment of GEN-1 in conjunction with neoadjuvant chemotherapy resulted in dose dependent increases in IL-12 and Interferon-gamma (IFN-g) levels that were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic circulation. These and other post-treatment changes including decreases in VEGF levels in peritoneal fluid are consistent with an IL-12 based immune mechanism.

Consistent with the previous partial reports, the effects observed in the IHC analysis were pronounced decreases in the density of immunosuppressive T-cell signals (Foxp3, PD-1, PDL-1, IDO-1) and increases in CD8+ cells in the tumor microenvironment.

The ratio of CD8+ cells to immunosuppressive cells was increased in approximately 75% of patients suggesting an overall shift in the tumor microenvironment from immunosuppressive to pro-immune stimulatory following treatment with GEN-1. An increase in CD8+ to immunosuppressive T-cell populations is a leading indicator and believed to be a good predictor of improved overall survival.

Analysis of peritoneal fluid by cell sorting, not reported before, shows treatment-related decrease in the percentage of immunosuppressive T-cell (Foxp3+), which is consistent with the reduction of Foxp3+ T-cells in the primary tumor tissue, and a shift in tumor naïve CD8+ cell population to more efficient tumor killing memory effector CD8+ cells.

These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and creates a shift in the primary tumor and in the surrounding tumor environment in the peritoneal cavity that promotes a pro-immune T-cell population dynamic and conversion of tumor naïve T-cell into cytotoxic effector T-cells in the tumor microenvironment.

“These distinct immunological changes in the local disease environment are likely to translate into clinical benefit and warrant the continued development of our GEN-1 IL-12 immunotherapy as a potential adjuvant, in both first and second-line ovarian cancer,” said Dr. Kunle Odunsi, Deputy Director, Chair of Gynecologic Oncology and Center for Immunotherapy Executive Director at Roswell Park Cancer Institute. “Furthermore, pro-immune changes in the tumor microenvironment appear to support research combining GEN-1 with other exciting immuno-oncology therapies including adaptive T-cell and check point inhibitors.”

Clinical Data

Celsion also reported highly encouraging clinical data from the first fourteen patients who have completed treatment in the OVATION Study. GEN-1 plus standard chemotherapy produced positive clinical results, with no dose limiting toxicities and promising dose dependent efficacy signals which correlate well with successful surgical outcomes as summarized below:

Of the fourteen patients treated in the entire study, two (2) patients demonstrated a complete response, ten (10) patients demonstrated a partial response and two (2) patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate (“DCR”) and an 86% objective response rate (“ORR”). Of the five patients treated in the highest dose cohort, there was a 100% objective response rate with one (1) complete response and four (4) partial responses.

Fourteen patients had successful resections of their tumors, with nine (9) patients (64%) having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Seven out of eight (87%) patients in the highest two dose cohorts experienced a R0 surgical resection. All five patients treated at the highest dose cohort experienced a R0 surgical resection.

All patients experienced a clinically significant decrease in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells.

Of the eight patients who have received GEN-1 treatment over one year ago (cohort 1 – 3) and are being followed; only two patients’ cancer has progressed. This compares favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer that undergo neoadjuvant chemotherapy followed by interval debulking surgery. Of the remaining six patients who have been on the study for over one year, their average PFS as of September 30, 2017 is 18 months with the longest progression-free patient at 24 months.

“We have completed enrollment of our Phase Ib OVATION Study in newly diagnosed ovarian cancer patients to determine GEN-1’s clinical and biological activity in combination with standard chemotherapy. The remarkable surgical outcomes for all patients completing the prescribed eight weekly treatments of GEN-1 reinforce our belief in the promise of GEN-1’s ability to work safely and effectively in advanced ovarian cancer,” said Dr. Nicholas Borys, Celsion’s senior vice president and chief medical officer. “The Advisory Board Meetings held in late September 2017 with our clinical investigators and scientific experts in immuno-oncology provided an important endorsement of our development program for this innovative immunotherapy for first line ovarian cancer.”

The poster presentation will be available on Celsion’s website under “News & Investors – Scientific Presentations.”

OVATION Study Design

The Phase Ib trial was designed to evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments in total, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety and tolerability.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.

On October 03, 2017 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported final clinical and translational research data from its OVATION Study, a Phase Ib dose escalating clinical trial combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced Stage III/IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery (Press release, Celsion, OCT 3, 2017, View Source [SID1234520758]). GEN-1 is an IL-12 DNA plasmid vector formulated as a nanoparticle in a non-viral delivery system to cause the sustained local production and secretion of the Interleukin-12 (IL-12) protein loco-regionally to the tumor site.

The Company updated the translational data from the OVATION Study in a poster presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Special Conference entitled “Addressing Critical Questions in Ovarian Cancer Research and Treatment” at the Wyndham Grand Pittsburgh Downtown in Pittsburgh, PA. The poster entitled “Immunological changes following intraperitoneal administration of a formulated IL-12 plasmid in combination with neoadjuvant chemotherapy in newly diagnosed advanced ovarian cancer patients,” was presented by Dr. Khursheed Anwer, Celsion’s executive vice president and chief scientific officer in a poster session on Monday, October 2, 2017 from 6:00 PM to 8:30 PM.

The Company also held an Advisory Board Meeting on September 27, 2017 with the clinical investigators and scientific experts including those from Roswell Park Cancer Institute, Vanderbilt University Medical School, and M.D. Anderson Cancer Center to review and finalize clinical, translational research and safety data from the OVATION Study in order to determine the next steps forward for this exciting new immunotherapy. With the endorsement and recommendations from the Advisory Board, the Company expects to file a next phase protocol with FDA later this year.

Translational Research Data

Key translational research findings from all evaluable patients are consistent with the earlier reports from partial analysis of the data and are summarized below:

The intraperitoneal treatment of GEN-1 in conjunction with neoadjuvant chemotherapy resulted in dose dependent increases in IL-12 and Interferon-gamma (IFN-g) levels that were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic circulation. These and other post-treatment changes including decreases in VEGF levels in peritoneal fluid are consistent with an IL-12 based immune mechanism.

Consistent with the previous partial reports, the effects observed in the IHC analysis were pronounced decreases in the density of immunosuppressive T-cell signals (Foxp3, PD-1, PDL-1, IDO-1) and increases in CD8+ cells in the tumor microenvironment.

The ratio of CD8+ cells to immunosuppressive cells was increased in approximately 75% of patients suggesting an overall shift in the tumor microenvironment from immunosuppressive to pro-immune stimulatory following treatment with GEN-1. An increase in CD8+ to immunosuppressive T-cell populations is a leading indicator and believed to be a good predictor of improved overall survival.

Analysis of peritoneal fluid by cell sorting, not reported before, shows treatment-related decrease in the percentage of immunosuppressive T-cell (Foxp3+), which is consistent with the reduction of Foxp3+ T-cells in the primary tumor tissue, and a shift in tumor naïve CD8+ cell population to more efficient tumor killing memory effector CD8+ cells.

These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and creates a shift in the primary tumor and in the surrounding tumor environment in the peritoneal cavity that promotes a pro-immune T-cell population dynamic and conversion of tumor naïve T-cell into cytotoxic effector T-cells in the tumor microenvironment.

“These distinct immunological changes in the local disease environment are likely to translate into clinical benefit and warrant the continued development of our GEN-1 IL-12 immunotherapy as a potential adjuvant, in both first and second-line ovarian cancer,” said Dr. Kunle Odunsi, Deputy Director, Chair of Gynecologic Oncology and Center for Immunotherapy Executive Director at Roswell Park Cancer Institute. “Furthermore, pro-immune changes in the tumor microenvironment appear to support research combining GEN-1 with other exciting immuno-oncology therapies including adaptive T-cell and check point inhibitors.”

Clinical Data

Celsion also reported highly encouraging clinical data from the first fourteen patients who have completed treatment in the OVATION Study. GEN-1 plus standard chemotherapy produced positive clinical results, with no dose limiting toxicities and promising dose dependent efficacy signals which correlate well with successful surgical outcomes as summarized below:

Of the fourteen patients treated in the entire study, two (2) patients demonstrated a complete response, ten (10) patients demonstrated a partial response and two (2) patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate (“DCR”) and an 86% objective response rate (“ORR”). Of the five patients treated in the highest dose cohort, there was a 100% objective response rate with one (1) complete response and four (4) partial responses.

Fourteen patients had successful resections of their tumors, with nine (9) patients (64%) having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Seven out of eight (87%) patients in the highest two dose cohorts experienced a R0 surgical resection. All five patients treated at the highest dose cohort experienced a R0 surgical resection.

All patients experienced a clinically significant decrease in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells.

Of the eight patients who have received GEN-1 treatment over one year ago (cohort 1 – 3) and are being followed; only two patients’ cancer has progressed. This compares favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer that undergo neoadjuvant chemotherapy followed by interval debulking surgery. Of the remaining six patients who have been on the study for over one year, their average PFS as of September 30, 2017 is 18 months with the longest progression-free patient at 24 months.

“We have completed enrollment of our Phase Ib OVATION Study in newly diagnosed ovarian cancer patients to determine GEN-1’s clinical and biological activity in combination with standard chemotherapy. The remarkable surgical outcomes for all patients completing the prescribed eight weekly treatments of GEN-1 reinforce our belief in the promise of GEN-1’s ability to work safely and effectively in advanced ovarian cancer,” said Dr. Nicholas Borys, Celsion’s senior vice president and chief medical officer. “The Advisory Board Meetings held in late September 2017 with our clinical investigators and scientific experts in immuno-oncology provided an important endorsement of our development program for this innovative immunotherapy for first line ovarian cancer.”

The poster presentation will be available on Celsion’s website under “News & Investors – Scientific Presentations.”

OVATION Study Design

The Phase Ib trial was designed to evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments in total, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety and tolerability.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.

On October 3, 2017 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that Margo Heath-Chiozzi, M.D., has joined the Company as Senior Vice President, Regulatory Affairs (Press release, Celldex Therapeutics, OCT 3, 2017, View Source [SID1234520756]). She was previously Vice President, Global Submissions and Regulatory Policy at Bristol-Myers Squibb Company, where she provided executive global regulatory strategy leading to nine product approvals. Dr. Heath-Chiozzi brings over 25 years of experience in senior leadership roles in regulatory sciences, pharmacogenetics and product development within the pharmaceutical industry and as a practicing physician and clinical researcher.

“Dr. Heath-Chiozzi’s strong track record of drug approvals and her exceptional understanding of the regulatory environment position her well to lead our global regulatory strategy,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “She is sincerely passionate about drug development and making a difference in the lives of patients, and we look forward to working with her as we execute across our deep pipeline of drug candidates.”

“I’m looking forward to working with the Celldex team to develop commercial strategies across its deep pipeline, especially as topline results from the METRIC study of glembatumumab vedotin in patients with triple-negative breast cancer are anticipated within the coming months,” said Dr. Heath-Chiozzi. “It’s an exciting time for the organization, and I’m thrilled to be a member of the team.”

Dr. Heath-Chiozzi joined Bristol-Myers Squibb in 2003, and prior to her most recent role, she served as Vice President, Global Regulatory Strategy, contributing to several business units including oncology, immunology, virology and genetically defined diseases. While at Bristol-Myers Squibb, she supported the global launches of several successful therapies in the areas of oncology, inflammation and infectious disease, including Yervoy, Erbitux, Orencia, Sprycel, Daklinza, Sunvepra, Baraclude, Atripla and Reyataz. From 1995 to 2003, Dr. Heath-Chiozzi served in roles of increasing responsibility at Abbott Laboratories, including Medical Director, Pharmacogenetics; Senior Director, Global Marketed Product Development and Outcomes Research; and Global Project Head, Abbott/Millennium Obesity/Diabetes Alliance. Before joining Abbott, she was appointed to the University of Hawaii John A. Burns School of Medicine, where she served as Assistant Professor, and was concurrently Director of the HIV Research Clinical at the Queen’s Medical Center as well as Director of the Women’s Immunology Clinical at the Kapiolani Medical Center for Women and Children, in Honolulu. Dr. Heath-Chiozzi received her B.S. and M.D. from the University of Utah. She received further medical training in internal medicine at Duke University and completed fellowships in infectious disease at Brigham & Women’s Hospital and Dana-Farber Cancer Institute in Boston.

On October 3, 2017 Roche (SIX: RO, ROG; OTCQX:RHHBY), reported the launch of the NAVIFY Tumor Board solution, a clinical workflow and decision support software that optimises decision-making for cancer patient case reviews in tumor boards, or multi-disciplinary team meetings (Press release, Hoffmann-La Roche, OCT 3, 2017, View Source [SID1234520752]). The solution fundamentally changes the way these meetings are organised and conducted. It is initially available in the US, UK, Germany, Spain, Sweden, and Switzerland.

Tumor board coordination is labour intensive and time consuming for health care providers with patients’ medical history, biomarkers, tumor information, radiology images, microscope slide images, pathology reports, and electronic medical record notes frequently having to be collected and organised manually.

The new NAVIFY Tumor Board solution streamlines and standardizes workflows by aggregating relevant patient data from these disparate sources into a workflow software solution that facilitates efficient team collaboration, reduces errors, and gives the care team more time to evaluate potential treatment options.
To facilitate interaction, the NAVIFY Tumor Board solution also allows remote participation of experts from outside the location during the meeting.

“Oncology care teams are now able to collaborate on the review of patient cases and tailor treatments to the individual with a higher degree of confidence and more efficiently,” said Roland Diggelmann, Chief Executive Officer, Roche Diagnostics. “At Roche, we are passionate about personalised healthcare and providing decision support that helps ensure that all available data is used to accelerate and optimise patient care.”

About NAVIFY

Roche Diagnostics is launching the NAVIFY brand demonstrating its commitment to provide healthcare professionals with digital decision support solutions that transform patient care. The NAVIFY portfolio’s first product is the NAVIFY Tumor Board solution, being launched. The portfolio will in the near future, evolve rapidly to include additional decision support applications and workflow products that address challenges faced by healthcare providers as well as research and development applications.

Patient data security and privacy are of the highest priority for Roche. The NAVIFY Tumor Board solution is built on a secure cloud platform that is HIPAA compliant.

On October 3, 2017 DelMar Pharmaceuticals (Nasdaq: DMPI) (“DelMar” and “the Company”), a biopharmaceutical company focused on the development of new cancer therapies, reported the presentation of a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Addressing Critical Questions in Ovarian Cancer Research and Treatment, being held October 1-4, 2017 in Pittsburgh, PA (Press release, DelMar Pharmaceuticals, OCT 3, 2017, View Source [SID1234520751]). The poster entitled “Distinct mechanism of action of DNA damaging agent dianhydrogalactitol (VAL-083) suggests combination therapy with PARP inhibitors,” and focuses on the unique mechanism of action of the Company’s lead agent, VAL-083.

Data presented in the Company’s poster demonstrates how its lead asset VAL-083 targets the DNA of cancer cells in a mechanistically different fashion than platinum (Pt)-based chemotherapeutic agents or PARP Inhibitors, and how these differences position VAL-083 as a potential new therapeutic option in the treatment of ovarian cancer.

Platinum-based chemotherapy is the standard-of-care in the treatment of advanced ovarian cancer. Treatment with platinum-based chemotherapy often leads to initial efficacy but subsequent emergence of multiple resistance mechanisms that limit the long-term utility of these agents (cisplatin and carboplatin).

Dysfunctional p53 tumor-suppressor protein, seen in a majority of advanced ovarian cancers, is a primary resistance mechanism that diminishes the therapeutic cytotoxicity of many DNA targeting drugs, particularly Pt-agents. In addition, deficiencies in the mismatch repair (MMR) pathway are correlated with platinum resistance.

DelMar’s data demonstrates that VAL-083 can overcome platinum resistance because its cytotoxic activity is independent of both the MMR pathway and the p53 status of a cancer cell.

Recently, PARP inhibitors have been shown to offer benefit as maintenance therapy in platinum-sensitive ovarian cancer, demonstrating improvements in progression free survival. However, an overall survival benefit has not been reported and recent literature cites PARP inhibitor-resistance as an emerging unmet need in the treatment of ovarian cancer.

Defects in the non-homologous end joining (NHEJ) pathway have been implicated in tumor resistance to PARP inhibitors. DelMar’s data indicates that VAL-083’s activity remains unaffected by defects in the NHEJ repair pathway and provides a mechanistic rationale for VAL-083 to overcome PARP inhibitor-resistance in the treatment of cancer.

DelMar’s poster also provides preclinical data demonstrating that VAL-083 displays synergy and/or super-additivity when combined with Pt-based agents (cisplatin and oxaliplatin) and PARP inhibitors (olaparib, veliparib and talazoparib). This supports a rationale for combination therapy with VAL-083 in front-line (platinum agents + VAL-083) or recurrent (PARP inhibitors +VAL-083) disease.

With a significant body of emerging preclinical evidence and historic clinical data suggesting reversal of platinum resistance by VAL-083, DelMar has recently obtained an Investigational New Drug Application (IND) allowance from the U.S. Food and Drug Administration (FDA) to initiate the REPROVe phase 1/ 2 trial of this agent in patients with recurrent platinum resistant ovarian cancer.

About the VAL-083 REPROVe Trial

On September 18th, 2017, DelMar announced that the FDA had accepted the Company’s IND for an open label multi-center Phase 1/2 Study of VAL-083 in Patients with Recurrent Platinum Resistant Ovarian Cancer (VAL-083 REPROVe Trial).

The Phase 1 portion of the trial is planned to enroll approximately 24 patients with Pt-resistant ovarian cancer to evaluate the response to treatment with VAL-083. Ovarian cancer patients enrolled in the trial will have been previously treated with at least two lines of Pt-based chemotherapy and up to two other cytotoxic regimens, and whose cancer has recurred within six months of prior Pt-based chemotherapy.

The primary efficacy of the trial will be overall response rate (ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria. RECIST is a set of published rules that define when tumors in cancer patients improve (“respond”), stay the same (“stabilize”), or worsen (“progress”) during treatment.

DelMar plans to request a meeting with FDA following completion of the Phase 1 portion of the REPROVe trial. If successful, data from this trial would lead to a confirmatory Phase 2 study of approximately 60 patients, which if successful, and subject to feedback from the FDA may position DelMar to potentially file an application for accelerated approval or to advance to a pivotal Phase 3 trial.

Further details regarding the VAL-083 REPROVe Ovarian Cancer trial can be found on clinicaltrials.gov: View Source

About VAL-083

VAL-083 (dianhydrogalactitol) is a “first-in-class”, DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes (NCI).

VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas. VAL-083 is currently being studied in multiple clinical trials as a potential new treatment for glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

DelMar has demonstrated that VAL-083’s mechanism of action is distinct from multiple chemotherapies widely used in the treatment of cancer and that this unique mechanism may offer opportunities to overcome treatment resistance thereby offering new treatment options to cancer patients. Further details regarding these studies can be found at View Source