On February 16, 2016 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported its financial results for the second quarter of the 2016 fiscal year ending December 31, 2015 (Press release, DelMar Pharmaceuticals, FEB 16, 2016, View Source [SID:1234509066]). The Company also highlighted recent corporate and clinical achievements and provided an overview of expected near-term milestones.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

DelMar management will host a business update conference call and live webcast for investors, analysts and other interested parties on Wednesday, February 17, 2016, at 5:00 pm EST.

"The progress we continued to achieve this quarter for our VAL-083 (dianhydrogalactitol) clinical program and the consistent positive data from preclinical studies, along with the recently announced collaboration with University of Texas MD Anderson Cancer Center, not only further validates the promise of VAL-083 as a potential new treatment for chemo-resistant tumors, but also sets the stage for 2016 to be a transformational year for our Company," stated Jeffrey Bacha, Chairman and CEO of DelMar Pharmaceuticals.

RECENT CORPORATE HIGHLIGHTS

Announced a collaboration with the University of Texas MD Anderson Cancer Center (MD Anderson) to extend and accelerate the clinical development of VAL-083 for glioblastoma multiforme (GBM) patients following first recurrence of the disease. MD Anderson will initiate a new Phase II clinical study with VAL-083 at first recurrence/progression, prior to Avastin (bevacizumab) exposure. Eligible patients will have recurrent GBM characterized by a high expression of MGMT, the DNA repair enzyme implicated in drug-resistance and poor patient outcomes following current front-line chemotherapy.

Completed enrollment of the Phase II expansion cohort for the GBM study at a dose of 40mg/m2. Confirmed 40mg/m2 as the maximum tolerated dose (MTD) for advancement into registration directed clinical trials. This optimized dosing regimen may enhance the potential of VAL-083 to impact a patient’s tumor as well as to improve patient outcomes.

Presented interim Phase II data at the 2015 Society for Neuro-Oncology Annual Meeting. A Kaplan Meier survival estimate, based on these preliminary interim data, projects a clinically meaningful survival benefit for refractory GBM patients whose tumors have recurred following both front-line therapy with temozolomide and second-line bevacizumab treatment.

Presented data supporting VAL-083’s potential as a treatment for pediatric brain tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Advances in Pediatric Research Conference. The preclinical and clinical data support advancement of VAL-083 into a clinical study in pediatric patients with recurrent or resistant medulloblastoma (MB) and high grade gliomas (HGGs).

Presented data indicating the promising potential of VAL-083 as a solution for major unmet needs in the treatment of a variety of cancers, including GBM, non-small cell lung cancer (NSCLC), ovarian cancer and pediatric brain tumors, at the AACR (Free AACR Whitepaper) New Horizons in Cancer Research Conference.

Announced additional data on the unique molecular mechanisms responsible for VAL-083 activity against cancer at the 2015 Canadian Cancer Research Conference. These data suggest that VAL-083’s activation of immune response pathways may represent a promising personalized medicine approach in the treatment of cancer.

Presented positive data on the benefit of VAL-083 in combination with platinum-based chemotherapy for non-small cell lung cancer at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The data demonstrate that VAL-083 retains activity in chemo-resistant NSCLC tumor types and has a super-additive effect in NSCLC when used in combination with platinum-based chemotherapeutic agents.

Presented positive preclinical data supporting the activity of VAL-083 in treatment-resistant ovarian cancer. The data support VAL-083 as a viable treatment option for patients failing platinum-based chemotherapy and demonstrates a potential benefit in combination with platinum therapy.

"For the first half of 2016 we will focus on accomplishing several actionable milestones that will position DelMar to expand clinical development around VAL-083 and also serve to maximize shareholder value. We believe that DelMar’s recent data, combined with historical clinical validation, positions VAL-083 as a superior alternative to currently available chemotherapy for GBM patients whose tumors are characterized by high expression of MGMT. Our goal is nothing short of creating a paradigm-shift in the treatment of this horrific cancer," added Mr. Bacha.

"We anticipate reporting top-line survival data from the Phase II expansion cohort of our refractory GBM clinical trial in the first half of 2016. Based on our observations to date, we believe that we are well positioned to advance VAL-083 into Phase II/III registration clinical trials in refractory GBM during 2016. New non-clinical data reported in 2015 continued to demonstrate VAL-083’s unique cytotoxic anti-cancer mechanism, and we anticipate leveraging these data by expanding our clinical development programs around VAL-083 also during 2016," concluded Mr. Bacha.

EXPECTED NEAR-TERM MILESTONES

Report top-line data from the Phase II study with VAL-083 in refractory GBM in the first half of 2016;

Engage the U.S. Food and Drug Administration (FDA) regarding the design of a proposed registration-directed Phase II/III clinical trial for VAL-083 in refractory GBM;

Initiate registration-directed Phase II/III clinical trials for VAL-083 as a new treatment option for refractory GBM in 2016;

Initiate the Phase II clinical study at MD Anderson with VAL-083 in patients with GBM at first recurrence/progression;

Initiate clinical studies in newly-diagnosed GBM patients as an alternative to temozolomide in patients with high expression of MGMT;

Initiate new clinical trials with VAL-083 in refractory NSCLC;

Continue to pursue pre-clinical research with leading investigators to advance VAL-083 as a potential treatment for other chemo-resistant cancers including ovarian cancer and pediatric medulloblastoma;

Maximize the value of the VAL-083 pipeline through potential partnership opportunities in high value oncology markets;

Continue to build the Company’s intellectual property portfolio; and

Continue to implement strategies that enable DelMar to meet qualifications to list its shares on a national stock exchange.

CONFERENCE CALL DETAILS
DelMar plans to host a conference call on Wednesday, February 17, 2016, at 5:00 p.m. EST, to discuss quarterly results and provide a corporate update. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is (800) 895‑1715 (toll-free) or (785) 424‑1059 (toll) with Conference ID "DelMar." A link to the webcast and slides will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE SECOND QUARTER OF FISCAL YEAR 2016 ENDED DECEMBER 31, 2015
For the three months ended December 31, 2015 the Company reported a net loss of $2,646,690, or a net loss per share of $0.06, compared to a net loss of $619,633, or a net loss per share of $0.02 for the three months ended December 31, 2014 as restated.

FINANCIAL SUMMARY
The following represents selected financial information as of December 31, 2015. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and Management’s Discussion and Analysis (MD&A), as filed.

DelMar’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company’s website at: View Source

About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas.

DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes in GBM patients following standard front-line treatment with Temodar (temozolomide).

DelMar recently announced the completion of enrollment in a Phase II clinical trial of VAL-083 in refractory GBM. Patients have been enrolled at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO).

In the Phase I dose-escalation portion of the study, VAL-083 was well tolerated at doses up to 40mg/m2 using a regimen of daily x 3 every 21 days. Adverse events were typically mild to moderate; no treatment-related serious adverse events reported at doses up to 40 mg/m2. Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed in two of six (33%) of patients at 50 mg/m2. Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment, although one patient who presented with hemorrhoids received a platelet transfusion as a precautionary measure.

Sub-group analysis of data from the Phase I dose-escalation portion of the study suggested a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083 in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

Patients in a low dose (≤5mg/m2) sub-group had a median survival of approximately five (5) months versus median survival of approximately nine (9) months for patients in the therapeutic dose (30mg/m2 & 40mg/m2) sub-group following initiation of VAL-083 treatment. DelMar reported increased survival at 6, 9 and 12 months following initiation of treatment with VAL-083 in the therapeutic dose sub-group compared to the low dose sub-group.

Further details can be found at View Source

On February 16, 2016 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the fourth quarter and full year ended December 31, 2015 (Press release, CTI BioPharma, FEB 16, 2016, View Source;p=RssLanding&cat=news&id=2139676 [SID:1234509071]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"While we were disappointed and surprised by the FDA’s decision to place pacritinib’s IND on full clinical hold, our priority and sense of purpose has always been to do what is best for patients," said James A. Bianco, M.D., president and chief executive officer of CTI BioPharma."There remains a significant unmet medical need in the treatment of myelofibrosis, especially for those with low platelet counts. We continue to see the potential of pacritinib to help this patient population and we are committed to resolving the FDA’s concerns in order to identify a path forward. Additionally, we plan to define the registration path for tosedostat, which recent interim data from a cooperative group study showed the potential therapeutic utility of this oral aminopeptidase inhibitor for older patients with AML and high-risk MDS. We ended the year with a strong financial position that we believe will enable us to achieve our goals in 2016 and beyond."

Recent Highlights

Pacritinib

In January 2016, CTI BioPharma announced the completion of the rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. CTI BioPharma and Baxalta Incorporated (Baxalta) are seeking U.S. marketing approval of pacritinib for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (<50,000/µL). In February 2016, the FDA placed pacritinib’s investigational new drug application (IND) on a full clinical hold and CTI BioPharma subsequently withdrew its NDA.

In December 2015, researchers presented results from a new analysis of the pivotal Phase 3 trial, PERSIST-1, evaluating pacritinib versus best available therapy, excluding treatment with JAK2 inhibitors (BAT), in patients with myelofibrosis. Data examining patient outcomes across baseline demographic factors that are associated with prognosis showed that treatment with pacritinib resulted in consistent rates of spleen volume reduction and control of disease-related symptoms across all intermediate or high-risk myelofibrosis subgroups.

Tosedostat

In December 2015, researchers presented an update on results from an investigator-sponsored Phase 2 trial of tosedostat – CTI BioPharma’s investigational oral selective aminopeptidase inhibitor – in elderly patients with either primary (de novo) acute myeloid leukemia (AML) or secondary AML. The data showed a complete response (CR) rate of 48.5 percent with tosedostat in combination with low dose cytarabine/Ara-C (LDAC) – 33 percent of these patients were still responding after a median of 506 days.

In November 2015, CTI BioPharma announced that the United Kingdom’s National Cancer Research Institute (NCRI) Haematological Oncology Clinical Studies Group has chosen to advance tosedostat to the second stage of a randomized clinical trial of low-dose cytarabine plus or minus tosedostat in older patients with AML or high risk myelodysplastic syndrome (MDS). The AML Less Intensive (LI-1) trial is designed as a "Pick-a-Winner" trial to be able to simultaneously test a number of promising agents added to standard therapy with low-dose cytarabine in older patients with AML or MDS who are unfit for standard aggressive induction therapy. Nine regimens have been tested in the Pick-a-Winner program, of which only four, including tosedostat, have passed the initial hurdle for progression (which requires evidence of an improvement in remission rate with acceptable safety). CTI BioPharma plans to discuss potential approval pathways with regulators in the U.S. and EU in 2016.

Fourth Quarter and Full Year Financial Results

Total revenues for the fourth quarter and the full year ended December 31, 2015, were $11.3 million and $16.1 million, respectively, compared to $17.8 million and $60.1 million for the same periods in 2014. The decrease in total revenue for the full year ended December 31, 2015, as compared to December 31, 2014, is primarily due to recognition of milestone payments in 2014, specifically a $20.0 million development milestone payment received from Baxalta for completion of enrollment in the PERSIST-1 Phase 3 clinical trial of pacritinib and $17.3 million from an upfront payment under the PIXUVRI collaboration agreement with Servier. Net product revenues of PIXUVRI for the fourth quarter and the full year ended December 31, 2015, were $1.1 million and $3.5 million, respectively, compared to $2.5 million and $6.9 million for the same periods in 2014. The decrease in net product sales for the full year ended December 31, 2015, as compared to December 31, 2014, was primarily related to the pricing and volume variances between the periods as well as the decline in average exchange rate of the euro for our euro-denominated sales.

The non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the fourth quarter and full year ended December 31, 2015, was $24.4 million and $101.8 million, respectively, compared to non-GAAP operating loss of $36.2 million and $66.0 million for the same periods in 2014. The GAAP operating loss for the fourth quarter and full year ended December 31, 2015, was $26.2 million and $116.7 million, respectively, compared to a GAAP operating loss of $39.4 million and $86.2 million for the same period in 2014. The increase in operating loss for the full-year ended December 31, 2015, as compared to December 31, 2014, is predominantly associated with the Phase 3 development program for pacritinib and the PIXUVRI post-authorization Phase 3 trial as well as the milestone and the upfront payments received in 2014 mentioned above. Non-cash share-based compensation expense for the fourth quarter and full year ended December 31, 2015, was $1.8 million and $14.8 million, respectively, compared to $3.2 million and $20.2 million for the same periods in 2014. For information on CTI BioPharma’s use of the aforementioned non-GAAP measure and a reconciliation of such measure to GAAP operating loss, see the section below entitled "Non-GAAP Financial Measures."

Net loss for the fourth quarter of 2015 was $28.8 million, or $(0.13) per share, compared to a net loss of $44.2 million, or ($0.27) per share, for the same period in 2014. Net loss for the full year of 2015 was $122.6 million, or $(0.65) per share, compared to a net loss of $96.0 million, or $(0.65) per share, for the same period in 2014.

As of December 31, 2015, cash and cash equivalents totaled $128.2 million, compared to $70.9 million as of December 31, 2014.

On February 16, 2016 Varian Medical Systems (NYSE: VAR) reported its ARIA oncology information system and Eclipse treatment planning software have been named "2015/2016 Category Leader" in the "Best in KLAS: Software and Services Report" by KLAS, an independent research firm specializing in monitoring and reporting on the performance of healthcare vendors (Press release, InfiMed, FEB 16, 2016, View Source [SID:1234509075]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In use in some 3,200 cancer treatment centers around the world, ARIA was named the "2015/2016 Category Leader" for Oncology software. ARIA is a comprehensive electronic medical record and image management system that aggregates patient data into an organized, oncology-specific medical chart with functional components for managing clinical, administrative and financial operations for medical, radiation and surgical oncology. The ARIA system provides a seamless flow of information for managing the patient’s entire journey—from diagnosis through follow-up.

ARIA users shared these comments posted on KLASresearch.com: a director stated, "ARIA is a great solution. It works well for both medical and radiation oncology." While a CIO shared these comments about the ARIA solution: "ARIA is tightly linked with the functionality of our linear accelerator, and that is incredible. That connection is what makes ARIA very valuable to our oncologists and radiologists. The linear accelerator is controlled through the software, so the charting and things we do with patients become almost invisible. All the documentation we have to do is automatically put in to the system. On the oncology side, all the formulas are streamlined. Doctors don’t have to look for a lot of things. There are a lot of customized fields doctors can set up."

For more information on ARIA, visit View Source

Named a "2015/2016 Category Leader" for Treatment Planning software for the third year in a row, the market and technology-leading Eclipse software is in use at some 3,400 cancer treatment centers around the world. The software creates an optimized radiotherapy treatment plan based on a physician’s dose instructions, and information about the size, shape and location of the tumor to be treated with radiation. The Eclipse software incorporates unique features such as RapidPlan knowledge-based planning, which makes it easier and faster to plan sophisticated cancer treatments like intensity-modulated radiotherapy (IMRT), image-guided radiotherapy (IGRT), and RapidArc radiotherapy.

In comments posted on KLASresearch.com, a vice president who uses Eclipse said: "We really like Eclipse and feel it is the very best treatment planning software out there." A physicist using Eclipse stated: "We find it very easy to create good, efficient dose management using the system."

For more information on Eclipse, visit View Source

"These rankings acknowledge the hard work the Varian team has done. Working closely with oncology clinicians and administrators has allowed us to understand their needs, enhance the ARIA information system and Eclipse software, and provide the best-in-class tools for fighting cancer," said Kolleen Kennedy, president of Varian’s Oncology Systems business.

The 2015/2016 Best in KLAS report, published at the end of January, ranks healthcare vendors and their solutions by the professionals who use them—healthcare providers. For a full list of Best in KLAS winners, Global (Non-U.S.) Best in KLAS winners, and Category Leaders, visit View Source

On February 16, 2016 BIND Therapeutics, Inc. and Synergy Pharmaceuticals Inc. reported they have entered into a research collaboration to engineer ACCURINS incorporating Synergy’s proprietary uroguanylin analogs to explore the potential targeting of guanylate cyclase-C (GC-C) receptors expressed on tumors, specifically GI malignancies (Press release, BIND Therapeutics, FEB 16, 2016, View Source [SID:1234513873]). Upon achievement of proof-of-concept, the companies anticipate expanding the collaboration to enhance the potential effect of uroguanylin-based ACCURINS by incorporating therapeutic payloads.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This collaboration represents another important advance as we develop ACCURINS with the potential to target a broad range of cells with novel therapeutic payloads," said Jonathan Yingling, Ph.D., chief scientific officer, BIND Therapeutics. "The versatility of our platform is demonstrated by our wide range of collaborations and the ability to leverage our technology platform in a wide variety of applications. We believe the complementary technologies of Synergy and BIND have the potential to generate novel uroguanylin-based therapies that could have a profound impact on the treatment of diseases."

Uroguanylin is a naturally occurring GI peptide and activator of the intestinal GC-C receptor, which is a known target for stimulating a variety of physiological responses. Plecanatide, Synergy’s lead uroguanylin analog for functional GI disorders, successfully completed phase 3 clinical trials for chronic idiopathic constipation (CIC) in 2015, and the Company recently filed a new drug application (NDA) for plecanatide to treat CIC. Synergy also recently announced positive data on its second uroguanylin analog, dolcanatide, in a phase 1b proof-of-concept study in ulcerative colitis patients.

"We are pleased to collaborate with BIND Therapeutics on this project, which we believe can broaden the potential therapeutic applications of our proprietary uroguanylin-based platform," said Kunwar Shailubhai, Ph.D., M.B.A., chief scientific officer and executive vice president of Synergy Pharmaceuticals. "BIND’s ACCURIN technology has been shown to target diseased tissues with a wide variety of therapeutic payloads. We have separately presented data showing that uroguanylin analogs specifically bind to different types of colorectal polyps and tumor in mice. Together, we believe that we can create uroguanylin-based ACCURINS that have the potential to provide new treatment options in GI cancer."

This early research collaboration is not expected to have a material financial impact on Synergy Pharmaceuticals or BIND Therapeutics.

About ACCURINS
ACCURINS, a new class of targeted therapeutics developed using BIND’s Medicinal Nanoengineering platform, are nanoparticles engineered to have a profound impact on the treatment of disease. The elegant and novel design of ACCURINS allow for prolonged circulation, controlled and tunable release and selective targeting of a therapeutic payload to diseased tissue or cells while avoiding immune surveillance detection and systemic toxicities.

ACCURINS can be engineered for multiple therapeutic applications and have the potential to integrate numerous payloads, including highly potent drugs with mechanism-based toxicities that limit therapeutic benefit, DNA, RNA, proteins and immunotherapy agents. This attribute enables ACCURINS to target multiple diseases, including cancer, inflammatory, vascular, and infectious disease.

On February 15, 2016 GtreeBNT Co., Ltd., reported it has entered into an agreement with the Oklahoma Medical Research Foundation (OMRF) to acquire the rights to OKN-007, a new investigational drug for the treatment of glioblastoma, a deadly form of brain cancer (Press release, GtreeBNT Co, FEB 15, 2016, View Source [SID:1234514931]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under a new company, Oblato, Inc., GtreeBNT will assume exclusive rights to the compound, which was developed by OMRF researchers Rheal Towner, Ph.D., and Robert Floyd, Ph.D.

OKN-007 has been evaluated as a novel therapeutic that protects nerves and reduces both necrosis and glioblastoma cell proliferation by eliminating reactive oxygen species, a known cause of cancer. In studies at OMRF, the drug reduced tumor size and increased lifespan in animal models of glioblastoma. An estimated 12,000 Americans are diagnosed with glioblastoma each year, according to the American Brain Tumor Foundation.

OKN-007 has undergone phase I-B clinical testing at the University of Oklahoma’s Stephenson Cancer Center, where physicians assessed its safety in patients suffering from glioblastoma.

"There is currently no cure for glioblastoma, and the development of new treatments is a very important unmet need," said GtreeBNT and Oblato’s President and Chief Executive Officer Won S. Yang, Ph.D. "Oblato will conduct glioblastoma clinical trials on patients in the U.S. and will work to develop this new drug worldwide. With our history of work in the orphan drug market, this new drug fits well into our portfolio and matches the goals of GtreeBNT."

Oblato will initiate additional trials to study the efficacy and safety of this investigational drug in larger patient populations. At this time, OKN-007 is administered as an infusion. This agreement will provide the resources to expand the size of the patient cohort and to eventually develop an oral form of the drug.

Since 2014, GtreeBNT has been focusing on the development and commercialization of biopharmaceutical drugs, particularly first-in-class medications for ophthalmic indications, such as dry eye disease and the orphan ocular disease neurotrophic keratopathy. By acquiring the rights to OKN-007, GtreeBNT has expanded its interests to developing cancer treatments. Due to GtreeBNT’s highly experienced and qualified team, it is able to rapidly bring early clinical stage drugs to market.

"GtreeBNT’s focus on rare and orphan disease indications makes them an attractive partner to help us take the next steps in getting this drug to market," said OMRF Vice President of Technology Ventures Manu Nair. "Their ultimate goal is to see OKN-007 benefit patients living with this terrible disease. The company’s interest in the project and its ability to work quickly makes them an excellent fit for us."

Through execution of this agreement, it is expected that GtreeBNT will advance toward becoming a leading biopharmaceutical company that is able to consistently grow by securing worldwide exclusive rights to develop and commercialize new drugs to treat various diseases, including glioblastoma and ophthalmic indications.

"Right now, there is no effective treatment for glioblastoma," said OMRF’s Nair. "Patients typically receive a prognosis of 12 to 18 months from their initial diagnosis. We hope this new partnership can change those numbers for the better."