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DelMar Pharmaceuticals and MD Anderson Initiate New Phase Two Clinical Trial of VAL-083 for MGMT-unmethylated Recurrent Glioblastoma Multiforme (GBM)

On January 25, 2017 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported the opening of enrollment of a Phase II study of VAL-083 at the University of Texas MD Anderson Cancer Center in Houston, Texas (Press release, DelMar Pharmaceuticals, JAN 25, 2017, View Source [SID1234517555]).

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DelMar Pharmaceuticals Logo (PRNewsFoto/DelMar Pharmaceuticals, Inc.)
The Phase II study of VAL-083 (dianhydrogalactitol) in patients with MGMT-unmethylated, Avastin (bevacizumab)-naïve recurrent glioblastoma will enroll 48 patients in a single-arm design to determine if treatment with VAL-083 improves overall survival, compared to historical control. Further information regarding the clinical trial can be found on DelMar’s website and at clinicaltrials.gov (clinicaltrials.gov identifier: NCT02717962).

"This study is a keystone in our strategy to expand the development of VAL-083 to target MGMT-unmethylated GBM, a significant unmet medical need," said Jeffrey Bacha, chairman & CEO of DelMar Pharmaceuticals. "We are pleased to launch this important trial in collaboration with the University of Texas MD Anderson Cancer Center, one of the world’s most respected medical centers devoted exclusively to cancer patient care, research, education and prevention."

Approximately two-thirds of newly diagnosed GBM patients have tumors with an unmethylated MGMT promoter, which is correlated with high expression of the DNA repair enzyme, MGMT. Published studies have documented that expression of MGMT is an important factor in predicting the outcome of GBM patients treated with alkylating agents such as temozolomide (TMZ), carmustine (BCNU), and lomustine (CCNU).

Patients whose tumors exhibit high expression of MGMT have a poor prognosis and significantly shorter progression free survival (PFS) and overall survival (OS) in comparison to patients with a methylated MGMT promoter and low MGMT expression. In a 2011 study of more than 800 GBM patients, those with tumors carrying the unmethylated MGMT promoter had a median overall survival of 14 months versus 21 months for those with a methylated MGMT promoter. The difference in progression-free survival – the period after treatment during which the cancer does not worsen – was 5.7 and 8.7 months, respectively.

About VAL-083

VAL-083 is a "first-in-class," small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes. DelMar has demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro. Further details can be found at View Source

VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.

DelMar has also announced plans to advance VAL-083 into a pivotal randomized multi-center Phase III clinical trial for the treatment of bevacizumab-failed GBM and into a separate international Phase II trial for newly diagnosed GBM patients with an unmethylated MGMT promoter.

"We believe that data from these upcoming clinical trials, if successful, will form the basis of a new treatment paradigm for the vast majority of GBM patients whose tumors exhibit features that make them unlikely to respond to currently available chemotherapy," added Mr. Bacha.

"Our data demonstrating that VAL-083’s activity against GBM is independent of MGMT expression combined with VAL-083’s established clinical activity against GBM from published NCI-sponsored clinical studies provides confidence to our hope that VAL-083 will give doctors and their patients a new and unique chemotherapy to address this enormous global unmet medical need."

About Glioblastoma Multiforme (GBM)

GBM is the most common and the most lethal form of glioma. Approximately 15,000 new cases of GBM are expected to be diagnosed in the United States during 2017. GBM progresses quickly and patients deteriorate rapidly. Common symptoms include headaches, seizures, nausea, weakness, paralysis and personality or cognitive changes such as loss of speech or difficulty in thinking clearly. The majority of GBM patients do not survive for more than two years following diagnosis, and the median survival in newly diagnosed patients with best available treatments is less than 15 months.

PHASE III TRIAL OF ANTICANCER AGENT LENVIMA(R) AS FIRST-LINE TREATMENT FOR UNRESECTABLE HEPATOCELLULAR CARCINOMA MEETS PRIMARY ENDPOINT

On January 25, 2017 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that a Phase III clinical trial (Study 304) of its in-house discovered and developed anticancer agent Lenvima (lenvatinib mesylate, "lenvatinib") against the comparator sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma has achieved its primary endpoint (Press release, Eisai, JAN 25, 2017, View Source [SID1234517544]).

Study 304 is a multicenter, randomized, open-label, global Phase III study comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for advanced hepatocellular carcinoma, as a first-line treatment for patients with unresectable hepatocellular carcinoma. In the study, 954 patients were randomized in a 1:1 ratio to receive lenvatinib 12 mg or 8 mg once a day, depending on baseline body weight (n= 478) or sorafenib 400 mg twice a day (n= 476). Treatment was continued until disease progression or unacceptable toxicity.
The primary endpoint of the study was overall survival (OS), with the goal of demonstrating non-inferiority. Other factors including progression free survival (PFS), time to progression (TTP) and objective response rate (ORR) were assessed as secondary endpoints.

According to the results of the study, lenvatinib met the statistical criteria for non-inferiority of OS compared to sorafenib, and showed statistically significant and clinically meaningful improvement for PFS, TTP and ORR. In this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib. Analyses of the remaining secondary endpoints of quality of life and plasma PK parameters as well as safety are ongoing.

Eisai plans to hold discussions with regulatory authorities for submission in Japan, the United States, Europe and Asia, including China. Eisai will also present the details at an upcoming academic conference.

Liver cancer is the second leading cause of cancer related deaths, and is estimated to be responsible for approximately 700,000 deaths per year in the world1. The majority of cases occur in Asia, including China, and Africa. Hepatocellular carcinoma accounts for 85% to 90% of primary liver cancer cases. Early stage hepatocellular carcinoma is treatable by a wide variety of means, including surgery, radiofrequency ablation, ethanol injection, chemoembolization therapy, but treatment opinions for unresectable hepatocellular carcinoma are limited and the prognosis is very poor, meaning that this is an area of high unmet medical need.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai remains committed to providing further clinical evidence for lenvatinib aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

Propanc Provides Progress Update on Additional Patent Applications

On January 24, 2017 Propanc Health Group Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging healthcare company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported an update on the progress of additional pending patent applications, since the recent allowance of the Company’s first key patent application in the US this year (Press release, Propanc, JAN 24, 2017, View Source [SID1234517563]).

The Company received a written opinion from the International Search Authority regarding the novelty, inventive step and industrial applicability of a recent Patent Cooperation Treaty (PCT) application, filed in November 2016, in Australia. The PCT application titled "Proenzyme composition" is directed to a composition comprising trypsinogen and chymotrypsinogen, targeting specific weight ratios and certain dosage levels for the Company’s lead product, PRP. The majority of claims in the written opinion were considered novel and inventive, as determined by the Authorized Officer from the Australian Patent Office. The PCT assists applicants in seeking patent protection internationally for their inventions and can assist national patent offices with their patent granting decisions. By filing one international patent application under the PCT, applicants can simultaneously seek protection for an invention in over 150 countries.

Another patent application filed in Spain in January, 2016, titled "Cancer Treatment", was updated with animal data showing reduced density in tumors excised from mice post treatment with trypsinogen and chymotrypsinogen and as a result, a second application was filed with additional claims regarding a method of minimizing cancer progression, preventing recurrence, or preventing cancer in a subject by either reducing, or controlling the amount of cancer stem cells. The method may also include the step of identifying cancer stem cells in the subject.

"We are making new and exciting discoveries regarding the application of PRP in a clinical setting, which I firmly believe could become a breakthrough product that revolutionizes the way we treat cancer and reduces the threat of this killer disease for many different cancers," said Dr Julian Kenyon, Propanc’s Chief Scientific Officer. "I have been treating cancer patients for many years and have seen a number of innovations, particularly with the recent advancements of immuno-oncology. In my opinion, PRP, as a once daily IV administration with minimal toxicity, compared to standard treatments, whilst minimizing the threat of recurrence, or preventing cancer in patients, could become one of the most important discoveries made in the next 20 years."

The Company’s lead product, PRP, is a novel, patented, formulation consisting of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Currently in formal preclinical development and progressing towards first-in man studies, PRP aims to prevent tumor recurrence and metastasis in solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. The Company’s initial target patient populations include pancreatic, ovarian and colorectal cancers.

Actinium’s Chief Medical Officer, Dr. Mark Berger, to Present Talk Titled, Iomab-B: Radiolabeled CD45 at the 3rd Annual Expert Forum on Acute Leukemias and Myeloproliferative Neoplasms

On January 24, 2017 Actinium Pharmaceuticals, Inc. (NYSE:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, reported that recently appointed Chief Medical Officer, Dr. Mark Berger, has been selected to present at the 3rd Annual Think Tank on Integrating New Molecular Targets in Acute Leukemias and Myeloproliferative Neoplasms being held on January 27 – 28, 2017 in Dallas, Texas (Press release, Actinium Pharmaceuticals, JAN 24, 2017, View Source [SID1234517547]). This event is being sponsored by Dava Oncology as part of their Oncology Meeting Innovations program. Dr. Berger’s talk will focus on Actinium’s Iomab-B, which is currently in a pivotal Phase 3 clinical trial and upon approval is intended to simultaneously prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant.

"I am looking forward to highlighting Iomab-B to the highly experienced group of physicians that will be attending this event," said Dr. Berger. "Iomab-B has the potential to revolutionize the way we transplant patients with acute leukemia, particularly amongst the most difficult to treat older patients with relapsed or refractory acute leukemia. I believe the attending hematologists and transplant physicians will come away from this event with great enthusiasm for Iomab-B."

About Iomab-B

Iomab-B is Actinium’s lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a hematopoietic stem cell transplant, also referred to as a bone marrow transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, BC8, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDA) age 50 and older, Iomab-B produced complete remissions in 100% of patients and patients experienced transplant engraftment at day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 300 patients in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.

PTX-100 (GGTI-2418)

PTX-100, is a first in class drug that kills cancer cells by blocking geranylgeranyl transferase-1 (GGT-1), a protein required for the cancer-causing activity of Ral and Rho, that are in turn required for the cancer-causing protein Ras. PTX-100 was well tolerated and achieved stable disease in a Phase 1 trial in advanced solid tumors. Prescient expects to commence Phase 1b/2 clinical trials in breast cancer and multiple myeloma in Q4 2016. At the same time, Prescient plans to develop its novel p27 cancer biomarker as a companion diagnostic that will potentially identify those patients that are most likely to respond to PTX-100 therapy.