Over 340 life science executives converged on Santiago de Chile for Biolatam® 2015 global life science partnering event Nov. 16-17
CARLSBAD, Calif. and SANTIAGO, Chile, Nov. 23, 2015 /PRNewswire/ — Biolatam® international life science partnering conference took place in Santiago, Chile, November 16–17 with great success. The event, produced by EBD Group and ASEBIO in collaboration with ProChile and Chile Biotech, was attended by over 340 life science dealmakers from pharma, biotech and service companies representing US, Latin American and European entities.
Biotech companies in attendance ranged in speciality area including health, biofuels, cosmetics, agrifood, and mining, and emerging medical technology companies. Also represented were established large medtech companies; venture capital, private equity, institutional firms and business angels; distributors and hospitals.
“We are pleased by the success of this second edition of Biolatam,” said Anna Chrisman, Group Managing Director, EBD Group. “The energy was palpable, and innumerable connections were made to propel the market, both through partnering and through networking in the exhibition and evening event. Latin America is definitely a thriving emerging market that is only expected to grow.”
“We have received many congratulations for this event, with a great interest of all participants, confirming the success of Biolatam as Latin America’s leading biotechnology event,” said Regina Revilla, Chair of ASEBIO.
Across Latin America, healthcare spending is projected to increase an average of 4.6 percent annually over 2014–2018, according to a recent Deloitte report, with pharmaceutical spending growth expected to rise an average of 6.1 percent annually. This is evidence of a growing emerging life science market, ripe for dealmaking with international companies who are actively seeking a presence in the region. Biolatam was created to foster these partnerships through dedicated one-to-one meetings facilitated by partneringONE® that could result in collaborations between companies that will fuel future growth.
The highly anticipated third edition of Biolatam will take place in San Juan, Puerto Rico, November 29–30, 2016.
Additional links and information:
Follow Biolatam 2015 on Twitter: @EBDGroup (hashtag: #BLT15) and @BIOLATAM.
About EBD Group
EBD Group is the leading partnering firm for the global life science industry. Since 1993, biotech, pharma and medical device companies have leveraged EBD Group’s partnering conferences, technology and services to identify business opportunities and develop strategic relationships essential to their success.
EBD Group’s conferences are run with the support of leading corporations and international trade associations and include:
- BIO-Europe® and BIO-Europe Spring®, Europe’s largest life science partnering conferences, supported by the Biotechnology Industry Organization (BIO)
- BioPharm America™, the fastest growing partnering event in North America
- Biotech Showcase™, a unique forum in San Francisco for presenting to investors and business development executives, co-produced with Demy-Colton Life Science Advisors
- BioEquity Europe, the investor conference co-organized with BioCentury Publications and BIO
- ChinaBio® Partnering Forum, the first dedicated biotech/pharma partnering conference in China, co-produced with ChinaBio® Group
- Biolatam®, facilitating partnering among global life sciences executives in Latin America’s vibrant life science hubs
EBD Group’s sophisticated web-based partnering service, partneringONE®, is used as the partnering engine at numerous third-party events around the world, and partnering360® is the open online community of life science dealmakers that enhances partnering experiences throughout the year.
EBD Group is an Informa company. Informa is the largest publicly-owned organizer of exhibitions, conferences and training in the world.
EBD Group has offices in the USA and Europe.
For more information please visit www.ebdgroup.com.
The Spanish Bioindustry Association (ASEBIO), brings together 280 companies, associations, foundations, universities, research and technology centers that carry out activities directly or indirectly related to biotechnology in Spain.
Since 1999 ASEBIO has been acting as a meeting and promotion platform for those organizations interested in stimulating the national biotechnology scene.
In order to do this, ASEBIO works closely with regional, national and European governments as well as all the social organizations interested in using biotechnology to improve quality of life, the environment and generating skilled employment. ASEBIO, ranking fourth in Europe by number of members, is part of and supported by Europabio, the European Association for Bioindustries. ASEBIO is also the organizer of Biospain. (www.biospain2016.org).
For more information please visit: www.asebio.com
SOURCE EBD Group
Article One Partners (AOP), the world’s largest online patent and technical literature research community is seeking immediate, part-time Technical Literature Researchers to support our growing inventory of technical and research studies […
DelMar Pharmaceuticals Updates VAL-083 Clinical Trial in Refractory Glioblastoma Multiforme at Society for Neuro-Oncology Annual Meeting
- Interim Phase II data supports clinically meaningful survival benefit in post bevacizumab refractory GBM — Quarterly business update conference call with webcast today at 4:30 p.m. ET / 1:30 p.m. PT to incorporate data review –
VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 23, 2015 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) (“DelMar” and the “Company”), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, presented updated data from the fully enrolled 14-patient expansion cohort of the Company’s ongoing Phase II clinical study of VAL-083 (dianhydrogalactitol) in refractory glioblastoma multiforme (GBM) that is being conducted at Sarah Cannon Research Institute, Mayo Clinic, and UCSF Medical Center.
The data were presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) in San Antonio, Texas, held November 19-22, in a poster entitled, “Phase I/II study of Dianhydrogalactitol (VAL-083) In Patients With Recurrent Malignant Glioma.” Interested parties can access the poster here.
DelMar will host a conference call and live webcast for investors, analysts and other interested parties today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to provide a business update and discuss these new data.
“The interim survival data from the Phase II expansion cohort is highly promising and consistent with our observations from the Phase I dose-escalation portion of the trial,” stated Jeffrey Bacha, DelMar’s chairman & CEO. “A Kaplan Meyer survival estimate, based on these preliminary interim data, projects a greater than 9-month median survival in refractory GBM patients whose tumors have recurred following both front-line therapy with temozolomide and second-line bevacizumab (Avastin®) treatment.”
“These results continue to support the potential of VAL-083 to address the significant unmet medical need for these patients who currently have no approved therapeutic options,” said Mr. Bacha.
“The Phase II portion of the VAL-083 study in patients with recurrent GBM enrolled very quickly. This rapid enrollment, combined with the enthusiasm we have seen from clinical investigators, is a clear demonstration of the overwhelming unmet medical need for new therapies in the treatment of GBM,” stated Mr. Bacha.
“The data from the Phase II cohort of our clinical study continue to show that VAL-083 is well-tolerated at the 40 mg/m2 dosing regimen. This dose previously demonstrated the potential to improve survival outcomes in post-bevacizumab refractory GBM,” Mr. Bacha continued. “The expanded Phase II data set support 40 mg/m2 as the appropriate dose for advancement into registration-directed Phase II/III clinical trials with VAL-083 in patients with recurrent GBM.”
“Additionally, we have continued to demonstrate that the cytotoxic mechanism of VAL-083 is distinct from other chemotherapies used in the treatment of cancer. We can leverage this new understanding of how VAL-083 attacks the tumor with clinical trial data from previously conducted Phase I and Phase II NCI-sponsored clinical trials that validates VAL-083’s clinical activity against a range of tumor-types to address modern unmet medical needs in the treatment of cancer,” added Mr. Bacha.
“In the case of GBM, we have shown that the anti-tumor activity of VAL-083 is independent of MGMT, the resistance mechanism which causes the majority of GBM patients to fail currently available cytotoxic chemotherapy,” said Mr. Bacha.
“Taken together with historical and recently demonstrated clinical activity, these results suggest that VAL-083’s distinct anti-cancer mechanism has the potential to overcome chemo-resistance and surpass the standard of care in the treatment of GBM,” Mr. Bacha concluded.
DelMar is conducting an open-label, single-arm Phase I/II dose-escalation study with VAL-083 in patients with histologically-confirmed GBM, previously treated with radiation who have failed both front-line therapy temozolomide and second-line Avastin (bevacizumab), and, in most cases, one or more salvage therapies. The study utilized 3+3 dose-escalation design. Patients received VAL-083 on days 1, 2, 3 of a 21-day cycle (ClinicalTrials.gov Identifier NCT01478178) at Sarah Cannon Research Institute, Mayo Clinic, and UCSF Medical Center.
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. The 40 mg/m2/d dose exhibited a favorable safety profile, with a trend toward improved survival versus lower doses. Following determination of the maximum tolerated dose (MTD) at 40 mg/m2/d, a 14-patient Phase II expansion cohort was rapidly enrolled at a dose of 40 mg/m2/d on day 1, 2, 3 of a 21 day cycle.
Update on Status of Phase II Expansion Cohort
- 14 patients have been enrolled in the Phase II expansion cohort and all patients have received at least one cycle of treatment to date.
- Safety observations in the Phase II expansion cohort to date are consistent with the Phase I dose-escalation cohort. Generally, observed myelosuppression is mild (Grade 1), with the exception of one patient.
- One subject previously treated with CCNU developed Grade 4 thrombocytopenia suggesting patients with prior nitrosourea treatment who may exhibit higher susceptibility to thrombocytopenia. The inclusion criteria were modified to account for this observation.
- A Kaplan Meyer survival estimate based on interim analysis of patients enrolled in the Phase II expansion cohort is consistent with observations made in the Phase I dose-escalation portion of the study. This preliminary interim analysis suggests a potentially meaningful survival benefit in this population following treatment with VAL-083 at doses >30 mg/m2/d in comparison to published reports for the same refractory GBM population.
GBM is the most common and deadly form of brain cancer. Standard front-line treatment following surgical resection is temozolomide chemotherapy combined with radiation treatment followed by maintenance therapy with temozolomide. Temozolomide is often ineffective in the majority of GBM patients by O6-methylguanine-DNA-methyltransferase (MGMT), a naturally occurring DNA-repair enzyme causing resistance to treatment. Bevacizumab (Avastin®) has been approved as second-line therapy for patients failing front-line therapy; however, data presented at the SNO2015 meeting suggest that bevacizumab treatment does not prolong survival for refractory GBM patients. 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 temozolomide.
Taken together with historical and recently demonstrated clinical activity, these data suggest a distinct anti-cancer mechanism for VAL-083 which has the potential to overcome chemo-resistance and surpass the standard of care in the treatment of GBM.
The poster on the clinical trial data presented at SNO may be found on DelMar’s website under http://www.delmarpharma.com/scientific-publications.html.
CONFERENCE CALL DETAILS
DelMar is hosting a conference call today at 4:30 p.m. Eastern Time / 1:30 p.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 (844) 303-8663 (toll-free) with Conference ID 81768802. 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.
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.
VAL-083 is a bi-functional DNA N7 cross-linking agent that crosses the blood-brain barrier that has demonstrated historical clinical activity against a range of cancers, including GBM, in prior NCI-sponsored clinical trials. DelMar has demonstrated that VAL-083 induces phosphorylation of H2AX, a hallmark of double-strand DNA breaks, leading to cell cycle arrest in the late G2/S phase. H2AX is a histone involved in the CHK2 checkpoint activation pathway, a key component of the body’s immune response to DNA damage that activates down-stream signaling ultimately resulting in apoptosis (cancer cell death). Additionally, the cytotoxic activity of VAL-083 appears to be less dependent on wild type p53 in comparison to other chemotherapeutic agents. Alteration in p53 has been correlated with poor patient outcomes in GBM. In particular, gain-of-function mutant p53 is strongly associated with a poor prognosis for overall survival in patients with glioblastoma, potentially by increasing expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance to temozolomide and poor outcomes in GBM patients.
DelMar has previously demonstrated that VAL-083’s anti-tumor activity is unaffected by the expression of MGMT. Taken together with historical and recently demonstrated clinical activity, these data suggest a distinct anti-cancer mechanism for VAL-083 which has the potential to overcome chemo-resistance and surpass the standard of care in the treatment of GBM.
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 http://www.delmarpharma.com/scientific-publications.html.
About DelMar Pharmaceuticals, Inc.
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize new cancer therapies in indications where patients are failing or have become intolerable to modern targeted or biologic treatments. The Company’s lead drug in development, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for refractory glioblastoma multiforme. VAL-083 has been extensively studied by U.S. National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action that could provide improved treatment options for patients.
For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: email@example.com / (604) 629-5989. Connect with the Company on Twitter, LinkedIn, Facebook, and Google+.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including, our current reports on Form 8-K.
SOURCE DelMar Pharmaceuticals, Inc.
Tocagen Presents Interim Data from Studies Evaluating Toca 511 & Toca FC at the Annual Meeting of the Society for Neuro-Oncology (SNO)
SAN DIEGO, Nov. 23, 2015 /PRNewswire/ — Tocagen Inc., a clinical-stage, cancer-selective immunotherapy company, today announced interim data from ongoing Phase 1 and preclinical studies of Toca 511 in combination with Toca FC were presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) and the SNO-SCIDOT Joint Conference on Therapeutic Delivery to the CNS in San Antonio, TX.
Together, the presented data demonstrate Toca 511 & Toca FC continue to show potential benefits, including a favorable safety profile and extended overall survival (OS) in patients with recurrent high grade glioma (HGG) compared to historical benchmarks. In addition, data supported further evaluation of intravenous (IV) delivery of Toca 511 in metastatic solid tumors, and evidence of anti-cancer immune activation following treatment with Toca FC was reported.
Highlights of results from the podium and poster presentations are below.1 More information about the presentations, including abstract number and title, can be found on Tocagen’s website. In the ongoing clinical studies, Toca 511 is administered first and followed by cycles of orally administered Toca FC.
Survival Data from Administration of Toca 511 at the Time of Tumor Removal (Resection/Injection)
- Survival rates for patients with recurrent HGG at 12 and 24 months were 52.5 percent and 31.6 percent, respectively
- Patients with recurrent HGG had a median survival of 13.6 months (N=43)
- Patients with first or second recurrence of HGG and no prior bevacizumab (the patient population to be studied in Tocagen’s ongoing Phase 2/3 clinical trial) had a median survival of 14.6 months (N=30)
- Patients with first or second recurrent glioblastoma (GBM) had a statistically significant improvement (p=0.0028) in OS of 13.6 months compared to 7.1 months for an external lomustine historic data set
- Higher dose cohorts had a median OS of 14.4 months compared to 11.9 months for lower dose cohorts in patients with recurrent HGG, suggesting a dose-response trend for survival
IV Administration of Toca 511
- Following IV delivery of Toca 511, the tumor was removed and Toca 511 administered to resection cavity walls
- Ten of eleven patients in this ongoing clinical trial remain alive with follow up of up to 15.4 months
- Viral DNA and cytosine deaminase (CD) protein were present in resected tumor, with increasing levels of viral DNA with increasing dose
- Trial results support evaluation of IV delivery of Toca 511 in metastatic solid cancers, including breast, lung, colorectal, melanoma and renal
Administration of Toca 511 via Biopsy Needle or Convection Enhanced Delivery (Intratumoral)
- Median survival for patients with recurrent HGG who were not surgical candidates was 13.8 months using biopsy needle delivery (transcranial) versus 7.9 months using convection enhanced delivery (non-biopsy needle delivery)
Evidence of Safety and Mechanism of Action
- Across all ongoing studies, Toca 511 & Toca FC continue to be well tolerated
- Quantitative viral RNA and DNA from Toca 511 was cleared from blood by all patients within early cycles of Toca FC, and detected at low levels in the urine or saliva of a few patients
- Tumor resections from patients previously receiving Toca 511 demonstrate Toca 511 selectively infects and persists in tumor cells in situ
Independent Radiology Reviews
- Objective responses seen in the resection/injection clinical trial and the intratumoral clinical trial
Evidence of Anti-Tumor Immune Activation Following Toca FC Treatment in Patients
- Average increases of 42 percent and 21 percent were observed in total CD4 and CD8 counts respectively
- Nearly significant association (p=0.0587) for CD8 increase with better survival in multivariate model
Toca 5, Phase 2/3 Clinical Trial in Patients with First or Second Recurrent High Grade Glioma Undergoing Resection, Now Enrolling Patients
- Randomized, controlled Phase 2/3 clinical trial designed to serve as potential registrational trial
- Primary endpoint is OS; investigators may choose chemotherapy (lomustine or temozolomide) or antiangiogenic therapy (bevacizumab) for control arm
- More information about the clinical trial can be found at www.tocagen.com/toca5 or by searching clinicaltrials.gov using the clinical trial identifier NCT02414165
About Toca 511 & Toca FC
Tocagen’s cancer-selective gene therapy platform is built on retroviral replicating vectors (RRVs) which are designed to selectively integrate into the DNA of cancer cells which then serve as factories for these RRVs to replicate and infect neighboring cancer cells, providing long-term presence of the therapeutic gene(s). Tocagen’s lead product candidate is a combination of an investigational biologic, Toca 511, and an investigational small molecule drug, Toca FC, designed to be used together. Toca 511 is a proprietary injectable RRV that encodes a prodrug activator enzyme, cytosine deaminase (CD). Its selective delivery to cancer cells means that the infected cancer cells selectively carry the CD gene and produce CD protein. Toca FC is an orally administered, proprietary extended-release version of 5-FC, a prodrug that is inactive as an anti-cancer drug. Toca FC is converted into the active anti-cancer drug, 5-FU, at high concentrations in Toca-511-infected cancer cells that are producing CD protein. 5-FU is a well-established anti-cancer agent used effectively in many conventional chemotherapy settings. In addition to the direct killing of Toca 511-infected cancer cells, 5-FU kills neighboring uninfected cancer cells and myeloid derived suppressor cells (MDSCs) in the tumor.
About Tocagen Inc.
Tocagen is a clinical-stage, cancer-selective immunotherapy company focused on developing first-in-class, broadly-applicable product candidates designed to activate a patient’s immune system against their own cancer from within. The company is developing its lead product candidate, Toca 511 & Toca FC, initially for the treatment of recurrent high grade glioma (HGG), a disease with significant unmet medical need. Tocagen has initiated the Phase 2 portion of a randomized, controlled Phase 2/3 clinical trial of Toca 511 & Toca FC in patients with recurrent HGG, which is designed to serve as a potential registrational trial. In 2016, Tocagen plans to initiate clinical trials of Toca 511 & Toca FC in patients with newly diagnosed HGG and other solid tumors. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration, for Toca 511 & Toca FC for the treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma (GBM), a subset of HGG. For more information visit www.tocagen.com or follow @Tocagen.
1 Clinical data are from the efficacy evaluable population. Data cutoff is Sept. 18, 2015.
SOURCE Tocagen Inc.
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