On May 6, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported that the Company has received approval from regulatory authorities in Canada, the United Kingdom and the Netherlands to initiate the ICT-107 Phase 3 registration trial in patients with newly diagnosed glioblastoma (Press release, ImmunoCellular Therapeutics, MAY 6, 2016, View Source [SID:1234512004]). Schedule your 30 min Free 1stOncology Demo! Patient screening is anticipated to commence shortly and the first clinical supplies could be manufactured for qualifying patients in Canada and Europe in the third quarter of 2016. The Company also is near to completing interactions with regulatory authorities in six other European countries and currently expects approval of those clinical trial applications in June 2016, with patient screening to begin in the third quarter of 2016.
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"We are very pleased with the progress of our ICT-107 registrational trial in the US, Canada and Europe," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "We recently held our European investigator kick off meeting in Barcelona and had 100% attendance of investigators and coordinators from the 48 European clinical sites planning to participate in the trial. We are deeply appreciative of the support and enthusiasm expressed by our European colleagues, and their recognition of the importance and potential promise of the ICT-107 program, in light of the high unmet need and lack of new treatments for patients with brain cancer. We think that the ICT-107 program could be the best designed registrational program underway in newly diagnosed glioblastoma and look forward to announcing the treatment of our first patient."
Author: [email protected]
EISAI RECEIVES APPROVAL FOR NEW INDICATION FOR ANTICANCER AGENT HALAVEN(R) FOR TREATMENT OF ADVANCED LIPOSARCOMA IN EUROPE
On May 6, 2016, Eisai Co. , Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that its European regional headquarters Eisai Europe Ltd. (Location: U. K. )has received from the European Commission approval foranti cancer agent Halaven(eribulin mesylate)for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy(unless unsuitable)for advanced or metastatic disease (Press release, Eisai, MAY 6, 2016, View Source [SID:1234511989]). Schedule your 30 min Free 1stOncology Demo! Halaven is the first and only single agent to demonstrate a statistically significant overall survival (OS) benefit in a Phase III trial in patients with advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma). Following approval for use in the treatment of metastatic breast cancer, this marks the second indication for which Halaven has received approval based on an extension ofOS. The approval was based on the results of a Phase III study (Study 309)1comparing the efficacy and safety of Halaven versus dacarbazine in 452 patients (aged 18 or over) with locally advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen. Halaven demonstrated a statistically significant extension in the study’s primary endpoint of OS over the comparator treatment dacarbazine(Halaven median OS: 13. 5 months vs dacarbazine median OS: 11. 5 months; Hazard Ratio (HR) 0. 77[95% CI=0. 62-0. 95], p=0. 0169). For patients with liposarcoma, Halaven demonstrated a significant improvement in OS over dacarbazine (Halaven,median OS: 15. 6months vs dacarbazine, median OS: 8. 4months;HR 0. 51[95% CI=0. 35-0. 75]). In this study, the most common treatment-emergent adverse events (incidence greater than or equal to 25%) in patients treated with Halaven were fatigue, neutropenia, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia, which was consistent with the known side-effect profile of Halaven. Halaven is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile. Recent non-clinical studie showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores. 2Halavenpromotes the epithelial state and decreases the capacity of breast cancer cells to migrate. 3Halaven is currently approved for use in the treatment of breast cancer inapproximately60 countries including Japan and countries in Europe ,the Americas and Asia. Halaven was approved in the United States for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen in January 2016, and was approved in Japan for the treatment of soft tissue sarcoma in February 2016. Soft tissue sarcoma is a collective term for a diverse group of malignant tumors that occur throughout the soft tissue(fat, muscle, nerves, fibrous tissues and blood vessels). Approximately29,000 patients in Europe are diagnosed with soft tissue sarcoma each year or about1% of all cancers diagnosed in Europe. Liposarcoma is one of the most common forms of soft tissue sarcoma. As outcomes are poor for patients with advanced disease, it remains a disease with significant unmet medical need.
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Novocure Delivers New Informational Resource for Glioblastoma Brain Cancer
On May 5, 2016 Novocure (NASDAQ: NVCR) reported the availability of a new online resource to raise awareness of glioblastoma (GBM) and share stories of inspiration with the GBM community (Press release, NovoCure, MAY 5, 2016, View Source [SID:1234512063]). An interactive exhibit featuring patients, caregivers, doctors, nurses and advocates will also be displayed within the coming months.
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Approximately 12,500 GBM tumors, or tumors that may transform to GBM, are diagnosed in the U.S. each year. GBM can spread quickly and is one of the deadliest forms of cancer.
The website, GBMcommunity.com, features a mosaic of videos and images from the GBM community offering messages of hope and inspiration. The website also provides an overview of GBM and links to resources and advocacy groups.
"Novocure actively engaged members of the community to determine the resources they felt they needed most," said Pritesh Shah, Senior Vice President, Americas. "This new website and exhibit were born from the GBM community, and created with assets provided by the community. No one can speak to the experiences, hopes and needs of those affected by GBM better than they can. We are proud to bring this important resource to the GBM community, and thank all who have provided their words of support and images to this project, and encourage others to do the same. Only by making our collective voices heard can we raise awareness of this disease and deliver increased support."
About Glioblastoma Multiforme
Glioblastoma, also called glioblastoma multiforme, or GBM, is a type of primary brain cancer. This means that GBM tumors begin in the brain, rather than traveling to the brain from other parts of the body, such as the lungs or breasts. GBM is the most common type of primary brain cancer in adults. It is more likely to appear in adults than children and to affect men than women.
Akebia Announces First Quarter 2016 Financial Results and Provides Corporate Update
On May 5, 2016 Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients through the biology of hypoxia-inducible factor (HIF), reported financial results for the first quarter ended March 31, 2016 (Press release, Akebia , MAY 5, 2016, View Source [SID:1234512062]). Akebia also provided an update on its Phase 3 INNO2VATE program for vadadustat in dialysis-dependent chronic kidney disease (DD-CKD), and reported data from an ethnobridging study for vadadustat.
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"We continue to execute our strategy designed to position vadadustat as a best-in-class treatment for renal anemia, define a clear path to registration and establish strong commercial support in key markets," said John P. Butler, President and Chief Executive Officer of Akebia. "With the recent European Patent Office decision, we have preserved our access to an important region and are well-positioned to pursue a European collaboration that would provide funding for the balance of our Phase 3 program."
Mr. Butler continued, "On the clinical front, we have now reached alignment with regulators regarding our global Phase 3 program. We are advancing our ongoing global Phase 3 PRO2TECT program in non-dialysis dependent patients (NDD-CKD), and look forward to initiating the INNO2VATE program in DD-CKD patients in the third quarter of 2016. We are also expanding our experience with HIF-PH inhibitors, and plan to begin a Phase 1 trial with our second clinical candidate, AKB-6899, this year."
INNO2VATE Program
Akebia announced today that it has reached alignment with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding key elements of the Phase 3 INNO2VATE program and expects to launch the program in the third quarter of 2016. The INNO2VATE program includes two separate studies and will collectively enroll approximately 2,600 DD-CKD patients globally. The correction study will enroll approximately 400 patients not currently being treated with recombinant erythropoiesis stimulating agents (rESAs). The conversion study will enroll approximately 2,200 patients currently receiving rESA who will be converted to either vadadustat or the active control with the goal of maintaining their baseline hemoglobin levels. Both studies will include a 1:1 randomization and an open label, active-control, non-inferiority design. Primary endpoints include an efficacy assessment of the hemoglobin response and an assessment of cardiovascular safety measured by major adverse cardiovascular events.
Ethnobridging Study Results
The company announced today that data from its recent ethnobridging study demonstrated that the pharmacokinetics of vadadustat in Japanese volunteers is similar to that in Caucasians at all doses studied. The double-blind study was designed to assess the pharmacokinetics and pharmacodynamics of vadadustat following the administration of multiple ascending doses (150 mg, 300 mg and 600 mg) once daily for 10 days in Japanese and Caucasian healthy volunteers. At all doses studied, the pharmacokinetics and pharmacodynamics of vadadustat in the Japanese population were similar to that observed in Caucasians.
"As we anticipated, these results demonstrate that ethnicity has no effect on the clearance of vadadustat, an important finding that further supports our global development and commercialization strategy in Japan and other Asian markets," stated Brad Maroni, Chief Medical Officer of Akebia. "Together with our partner in Asia, Mitsubishi Tanabe, we look forward to incorporating these results into our plans for vadadustat in the region."
First Quarter 2016 Corporate Highlights
Preserved access to the European market for vadadustat by prevailing in a patent dispute in which the European Patent Office confirmed that none of FibroGen, Inc.’s patent claims met the requirements for patentability and, as a result, revoked the patent in its entirety; and,
Raised approximately $61.0 million, net, in a public offering of approximately 7.3 million shares of common stock in January 2016.
Financial Results
Akebia reported a net loss of ($25.8) million, or ($0.70) per share, for the first quarter of 2016. Net loss for the first quarter of 2015 was ($10.7) million or ($0.53) per share.
Research and development expenses were $20.2 million for the first quarter of 2016 compared to $6.7 million for the first quarter of 2015. The increase is primarily attributable to costs related to the initiation of the PRO2TECT Phase 3 program. Research and development expenses were further increased by personnel-related costs due to additional headcount.
General and administrative expenses were $5.8 million for the first quarter of 2016 compared to $4.2 million for the first quarter of 2015. The increase is primarily due to the following expense increases: $0.8 million due to increased headcount and compensation related costs and $0.8 million in commercial planning costs as well as legal costs.
The Company’s cash provided by operations during the first quarter of 2016 was $17.4 million, an increase of $25.8 million from $8.3 million used in operations for the same period of 2015. The increase is primarily related to the upfront payment of $40.0 million received in January 2016 from Mitsubishi Tanabe in connection with our collaboration agreement. The Company ended the first quarter of 2016 with cash, cash equivalents and available for sale securities of $217.0 million and expects its cash resources to fund its current operating plan through at least the second quarter of 2017.
Threshold Pharmaceuticals Reports First Quarter Financial Results
On May 05, 2016 Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), a clinical-stage biopharmaceutical company developing novel therapies for cancer, reported financial results for the first quarter ended March 31, 2016 and provided an update on the Company’s corporate and clinical development activities (Press release, Threshold Pharmaceuticals, MAY 5, 2016, View Source [SID:1234512061]).
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"We remain focused on establishing a potential regulatory path forward for evofosfamide as well as a possible strategic partnering initiative, and we are making progress on both of these fronts," said Barry Selick, Ph.D., Chief Executive Officer of Threshold. "I am also pleased with the appointment of Stew Kroll as Chief Operating Officer who most capably leads the strategy, design and execution of our clinical development programs."
Recent Highlights
Evofosfamide – The Company’s lead product candidate is an investigational hypoxia-activated prodrug that is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers. Additional analysis of the MASTRO Phase 3 data combined with previous Phase 2 experience strongly suggests that evofosfamide plus gemcitabine is an active regimen in patients with pancreatic cancer, most notably in the Japanese patients.
Conducted additional analyses of evofosfamide data in pancreatic cancer; the Company intends to discuss potential registration pathways with health regulatory authorities; and
Continued ongoing clinical development collaborations investigating evofosfamide in patients with pancreatic neuroendocrine tumors (pNET), recurrent glioblastoma (GBM) and hepatocellular carcinoma (HCC).
Tarloxotinib – Beyond the Company’s evofosfamide program, the clinical development team is focused on tarloxotinib, a hypoxia-activated epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), which is designed to selectively release an irreversible EGFR-TKI in hypoxic tumors.
Continued to enroll patients in two proof-of-concept Phase 2 clinical trials in patients with advanced non-small cell lung cancer (NSCLC) as well as metastatic head and neck squamous cell carcinoma; the Company plans to share preliminary results from both trials in mid-2016.
First Quarter 2016 Financial Results
Cash, cash equivalents and marketable securities totaled $38.0 million at March 31, 2016 compared to $48.7 million at December 31, 2015; the net decrease was a result of operating cash requirements for the quarter ended March 31, 2016, including the payment of $2.3 million of accrued severance benefits related to the previously announced workforce reduction in December of 2015. With the previously announced decision to cease joint development of evofosfamide under the Company’s former collaboration with Merck KGaA and the workforce reduction, the Company expects its quarterly operating cash requirements to decrease for the remainder of fiscal year 2016 compared to the first quarter ended March 31, 2016.
No revenue was recognized in the first quarter ended March 31, 2016 compared to $3.7 million for the same period of 2015. Revenue for the quarter ended March 31, 2015 related to the amortization of the aggregate of $110 million in upfront and milestone payments received from the Company’s former collaboration with Merck KGaA, Darmstadt, Germany. The revenue from the upfront payment and milestone payments received under the agreement were previously being amortized over the relevant performance period, rather than being immediately recognized when the upfront payment and milestones were earned or received. As a result of Merck KGaA, Darmstadt, Germany’s and the Company’s decision to cease further joint development of evofosfamide in December 2015, the Company immediately recognized all of the remaining deferred revenue into revenue during the quarter ending December 31, 2015. Also as a result of the termination of the agreement, the Company is no longer eligible to receive any further milestone payments from Merck KGaA, Darmstadt, Germany.
Research and development expenses were $6.0 million for the first quarter ended March 31, 2016, compared to $10.7 million for the same period in 2015. The decrease in research and development expenses, net of reimbursement for Merck KGaA, Darmstadt, Germany’s 70 percent share of total eligible collaboration expenses for evofosfamide, was due primarily to a $3.1 million decrease in employee related expenses, including a $0.5 million decrease in non-cash stock-based compensation expense and a $1.6 million decrease in clinical development expenses and consulting expenses. The Company expects research and development expenses to continue to decline in 2016 as result of the decision to cease further joint development of evofosfamide under the Company’s former collaboration with Merck KGaA and the workforce reduction.
General and administrative expenses were $2.2 million for the first quarter of 2016 compared to $2.6 million for the same period in 2015. The decrease in general and administrative expenses was due primarily to a $0.2 million decrease in consulting expenses and a $0.2 million decrease in employee related expenses.
Non-cash stock-based compensation expense included in total operating expenses was $0.8 million for the first quarter of 2016 compared to $1.4 million for the same period in 2015. The decrease in stock-based compensation expense was due to the amortization of a smaller number of options with lower fair values.
Net loss for the first quarter of 2016 was $7.9 million compared to $11.2 million for the same period in 2015. Included in the net loss for the first quarter of 2016 was an operating loss of $8.3 million and non-cash income of $0.4 million compared to an operating loss of $9.6 million and non-cash expense of $1.5 million for the first quarter of 2015. The non-cash income or expense is related to changes in the fair value of the Company’s outstanding and exercised warrants that was classified as other income (expense).
About Evofosfamide
Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug of a bis-alkylating agent that is preferentially activated under severe hypoxic tumor conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic. On December 6, 2015, the Company announced the outcomes of two Phase 3 studies (MAESTRO and TH-CR-406/SARC021) of evofosfamide stating that neither study met its primary endpoint.
About Tarloxotinib Bromide
Tarloxotinib bromide (the proposed International Nonproprietary Name, previously known as TH-4000), or "tarloxotinib", is a prodrug designed to selectively release a covalent (irreversible) EGFR tyrosine kinase inhibitor under severe hypoxia, a feature of many solid tumors. Accordingly, tarloxotinib has the potential to effectively shut down aberrant EGFR signaling in a tumor-selective manner, thus potentially avoiding or reducing the systemic side effects associated with currently available EGFR tyrosine kinase inhibitors. Tarloxotinib is currently being evaluated in two Phase 2 proof-of-concept trials: one for the treatment of patients with mutant EGFR-positive, T790M-negative advanced non-small cell lung cancer progressing on an EGFR tyrosine kinase inhibitor, and the other for patients with recurrent or metastatic squamous cell carcinomas of the head and neck or skin. Threshold licensed exclusive worldwide rights to tarloxotinib from the University of Auckland, New Zealand, in September 2014.