VANCOUVER, British Columbia, March 20, 2019 (GLOBE NEWSWIRE) — Premier Health Group (CSE: PHGI, OTCQB: PHGRF, Frankfurt: 6PH) (the “Company” or “Premier Health”), a Company focused on developing innovative approaches that combine human skill-based expertise with emerging technologies for the healthcare industry, is pleased to announce it will be launching a range of virtual and remote services to be offered to primary care clinics, including Nurses, Medical Office Assistants (MOA) and Office Managers. The initial launch will focus on current Juno EMR clients in BC with plans to roll out to other provinces by the end of Q2 2019.
More and more physicians are opting to become hospitalists, citing higher income and no business overhead or administrative headaches. With a rising number of family physicians retiring and/or burning out, high fixed overhead and the lack of business support represent major deterrents to recruiting young doctors to take over private practices. As a result, patients are suffering. In a cost effective and efficient division of labor, physicians would focus on formulating diagnoses and treatment plans, while nurses and MOAs oversee routine health maintenance, discuss lifestyle changes, and educate patients on their medical conditions and treatment needs.
Premier Health’s remote nurses will be automatically alerted of any patient follow-up. This process is enabled through the Juno EMR with no manual interaction or need for dedicated labour by the clinic. In addition to improving the patient backlog and long wait times that currently afflicts our healthcare system, this remote shared service model will increase the clinics billings revenue by allowing physicians to be dedicated to seeing patients while reducing the clinic’s fixed labor cost. In some cases, where smaller clinics don’t have the resources for adequate patient follow-up, implementing an automatically-prompted and systematic process could significantly improve the quality of care and improve patient health outcomes. In addition to remote shared nurses, Premier is also planning to add remote shared billing services by Q3 2019. This initiative will include forensic billing to detect missed or incorrect billing.
MOAs and Office Managers can improve workflow and increase clinic efficiency by focusing on EMR documentation, managing the day to day clinic operations and other administrative tasks. Premier is launching both a virtual AI powered phone assistant and a shared MOA/Office Manager system for Juno EMR clients. The AI system will be able to triage and manage many of the repetitive tasks while the shared MOA will complete the back-end administrative tasks needed to operate a clinic. Both systems will work seamlessly with the clinic’s current staff and doctors. As an added service, to complement this offering, Premier Health has developed comprehensive templates for manuals required in clinics including, but not limited to, privacy and equipment training manuals. Keeping up with documentation requirements is a real problem for many smaller clinics today who are unable to afford the time or resources involved in adhering to stringent and evolving regulations placed on them.
Rising labour costs and inefficient use of resources amount to increasing challenges in primary care. Premier Health’s new initiative is curated for medical clinic owners and operators to reduce the burdensome overhead associated with day to day operations. These offering will transform the primary care landscape from a fixed labor cost to a variable cost model that is customized for the individual needs of clinics. This increased efficiency and lower operating cost will increase the overall profitability of primary care clinics.
“From my own clinical experience, I see the benefit of offering these services to other privately-owned clinics,” said Dr. Essam Hamza, CEO of Premier Health. “We have successfully integrated shared resources across our four HealthVue Medical clinics. With rising labour costs, many clinics simply cannot afford dedicated staffing. With our recent acquisition of Cloud Practice, we have the opportunity to provide virtual and remote services to the 287 clinics currently using Juno EMR.”
The company already has a list of clinics immediately interested in virtual nursing services in BC and plans to provide further expansion updates in Q2 2019.
ON BEHALF OF THE BOARD OF DIRECTORS
“Dr. Essam Hamza, MD”
Chief Executive Officer
About Premier Health
Premier Health is a Canadian company that is strategically poised to take advantage of business opportunities in the global health care industry. We are focused on innovative health care approaches that combine human skill-based expertise with emerging technologies. Premier Health, in conjunction with its subsidiary Cloud Practice, a cloud-based SAAS Electronic Medical Records software company, is developing proprietary technology to deliver quality healthcare through the combination of connected primary care clinics with telemedicine and artificial intelligence (AI). We currently have a combined ecosystem of 290 clinics, over 3000 licensed practitioners and almost 3 million registered patients. The Premier Health team has deep clinical, operational and financial expertise and a passion for improving healthcare for all patients.
The Canadian Securities Exchange does not accept responsibility for the adequacy or accuracy of this release.
FOR ADDITIONAL INFORMATION CONTACT:
Premier Health Group Inc.
Pursuant to an agreement between MIDAM VENTURES, LLC and Premier Health Group Inc. we were hired for a period from 10/1/2018 – 4/1/2019 to publicly disseminate information about Premier Health Group Inc. including on the Website and other media including Facebook and Twitter. We were paid $300,000 CASH for & were paid “500,000” shares of restricted common shares (as of 1/2/2019). Midam has been compensated an additional $100,000 by Premier Health Group to extend the period of coverage to June 1, 2019. We own zero shares of Premier Health Group Inc., which we purchased in the open market. Once the (6) Six-month restriction is complete on 4/1/2019 we plan to sell the “500,000” shares of Premier Health Group Inc. that we hold currently in restricted form during the time the Website and/or Facebook and Twitter Information recommends that investors or visitors to the website purchase without further notice to you. We may buy or sell additional shares of Premier Health Group Inc. in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information.
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InCaseYouMissedIt: Tiziana Life Sciences (TLSA) Reports Positive Phase 2a Clinical Data
Tiziana Life Sciences plc (TLSA), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, this week announced additional positive Phase 2a clinical data exhibiting impressive clinical activity of Milciclib monotherapy in patients with advanced Sorafenib-resistant or -intolerant patients with unresectable or metastatic hepatocellular carcinoma (HCC).
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Tiziana Life Sciences (TLSA) Reports Positive Phase 2a Clinical Data Exhibiting Positive Clinical Activity with Milciclib Monotherapy in Advanced Sorafenib-refractory or -intolerant Patients with Unresectable or Metastatic Hepatocellular Carcinoma
NEW YORK–(BUSINESS WIRE)–
Tiziana Life Sciences plc (TLSA), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, today announced additional positive Phase 2a clinical data exhibiting impressive clinical activity of Milciclib monotherapy in patients with advanced Sorafenib-resistant or -intolerant patients with unresectable or metastatic hepatocellular carcinoma (HCC).
This Phase 2a multi-center, single-arm, repeated-dose (100 mg once daily; 4 days on/3 days off for 4 weeks; defining each cycle) and 6-month duration study was conducted to evaluate the safety, tolerability and anti-tumor activity of Milciclib in Sorafenib-resistant patients with unresectable or metastatic advanced HCC. The trial enrolled 31 patients in Italy, Greece and Israel, of which 28 patients were evaluable. While the primary endpoint of this study was overall safety, secondary endpoints were also evaluated.
As previously announced on 22 July 2019, the clinical data from the Phase 2a trial indicated that Milciclib was well tolerated with manageable toxicities and no recorded drug related deaths, thereby meeting the trial’s primary endpoint. The Company now announces all the major highlights of the clinical data from the trial, which also indicate positive clinical activity relating to the secondary endpoints including progression-free survival (“PFS”) and time to progression (“TTP”).
MAJOR HIGHLIGHTS OF THE CLINICAL DATA
As per the study protocol, data collection was limited to 6-months. Thus, clinical data were not collected from patients under compassionate use treatment. The clinical activity assessment in evaluable patients was based on the investigators’ review using the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- 14 out of 28 (50%) evaluable patients completed 6-month duration of the trial.
- 9 out of 14 patients (64.2%) were approved by their respective ethical committees to continue the treatment.
- 5 of the 9 patients on compassionate use had received Milciclib for a total of 9, 9, 11, 13 and 16 months.
- As of 1 September 2019, the remaining 4 patients continuing the treatment are in their 10th, 11th, 11th and 12th months.
- Both median TTP and PFS were 5.9 months (95% Confidence Interval (“CI”) 1.5-6.7 months) out of the 6-months duration of the trial.
- 17 of 28 (60.7%) evaluable patients showed ‘Stable Disease’ (SD; met at least once in an 8-week interval).
- One patient (3.6%) showed ‘Partial Response’ (PR).
- 18 of 28 (64.3%) evaluable patients showed ‘Clinical Benefit Rate’ defined as CBR=CR+PR+SD (with CR representing Complete Remission).
Sorafenib® (Bayer) was approved, based on the clinical data from the pivotal Phase 3 (SHARP) clinical trial1, as the first line therapy for naive HCC patients. The clinical data from that study showed median TTP of 5.5 months (95% CI 4.1-6.9 months), CBR of 43% and 71% SD by RECIST criteria1. Conversely, the clinical data from a phase 2 trial with Sorafenib in patients with advanced HCC, showed SD (33.6%), TTP of 4.2 months and median OS of 9.2 months2.
Regorafenib was approved, based on the clinical data from the pivotal Phase 3 (RESORCE) clinical trial3, as the second line therapy for sorafenib-resistant HCC patients. In this study, Regorafenib showed median PFS of 3.1 months (95% CI 2.8-4.2 months), median TTP of 3.2 months (95% CI 2.9-4.2 months) and disease control rate (DCR, similar to CBR) of 65% by mRECIST. On the other hand, the clinical data from a Phase 2 study in patients with intermediate and advanced HCC, Regorafenib showed median TTP of 4.3 months (95% CI 2.9-13.1 months), SD (69%) and PR was 3%4.
“The current therapies for HCC are often associated with severe toxicities, resulting in poor patient compliance. Hence, there is an immediate need for efficacious therapies that will not compromise patients’ quality of life. We believe that the overall safety profile of Milciclib is an important competitive advantage over existing therapies currently used for treating HCC” said Gabriele Cerrone, Chairman and founder of Tiziana Life Sciences.
“The positive clinical activity and tolerability data of Milciclib in Sorafenib-resistant and advanced HCC patients are very encouraging and provides affirmation for continued development of Milciclib, either as monotherapy or combination therapy” said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana. “We reported last year at AASLD that Milciclib produced pronounced synergistic anti-HCC activity in combination with any one of the FDA approved tyrosine kinase inhibitor (TKI) class of drugs, including Sorafenib (Nexavar®), Regorafenib (Stivarga®), and Lenvatinib (Lenvima®)5. Thus, we believe that Milciclib in combination with any one of the TKI drugs has good potential to expand the Clinical Benefit Rate in HCC patients.”
1. Llovet, J., Ricci, S., Mazzaferro, V., Hilgard, P., Gane, E., Blanc, J-F., de Oliveira, A., Santoro, A., Raoul, J-L, Forner, A., Schwartz, M., Porta, C., Zeuzem, S., Bolondi, L., Greten, T., Galle, P., Seitz, J-F., Borbatch, I., Haussinger, D., Giannaris, T., Shan, M., Moscovici, M., Voliotiz, D., and J. Bruix. (2008) Sorafenib in Advance Hepatocellular Carcinoma. N Engl. J Med. 359:378.
2. Abou-Alfa, G., Schwartz, L., Ricci., S., Amadori, D., Santoro, A., Figer, A. De Greve, J., Douillard, J-Y., Lathia, C., Schwartz, B., Taylor, I., Moscovici, M. and L. Saltz. (2006). Phase II Study of Sorafenib in Patients with Advanced Hepatocellular Carcinoma. J. Clin. Oncol. 24:4293.
3. Bruix, J, Qin, S., Merle, P., Granito, A., Huang, Y-H, Bodoky, G., Pracht, M., Yokosuka, O., Rosmorduc, O., Breder, V., Gerolami, R., Masi, G., Ross, P., Song, T., Bronowicki, J-P., Ollivier-Hourmand, I., Kudo, M., Cheng, A-L., Llovet, J.M., Finn, R., LeBerre, M-A., Baumhauer, A., Meinhardt, G. and Han, G. (2017)Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet 389: 56.
4. Bruix, J., Tak, W-Y., Gasbarrini, A., Santoro, A., Colombo, M., Lim, H-Y., Mazzaferro, V., Wiest, R., Reig, M., Wagner, A., and Bolondi, L.(2013) Regorafenib as Second-Line Therapy for Intermediate or Advanced Hepatocellular Carcinoma: Multicentre, Open-Label Phase II Safety Study. Eur.J. Cancer 49:3412.
5. Jindal, A., Palejwala, V. and Shailubhai, K. (2018). Oral treatment with milciclib either alone or in combination with sorafenib inhibited tumor growth in an orthotopic model of hepatocellular carcinoma. Hepatology 68 Number 1 (Suppl): 879A (Abstract 1543)
The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.
Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts straight to you on https://ir. tizianalifesciences. com
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
HCC is the fifth most common cancer and the third highest cause of cancer mortality worldwide. The primary risk factor for HCC is hepatic cirrhosis. Between 2003 to 2012, rates of new liver cancer cases went up 38% according to the Centers for Disease Control and Prevention. Most HCC patients present with advanced disease and do not benefit from transplantation, surgical resection, or locoregional therapies. Sorafenib (standard of care) and Lenvatinib are approved in the United States and EU as first line-treatment for advanced HCC patients.
Regorafenib (Stivarga®) and Nivolumab (Opdivo®) are both approved by the FDA for second line treatment of advanced HCC. The complex multi-factorial etiology of HCC warrants a need for systemic therapies that target different signaling cascades to provide improved efficacy and safety for both naive patients presenting with unresectable, advanced stage and those who suffer recurrence after curative treatments (resection, ablation and transplantation).
Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK2, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signaling pathways that regulate cell cycles have been frequently associated with development of resistance towards chemotherapies. In a Phase 1 study, oral treatment with Milciclib was well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon cancer, thymic carcinoma and thymoma. Additionally, milciclib met its primary endpoint in two separate Phase 2 multi-center clinical trials (CDKO-125A-006: 72 patients and CDKO-125A-007: 30 patients) in thymic carcinoma and thymoma patients.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.
View source version on businesswire.com: https:// www.businesswire. com /news/home/20190904005447/en/Contact:Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder
+44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated adviser)
Liam Murray / Jo Turner
+44 (0)20 7213 0883
Shore Capital (Broker)
Andy Crossley / Antonio Bossi
+44 (0)20 7601 6125
View Original Release on BusinessWire.com:
Pursuant to an agreement between Midam Ventures LLC and Tiziana Life Sciences plc (TLSA), Midam has been paid $150,000 by Tiziana Life Sciences plc (TLSA) for a period from August 22, 2019 to September 22, 2019. We may buy or sell additional shares of Tiziana Life Sciences plc (TLSA) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about Tiziana Life Sciences plc (TLSA). Full Disclaimer Click Here
PharmaCyte Biotech (PMCB) Confirms Dr. Manuel Hidalgo Will Be Principal Investigator for Clinical Trial in Pancreatic Cancer
LAGUNA HILLS, Calif.–(BUSINESS WIRE)–
PharmaCyte Biotech, Inc. (PMCB), a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that nationally and internationally renowned clinician and oncologist, Dr. Manuel Hidalgo, has confirmed that he will be Principal Investigator (PI) for PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) now that he is at Weill Cornell Medical Center.
Dr. Hidalgo, a leading physician-scientist who specializes in pancreatic cancer and drug development, was recently appointed Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center. Previously, Dr. Hidalgo was a Professor of Medicine at the Harvard Medical School and the Chief of the Division of Hematology Oncology and Director of the Rosenberg Clinical Cancer Center at the Beth Israel Deaconess Medical Center.
Dr. Hidalgo commented, “With PharmaCyte proceeding with the GMP production of the clinical trial product for its LAPC trial, I am more excited than ever to be a part of PharmaCyte’s clinical trial team. I remain enthusiastic about being the PI for the trial. I am also optimistic about the potential that PharmaCyte’s treatment may hold for patients suffering from LAPC and possibly other types of solid cancerous tumors. For example, PharmaCyte’s therapy for cancers involving the pancreas, liver and breast may offer an effective way to specifically target those cancers with little to no side effects from the chemotherapy.”
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. (PharmaCyte) is a clinical stage biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is exploring the use of genetically modified liver cells, stem cells and beta islet cells. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they will function as a “bio-artificial pancreas” for purposes of insulin production.
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of the management of PharmaCyte, including statements regarding the timing and commencement of our first Phase 2b clinical trial. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise
More information about PharmaCyte can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190828005190/en/
Dr. Gerald W. Crabtree
PharmaCyte Biotech, Inc.
Investor Relations Department
View Original Release on BusinessWire.com:
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