On September 7, 2015 Bristol-Myers Squibb Company (NYSE:BMY) reported longer term survival and safety data from CheckMate -017 and -063, two pivotal trials evaluating Opdivo in previously treated squamous (SQ) non-small cell lung cancer (NSCLC), showing sustained survival benefit across these studies (Press release, Bristol-Myers Squibb, SEP 7, 2015, View Source [SID:1234507403]). In both trials, Opdivo showed an estimated 18 month overall survival (OS) rate of 27% (CheckMate -063) to 28% (CheckMate -017); survival benefit was independent of PD-L1 expression. Schedule your 30 min Free 1stOncology Demo! The safety profile of Opdivo is consistent with previously-reported trials, and in CheckMate -017, is also favorable compared to docetaxel. These data will be presented today at the 16th World Conference on Lung Cancer (Abstract #736, CheckMate -017 and #828, CheckMate -063).
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"Immuno-Oncology agents like Opdivo provide a novel approach to treating cancer. The improvement in survival observed in advanced squamous non-small cell lung cancer represents an important step forward for our patients," said Suresh S. Ramalingam, M.D., director, Division of Medical Oncology, Winship Cancer Institute of Emory University. "These updated results demonstrate the ability to achieve longer term survival outcomes in this patient population. In fact, the Kaplan-Meier curve from this study suggests a prolonged survival benefit for a subset of patients."
Previously-reported one year results from CheckMate -017 showed a significantly superior OS rate of 42% versus 24% for docetaxel. In CheckMate -063, the estimated one-year survival rate was 39%.
"Our approach to Immuno-Oncology research is intended to show meaningful improvement over the traditional standard of care on the benchmark endpoint of overall survival," said Michael Giordano, senior vice president, head of Development, Oncology. "We have taken a comprehensive research approach in lung cancer, one focused on a commitment to providing the first major advancement in squamous non-small cell lung cancer in more than a decade – Opdivo – that offers the potential to replace chemotherapy. With the data presented today, we remain confident in our Immuno-Oncology strategy, including fulfilling our goal in showing the survival benefit for Opdivo, not only in non-small cell lung cancer, but similar to the data already observed in advanced melanoma and other tumor types."
About CheckMate -017 & CheckMate -063
CheckMate -017 and CheckMate -063 demonstrated the efficacy and safety of Opdivo in patients with advanced or metastatic SQ NSCLC who had progressed following previous chemotherapy treatment. Together, the trials investigated Opdivo monotherapy at a dose of 3 mg/kg every two weeks, which has been well-established across the Phase 3 Opdivo clinical development programs for various tumors. These trials also formed the basis for Opdivo’s approvals in the U.S. and European Union, and helped to establish the agent as standard of care for previously treated SQ NSCLC.
CheckMate -017 is a landmark Phase 3, open-label, randomized clinical trial that evaluated Opdivo (n=135) 3mg/kg intravenously over 60 minutes every two weeks versus standard of care, docetaxel (n=137) 75 mg/m2 intravenously administered every three weeks in patients with advanced SQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. The study’s primary endpoint was OS and secondary endpoints included progression-free survival (PFS) and objective response rate (ORR). The trial included patients regardless of their PD-L1 expression status.
CheckMate -017 showed a doubling in 18 month OS benefit with an estimated 28% of patients alive at 18 months for Opdivo versus 13% for docetaxel. The median OS for the Opdivo arm was 9.2 months and 6.0 months for docetaxel (hazard ratio: 0.62 [95% CI, 0.48, 0.81; P = 0.0004]). In addition, Opdivo showed a statistically significant improvement in PFS and ORR. The PFS rate at 18 months was 17% for the Opdivo arm versus 2.7% for docetaxel. Median PFS was 3.5 months for patients administered Opdivo versus 2.8 months for docetaxel (hazard ratio: 0.63; [95% CI, 0.48, 0.83; P = 0.0008]). The ORR was 20% for the Opdivo arm versus 9% for docetaxel for an estimated odds ratio of 2.6 (95% CI, 1.3, 5.5; P = 0.0083), with an ongoing response seen in 63% of patients treated with Opdivo. In the trial, 28 patients were treated with Opdivo beyond initial progression, and nine demonstrated a non-conventional pattern of benefit (7%). The safety profile of Opdivo continued to be favorable versus docetaxel and treatment-related AEs occurred less frequently with Opdivo (n=131; any grade, 59%; grade 3–5, 8%; no grade 5 events) than docetaxel (n=129; any grade, 87%; grade 3–5, 58%), including both hematologic and non-hematologic toxicities. The majority of treatment-related select AEs in patients receiving Opdivo occurred within the first three months of treatment.
CheckMate -063 is a Phase 2, single-arm, open-label trial that included patients with metastatic SQ NSCLC who had progressed after receiving a platinum-based therapy and at least one additional systemic treatment regimen (n=117). In this trial, Opdivo showed an estimated 18-month OS rate of 27%. At 18 months, confirmed objective response rate, the study’s primary endpoint, was 15% (95% CI: 9, 22). Median OS was 8.1 months (95% CI: 6.1, 10.9). Most treatment-related AEs were of low grade (any grade, 75%; grade 3-4, 17%) and managed using established treatment algorithms.
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally, resulting in more than 1.5 million deaths each year, according to the World Health Organization. Lung cancer results in more deaths worldwide than colorectal, breast and prostate cancers combined. Non-small cell lung cancer (NSCLC) is one of the most common types of the disease and accounts for approximately 85% of cases. Squamous cell NSCLC accounts for approximately 25% to 30% of all lung cancer cases. Five year survival rates vary globally depending on the stage and type of lung cancer.
About Opdivo
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as a monotherapy or in combination with other therapies – in which more than 8,000 patients have been enrolled worldwide.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the FDA as a monotherapy in two cancer indications. Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world on July 4, 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. In the U.S., the Food and Drug Administration (FDA) granted its first approval for Opdivo for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. On March 4, 2015, Opdivo received its second FDA approval for the treatment of patients with metastatic squamous (SQ) non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. On July 20, the European Commission approved Nivolumab BMS for the treatment of locally advanced or metastatic SQ NSCLC after prior chemotherapy.
INDICATION
OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
IMPORTANT SAFETY INFORMATION
Immune-Mediated Pneumonitis
Severe pneumonitis or interstitial lung disease, including fatal cases, occurred with OPDIVO treatment. Across the clinical trial experience in 691 patients with solid tumors, fatal immune-mediated pneumonitis occurred in 0.7% (5/691) of patients receiving OPDIVO; no cases occurred in Trial 1 or Trial 3. In Trial 1, pneumonitis, including interstitial lung disease, occurred in 3.4% (9/268) of patients receiving OPDIVO and none of the 102 patients receiving chemotherapy. Immune-mediated pneumonitis occurred in 2.2% (6/268) of patients receiving OPDIVO; one with Grade 3 and five with Grade 2. In Trial 3, immune-mediated pneumonitis occurred in 6% (7/117) of patients receiving OPDIVO, including, five Grade 3 and two Grade 2 cases. Monitor patients for signs and symptoms of pneumonitis. Administer corticosteroids for Grade 2 or greater pneumonitis. Permanently discontinue OPDIVO for Grade 3 or 4 and withhold OPDIVO until resolution for Grade 2.
Immune-Mediated Colitis
In Trial 1, diarrhea or colitis occurred in 21% (57/268) of patients receiving OPDIVO and 18% (18/102) of patients receiving chemotherapy. Immune-mediated colitis occurred in 2.2% (6/268) of patients receiving OPDIVO; five with Grade 3 and one with Grade 2. In Trial 3, diarrhea occurred in 21% (24/117) of patients receiving OPDIVO. Grade 3 immune-mediated colitis occurred in 0.9% (1/117) of patients. Monitor patients for immune-mediated colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO for Grade 2 or 3. Permanently discontinue OPDIVO for Grade 4 colitis or recurrent colitis upon restarting OPDIVO.
Immune-Mediated Hepatitis
In Trial 1, there was an increased incidence of liver test abnormalities in the OPDIVO-treated group as compared to the chemotherapy-treated group, with increases in AST (28% vs 12%), alkaline phosphatase (22% vs 13%), ALT (16% vs 5%), and total bilirubin (9% vs 0). Immune-mediated hepatitis occurred in 1.1% (3/268) of patients receiving OPDIVO; two with Grade 3 and one with Grade 2. In Trial 3, the incidences of increased liver test values were AST (16%), alkaline phosphatase (14%), ALT (12%), and total bilirubin (2.7%). Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4 immune-mediated hepatitis.
Immune-Mediated Nephritis and Renal Dysfunction
In Trial 1, there was an increased incidence of elevated creatinine in the OPDIVO-treated group as compared to the chemotherapy-treated group (13% vs 9%). Grade 2 or 3 immune-mediated nephritis or renal dysfunction occurred in 0.7% (2/268) of patients. In Trial 3, the incidence of elevated creatinine was 22%. Immune-mediated renal dysfunction (Grade 2) occurred in 0.9% (1/117) of patients. Monitor patients for elevated serum creatinine prior to and periodically during treatment. For Grade 2 or 3 serum creatinine elevation, withhold OPDIVO and administer corticosteroids; if worsening or no improvement occurs, permanently discontinue OPDIVO. Administer corticosteroids for Grade 4 serum creatinine elevation and permanently discontinue OPDIVO.
Immune-Mediated Hypothyroidism and Hyperthyroidism
In Trial 1, Grade 1 or 2 hypothyroidism occurred in 8% (21/268) of patients receiving OPDIVO and none of the 102 patients receiving chemotherapy. Grade 1 or 2 hyperthyroidism occurred in 3% (8/268) of patients receiving OPDIVO and 1% (1/102) of patients receiving chemotherapy. In Trial 3, hypothyroidism occurred in 4.3% (5/117) of patients receiving OPDIVO. Hyperthyroidism occurred in 1.7% (2/117) of patients, including one Grade 2 case. Monitor thyroid function prior to and periodically during treatment. Administer hormone replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism.
Other Immune-Mediated Adverse Reactions
In Trial 1 and 3 (n=385), the following clinically significant immune-mediated adverse reactions occurred in <2% of OPDIVO-treated patients: adrenal insufficiency, uveitis, pancreatitis, facial and abducens nerve paresis, demyeliniation, autoimmune neuropathy, motor dysfunction, and vasculitis. Across clinical trials of OPDIVO administered at doses 3 mg/kg and 10 mg/kg, additional clinically significant, immune-mediated adverse reactions were identified: hypophysitis, diabetic ketoacidosis, hypopituitarism, Guillain-Barré syndrome, and myasthenic syndrome. Based on the severity of adverse reaction, withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone- replacement therapy.
Embryofetal Toxicity
Based on its mechanism of action, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and for at least 5 months after the last dose of OPDIVO.
Lactation
It is not known whether OPDIVO is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO, advise women to discontinue breastfeeding during treatment.
Serious Adverse Reactions
In Trial 1, serious adverse reactions occurred in 41% of patients receiving OPDIVO. Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase.
In Trial 3, serious adverse reactions occurred in 59% of patients receiving OPDIVO. The most frequent serious adverse drug reactions reported in ≥2% of patients were dyspnea, pneumonia, chronic obstructive pulmonary disease exacerbation, pneumonitis, hypercalcemia, pleural effusion, hemoptysis, and pain.
Common Adverse Reactions
The most common adverse reactions (≥20%) reported with OPDIVO in Trial 1 were rash (21%) and in Trial 3 were fatigue (50%), dyspnea (38%), musculoskeletal pain (36%), decreased appetite (35%), cough (32%), nausea (29%), and constipation (24%).
Presentation of IPH4102 rationale and Phase I protocol to be presented at the upcoming EORTC cutaneous lymphoma task force meeting
On September 7, 2015 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that Professor Martine Bagot, Head of the Dermatology Department at the Saint-Louis Hospital in Paris and co-discoverer of the target KIR3DL2, will present the rationale of IPH4102, a first-in-class anti-KIR3DL2 monoclonal antibody for the treatment of CTCL, as well as the protocol of the upcoming Phase I trial at the EORTC cutaneous lymphoma task force meeting (September 25-27, 2015 in Turin, Italy) (Press release, Innate Pharma, SEP 5, 2015, http://innate-pharma.com/en/news-events/presentation-iph4102-rationale-and-phase-i-protocol-be-presented-upcoming-eortc-cutaneous-lymphoma-task-force-meeting [SID:1234507402]).
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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
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Presentation title: "A novel targeted immunotherapy for CTCL: anti-KIR3DL2 mAb IPH4102 is potent and safe in non-clinical studies"
Session Name: Neil-Smith memorial lecture
Date: Saturday, September 26, 2015
Presentation Time: 12:30 AM – 1:00 PM
U.S. FDA Grants Priority Review for Daratumumab for Double Refractory Multiple Myeloma
On September 4, 2015 Genmab A/S (OMX: GEN) reported that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for daratumumab (Press release, Genmab, SEP 4, 2015, View Source [SID:1234507401]). The BLA is for daratumumab as a treatment for patients with multiple myeloma who have received at least three different lines of therapy including both a proteasome inhibitor and an immunomodulatory agent (IMiD) or who are double refractory to a proteasome inhibitor and an IMiD. A rolling BLA submission was started by Genmab’s licensing partner, Janssen Biotech, Inc. in June and was completed on July 9, 2015. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
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Priority Review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The FDA aims to complete its review of the daratumumab BLA within six months and has assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016.
"We are pleased that the FDA has granted Priority Review for daratumumab in double refractory multiple myeloma. If approved, daratumumab has the potential to make a real difference in the lives of people who have run out of other treatment options for multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
The BLA submission includes data from the Phase II study (Sirius MMY2002) of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a PI and an IMiD, or who are double refractory to a PI and an IMiD. However, safety and efficacy data from the Phase I/II study (GEN501) and safety data from three other studies, have also been included in the BLA submission. Daratumumab received a Breakthrough Therapy Designation for this indication from the FDA in May 2013.
About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in the U.S. in 2015.3 Globally, it is estimated that 124,225 people will be diagnosed and 87,084 will die from the disease in 2015.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5 Patients who relapse after treatment with standard therapies, including PIs or IMiDs, have poor prognoses and few treatment options.6
About daratumumab
Daratumumab is an investigational human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. It induces rapid tumor cell death through multiple immune-mediated mechanisms7, including complement-dependent cytotoxicity7, antibody-dependent cellular phagocytosis8 and antibody-dependent cellular cytotoxicity7, as well as via induction of apoptosis9 . Five Phase III clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA.
Clovis Oncology Announces Data Presentations at 16th World Conference on Lung Cancer
On September 4, 2015 Clovis Oncology (NASDAQ:CLVS)reported that rociletinib, the company’s oral targeted covalent (irreversible) mutant-selective inhibitor of epidermal growth factor receptor (EGFR) in development for the treatment of EGFR-mutated, T790M positive non-small cell lung cancer (NSCLC), is the subject of four mini-oral presentations and two poster sessions at the 16th World Conference on Lung Cancer (Press release, Clovis Oncology, SEP 4, 2015, View Source;p=RssLanding&cat=news&id=2085448 [SID:1234507399]). Hosted by the International Association for the Study of Lung Cancer (IASLC), the conference will take place September 6-9, 2015 in Denver.
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"We look forward to sharing updated data from the pivotal TIGER-X trial, analyzing the clinical activity of rociletinib in multiple subsets of patients with advanced EGFR mutant NSCLC, specifically in those with a history of CNS metastases, as well as in patients with T790M negative disease," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The coming months are shaping up to be a very busy and important time for rociletinib, as we move forward with our pivotal TIGER clinical trial program and prepare for potential product launches in both the United States and Europe."
Mini-Oral Presentations
Rociletinib in NSCLC patients with negative central testing for T790M in TIGER-X (Abstract #951/MINI03.10)
Heather Wakelee, MD, Stanford University Medical Center
Monday, Sept. 7, 4:45-6:15pm MT
Location: Four Seasons Ballroom F1 + F2
Identification of effective drug combinations to prevent or delay resistance to the EGFR mutant selective inhibitor rociletinib (CO-1686) (Abstract #3010/MINI09.04)
Andrew D. Simmons, PhD, Clovis Oncology
Monday, Sept. 7, 4:45-6:15pm MT
Location: Rooms 205 + 207
Dose optimization of rociletinib for EGFR mutated NSCLC (Abstract #967/MINI16.03)
Jonathan W. Goldman, MD, UCLA Health
Tuesday, Sept. 8, 4:45-6:15pm MT
Location: Four Seasons Ballroom F3 + F4
Activity of rociletinib in EGFR mutant NSCLC patients with a history of CNS involvement (Abstract #965/MINI16.04)
D. Ross Camidge, MD, PhD, University of Colorado Denver
Tuesday, Sept. 8, 4:45-6:15pm MT
Location: Four Seasons Ballroom F3 + F4
Poster Sessions
Poster P1.01-076 – TIGER-1: A randomized, open-label, phase 2/3 study of rociletinib (CO-1686) or erlotinib as first-line treatment for EGFR-mutant non-small cell lung cancer
D. Ross Camidge, MD, PhD, University of Colorado Denver
Monday, Sept. 7, 9:30am-4:45pm MT
Location: Exhibit Hall
Poster P1.01-086 – TIGER-3: A phase 3, open-label, randomized study of rociletinib versus cytotoxic chemotherapy in patients with mutant EGFR non-small cell lung cancer progressing on prior EGFR tyrosine kinase inhibitor therapy and doublet chemotherapy
James Chih-Hsin Yang, National Taiwan University Hospital
Monday, Sept. 7, 9:30am-4:45pm MT
Location: Exhibit Hall
About Rociletinib
Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) under investigation for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Rociletinib targets the activating mutations of EGFR (L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M, which develops in approximately 60 percent of patients treated with first- and second-generation EGFR inhibitors, while sparing wild-type, or "normal" EGFR at anticipated therapeutic doses. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.
DelMar Pharmaceuticals Reports Fiscal 2015 Year-End Financial Results and Provides Corporate Update
On September 4, 2015 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 fiscal year ending June 30, 2015 and provided an overview of recent Company highlights and expected near-term milestones (Press release, DelMar Pharmaceuticals, SEP 4, 2015, View Source [SID:1234507397]).
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RECENT HIGHLIGHTS
VAL-083 (dianhydrogalactitol), for the treatment of refractory glioblastoma multiforme (GBM)
Completed Phase I dose-escalation in the clinical trial in refractory GBM and presented data supporting a dose response trend.
Patients receiving a dose >/= 30mg/m2 had a median survival of nine (9) months vs. five (5) months at doses up to 5mg/m2.
Initiated a Phase II expansion cohort for the GBM study at a dose of 40mg/m2. We anticipate enrolling approximately 14 patients in the Phase II expansion cohort.
To date, 19 patients have been screened and six (6) patients have initiated treatment with VAL-083 at the 40mg/m2 dose.
To further explore the therapeutic window, three (3) patients have also initiated treatment at an interim dose of 45mg/m2. The Phase II expansion cohort may be continued at this higher dose if warranted by safety data.
Continued preparation for advancement into registration-directed Phase II/III clinical trials.
Presented additional data on the activity of VAL-083 against temozolomide-resistant GBM and its potential as a therapeutic option for patients who fail or are unlikely to respond to current front-line therapy.
Added the fourth and fifth Phase I/II clinical trial sites at Mayo Clinic Cancer Center in Rochester, MN and Sarah Cannon Cancer Research Center at HealthOne in Denver, CO.
Expanding our drug development pipeline: Lung and Ovarian Cancer
Non-small cell lung cancer (NSCLC)
Presented preclinical data in lung cancer models supporting differentiation of VAL-083 versus platinum-based chemotherapy in treatment of drug-resistant NSCLC.
Announced plans to initiate clinical research in NSCLC in collaboration with Guangxi Wuzhou Pharmaceutical Group (Co) Ltd.
Ovarian Cancer
Announced the upcoming presentation of new non-clinical data supporting the activity of VAL-083 in treatment-resistant ovarian cancer.
Corporate
Raised $2.6 million gross proceeds in a registered direct offering.
Announced an additional non-dilutive funding increase of up to CDN$287,000 from the National Research Council of Canada Industrial Research Assistance Program for continued support of our non-clinical research programs.
Continued to take steps toward listing our common shares on a national stock exchange including reducing the derivative liability component of our balance sheet, appointing new independent directors and establishing required corporate governance structures and policies.
"We have made tremendous progress during this fiscal year in executing our clinical development strategy and driving value into our lead product candidate VAL-083. The promising results of the Phase I dose-escalation study were instrumental in advancing the program in GBM. We anticipate reporting additional data from the Phase II expansion cohort at upcoming peer reviewed scientific meetings and are implementing our plan to advance VAL-083 into a Phase II/III registration-directed clinical program in refractory GBM," stated Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals.
"Based on promising results of grant-funded research, we are also preparing to expand the VAL-083 clinical research portfolio into non-small cell lung cancer (NSCLC), which will be funded through our collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.," added Mr. Bacha. "We believe our VAL-083 program in NSCLC has significant future potential for partnering opportunities."
Mr. Bacha concluded, "We believe that the unique mechanism of action of VAL-083 provides a basis to address unmet medical needs in a range of cancers."
FY2016 MILESTONES
Complete enrollment of the Phase II expansion study in refractory GBM;
Advance VAL-083 into registration-directed Phase II/III clinical trials;
Expand our clinical development activities through new trials supported by our collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co. Ltd.;
Continue to actively communicate our progress to the investment and medical communities through presentations at peer-reviewed scientific meetings;
Continue to build our intellectual property portfolio; and
Implement strategies to enable DelMar to meet qualifications to list its shares on a national stock exchange.
CONFERENCE CALL DETAILS
The DelMar business update conference call and live webcast is scheduled to begin today at 11:00 a.m. Eastern Time / 8:00 a.m. Pacific Time. 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 (866) 394-9399 (toll-free) with Conference ID 22042321. 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 FISCAL YEAR ENDED JUNE 30, 2015
For the twelve months ended June 30, 2015 the Company reported a net loss of $4,796,030, or a net loss per share of $0.13, compared to a net income of $3,129,348, or a net income per share of $0.10 for the twelve months ended June 30, 2014. The income from 2014 was due to the revaluation of our derivative liability. During the twelve months ended June 30, 2015 the Company has reduced its derivative liability from approximately $3.3 million at June 30, 2014 to approximately $1.0 million at June 30, 2015 through warrant exercises and exchanges.
The Company ended the 2015 fiscal year with approximately $1.75 million of cash and cash equivalents. Subsequent to the 2015 fiscal year end, the company announced the closing of a registered direct placement with $2.6 million in gross proceeds received from the offering.
Based on management’s current projections, the Company has enough capital to fund its operations into the third quarter of 2016.