Archive | January, 2014

Dr. Michael Har-Noy Details Remarkable Results in Breast Cancer Treatment

24 Jan

Dr. Michael Har-Noy says that the immune mechanism of an allogeneic stem cell transplant is very effective in destroying chemotherapy-resistant metastatic tumors despite their immunoavoidance mechanisms, but this tumor-killing immune effect is unfortunately closely linked to the very lethal graft versus host disease (GVHD) and is thus of limited clinical use.

 

Dr. Michael Har-Noy, founder and C.E.O. of Immunovative Therapies Ltd., a biotech company in Israel, has developed a revolutionary new drug, AlloStimTM, that elicits a host anti-tumor response without causing GVHD toxicity.  Dr. Michael Har-Noy describes how this drug was recently tested in an FDA-approved Phase I/II trial of 42 late-stage metastatic cancer patients with a variety of different tumors.   Most study patients showed evidence of improved survival and immune-mediated tumor destruction and experienced only minor side effects. Conventional RECIST criteria tended to overestimate tumor size because responding lesions swelled and appeared larger on computed tomographic scan.

 

Dr. Michael Har-Noy noted that serum interleukin 12 (IL-12) levels were identified as the best predictor of a positive response to AlloStimTM.   Fifty percent of patients treated with Dr. Michael Har-Noy’s proprietary drug were  IL-12 positive and survived a median of 211 days, compared with 131 days for IL-12 negative patients.   Nine of 16 refractory metastatic breast cancer patients exhibited adequate IL-12 levels. The HER2+ subset of  five breast cancer patients were all IL-12 positive and had a median survival of 416 days, while the 11 HER2- patients had a median survival of only 134 days

 

Dr. Michael Har-Noy points out that HER2+ breast malignancies usually spread faster and have a worse prognosis than HER2- tumors. The superior response to allogeneic cell treatment in the HER2+  metastatic breast cancer patients may result from the high quantities of anti-HER2 antibodies exhibited by this patient subset.   Theoretically, treatment with AlloStimTM should potentiate the ability of these HER2+ antibodies to cause tumor destruction.

 

This preliminary study describes a dramatically increased survival time in a gravely ill subset of breast cancer patients with a very short life expectancy.  Dr. Michael Har-Noy  will ultimately conduct a randomized, double-blind Phase II/III study of AlloStimTM this unique treatment in metastatic breast cancer patients.

 

In Bangkok, Thailand, Dr. Michael Har-Noy is now conducting a combined Compassionate Use-Phase I/II Trial of CRCL-AlloVaxTM, a personalized anti-cancer vaccine.  Interested patients may read about and register for the trial at www.immunocare.net.

 

Sources: www.immunocare.net, www.michaelhar-noy.com, www.immunovative.co.il

Dr. Michael Har-Noy’s Compassionate Use-Phase I/II Trial of CRCL-AlloVaxTM in Thailand

21 Jan

Dr. Michael Har-Noy has announced that his experimental individualized cancer vaccine, known as CRCL-AlloVaxTM, is now available under a combined “Compassionate Use” /Phase I/II study protocol in Bangkok, Thailand.  Dr. Michael Har-Noy says this experimental vaccine is produced from a sample of the patient’s own tumor. The vaccine can be produced from viurtually any type of solid tumor, including those arising from the breast, prostate, pancreas, lung,  kidney, gastrointestinal tract, bladder, and thyroid gland.  Dr. Michael Har-Noy indicates that the vaccine can also be produced from gynecologic tumors (those arising from the vagina, uterus, cervix, and ovary), melanomas, sarcomas (including Kaposi’s), and lymphomas.

Dr. Michael Har-Noy has created a new website, www.immunocare.net, where patients may register for the upcoming Phase I/II trial.

Dr. Michael Har-Noy indicates that in order to qualify for the study protocol, patients should meet the following criteria:  1) have a tumor that is not responding to chemotherapy, or are seeking an alternative to chemotherapy, 2) be generally healthy, 3) agree to try an experimental protocol to train his/her immune system to potentially kill the tumor and prevent further spread, 4) be willing to travel to Bangkok for a month, 5) be willing to cooperate with study doctors and study protocol after their return from Bangkok, and 6) be able to pay the cost of participation.

Dr. Michael Har-Noy says that patients wanting more information should visit www.immunocare.net On the website they can: 1) view a slide presentation describing the technology, 2) read detailed information about the trial, 3) chat with a specialist live in their native language, 4) submit questions by email to study specialists, and 5) register for the trial.

This clinical trial, indicates Dr. Michael Har-Noy, will be conducted in compliance with all international standards for Good Clinical Practices (GCP/ICH).  All patients will be provided with an informed consent document and a contract.  Dr. Michael Har-Noy adds that all trial protocols are approved and monitored by an Institutional Review Board (Ethics Committee).  Also, an independent Data Safety Monitoring Board will oversee the study. The study’s principle investigator is a physician who was trained in the United States and who is board certified in hematology and oncology.

Source: www.michaelhar-noy.com

Dr. Michael Har-Noy Discusses His Upcoming Phase I/II trial of CRCL-AlloVaxTM

18 Jan

Dr. Michael Har-Noy, founder and C.E.O. of Immunovative Therapies, Ltd., will soon conduct a Phase I/II clinical trial of CRCL-AlloVaxTM, a novel anti-cancer vaccine.  Dr. Michael Har-Noy indicates that this new drug will likely have activity against many different tumor types.   He will conduct the study in Thailand as part of a “Compassionate Use Program” (CUP). The study gives metastatic cancer patients an experimental treatment option after conventional methods have failed.  Interest patients may enroll at www.immunocare.net.

Dr. Michael Har-Noy says that the study will test the effects of CRCL-AlloVax™ against a variety of different tumor types. The vaccine is designed to teach the patient’s immune system to recognize and kill malignant cells that were previously able to avoid the host immune response.  Dr. Michael Har-Noy hopes this will result in a minimally toxic yet effective treatment for metastatic cancer patients, thereby leading to increased survival and a better quality of life.  However, Dr. Michael Har-Noy indicates that at this time it is unknown if and how well patients will respond to CRCL-AlloVax™.  This preliminary study will result in data that may be used to determine which types of malignancies respond best to this vaccine.  Dr. Michael Har-Noy adds that this study data will likely uncover other factors predictive of response, such as tumor size and location, immune status, and prior cancer therapies.

Dr. Michael Har-Noy states that while this experimental anti-cancer vaccine may result in increased longevity for many types of cancer patients, there is currently insufficient data to make any claims about its ultimate efficacy.   He adds that most currently available cancer drugs work only for some patients and usually have very significant side-effects.

In a previously conducted Phase I/II trial of AlloStimTM, one of the components of CRCL-AlloVaxTM, 42 patients with various tumors were given AlloStimTM  and had almost triple the estimated survival of historic control patients.  Dr Michael Har-Noy says that these non-randomized but very encouraging results will soon be detailed in a peer-reviewed journal.

Source: www.immunocare.net

Dr. Michael Har-Noy Describes Amazing Results of Phase I/II Trial of AlloStim

10 Jan

Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, an Israeli biotechnology company, reviews the results of a Phase I/II FDA-approved trial in which AlloStim, along with tumor cryoablation, was used to treat forty-two patients with various types of metastatic cancer.  Dr. Michael Har-Noy says these results will soon be published in a peer-reviewed journal.

This study was conducted in Carlsbad.  Dr. Michael Har-Noy indicated that forty-two patients, all heavily pre-treated with conventional therapy, were enrolled in the study.  All patients had a life expectancy of two months or less.  The average patient age was 61 years; 90% had prior surgery, 45% had prior radiation, and all had received prior chemotherapy.  The cancer types were 14 breast, 7 colorectal, 3 biliary, 3 squamous cell, 3 ovarian, 2 sarcoma, 2 esophageal, 2 pancreatic, 2 lung, 2 prostate, and 1 bladder.  Study patients had an average of 22.2 metastatic lesions; their ECOG (Eastern Cooperative Oncology Group) score averaged 2.2, indicating severe disability.

Dr. Michael Har-Noy said the study patients were first treated with 3 intradermal Allostim injections, followed by cryoablation of an accessible lesion and intravenous Allostim administration.  Cryoablation was done in the Carlsbad clinic for cutaneous or easily palpable tumors and, for deeper lesions, at a nearby radiology facility using computed tomographic (CT) guidance.

Dr. Michael Har-Noy noted that the forty-two patients had few adverse effects from the AlloStim.  The most commonly encountered reaction was a flu-like condition that began within the first few days after Allostim administration.  There were no severe reactions.

The mean survival of the patients was 163 days – three times the predicted survival in historic untreated controls.  Fully 20% of the study patients stayed in remission one full year after treatment!  Dr. Michael Har-Noy noted that some of these patients are still alive after four years.  This author does not know the longevity of each study patient, but as a group these results are far better than anything in the current medical literature.  Dr. Michael Har-Noy will soon publish this study in a peer-reviewed journal.  He says these results must be interpreted cautiously, as this was a non-controlled, non-randomized study.

Dr. Michael Har-Noy will soon conduct a Phase I/II trial of CRCL-AlloVaxTM, the company’s new ant-cancer vaccine, in Thailand.  Interested patients may register at www.immunocare.net.

Source: www.immunocare.net