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Quarta-feira, 19.08.15

ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

GLIOBASTOMA GBM

ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

Published on August 13, 2015 at 8:32 AM ·

ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) announced today that it has reached agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the phase 3 registrational trial of its cancer immunotherapy ICT-107 to treat patients with newly diagnosed glioblastoma.

The phase 3 trial is designed as a randomized, double-blind, placebo-controlled study of about 400 HLA-A2 positive subjects, which will be conducted at about 120 sites in the US, Canada and the EU. The primary endpoint in the trial is overall survival, which the FDA and EU regulators have stated is the appropriate endpoint for registrational clinical studies in glioblastoma. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups. Patient enrollment is anticipated to begin in the late third quarter or early fourth quarter of 2015.

A Special Protocol Assessment is a written agreement between the sponsor company and the FDA on the design, clinical endpoints, size and statistical design of a clinical trial intended to form the primary basis of an efficacy claim in the marketing application, such as a biologic licensing application (BLA) or a new drug application (NDA). Final marketing approval depends upon the safety and efficacy results demonstrated in the phase 3 clinical program.

Andrew Gengos, ImmunoCellular's Chief Executive Officer Commented: "We are pleased to have achieved this important milestone, and think that successful completion of the SPA process adds meaningful validation to the ICT-107 phase 3 program and design, especially the use of the gold standard primary endpoint of overall survival. With this SPA in place, we think that ICT-107 is uniquely positioned in the field of immuno-oncology approaches being tested in glioblastoma. We are making significant progress toward establishing our clinical site network and obtaining the necessary institutional review board approvals. We are confident that we are on track to begin patient enrollment in the late third quarter or early fourth quarter of this year."

Source:

ImmunoCellular Therapeutics, Ltd.

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por cyto às 11:37

Terça-feira, 21.07.15

Novel cancer drug candidate developed in Singapore advances into clinical trials

 

Novel cancer drug candidate developed in Singapore advances into clinical trials

Published on July 17, 2015 at 2:01 AM

A made-in-Singapore cancer drug has advanced into clinical trials, charting a milestone in Singapore's biomedical sciences initiative that will go towards improving the lives of cancer patients in Singapore, and worldwide. The Agency for Science, Technology and Research (A*STAR) and Duke-National University of Singapore Graduate Medical School (Duke-NUS) today announced the start of a Phase I clinical trial of novel cancer drug candidate, ETC-159. This is the first publicly-funded drug candidate discovered and developed in Singapore to advance into first-in-human trials, and will target a range of cancers. Overall, cancer is the leading cause of death in Singapore, accounting for 30 percent of deaths in 2013. Cancer has also resulted in 8.2 million deaths world-wide .

ETC-159 targets a number of cancers including colorectal, ovarian and pancreatic cancers which contribute to a significant proportion of Singapore's cancer burden. These cancers are linked to a group of cell signalling pathways known as Wnt signalling, that have been identified to promote cancer growth and spread when elevated or dysregulated. As ETC-159 is an inhibitor of these pathways, it could suppress cancer proliferation and prevent cancer progression.

This drug candidate therefore offers a promising novel and targeted cancer therapy that could shape future cancer therapeutic strategies.

ETC-159 was discovered and developed through a collaboration between A*STAR's Experimental Therapeutics Centre (ETC), Drug Discovery and Development (D3) unit and Duke-NUS since 2009. This was based on the discovery work of Prof David Virshup from Duke-NUS, who has continued to contribute to the development of the drug candidate.

The Phase I clinical trial will evaluate the safety and tolerability of ETC-159 in advanced solid tumours of up to 58 patients. The first patient was dosed on 18 June 2015.

Dr Benjamin Seet, Executive Director of A*STAR's Biomedical Research Council, said, "This breakthrough, which closely follows local company MerLion Pharmaceuticals' recent success in obtaining FDA approval for one of its drugs, marks an inflection point in Singapore's biomedical sciences initiative. Despite the protracted process of drug discovery and development, I am confident that we will see more locally developed drugs in the pipeline being tested and implemented."

Prof Ranga Rama Krishnan, Chairman of the National Medical Research Council (NMRC), Singapore, said, "The first dosing of a drug developed by A*STAR based on a scientific discovery by Duke-NUS researchers, is an example of the terrific and exciting progress that has been made when different entities come together to work on a common problem. This will lead to developing new treatments that can benefit patients in Singapore and beyond."

Prof Alex Matter, Chief Executive Officer of ETC and D3 said, "The discovery and subsequent development of this drug candidate marks a major breakthrough in cancer therapeutics. It also demonstrates the world-class drug discovery and development capabilities we have built up at ETC and D3, complemented by valued partners like Duke-NUS. We will continue to strengthen these capabilities and partnerships to continue developing a pipeline of promising drug candidates and advancing them into the clinic."

Prof David Virshup, inaugural Director of the Programme in Cancer and Stem Cell Biology at Duke-NUS, said, "As the drug candidate provides a targeted cancer therapy, it could potentially minimise side effects and make cancer treatments more bearable for cancer patients. This is a major milestone that was made possible by Singapore's ongoing investment in basic and translational biomedical research to address unmet medical needs. It is fitting that Singaporeans might be the first to benefit from this Singapore-developed drug."

A*STAR's ETC and Duke-NUS are the primary drivers of the discovery and development of the drug candidate. D3 joined the collaboration in 2013 to bring the project forward to achieve proof of concept in humans.

D3 has obtained ethics and regulatory approval for this trial from the SingHealth Centralised Institutional Review Board (CIRB) and the Singapore Health Sciences Authority (HSA) respectively. The first two sites for the trial are the National Cancer Centre Singapore (NCCS) and the National University Hospital (NUH), Singapore. Trial sites in the United States will be opened as the trial progresses.

Source:

Biomedical Sciences Institutes (BMSI)

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por cyto às 18:15

Sábado, 04.07.15

new immunotherapy treatment for cancer patients

 

CTCA at Western begins Phase Ib/II trial of new immunotherapy treatment for cancer patients

Published on June 27, 2015 at 2:15 AM · 

Cancer Treatment Centers of America® (CTCA) at Western Regional Medical Center (Western) in Goodyear, Arizona, has begun a new Phase Ib/II clinical trial using a new immunotherapy treatment for patients with advanced kidney, non-small cell lung cancer, pancreatic cancer and colorectal carcinoma.

This "NivoPlus" clinical trial combines an immunotherapy drug (nivolumab) with already FDA-approved chemotherapy drugs (temsirolimus, irinotecan, and a combination of irinotecan and capecitabine).

The addition of nivolumab is intended to activate the body's own immune system to improve on the results that otherwise might not be achieved from chemotherapy alone. This combination of chemotherapy and immunotherapy drugs is investigational in this study and is the third such combination clinical trial launched in the past year by CTCA® at Western.

There are anticipated to be up to 49 patients enrolled on the multi-arm NivoPlus study. The first patient received treatment on this study earlier this month.

"Some of these drug combinations are not available elsewhere, giving CTCA patients additional treatment options," said Dr. Glen Weiss, Director of Clinical Research and Medical Oncologist, CTCA at Western. "Our ultimate goal is to evaluate if these combinations yield improved results for our patients."

Nivolumab works by inhibiting a protein called PD-1, which otherwise blocks the body's immune system from attacking cancerous cells.

Nivolumab was approved by the Food and Drug Administration in December 2014 for the treatment of advanced melanoma and on March 4, 2015, for patients with previously treated metastatic squamous non-small cell lung cancer.

"Patients with these types of advanced-stage cancers have tumors that may be challenging to treat," said Dr. Vivek Khemka, Medical Oncologist, CTCA Western and NivoPlus Principal Investigator. "We are investigating whether combining nivolumab with these chemotherapy drugs will be a more powerful approach against their disease."

Recent data reported in the New England Journal of Medicine and Lancet demonstrates promising results with antibody-based immunostimulatory therapy in treating melanoma, renal cell carcinoma, non-small cell lung cancer and colorectal cancer. Data has also shown synergetic effects of utilizing cytotoxic chemotherapy in combination with immunostimulatory therapy. NivoPlus will build upon this data, extending treatment options to additional cancer types.

CTCA investigators have been actively researching the impact of immunotherapy, a topic prominently highlighted this year at the annual conferences of both the American Association for Cancer Research (AACR) and the American Society of Clinical Oncologists (ASCO).

At AACR, physicians described immunotherapy as now being considered an integral part of cancer biology and cancer treatment, and recent clinical successes were described as "stunning" and "unprecedented" in their ability to improve the care of cancer patients.

At ASCO, a full press briefing was devoted to the subject of immunotherapy, which was described by doctors as "one of the most exciting advances in oncology," enabling the body's own immune system to target cancer tumors and key to helping accelerate the pace of progress "and ultimately achieve cures for cancer."

Additionally, in 2013, Science magazine named cancer immunotherapy the scientific breakthrough of the year.

CTCA physicians are committed to bringing the latest technologies and advanced treatment options to their patients as quickly as possible. At the same time, CTCA patients are supported with therapies to reduce side effects, boost energy levels and keep them strong during treatment.

Source:

Cancer Treatment Centers of America

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por cyto às 11:18

Quinta-feira, 02.07.15

CTCA at Western begins Phase Ib/II trial of new immunotherapy treatment for cancer patients

CTCA at Western begins Phase Ib/II trial of new immunotherapy treatment for cancer patients

Published on June 27, 2015 at 2:15 AM · 

Cancer Treatment Centers of America® (CTCA) at Western Regional Medical Center (Western) in Goodyear, Arizona, has begun a new Phase Ib/II clinical trial using a new immunotherapy treatment for patients with advanced kidney, non-small cell lung cancer, pancreatic cancer and colorectal carcinoma.

This "NivoPlus" clinical trial combines an immunotherapy drug (nivolumab) with already FDA-approved chemotherapy drugs (temsirolimus, irinotecan, and a combination of irinotecan and capecitabine).

The addition of nivolumab is intended to activate the body's own immune system to improve on the results that otherwise might not be achieved from chemotherapy alone. This combination of chemotherapy and immunotherapy drugs is investigational in this study and is the third such combination clinical trial launched in the past year by CTCA® at Western.

There are anticipated to be up to 49 patients enrolled on the multi-arm NivoPlus study. The first patient received treatment on this study earlier this month.

"Some of these drug combinations are not available elsewhere, giving CTCA patients additional treatment options," said Dr. Glen Weiss, Director of Clinical Research and Medical Oncologist, CTCA at Western. "Our ultimate goal is to evaluate if these combinations yield improved results for our patients."

Nivolumab works by inhibiting a protein called PD-1, which otherwise blocks the body's immune system from attacking cancerous cells.

Nivolumab was approved by the Food and Drug Administration in December 2014 for the treatment of advanced melanoma and on March 4, 2015, for patients with previously treated metastatic squamous non-small cell lung cancer.

"Patients with these types of advanced-stage cancers have tumors that may be challenging to treat," said Dr. Vivek Khemka, Medical Oncologist, CTCA Western and NivoPlus Principal Investigator. "We are investigating whether combining nivolumab with these chemotherapy drugs will be a more powerful approach against their disease."

Recent data reported in the New England Journal of Medicine and Lancet demonstrates promising results with antibody-based immunostimulatory therapy in treating melanoma, renal cell carcinoma, non-small cell lung cancer and colorectal cancer. Data has also shown synergetic effects of utilizing cytotoxic chemotherapy in combination with immunostimulatory therapy. NivoPlus will build upon this data, extending treatment options to additional cancer types.

CTCA investigators have been actively researching the impact of immunotherapy, a topic prominently highlighted this year at the annual conferences of both the American Association for Cancer Research (AACR) and the American Society of Clinical Oncologists (ASCO).

At AACR, physicians described immunotherapy as now being considered an integral part of cancer biology and cancer treatment, and recent clinical successes were described as "stunning" and "unprecedented" in their ability to improve the care of cancer patients.

At ASCO, a full press briefing was devoted to the subject of immunotherapy, which was described by doctors as "one of the most exciting advances in oncology," enabling the body's own immune system to target cancer tumors and key to helping accelerate the pace of progress "and ultimately achieve cures for cancer."

Additionally, in 2013, Science magazine named cancer immunotherapy the scientific breakthrough of the year.

CTCA physicians are committed to bringing the latest technologies and advanced treatment options to their patients as quickly as possible. At the same time, CTCA patients are supported with therapies to reduce side effects, boost energy levels and keep them strong during treatment.

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por cyto às 11:56

Terça-feira, 23.06.15

NW Bio releases promising new data on DCVax-Direct Phase I trial for inoperable solid tumors

NW Bio releases promising new data on DCVax-Direct Phase I trial for inoperable solid tumors

Published on June 2, 2015 at 10:00 AM · 

Northwest Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, over the weekend in Chicago released promising new data on their Phase I trial of DCVax-Direct for direct injection into all types of inoperable solid tumors.

The patients enrolled in the trial had late stage cancers, with an average of three inoperable tumors. The patients had failed multiple prior therapies and had a poor prognosis.

The trial enrolled 40 patients, and 39 were evaluable. A conservative treatment regimen was used. Although the patients had multiple inoperable tumors, only 1 tumor was injected with DCVax-Direct. The treatments included only 3 injections in the first 2 weeks (Day 0, 7 and 14), and up to 3 additional injections spaced months apart thereafter (Weeks 8, 16 and 32), over a total period of 8 months.

Patients typically received their first injection about 1-1/2 months after recruitment. Four patients are still in the process of completing the study visits, and data collection is ongoing on all of the patients.

The trial tested three different dose levels of DCVax-Direct, two different methods of activating the dendritic cells that comprise DCVax-Direct, and a dozen different cancers. Findings to date include encouraging survival data and substantial induction of immune checkpoint expression (PDL-1).

The webcast and presentation by Dr. Bosch can be found on the Company's website at nwbio.com/webcast

Findings to date include the following:

  • 27 of 39 patients are still alive at up to 18 months after first injection.
  • Patient survival correlates with the method of dendritic cell activation used. With the preferred method, 18 of 21 patients are still alive.
  • Treatment effects have been observed in diverse cancers, including lung, breast, colorectal, pancreatic, sarcoma, melanoma, neuro-endocrine and other cancers.
  • Patient survival correlates with the number of DCVax-Direct injections.
  • Patient survival also correlates with stabilization of disease at Week 8 (4th injection visit). Among patients treated with the preferred method of dendritic cell activation, 16 of 19 achieved stable disease (i.e., less than 25% increase in tumor size from baseline) at Week 8.

Findings to date relating to immunological responses include the following:

  • Induction of PDL-1 immune checkpoint expression was seen in 64% of evaluable patients (14 of 22) following DCVax-Direct treatment. This suggests that the tumors are putting up defenses against the immune responses induced by DCVax-Direct, and marks these patients as potential candidates for treatment with checkpoint inhibitor therapies.
  • An increase in T-cell infiltration into tumors, by functionally active T-cells, was seen following DCVax-Direct treatment.
  • Both local effects (in the injected tumor) and systemic effects were observed.

Based on the findings from the Phase I trial, the Company plans to enhance its Phase II trials in several ways, including by:

  • Using only the preferred activation method of the DCVax dendritic cells.
  • Injecting multiple inoperable tumors at each treatment visit, not just one.
  • Providing more frequent treatments and a larger total number of treatments.

The Company plans to pursue Phase II trials in non-small cell lung cancer and sarcoma, as well as a Phase II trial for multiple diverse types of cancers similar to the Phase I study. The Company also plans to expand the trial sites to include countries beyond the U.S.

"We are quite encouraged to see these results across diverse types of cancers, in late stage patients with multiple inoperable tumors who have exhausted other treatment options, and with quite a conservative DCVax-Direct treatment regimen," commented Linda Powers, CEO of NW Bio. "We are looking forward to proceeding with Phase II trials applying the lessons learned from this informative Phase I trial."

Source:

Northwest Biotherapeutics, Inc.

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por cyto às 17:20


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