The Schick Foundation has submitted the final requirements for getting approval from the FDA for Blue Green Algae. Final approval is expected from the FDA in 4 weeks. If it is approved it will be one of the first supplements or botanicals to have FDA approval for study. The Foundation has already developed a protocol for testing Blue Green Algae in HIV+ patients who are virologically suppressed by antiretroviral agents, preferably Atripla, and are treatment Naive except for beginning Atripla within the last 6 months.
The protocol might also help determine at what level of CD 4 count Blue green algae might be successful. The protocol is stratifying patients from CD 4 counts of 200-350, 350-500, and patients who have greater than 500 CD 4 counts/ml. The results of the study once started should take about 6 months, but the markers we are following, pro-viral DNA, viral load, CD 4 count, CD 4%, CD 8 count CD 8%, D-Dimer, C Reactive Protein, and others might give an indication of success much earlier than 6 months.
The Schick foundation had already gotten approval for presenting a poster at the large AMFAR meeting in New Orleans on :November 29. The meeting extends from November 28-December 1. The title of the original poster was The Role of APHANIZOMENON FLOS-ACQAE in treating HIV+ virologically suppressed patients with HAART:. The original submission was on 1 patient whom we term patient O. We continued to present updated material thru 14 weeks and as a result the poster was upgraded to a full presentation to this large meeting. The significant findings already show that we have found that APHANIZOMENON FLOS-ACQAE, abbreviated AFA or Blue green algae, statistically improved patient O's CD 4 count, and CD 4%, while other markers named above are stable. CD 34 was elevated showing that the product which increases the release of bone marrow stem cells from the person's bone marrow 30% 2 hours after ingestion of 1000 mg of the supplement is working. We expect to have more data especially with respect to how AFA might be working at the meeting in New Orleans.
The Schick Foundation has added 2 new members to their consultant staff. Dr. Annika Hylmo a PHD, and Dr. Michael Hamrell also a PHD give the foundation a greater presence in science, with one of these people, Dr. Hamrell, being previously associated with the FDA, and the NIH.
To see whether the protocols that the Schick Foundation has developed donate on line to the web sites www.schickfoundation.org or www.schickresearch.com . You could also submit a check to the Peter Schick Foundation at 1223 Wilshire Blvd.#1007, Santa Monica Ca., 90403. We are approaching the end of the year where people think about charitable donations and what better cause than to donate to a 501C3 foundation that has a chance to end the greatest pandemic in deaths since early times the world has seen.
How much does viral load need to fall to halve HIV transmission risk?
The partners in Prevention study of acyclovir as an HIV prevention measure showed that an average viral load reduction of .74 log is needed in order to reduce the risk of HIV transmission by 50%. The has important implications for future studies of HIV treatment as prevention.
This study though scant in data really hits the nail on the head. Microbicides, barrier protection for women, pre-exposure prophylaxis with antiretroviral drugs for those having unprotected sex have by and large failed as a preventative measure. Condoms and circumcision although successful are not particularly appealing to men having sex. HIV treatment as Prevention is the best way we believe of preventing the spread of HIV, especially in resource poor countries. In fact mathematical models in some provinces in Africa have shown that treating everyone could come close to stopping the spread of the infection in approximately 7/1/2 years. With no HIV preventative vaccine in sight, treatment as prevention may be the way to go.
The Schick Foundation Attended The AIDS Walk
The AIDS Walk
Board members Peter Schick and Arton Kabashi attended APLA's AIDS Walk on October l8,2009..This was the 25th anniversary of the AIDS walk. APLA has been the most successful fund raising organization mainly thru APLA and its generous sponsors such as MACY's. The day started out with a breakfast that Chairman of the Board Peter Schick attended. He listened to talks by various government and APLA officials including the Mayor of Los Angeles Antonoio Villaigarosa. This was followed by a celebrity introduction before a throng of at least 30,000 people, who amongst them were high school kids, collage kids, and people from all walks of life.
The goal of the 6.2 mile walk was 30,000 people walk to help 60,000 people infected with HIV in LA county.
People especially young people who are complacent about HIV in the USA, remember, at least 50,000 people are still infected in the USA each year, and an equivalent amount of people die of HIV/AIDS. There are at least 300,000 people walking around in the USA who are infected with the HIV virus and do not know it. We say get tested and if you test positive after a short period of time of counseling and talking to your partners or family start antiretroviral treatment. We have been advocating this for a long time The antiretroviral drugs available, are easier to take and have fewer side effects. Unchecked HIV is becoming a major health problem in this country being the cause of Cardiovascular problems, Liver problems, Kidney problems, and other organ system problems.
Our foundation wishes APLA well in the coming year, but if the AIDS walk is any indication they are in for a very good year.
The foundation is ready to present its second protocol and procedure for getting alpha sun for use as a supplement to HIV+ patients virologically suppressed who are on minimal antiretroviral medications. The pilot study being sent to the FDA will treat 30 patients stratified by CD4 counts of 200-350, 350-500, and those patients who have CD4 counts greater than 500. 1/2 of the patients will get standard antiretroviral therapy, and one half will get standard plus alpha sun. The markers of HIV infection will be followed monthly for 6 months. The markers that will be followed are CD 4, CD 4%, CD 8, CD 8%, D-Dimer, Viral load by PCR, pro-viral DNA, LPS, CRP, and viral culture. Based on the experience with patient zero who is HIV+ and has taken blue green algae for over 3 months there is no toxicity, improvement in some markers of HIV infection, and also improvement in some lab values which are consistent with side effect of antiretroviral treatment.
The Schick Foundation is ready to begin starting its postoperative inguinal hernia study using alpha sun, a bone marrow stem cell stimulator that increases circulating stem cells from the bone marrow 30% after daily ingestion of l000 mg of the algae (AFA).
The study is a 3 month study which will compare 30 patients who have inguinal hernia surgery and postoperatively 1/2 will receive alpha sun, and 1/2 will get standard post operative pain medications. In the alpha sun arm (AFA) we are looking at the markers, faster healing of the postoperative incision, fewer infections, less requirement for pain medications, and faster return to work. An abstract of the protocols has been submitted to the Southern California Chapter of the American College of Surgeons Meeting for January 2009 in Santa Barbara California.
October Newsletter 2009
Board members Peter Schick and Arton Kabashi attended APLA's AIDS Walk on October l8,2009..This was the 25th anniversary of the AIDS walk. APLA has been the most successful fund raising organization mainly thru APLA and its generous sponsors such as MACY's. The day started out with a breakfast that Chairman of the Board Peter Schick attended. He listened to talks by various government and APLA officials including the Mayor of Los Angeles Antonoio Villaigarosa.
This was followed by a celebrity introduction before a throng of at least 30,000 people, who amongst them were high school kids, collage kids, and people from all walks of life.
The goal of the 6.2 mile walk was 30,000 people walk to help 60,000 people infected with HIV in LA county. People especially young people who are complacent about HIV in the USA, remember, at least 50,000 people are still infected in the USA each year, and an equivalent amount of people die of HIV/AIDS.
There are at least 300,000 people walking around in the USA who are infected with the HIV virus and do not know it. We say get tested and if you test positive after a short period of time of counseling and talking to your partners or family start antiretroviral treatment. We have been advocating this for a long time The antiretroviral drugs available, are easier to take and have fewer side effects. Unchecked HIV is becoming a major health problem in this country being the cause of Cardiovascular problems, Liver problems, Kidney problems, and other organ system problems.
Our foundation wishes APLA well in the coming year, but if the AIDS walk is any indication they are in for a very good year.
The foundation is ready to present its second protocol and procedure for getting alpha sun for use as a supplement to HIV+ patients virologically suppressed who are on minimal antiretroviral medications. The pilot study being sent to the FDA will treat 30 patients stratified by CD4 counts of 200-350, 350-500, and those patients who have CD4 counts greater than 500. 1/2 of the patients will get standard antiretroviral therapy, and one half will get standard plus alpha sun. The markers of HIV infection will be followed monthly for 6 months. The markers that will be followed are CD 4, CD 4%, CD 8, CD 8%, D-Dimer, Viral load by PCR, pro-viral DNA, LPS, CRP, and viral culture. Based on the experience with patient zero who is HIV+ and has taken blue green algae for over 3 months there is no toxicity, improvement in some markers of HIV infection, and also improvement in some lab values which are consistent with side effect of antiretroviral treatment.
The Schick Foundation is ready to begin starting its postoperative inguinal hernia study using alpha sun, a bone marrow stem cell stimulator that increases circulating stem cells from the bone marrow 30% after daily ingestion of l000 mg of the algae (AFA).
The study is a 3 month study which will compare 30 patients who have inguinal hernia surgery and postoperatively 1/2 will receive alpha sun, and 1/2 will get standard post operative pain medications. In the alpha sun arm (AFA) we are looking at the markers, faster healing of the postoperative incision, fewer infections, less requirement for pain medications, and faster return to work. An abstract of the protocols has been submitted to the Southern California Chapter of the American College of Surgeons Meeting for January 2009 in Santa Barbara California.
This was followed by a celebrity introduction before a throng of at least 30,000 people, who amongst them were high school kids, collage kids, and people from all walks of life.
The goal of the 6.2 mile walk was 30,000 people walk to help 60,000 people infected with HIV in LA county. People especially young people who are complacent about HIV in the USA, remember, at least 50,000 people are still infected in the USA each year, and an equivalent amount of people die of HIV/AIDS.
There are at least 300,000 people walking around in the USA who are infected with the HIV virus and do not know it. We say get tested and if you test positive after a short period of time of counseling and talking to your partners or family start antiretroviral treatment. We have been advocating this for a long time The antiretroviral drugs available, are easier to take and have fewer side effects. Unchecked HIV is becoming a major health problem in this country being the cause of Cardiovascular problems, Liver problems, Kidney problems, and other organ system problems.
Our foundation wishes APLA well in the coming year, but if the AIDS walk is any indication they are in for a very good year.
The foundation is ready to present its second protocol and procedure for getting alpha sun for use as a supplement to HIV+ patients virologically suppressed who are on minimal antiretroviral medications. The pilot study being sent to the FDA will treat 30 patients stratified by CD4 counts of 200-350, 350-500, and those patients who have CD4 counts greater than 500. 1/2 of the patients will get standard antiretroviral therapy, and one half will get standard plus alpha sun. The markers of HIV infection will be followed monthly for 6 months. The markers that will be followed are CD 4, CD 4%, CD 8, CD 8%, D-Dimer, Viral load by PCR, pro-viral DNA, LPS, CRP, and viral culture. Based on the experience with patient zero who is HIV+ and has taken blue green algae for over 3 months there is no toxicity, improvement in some markers of HIV infection, and also improvement in some lab values which are consistent with side effect of antiretroviral treatment.
The Schick Foundation is ready to begin starting its postoperative inguinal hernia study using alpha sun, a bone marrow stem cell stimulator that increases circulating stem cells from the bone marrow 30% after daily ingestion of l000 mg of the algae (AFA).
The study is a 3 month study which will compare 30 patients who have inguinal hernia surgery and postoperatively 1/2 will receive alpha sun, and 1/2 will get standard post operative pain medications. In the alpha sun arm (AFA) we are looking at the markers, faster healing of the postoperative incision, fewer infections, less requirement for pain medications, and faster return to work. An abstract of the protocols has been submitted to the Southern California Chapter of the American College of Surgeons Meeting for January 2009 in Santa Barbara California.
Treatments and findings
Abacavir impairs endothelial function, possible explaining increased heart attack risk AIDS Sept. 24,2009
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Breast Tenderness After Starting Combination Hormone Therapy May Indicate Higher Breast Cancer Risk. Archives of Internal Medicine October 14,2009
Postmenopausal women who experience new-onset breast tenderness after starting combination hormone therapy may face increased risk for breast cancer,. Researchers examined data on l7,000 Women's Health Initiative participants who were randomized to receive estrogen-progestin or placebo daily. In the hormone group, women with new onset breast tenderness t 12 months were about 50% more likely to be diagnosed with breast cancer during 5.5 years follow-up, relative to those without tenderness. There was no such association among placebo recipients.
The sensitivity and specificity of breast tenderness for predicting cancer risk were 41% and 64% respectively--which, the authors say, are similar to values for the Gail model.
The authors note that hormone-induced elevations in serum estrone and estrone sulfate might lead to increased breast tenderness and heightened rsk. They futher state that these findings should be considered by prescribing physicians to inform decisons regarding continued combined hormone therapy.
____________________
Topical treatment for pre-cancerous anal cell changes safe and moderately effective Journal of Acquired Immune Deficiency Syndrome
A course of treatment with topical trichloracetic acid appears to provide a safe and effective treatment for pre-cancerous cell change in the anus, US investigators report in a study published in the online edition of the Journal of acquired Immune deficiency syndromes. The treatment was equally effective in HIV-Positive and HIV-negative men.
___________________
Food insecurity increases risk of death for patients taking HIV-treatment in Canada J.Acq. Def. Synd. October 2009
CD 4-cell-count below 400 increases cancer risk for patients with HIV October 9th Lancet Oncology
FDA committee recommends approval of maraviroc for first-line treatment in US
People with HIV in the United States are likely to get a further option for use in first-line drug combinations within the next few weeks, following the decision by the US FDA administration antiviral Drugs Advisory Committee to recommend marketing approval for maraviroc, the CCR5 inhibitor. CCR5 inhibitors work at the entry receptor level of the virus, T-cell interface.
Alpha sun with the preliminary finding that it may block entry of the virus into the T-cell may act in the same way.
______________
Four million now receiving Antiretroviral therapy, 6 million still in need. United Nations Agencies.
Although 4 million people are now receiving antiretroviral therapy in low and middle income countries, another 5 million adults and children lack access to treatment in low and middle income countries.
Abacavir a NRTI has been shown to impair endothelial function, providing a possible explanation for the drugs association with an increased risk of heart attack.
Abacavir toxicity has been the subject of intense debate whether it does or does not increase the risk of cardiovascular disease.
What is interesting is that we are studying Blue Green Algae, or Alpha Sun, a bone marrow stem cell stimulator which decreases inflammation in many settings. Endothelial function impairment is caused by inflammation. It seems logical that Blue green algae, as proposed as a possible solution to toxicity for HIV medication, could be used in Abacavir patients not only to stop the virus, but to decrease the side effects namely cardiovascular disease caused by inflammation of the endothelium of the arteries.
____________________
Breast Tenderness After Starting Combination Hormone Therapy May Indicate Higher Breast Cancer Risk. Archives of Internal Medicine October 14,2009
Postmenopausal women who experience new-onset breast tenderness after starting combination hormone therapy may face increased risk for breast cancer,. Researchers examined data on l7,000 Women's Health Initiative participants who were randomized to receive estrogen-progestin or placebo daily. In the hormone group, women with new onset breast tenderness t 12 months were about 50% more likely to be diagnosed with breast cancer during 5.5 years follow-up, relative to those without tenderness. There was no such association among placebo recipients.
The sensitivity and specificity of breast tenderness for predicting cancer risk were 41% and 64% respectively--which, the authors say, are similar to values for the Gail model.
The authors note that hormone-induced elevations in serum estrone and estrone sulfate might lead to increased breast tenderness and heightened rsk. They futher state that these findings should be considered by prescribing physicians to inform decisons regarding continued combined hormone therapy.
____________________
Topical treatment for pre-cancerous anal cell changes safe and moderately effective Journal of Acquired Immune Deficiency Syndrome
A course of treatment with topical trichloracetic acid appears to provide a safe and effective treatment for pre-cancerous cell change in the anus, US investigators report in a study published in the online edition of the Journal of acquired Immune deficiency syndromes. The treatment was equally effective in HIV-Positive and HIV-negative men.
___________________
Food insecurity increases risk of death for patients taking HIV-treatment in Canada J.Acq. Def. Synd. October 2009
Patients taking HIV treatment in Vancouver, Canada, who are food insecure have an increased risk of death, researchers report in the online edition of the Journal of acquired Immune deficiency Syndromes. The risk of death was especially hligh for food=insecure individuals who were of low weight.
_________________________
CD 4-cell-count below 400 increases cancer risk for patients with HIV October 9th Lancet Oncology
Maintaining a CD 4 cell count above 500 will protect HIV+ patients from a range of AIDS-defining and non-AIDS defining caners. this study was performed by french investigators and is presented in a paper published online on October 8th in The lancet Oncology.
____________
FDA committee recommends approval of maraviroc for first-line treatment in US
People with HIV in the United States are likely to get a further option for use in first-line drug combinations within the next few weeks, following the decision by the US FDA administration antiviral Drugs Advisory Committee to recommend marketing approval for maraviroc, the CCR5 inhibitor. CCR5 inhibitors work at the entry receptor level of the virus, T-cell interface.
Alpha sun with the preliminary finding that it may block entry of the virus into the T-cell may act in the same way.
______________
Four million now receiving Antiretroviral therapy, 6 million still in need. United Nations Agencies.
Although 4 million people are now receiving antiretroviral therapy in low and middle income countries, another 5 million adults and children lack access to treatment in low and middle income countries.
The Peter Schick Foundation has submitted its request for an IND Number from the FDA
The Peter Schick Foundation has submitted all the necessary data to obtain an IND number from the FDA for the product Alpha Sun. Alpha Sun is made by Simplexity Health of Klamath Falls, Oregon. The product, a bone marrow stem cell stimulator, increases the number of circulating stem cells 20-30% two hours after oral ingestion of l000mg/day. The foundation hopes to test the product in a number of clinical studies, namely Type 2 Diabetes and HIV+ patients who are virologically suppressed on antiretroviral therapy. Additional studies in the works include testing the product in osteoarthitis patients, osteoporosis patients, prostatitis patients, Acne patients, post-operative inguinal hernia patients, carpal tunnel patients, and Cardiac rehabilitation patients. The product has significant anti inflammatory capabilities, is a mood elevator, and has a carbohydrate that directs bone marrow stem cells to the point of inflammation and injury where it initiates repair of damage caused by an inflammatory process. Two initial trials will be done for Type 2 Diabetes, and another for HIV+ patients who are virologically suppressed on antiretroviral therapy.
The Peter Schick Foundation and Simplexity Health are forming a partnership to study in clinical trials Aphanizomenon Flos-Aquae (termed AFA), which is the major component of the product Alpha Sun.
A C corporation will be formed with available common shares of stock. If you wish to learn more about the offering or donate to the non-profit 501(c)(3) foundation, please email schickpm@aol.com or contribute by mail to the Schick Foundation, 1223 Wilshire Blvd. #1007, Santa Monica, CA 90403.
The Peter Schick Foundation and Simplexity Health are forming a partnership to study in clinical trials Aphanizomenon Flos-Aquae (termed AFA), which is the major component of the product Alpha Sun.
A C corporation will be formed with available common shares of stock. If you wish to learn more about the offering or donate to the non-profit 501(c)(3) foundation, please email schickpm@aol.com or contribute by mail to the Schick Foundation, 1223 Wilshire Blvd. #1007, Santa Monica, CA 90403.
The Perilous Success: What if the new HIV prevention methods work?
The Perilous Success: What if the new HIV prevention methods work?
AIDS Weekly
September 15, 2009
Within a couple of years, we may know if two crucial new HIV prevention approaches will work. If they do, what then? Who will pay for them, who will use them, and will their use have a positive or negative impact on the epidemic?
This was a debate carried on at the IAS conference advocacy coalition as they looked at the possibility of microbicides and pre-exposure prophylaxis(PrEP).
Microbicides are a long way from being a preventative approach to HIV infection, both because of scientific and behavioral concerns. Pre-exposure prophylaxis also has strong behavioral concerns even if it is accepted scientifically.
The only real way of prevention is to treat everyone with antiretroviral meds in a high incidence area.
AIDS Weekly
September 15, 2009
Within a couple of years, we may know if two crucial new HIV prevention approaches will work. If they do, what then? Who will pay for them, who will use them, and will their use have a positive or negative impact on the epidemic?
This was a debate carried on at the IAS conference advocacy coalition as they looked at the possibility of microbicides and pre-exposure prophylaxis(PrEP).
Microbicides are a long way from being a preventative approach to HIV infection, both because of scientific and behavioral concerns. Pre-exposure prophylaxis also has strong behavioral concerns even if it is accepted scientifically.
The only real way of prevention is to treat everyone with antiretroviral meds in a high incidence area.
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