Bangkok, Thailand (PRWEB) February ten, 2004
Privately held Thailänder biotech organization, Immunitor Company Co., Limited, has posted to the Thailänder FDA the application form for Stage III medical trial. The application form is based on impending investigational R& D medication permit which was granted within 2000. The main endpoint from the trial can be aimed at credit reporting the advantageous property associated with V-1 Immunitor (V1) demonstrated for AIDS-associated wasting. Whenever approved, the research will be performed by the medical team associated with Dr . Orapun Metadilogkul, the particular President associated with Occupational plus Environmental Medication Association associated with Thailand from Rajavithi Common Hospital within Bangkok the biggest public medical center of the Ministry of Community Health.
Recently released retrospective, considerable study within 650 HELPS patients proven that V1 was secure, effective, plus highly guaranteeing as an affordable therapy for your management associated with opportunistic bacterial infections and AIDS-associated decline within body bulk (http://www.nature.com/nature/view/040122.html#6). The particular probability worth obtained with this study (P=0. 00000000000000065) shows that acquired results were non-random and extremely significant statistically. These results support the outcomes of open up label stage I research published 2 yrs ago along with placebo-controlled stage II research completed a year ago.
V-1 Immunitor is an by mouth available restorative AIDS shot, which has been certified in Asia and particular countries within Africa as being a dietary supplement. The particular vaccine draw out mucosal defense response within the gut, which usually appears to lead to reversal associated with weight loss within 76% associated with AIDS sufferers. Several released clinical studies have shown that will V1 can be safer plus cheaper compared to standard antiviral therapy.
The Stage III test seeking licensure for AIDS-related wasting signifies a “streamlining” of the Carrier’s approval technique. Obtaining medication label regarding such an indicator is a moving stone regarding Immunitors continuing research system aimed at building effective and safe shot for therapy and avoidance of HIV. ”
Principal Detective, Dr . Aldar S. Bourinbaiar, the Technological Director from the Company, stated, “Our outcomes compare extremely favorably to the published outcomes of treatment with this indication. The final results we have observed are the best I have observed using this difficult-to-treat situation, which is related to certain passing away. Currently available supplements or drink antiviral medicines known as HAART are ineffective for modification of throwing away and V1 can be useful accessory option to HAART or because stand-alone treatment. Other treatment plans like recombinant human growth hormone (HGH), produced by Switzerland company Serono, are quite efficient but they are very expensive regarding third world nations.
Mister. Vichai Jirathitikal, the Chief of the Immunitor, said, All of us plan to start a similar Stage III multi-site trial system in 4 countries within Africa. Based on ethics committees decision within respective nations the studies will start at some time before Global AIDS Meeting to be kept in Come july 1st of this 12 months in Bangkok. We are specifically proud which our charitable function which offered free therapy to over 40, 500 AIDS sufferers in Asia and other building countries resulted in the candidate selection of the Firm for 2005 Bill Entrance Award within Global Wellness.
For additional information please visit Carrier’s website from http://www.immunitor.com/.
(PRWEB) October ten, 2003
A good oral demonstration – Stage II placebo-controlled study associated with therapeutic HELPS vaccine, V-1 Immunitor : was shipped by Doctor Aldar Ersus. Bourinbaiar, the particular Scientific Movie director of Immunitor, at the plenary session from the 6th Global Forum upon Global Vaccinology: Vaccines plus Immunization, twenty five – twenty six September the year 2003, Minsk, Weißrussland. The Discussion board was structured by the Bacterial infections Control Entire world Organization, Montreal, Canada, as well as the Research Company for Epidemiology and Microbiology, Minsk, Weißrussland, under auspices of the Ministry of Community Health from the Republic associated with Belarus plus National School of Sciences of Weißrussland (http://www.briem.ac.by/eng/konf.html).
The particular presented research was a consequence of collaboration using the clinical group led simply by epidemiologist Doctor Orapun Metadilogkul of Rajavithi General Medical center, the largest open public medical institution from the Thai Ministry of Community Health.
V-1 Immunitor (V1) is a polyvalent oral HELPS vaccine that was licensed within Thailand because orally accessible dietary supplement. Aside from V-1 Immunitor no other mouth killed shot against infections is available in a commercial sense. However , because noted simply by Dr . Bourinbaiar, there are many murdered bacterial mouth vaccines available. Among they are: a murdered whole cell-cholera toxin recombinant B subunit vaccine created in Sweden (WC/rBS); an easier version associated with cholera shot without recombinant B subunit manufactured in Vietnam; Soviet tableted cholera shot; E. coli oral shot against urinary : tract bacterial infections sold simply by OM Pharma (Geneva, Switzerland); Czech-made mouth vaccines Kanvakol, Alvakol, plus Urvakol towards several types of bacterias; multibacterial shot Luivac towards respiratory tract disease from Sankyo (Tokyo, Japan); oral anti-bacterial vaccine, Imocur, to prevent respiratory system infections (Zambon, France); Broncho-Vaxom (Fournier, France); tableted Buccaline preparation (Berna Biotech/Qualiphar); the broad-spectrum antigenic preparation through Klebsiella pneumoniae Biostim (Aventis Pharma); the particular Mexican/German anti-bacterial Paspat produced as an mouth tablet (Altana Pharma); french oral planning, Ribomunyl, that contains ribosomal fractions of bacterias (Pierre Fabre); Bulgarian polybacterial vaccine Respivax for bronchopulmonary infections; the particular Polish propionibacterium acne shot; and several Ruskies vaccines for any variety of microbes infections. These types of vaccine arrangements are used because therapeutic plus prophylactic strategies. Most medical trials concerning these vaccines are possibly unpublished or even published within non-English vocabulary journals, that makes them practically unknown in order to Western vaccinologists. With the exception of, probably, cholera shot almost all of these types of vaccines are usually marketed because immunomodulators or even food supplements. Nevertheless , this misnomer in regulating terminology can be semantic instead of scientific.
Placebo-controlled phase II study associated with V1 as being a prophylactic shot in healthful volunteers continues to be published within January thirty, 2003 problem of SHOT journal (Vol. 21, webpages 624-628; http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12531330&dopt=Abstract). However , the particular clinical experience of V1 as being a therapeutic technique was based mostly on open-label studies which usually demonstrated bodyweight gain, embrace CD4 plus CD8 cellular material, decrease in virus-like load, plus improved success of end-stage AIDS sufferers. In order to establish prior non-controlled studies the particular placebo-controlled stage II medical trial continues to be undertaken within 45 asymptomatic volunteers exactly who had more than 350/mm3 CD4 T-cells from study access. The results through 6-month followup were the following: HIV-positive volunteers who obtained V1 n. i. g. had acquired on average eighty-five CD4 T-cells (543 compared to 628). This particular gain has been statistically substantial (p=0. 0062) while a little increase in T-cell counts (530 vs 576) of sufferers on placebo failed to achieve the significance tolerance (p=0. 32). The medical benefit of V1 was more supported simply by steady embrace CD4/CD8 percentage among V1 recipients (0. 4455 compared to 0. 5840, p=0. 0011) and drop in CD4/CD8 ratio amongst patients upon placebo (0. 5581 compared to 0. 5113, p=0. 15). These outcomes suggest that V1 may invert the disease development without any contingency toxicity. Various other immune plus clinical enhancements were talked about during the demonstration and outcomes of this research will be posted for distribution to a peer-reviewed AIDS log in forseeable future.
Immunitors presentation has been praised with the Honorary Chief of the Discussion board, Professor Veniamin I. Votyakov, a member associated with Belarusian plus Russian School of Sciences, as an example of actually finding simple and affordable solution to worldwide health turmoil especially in nations that have simply no means to buy often-expensive antiviral drugs or even vaccines.
This important study enforces the value of the product and will also be further backed by outcomes of ongoing plus planned medical trials within Africa that is carried out simply by independent researchers, stated Mr. Vichai Jirathitikal, who will be a pharmacology graduate associated with Mahidol College in Bangkok and the primary developer from the vaccine. V1 is now signed up in Ghana and we have got pending permit in several various other African nations. We are presently discussing programs to build the vaccine vegetable in 2 of these nations as part of the long-term objective to provide inexpensive and safe treatment to the building world.
For even more information make sure you contact info@immunitor. com