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Provectus announces acceptance of PV-10 abstract at ESMO Congress » 07:04
07/19/21
07/19
07:04
07/19/21
07:04
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Provectus announced that…

Provectus announced that data from an ongoing clinical trial of investigational cancer immunotherapy PV-10 for the treatment of neuroendocrine tumors metastatic to the liver refractory to somatostatin analogs and peptide receptor radionuclide therapy will be presented at the European Society for Medical Oncology Congress, to be held online from September 16-21, 2021. The abstract accepted for electronic poster presentation is entitled: "Phase I study of hepatic intralesional rose bengal disodium, an autolytic immunotherapy, in metastatic neuroendocrine neoplasms".

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Over a month ago
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Provectus announces publication of data from research on oral delivery of PV-10 » 07:21
06/09/21
06/09
07:21
06/09/21
07:21
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Provectus announced that…

Provectus announced that preclinical data from the company's research on oral delivery of investigational cancer immunotherapy PV-10 for the treatment of adult solid tumors were published as an abstract as part at the American Society of Clinical Oncology 2021 Annual Meeting. Highlights from the ASCO 2021 abstract and UCal's associated presentation: Discussion. Testicular and colorectal cancer cell lines had lower IC50 values than normal PBMCs, displaying the wide therapeutic window for PV-10 treatment without affecting normal cells. In the breast cancer cell line panel, only MCF-7 had an IC50 value higher than normal PBMCs compared to MDA-MB-231 and T-47D, illustrating biological variability among cell lines; variability is observed in cancers. MCF-7 lacks the expression of executioner caspase-3, showing relatively more resistance to eventual PV-10-induced cell death. A majority of head and neck cancer cell lines had higher IC50 values than normal PBMCs, showing PV-10's differential biological activity for different types of cancers . PV-10 may be more potent in inducing cell death in certain types of cancers than others. Ongoing research continues to elucidate PV-10's underlying mechanism that lead to its selective and specific activity against different cancers.

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Provectus announces data from Phase 1 trial of PV-10 » 09:24
06/04/21
06/04
09:24
06/04/21
09:24
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Provectus announced that…

Provectus announced that preliminary full study data from the Company's Phase 1 clinical trial of investigational cancer immunotherapy PV-1 for the treatment of neuroendocrine tumors metastatic to the liver refractory to somatostatin analogs and peptide receptor radionuclide therapy is be presented at the American Society of Clinical Oncology 2021 Annual Meeting, held June 4-8 online. Highlights from the mNET Presentation at ASCO 2021: Baseline and disease characteristics 12 patients; 50% male; median age of 66 years; Primary tumor sites: 7 small bowel, 2 pancreas, 1 caecal, and 2 unknown; NET grades: 5 Grade 1 and 7 Grade 2; Refractory to SSA and PRRT; symptomatic progressive disease PV-10 treatment summaryl Median of 1 hepatic NET lesion injected; median of 1 injection cycle; 8 patients received 1 PV-10 treatment. Safety: Mild-to-moderate post-procedure pain reported by most patients; Grade 3 photosensitivity reaction in 1 patient, Grade 3 elevation of hepatic enzymes in 1 patient, and carcinoid flare in 2 patients; Injected lesion efficacy; 42% partial response and 42% objective response rate; Patient-level efficacy; 83%a disease control rate; Progression-free survival: median 9.2 months ; Overall survival: median 22.5 months; 6 patients undergoing response follow-up at the data cut-off of April 30, 2021. Immune response: Upregulation of NK cells and activated CD4+ T cells was observed in peripheral blood collected 7 and 28 days post-PV-10 injection; Biomarkers and quality of life; Chromogranin A levels remained stable in 10 patients; QOL assessments showed stable or improved carcinoid symptoms and global health status in most patients. This clinical trial, a single-center study at The Queen Elizabeth Hospital in Adelaide, Australia that completed enrollment in 2020, is led by Tim Price, MBBS, DHlthSc, FRACP, Head of Clinical Oncology Research and Chair of the combined Hematology and Medical Oncology Unit at TQEH and Clinical Professor in the Faculty of Medicine at the University of Adelaide. The primary endpoint of the trial is safety. Secondary endpoints include ORR of injected target and measurable bystander lesions, target lesion somatostatin receptor expression, and biochemical response. Disease response assessments are conducted by independent review using Response Evaluation Criteria in Solid Tumors criteria. Six patients in the first cohort each received one percutaneously-administered injection of PV-10 to one target lesion per treatment cycle. Patients in the six-person second cohort can receive PV-10 injections of multiple lesions per cycle.

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Provectus awarded $2.5M from State of Tennessee » 07:09
05/25/21
05/25
07:09
05/25/21
07:09
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Provectus announced that…

Provectus announced that the State of Tennessee, as part of its fiscal year 2021-2022 budget, has directed funding in the amount of $2.5M to develop animal health drug products through partnerships with state universities that have agriculture and veterinary medicine programs and the Knoxville-headquartered biotechnology company.

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Provectus announces publication of study involving patients treated with PV-10 » 07:11
03/31/21
03/31
07:11
03/31/21
07:11
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Provectus announced that…

Provectus announced that Melanoma Research had published results from an investigator-led, single-center study of Australian in-transit melanoma patients who received intralesional PV-10 under a Provectus-sponsored expanded access program. The Melanoma Research article, entitled "Treatment of in-transit melanoma metastases using intralesional PV-10," detailed the experience of investigators at Melanoma Institute Australia in Sydney, Australia who treated 48 patients from 2008 to 2016. Key highlights of the Melanoma Research publication include: baseline characteristics: 58% women; median age of 75.1 years; median of 5 lesions treated with PV-10; median of 1 PV-10 treatment; 46% complete response and 86% overall response rate in patients; and 12- and 24-month overall survival rates of 77% and 56%. This is the third publication about single-agent PV-10 treatment of ITM lesions under Provectus' EAP and the fifth publication overall.

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Provectus receives notice of allowance for patent for PV-10 immunotherapy » 07:19
03/30/21
03/30
07:19
03/30/21
07:19
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Provectus announced that…

Provectus announced that the United States Patent and Trademark Office has allowed US patent, or USP, application 16/678,133, which covers the use of intralesional PV-10, an injectable formulation of Provectus' proprietary small molecule rose bengal disodium, in concomitant combination with two immune checkpoint inhibitors for the treatment of adult solid tumor cancers such as melanoma, breast cancer, primary and metastatic liver cancers, prostate cancer, and small cell and non-small cell lung cancer. The allowed patent application is the fourth continuation of USP 9,107,887, Provectus' foundational cancer combination therapy patent granted by the USPTO in 2015. It is also related to USP 9,808,524, USP 9,839,688, and USP 10,471,144, which are also continuations. Provectus is the sole assignee on the allowed patent application. Dominic Rodrigues, Vice Chair of the company's board of directors, said, "This pending new patent further expands and enhances our intralesional oncology drug development program by protecting, in particular, the concomitant combination of PV-10 and the duo of anti-CTLA-4 and anti-PD-1 agents for the treatment of solid tumor cancers beyond melanoma, for which the combination of ipilimumab and nivolumab has been approved. There is emerging evidence of major differences in how the combination of anti-CTLA-4 and anti-PD-1 drugs acts on T cell populations and thus immune response, compared with either monotherapy."

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Provectus: USPTO allows patent for aka intratumoral use in solid tumor cancer » 07:16
03/23/21
03/23
07:16
03/23/21
07:16
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Provectus announced that…

Provectus announced that the United States Patent and Trademark Officehas allowed US patent application 16/412,872, which covers the use of intralesional PV-10, an injectable formulation of Provectus' proprietary small molecule rose bengal disodium , as both a monotherapy and in combination with immune checkpoint blockade or radiotherapy for the treatment of relapsed and refractory pediatric solid tumor cancers. The allowed patent application recognizes the first intellectual property (IP) generated from the Company's sponsored research of and collaboration with Aru Narendran, MD, PhD, Professor, Departments of Pediatrics, Oncology, Biochemistry & Molecular Biology, and Physiology & Pharmacology at the Cumming School of Medicine of the University of Calgary in Calgary, Alberta, Canada.

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AC Immune announces 2021 execution strategy » 07:08
03/23/21
03/23
07:08
03/23/21
07:08
ACIU

AC Immune

$7.70 /

-0.3 (-3.75%)

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AC Immune's…

AC Immune's execution strategy is focused on three key initiatives, which support the Company's overarching goal of enabling precision medicine for neurodegenerative diseases: The Company plans to accelerate the development of its late-stage therapies in AD in collaboration with its strategic partners, including its novel pTau vaccine with Janssen Pharmaceuticals Inc., which continues to show great promise. AC Immune is sharpening its strategic focus on non-AD indications with high unmet need. Currently this includes its anti-Abeta vaccine in people with DS, as well as its therapeutic and diagnostic candidates targeting TDP-43 and alpha-synuclein, where the Company may focus in-house efforts on select NeuroOrphan indications while seeking potential partnerships for larger indications like LATE and Parkinson's disease. Furthermore, AC Immune's NLRP3 inflammasome-targeted programs have broad applicability both within central nervous system and non-CNS indications. The Company plans to accelerate advancement of its diagnostic candidates to late-stage development, as continued leadership in precision medicine is a key differentiator for AC Immune. These candidates include its Tau, alpha-synuclein, and TDP-43 PET tracers, which potentially enable earlier disease diagnosis, improved clinical trial outcomes and additional revenue generation for the Company.

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08/21/20 SVB Leerink
AC Immune upcoming readout risk-reward skews positive, says SVB Leerink
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ACIU AC Immune
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Hot Stocks
Provectus announces release of manuscript on PV-10 preclinical study » 07:10
01/20/21
01/20
07:10
01/20/21
07:10
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Provectus announced that…

Provectus announced that H. Lee Moffitt Cancer Center has released a manuscript preprint describing how investigational autolytic cancer immunotherapy PV-10, an injectable formulation of Provectus' proprietary small molecule rose bengal disodium, in combination with gemcitabine may enhance the chemotherapy's efficacy against pancreatic tumors. Chemotherapy regimens that include gemcitabine are the standard of care for the treatment of pancreatic cancer. Moffitt co-authors/researchers Patrick Innamarato, Jennifer Morse, Amy Mackay, Sarah Asby, Matthew Beatty, Jamie Blauvelt, Scott Kidd, John Mullinax, Amod Sarnaik, and Shari Pilon-Thomas showed that: The injection of PV-10 into mouse pancreatic tumors caused lesion-specific ablation, The combination of PV-10 and systemic administration of gemcitabine caused lesion-specific ablation and delayed the growth of untreated distal tumors, The combination was markedly more successful in immunogenic tumors that express the neoantigen ovalbumin, suggesting PV-10 and gemcitabine enhanced the immune clearance of tumors, and The regression of tumors in mice that received PV-10 in combination with gemcitabine was associated with the depletion of myeloid-derived suppressor cells and increases in damage associated molecular patterns high-mobility group box 1, S100A8, and interleukin-1alpha. HMGB1, S100A8, and interleukin-1alpha are dual-function alarmins that have key intracellular and extracellular functions. PV-10 treatment-mediated DAMP-release has been demonstrated in three different tumor types: melanoma, colon cancer, and now pancreatic cancer. Intralesional PV-10 treatment alone or in combination with gemcitabine was capable of inducing the complete regression of injected pancreatic tumors, while gemcitabine monotherapy failed to induce complete regressions. This suggested that increased pancreatic tumor burden, which diminished gemcitabine efficacy, was overcome when PV-10 was combined with gemcitabine.

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Provectus presents updated data from cobination therapy trial of PV-10 » 07:24
12/07/20
12/07
07:24
12/07/20
07:24
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Provectus announced that…

Provectus announced that updated preliminary patient response, safety, and immune correlative data, as well as new preliminary PV-10-treated lesion response data, from the Company's ongoing Phase 1b/2 study of autolytic cancer immunotherapy PV-10, an injectable formulation of Provectus' proprietary small molecule rose bengal disodium, in combination with KEYTRUDA for the treatment of advanced cutaneous melanoma in patients refractory to immune checkpoint blockade was presented at Melanoma Bridge 2020, held online from December 3-5, 2020. The oral presentation, entitled "Response for combination of PV-10 autolytic immunotherapy and immune checkpoint blockade in checkpoint-refractory patients," was presented by Dr. Jonathan Zager, Chief Academic Officer at Moffitt Cancer Center, and a surgical oncologist and Senior Member in Moffitt's Departments of Cutaneous Oncology and Sarcoma. Dr. Zager is also the Director of Regional Therapies at Moffitt's Donald A. Adam Comprehensive Melanoma Research Center and a Professor of Surgery at the Morsani School of Medicine of the University of South Florida. Key highlights of the Melanoma Bridge 2020 presentation: Safety data on 18 patients; Consistent with the established patterns for single-agent use of each drug; Principally grades 1 and 2 injection-site reactions to PV-10; Principally grades 1 to 3 immune-mediated reactions to KEYTRUDA. 14 patients evaluable for overall efficacy; Investigator-assessed RECIST v1.1; All patients: 7% complete response, 36% overall response rate, and 64% disease control rate; Refractory to anti-PD-1: 75% ORR; Refractory to anti-CTLA-4 and anti-PD-1 combination therapy: 11% CR and 56% DRR. 16 lesions treated with PV-10; 38% CR, 50% ORR, and 69% DCR. 5 patient-completed immune correlative assessments; DAMPs and T cells present in peripheral blood are indicative of innate and adaptive immune signaling, respectively; Upregulation of innate and adaptive immune responses appears to be maintained in CB-refractory subjects; PV-10-hallmark DAMP and functional T cell responses in CB-refractory patients are consistent with responses in CB-naive patients who received either single-agent PV-10 or PV-10 and KEYTRUDA combination therapy in other Provectus melanoma clinical trials.

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