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I've been holding this stock for over a year.Good to see them makin' a positive move here..........Buyout of ADVB by LIME.........008 per share..........Reckon I'm gonna grab a handful down here-----Easy 100% profit...Then use that money to pick up some LIME------------- Green sector---OBAMA--Chicago based company------This is a no brainer >>>>>>>>>>>> Be cool
Yes..It is Lime Energy..The company is in one of the few sweet spots right now...There is big money with the right connections at the top..I look for a 10 bagger in the next few years out of LIME......
Link please. If you can, so I can start buying now.
Actually there were no purchases...It was all stock awarded in lieu of cash...The company is MERGING...Should see an 8k tomorrow....Already been filed it LIME for the ADVB merger..You can see the details of the merger from the 8k LIME filed yesterday........
Did you see all the insider buying in the last week? WOW!
10Q Out..1st profitable qtr. ever !!!eom
8K COMING SOON..Probably Monday...eom
It`s up and running alright.....They are not really in the biotech business anymore...They have ceased all R&D and have their patents up for sale..
The company has morphed into a holding enterprise that makes investments in "green technology"...The company is now debt free and has appx. 5 million cash in the bank....The 2 largest shareholders (Richard Kiphart and Michael Krasny) hold around 87% of the stock...The 2 together have a net worth of roughly 2 BILLION DOLLARS!!!!!...Krasny was just on the Forbes 400 with a net of 1.4billion....What the plans are exactly have not really been announced...Yahoo just had a feature story a few weeks ago about the city of Chicago wishing to become the largest "green" city in the country....The company is based in CHICAGO and both KIPHART and KRASNY live in CHICAGO...I fully expect big things in the very near future,especially with OBAMA being both from CHICAGO and a "GREENIE" to boot....I have the boat fully loaded and absolutely expect this stock to be a life changer for me in the very near future....Oh yeah...the O/S IS 1.2B....If you have any questions, call the CFO J.L. DREW...You can get the number from the Yahoo Finance page...Mr. Drew will call you back usually within 48 hours ....Have a good day....INSIDESTRAIGHT
Interesting co, insidestraight.
I see your from Wisconsin...What is your affiliation with the company ADVB just invested in????
Advanced Biotherapy, Inc. Announces Material Transactions
Advanced Biotherapy, Inc. (OTCBB:ADVB) announced today that, because it believes organic dairy products are a dynamic growth industry, it has made an investment in Organic Farm Marketing, LLC (“OFM”), a Wisconsin limited liability company, which distributes dairy products.
The Company acquired from OFM a convertible note through a loan to OFM of $800,000 (the “Working Capital Loan”), of which $293,750 was used by OFM to repurchase the membership interest of one of its two members, and the balance will be used for working capital. The OFM convertible note (“Convertible Note”) bears interest at the rate of 10% per annum, payable quarterly in arrears commencing on January 17, 2008, and continuing on each April 17, July 17, October 17 and January 17 thereafter, with a maturity date on May 17, 2009. The Company may elect at any time after June 18, 2008, to convert the Convertible Note into units of OFM at the conversion price of $10.00 per unit. The Company expects that the Working Capital Loan will be recognized by the Company as a note receivable on its financial statements.
In addition, the Company agreed to arrange for The Northern Trust Company of Chicago, Illinois (“Bank”) to issue a $1.0 million irrevocable letter of credit (“Letter of Credit”) for the benefit of the Wisconsin Department of Agriculture, Trade and Consumer Protection (“Wisconsin Department”), the designee of OFM. The Letter of Credit is expected to enable OFM to distribute certain dairy products in Wisconsin. As collateral for repayment of funds advanced under the Letter of Credit, the Company granted the Bank a security interest in a certificate of deposit account maintained by the Company at the Bank. OFM’s obligations to reimburse the Company for payments, if any, made to the Bank are evidenced by a promissory note (“OFM Note”) and a reimbursement agreement secured by OFM’s personal property and all proceeds thereof pursuant to a security agreement. OFM further agreed to pay the Company a cash fee of $50,000 and issue to the Company 5,000 units of OFM as payment for the Company’s obtaining the Letter of Credit. So long as the Company holds the Convertible Note or the underlying OFM units, the Company will have the right to appoint one director on the board of directors of OFM. The closing of the Working Capital Loan, the OFM Note and the related transactions occurred as of December 18, 2007 (“OFM Transaction”).
Concurrently with the OFM Transaction, and to provide capital to the Company, Richard P. Kiphart, Chairman of the Board of Directors of the Company, invested $2.0 million in the Company (“New Capital”) to purchase an aggregate of 181,818,182 shares of Company common stock, at $0.011 per share. In addition to providing funds for the Working Capital Loan, the New Capital will provide capital in the event the Company is obligated to reimburse the Bank and will generate interest income for future Company operations.
Prior to the Company entering into the OFM Transaction, Mr. Kiphart made loans to OFM totaling approximately $1.625 million, which loans also are evidenced by convertible notes. Mr. Kiphart has agreed that the Company’s OFM Note will rank senior to Mr. Kiphart’s OFM convertible notes, and the Company’s OFM Convertible Note will rank on the same priority as Mr. Kiphart’s OFM convertible notes, although his loans to OFM pre-date the Company’s.
According to information provided by OFM to the Company, OFM offers consumers two principal brands in value-added dairy: Grass Point Farms’ pasture-based dairy products and Wisconsin Organics’ certified organic dairy products. OFM-branded products are produced and created with a strong commitment to family farms, human and animal health, rural economic development, humane animal treatment and low environmental impact practices. The information about OFM regarding its business policies and mission has not been independently verified by the Company.
The number of shareholders was in the filing that you provided a link for....Your homework for tonight....
insidestraight: I plead puzzlement. How many shareholders are you referring to?
The vast number of outstanding shares is another issue. You may already know the story. Last year the company had approximately 52 million shares outstanding. The company was restructured, and the major creditor, Richard Kiphart, received shares in lieu of funds priced at .015. That, and distributions to others to whom the company was indebted, ramped up the number of shares. The rights offering, in which the dollar and dime shareholders can acquire 10 shares for every 1 share owned (also at .015), should put those shareholders in the same relative position they were before the dilution that occurred at the time of company restructuring last August.
Steve
That number of shareholders listed in the filing really has me baffled...Hard to believe it`s accurate....
P.S. The agreement to offer these rights was obtained at the time of the company's restructuring last August, and allows shareholders who wish to participate to negate the effect of the significant shareholder dilution that took place at that time. It also raises a significant amount of funds for the company. The company states that its intended use of the funds is to acquire a revenue generating business and for operational expenses.
Steve
ADVB has posted its proposed SB-2 pertaining to a shareholder rights offering (10 rights convertible into 1 share each) with the SEC. It may be seen at:
http://www.sec.gov/Archives/edgar/data/791833/000114420407005174/v063348_sb2.htm
If the link does not work, go directly to the SEC website:
http://www.sec.gov
Steve
That is interesting...........
But what does that have to do with ADVB and this board??
This is interesting...............
Is your portfolio ready for a parabolic rise in PPS..??
Did you see the sc13d Micharle Krasmy filed yesterday??
He is on the board of directors of the 5 billion dollar
marketing company CDWC!!!!
Why would someone from a marketing company suddenly
want a 6 percent stake in a little bity fledgling
biotech like advb????HMMMMM...
YOU FIGURE OUT THE REST..I KNOW YOU CAN DO IT..
drdata: I don't know the answer. The dilution is significant. Taking advantage of the rights offering allows a shareholder to offset it. You do the math. I hope that the restructured and refinanced company will be able to renew its quest to achieve a significant licensing agreement or joint venture. I understand that the company will visit or re-visit the candidates. No one questions the value of the patents or the science. It is an issue of making and completing an agreement.
Steve
Advanced Biotherapy, Inc. Completes Stock Sale and Debt Conversion
CHICAGO, Oct 13, 2006 (BUSINESS WIRE) -- Advanced Biotherapy, Inc. (OTCBB:ADVB) announced today that it has completed the sale of common stock to Richard P. Kiphart and other new investors in the amount of $5.4 million. This investment, plus the previous $1.1 million invested by Richard P. Kiphart around August 28, 2006, completes the $6.5 million capital raise previously announced by the Company. The Company also announced the conversion of all convertible notes, other promissory notes and accrued salaries owed by the Company, except for a nominal amount which was paid out in cash. The Company has no long-term debt and has approximately $6.2 million in cash, as of October 12, 2006.
About Advanced Biotherapy
The Company, a pioneer in anticytokine therapy, has demonstrated the effectiveness of its pioneering scientific strategy by conducting investigational clinical trials treating patients suffering from AIDS, multiple sclerosis, rheumatoid arthritis, corneal transplant rejection and certain autoimmune skin conditions, including alopecia, all Th1 mediated autoimmune diseases which appear to have the same proinflammatory Th-1 activity. Advanced Biotherapy is headquartered in Chicago with laboratories in Columbia, Maryland. The company has an extensive patent portfolio including 7 issued patents.
Forward-Looking Statements
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. Some of these forward-looking statements may be identified by the use of words in the statements such as "anticipate," "estimate," "could" "expect," "project," "intend," "plan," "believe," "seek," "should," "may," "assume," "continue," variations of such words and similar expressions. These statements are not guarantees of future performance and involve certain risks, uncertainties, and assumptions that are difficult to predict. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such forward-looking statements. Except as required under federal securities laws, we do not intend to update publicly any forward-looking statements to reflect actual results or changes in other factors affecting such forward-looking statements.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc.
Christopher W. Capps, 312-427-1912
www.advancedbiotherapy.com
Copyright Business Wire 2006
I have been a believer that this IP will generate a company for several years and have amassed a fairly large position. That said, I do not see any downside in executing on the Rights Offering. Does anyone see anything I am missing?
On the other hand why is it trading at 8 cents when 800M shares are being created at 1.5 cents?
Thanks in advance
News-Advanced Biotherapy Enters Into Share Purchase and Debt Restructure Agreement
CHICAGO, Aug 29, 2006 (BUSINESS WIRE) -- Advanced Biotherapy, Inc. (OTCBB: ADVB) announced today that it has entered into an agreement to raise $6,500,000 through a sale of stock to Richard P. Kiphart, a board member, and Christopher Capps and other related parties, at $.015 per share. In addition, Mr. Kiphart and other debt holders will convert their debt at $.015 per share resulting in Mr. Kiphart having personal control over approximately 80% of ADVB shares. Immediately following the infusion of capital, payables will be retired by both the use of cash as well as the conversion of some portion to stock at the same $.015 price. It is estimated that ADVB will be virtually debt free and have approximately $6.0 million in cash, following completion of the transaction.
The company will move its headquarters to Chicago, Illinois, from Woodland Hills, California, and Christopher W. Capps has been appointed Chief Executive Officer and Mr. Kiphart non-executive Chairman of the Board. It is the intention of management to maintain the current intellectual property portfolio and seek partnership with other companies for the licensing thereof. Management believes that interest earned on the fully subscribed amount of new capital, once received, will allow the company to operate on a profitable basis. Mr. Kiphart has funded $1,100,000 and expects the balance of the $6,500,000 to be funded in approximately thirty days upon satisfaction of certain conditions in the definitive agreement. In addition, ADVB intends to pursue acquisitions that it believes can help it maintain its profitable operations.
The company intends to register as soon as possible a rights offering allowing existing stockholders to purchase ten shares of common stock at $.015 per share for every share held.
Mr. Kiphart said, "I am excited to be more deeply involved with Advanced Biotherapy. The company has terrific intellectual property and now has sufficient capital to allow it to be profitable and consider acquisitions on a going forward basis."
Thomas J. Pernice, a member of the Board of Directors, stated, "On behalf of Richard Kiphart, the Board of Directors and the new management team, I would like to commend and thank Edmond Buccellato for his extraordinary personal efforts in establishing the company's extensive patent portfolio and enabling it to reach a stage that allows the company to pursue licensing and other partnership opportunities."
About Advanced Biotherapy
The Company, a pioneer in anticytokine therapy, has demonstrated the effectiveness of its pioneering scientific strategy by conducting investigational clinical trials treating patients suffering from AIDS, multiple sclerosis, rheumatoid arthritis, corneal transplant rejection and certain autoimmune skin conditions, including alopecia, all Th1 mediated autoimmune diseases which appear to have the same proinflammatory Th-1 activity. Advanced Biotherapy is headquartered in Chicago with laboratories in Columbia, Maryland. The company has an extensive patent portfolio including 7 issued patents.
Forward-Looking Statements
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. Some of these forward-looking statements may be identified by the use of words in the statements such as "anticipate," "estimate," "could" "expect," "project," "intend," "plan," "believe," "seek," "should," "may," "assume," "continue," variations of such words and similar expressions. These statements are not guarantees of future performance and involve certain risks, uncertainties, and assumptions that are difficult to predict. We caution you that our performance and results could differ materially from what is expressed, implied, or forecast by our forward-looking statements. Future operating results and the Company's stock price may be affected by a number of factors, including, without limitation: (i) availability of capital; (ii) opportunities for joint ventures and corporate partnering; (iii) opportunities for mergers and acquisitions to acquire non-bio technology businesses or to expand the Company's biotechnology base; (iv) regulatory approvals of preclinical and clinical trials; (v) intellectual property matters (patents); and (vi) competition. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2005. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such forward-looking statements. Except as required under federal securities laws and the rules and regulations of the SEC, we do not intend to update publicly any forward-looking statements to reflect actual results or changes in other factors affecting such forward-looking statements.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc.
Christopher W. Capps, 312-427-1912
www.advancedbiotherapy.com
Copyright Business Wire 2006
The Company submitted its 10-KSB Annual Report to the SEC. It includes an excellent discussion of the company's treatment methodology and patents. Of particular interest is how targeting overproduction of IFN-gamma is earlier in the immune system cascade than treatments already on the market that target other cytokines. This indicates the possibility, with some demonstrated results, of improved efficacy.
The Annual Report can be seen at the SEC website (http://www.sec.gov), and the Pinksheets website(http://www.pinksheets.com). I assume it will be posted on the company's website (http://www.advancedbiotherapy.com).
Steve
Good News. Advanced Biotherapy Signs Memorandum of Understanding with Battelle; Use of Monoclonal Antibodies as Treatment for Anthrax and Plague
WOODLAND HILLS, Calif.--(BUSINESS WIRE)--March 22, 2006--Advanced Biotherapy, Inc. (OTCBB:ADVB) today announced that it has entered into an initial Memorandum of Understanding (MOU) with Battelle for the development and use of monoclonal antibodies to treat humans and animals exposed to anthrax and plague as well as autoimmune diseases.
Edmond Buccellato, Chief Executive Officer of Advanced Biotherapy, stated, "Given the continued global threat of bioterrorism, the purpose of this initial MOU is to establish the basis for a cooperative institutional relationship between the Company and Battelle to jointly participate in the 'Initiatives for Proliferation Prevention' projects of the U.S. Department of Energy, specifically regarding the development of anti-cytokine therapy as a treatment for anthrax and plague affecting humans and animals. This program is related to matters of homeland security, safety and other public health interests. It is the intent of our Company and Battelle to enter into further collaborative relationships for using anti-cytokine therapy in treating other autoimmune conditions for which we have extensive experience and patent protection."
About Advanced Biotherapy
Headquartered in Los Angeles with laboratories in Columbia, Maryland, Advanced Biotherapy, Inc. is dedicated to pioneering the development of innovative antibody and other anticytokine therapies for treating severe and widespread autoimmune diseases. The Company's investigational therapies treat autoimmune diseases at their source, neutralizing biologic imbalances that impair immune system function. Its core technology is protected under U.S. patents and patents pending for the use of a class of inhibitors to the cytokines known as interferon-gamma and tumor necrosis factor-alpha. They also cover the use of inhibitors to other cytokines for treating a range of autoimmune diseases. The Company has demonstrated the effectiveness of its scientific strategy by conducting investigational clinical trials treating patients suffering from multiple sclerosis, rheumatoid arthritis, corneal transplant rejection and certain autoimmune skin conditions, including psoriasis.
About Battelle
Battelle is a global science and technology enterprise that develops and commercializes technology and manages laboratories for customers. Headquartered in Columbus, Ohio, Battelle has a vast science and technology reach. Battelle, with the national labs it manages or co-manages, oversees 19,000 staff members and conducts $3.4 billion in annual research and development. Battelle provides solutions and develops innovative products, helping commercial customers leverage technology into a competitive advantage. Battelle also teams with more than 800 federal, state and local government agencies, providing cost-effective science and technology in the areas of national security, homeland defense, health and life sciences, energy, transportation and environment.
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. Some of these forward-looking statements may be identified by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan or plans," "believe," "could," "may" or other words and terms of similar meaning. The risks and uncertainties which may affect the development, operations and results of our business include, but are not limited to the following: risks associated with clinical trials, the uncertainties of research and product development programs, the uncertainties of the regulatory approval process, the risks of competitive products, the risks of our current capital resources, the uncertainties as to the availability of future capital and our future capital requirements, and the risks associated with the extent and breadth of the Company's patent portfolio. There are no assurances that the Company's product candidates will receive regulatory approval. The foregoing discussion of the pending clinical investigations and the effect of the patents issued and pending involves risks and uncertainties, including but not limited to the risks that third parties may be successful in challenging such patents; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2004.
CONTACT: Advanced Biotherapy, Inc.
Amy Buccellato, 818-883-6716
News-Advanced Biotherapy Appoints Mr. Paul Hopper as Director of Business Development
WOODLAND HILLS, Calif., Mar 22, 2005 (BUSINESS WIRE) -- Advanced Biotherapy, Inc. (OTCBB:ADVB), dedicated to pioneering the development and use of therapeutic antibodies, announced today that Mr. Paul Hopper, former Chief Executive Officer of Australian Cancer Technology Limited, an international biotechnology company focused on developing immunotherapy and oncology products, has joined the Company as Director of Business Development.
Edmond Buccellato, CEO of Advanced Biotherapy, commented: "With Paul's relocation from Australia to California, we have the good fortune of attracting a seasoned biotech executive who has extensive experience in business development, both in terms of in-licensing of later-stage therapeutic compounds and business acquisitions. While CEO of Australian Cancer, he was solely responsible for in-licensing two new cancer drugs in four Phase I & 2 clinical trials in the US and Germany, commenced a Phase IIb clinical trial of a prostate cancer vaccine in Melbourne, Australia, negotiated and signed 3 'material transfer' agreements with the world renowned Memorial Sloan-Kettering Cancer Center and one of the word's foremost biotechnology companies, acquired Galencia Pharmaceuticals, and raised significant capital for the Company. During his tenure, the Australian Cancer's valuation increased from a market cap of $6.5 million to $35 million in just 15 months. Under Paul's leadership, Australian Cancer was rated the 4th best performing Biotech Company in Australia in 2004."
Mr. Hopper's experience includes his 25 year tenure in public company markets, with almost half that time as the Managing Director of Alpha Healthcare Limited, a diversified Australian Stock Exchange listed hospital, pathology, radiology and general practice provider of over 2,000 employees and annual sales of approximately $75 million which he co-founded in 1988, and ran until 1999.
From 2002-2004 he was also the Australian representative of Cappello Group, Inc, the LA based merchant bank, an association he has now re-established following his transfer to the US in 2005.
Mr. Hopper's Advanced Biotherapy responsibilities will fit within the company's overall strategic plan of pursuing licensing opportunities and targeting prospective acquisition and merger candidates.
Mr. Hopper commented, "Advanced Biotherapy represents an exciting opportunity to enhance its existing technology base by acquiring new compounds and projects in the most active biotech market in the world. I look forward to increasing the Company's pipeline not only in the targeted area of therapeutic antibodies, but across a wider scientific franchise, with the goal of providing investors with multiple targets and mitigated risk."
About Advanced Biotherapy
The Company has demonstrated the effectiveness of its pioneering scientific strategy in the use of therapeutic antibodies by conducting investigational clinical trials treating patients suffering from AIDS, multiple sclerosis, rheumatoid arthritis, corneal transplant rejection, uveitis and certain autoimmune skin conditions, including psoriasis and alopecia, all Th-1 mediated autoimmune diseases which appear to have the same proinflammatory Th-1 activity. Advanced Biotherapy is headquartered in Los Angeles, with laboratories in Columbia, Md. The company has an extensive patent portfolio, including 6 issued patents and over 34 patents pending.
This press release contains forward-looking statements. These statements are based upon the Company's beliefs and expectations. They are not guarantees of future performance and involve certain risks, uncertainties, and assumptions that are difficult to predict. The Company operates in a rapidly changing environment that involves a number of risks, some of which are beyond the Company's control. We caution you that our performance and results could differ materially from what is expressed, implied, or forecast by our forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings for more detailed information on the risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect the Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003. Furthermore, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult our periodic reports on Form 10-QSB and Form 8-K for further disclosures we make on related subjects.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc.
Edmond Buccellato, 818-883-6716
ed@advancedbiotherapy.com
or
Paul A. Hopper, 585-978-1389
Fax: 818-883-3353
Temporary Email: receptogen@earthlink.net
www.advancedbiotherapy.com
Copyright Business Wire 2005
This is a conservatively managed company. They are reported to be talking to prospective merger partners or licensees of their treatment. The announcement of positive results in human FDA Phase I testing of their treatment for Aids is significant. They talk about a "dramatic" decrease in viral load. Their study is applicable to patients who are resistant to the conventional package of Aid treatments. I think the widespread application and commercial success of the company will eventually occur.
Steve
News - Advanced Biotherapy Reports Preliminary Data in AIDS Clinical Trial
WOODLAND HILLS, Calif., Mar 15, 2005 (BUSINESS WIRE) -- Following the initiation of a Phase I, FDA-approved clinical trial at the Georgetown University Medical Center to study an investigational treatment for AIDS patients failing to respond to standard antiretroviral drugs, i.e., drug resistance, Dr. Joseph A. Bellanti MD, Chief Scientific Officer of Advanced Biotherapy (OTCBB:ADVB), reported that very preliminary results of this recently initiated clinical trial appear promising and suggest a beneficial effect in the treatment of AIDS by inhibiting Tumor Necrosis Factor-alpha (TNF-alpha).
Commenting on this announcement, Edmond Buccellato, Chief Executive and Chairman of the Board of Directors, stated, "In our opinion, the results of these very preliminary findings of a dramatic decrease in viral load support our hypothesis and gives us encouragement that we are pursuing a correct approach that may ultimately lead to an immune-based therapy in treating AIDS. The key purpose of this study is to provide further evidence that inhibiting overproduction of TNF-alpha, and other cytokines such as interferon-gamma and certain subtypes of interferon-alpha, implicated in stimulating viral replication in AIDS, may provide therapeutic benefit to those suffering from this disease. We will report more comprehensive data when it becomes available."
Drug resistance as reported remains the single most important reason for virological failure. In the January 15, 2005 American Medical Association media briefing entitled 'HIV/AIDS: The drug resistance epidemic' HIV drug resistance was explained to mean a decrease in the ability of a drug, or combination of drugs, to prevent HIV reproduction in the body. Typically soon after anti-HIV drug treatment is started the amount of virus in the body is reduced dramatically, however, there is always a small amount of the virus that continues reproducing, despite the presence of anti-HIV drugs. The briefing also states that as the virus mutates, the drugs lose their ability to prevent the virus from reproducing, and at present there are no HIV drugs that completely stop the virus.
About Advanced Biotherapy
The Company has demonstrated the effectiveness of its pioneering scientific strategy in the use of therapeutic antibodies by conducting investigational clinical trials treating patients suffering from AIDS, multiple sclerosis, rheumatoid arthritis, corneal transplant rejection, uveitis and certain autoimmune skin conditions, including psoriasis, alopecia and other autoimmune skin diseases, all mediated autoimmune diseases which appear to have the same proinflammatory activity. Advanced Biotherapy is headquartered in Los Angeles with laboratories in Columbia, Maryland. The company has an extensive patent portfolio including a number of issued patents and numerous patents pending, including anticytokine therapy to treat AIDS.
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. Some of these forward-looking statements may be identified by the use of words in the statements such as "hope," "appears," "may," "goal," "anticipate," "estimate," "expect," "project," "intend," "planning or plans," "believe," "could," or other words and terms of similar meaning. The risks and uncertainties which may affect the development, operations and results of our business include, but are not limited to the following: risks associated with clinical trials, the uncertainties of research and product development programs, the uncertainties of the regulatory approval process, the risks of competitive products, the risks of our current capital resources, the uncertainties as to the availability of future capital and our future capital requirements, and the risks associated with the extent and breadth of the Company's patent portfolio. There are no assurances that the Company's product candidates will receive regulatory approval. The foregoing discussion of the pending clinical investigations and the effect of the patents issued and pending involves risks and uncertainties, including but not limited to the risks that third parties may be successful in challenging such patents; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc., Woodland Hills, Calif.
Edmond Buccellato, 818-883-6716
Fax: 818-883-3353
ed@advancedbiotherapy.com
www.advancedbiotherapy.com
Copyright Business Wire 2005
Important News - Advanced Biotherapy Issued Patent for Treatment of AIDS
WOODLAND HILLS, Calif., Mar 14, 2005 (BUSINESS WIRE) -- Advanced Biotherapy, Inc. (OTCBB: ADVB) announced today that The United States Patent and Trademark Office has assigned U.S. Patent No. 6,863,890 to the Company for use of antibodies to Tumor Necrosis Factor-alpha (TNF-a), Interferon-Gamma (IFN-g) and Interferon-alpha (IFN-a) for the treatment of HIV infection and AIDS. The patent issued on March 6, 2005.
Edmond Buccellato, CEO of Advanced Biotherapy, states "we believe that the issuance of this patent now provides the Company with additional patent protection in this therapeutic area by inhibiting overproduction of certain cytokine activity."
Dr. Joseph A. Bellanti, the principal investigator of the 'Company-sponsored' Georgetown Medical University FDA phase I clinical trial, states "Many cytokines are altered in HIV infection contributing to viral replication. Prominent among these is TNF-a. This finding provides further linkage of HIV infection with autoimmune disease both from the standpoint of pathogenesis as well as treatment. IFN-g and TNF-a, which are substantially increased in HIV infection, contribute to the immune pathogenesis. The overproduction of TNF-a has the effect of promoting greater viral replication in AIDS patients and therefore we expect that its removal would decrease viral load and lead to clinical improvement."
About Advanced Biotherapy
The Company has demonstrated the effectiveness of its pioneering scientific strategy in the use of therapeutic antibodies by conducting investigational clinical trials treating patients suffering from AIDS, multiple sclerosis, rheumatoid arthritis, corneal transplant rejection, uveitis and certain autoimmune skin conditions, including psoriasis, and alopecia, all Th1 mediated autoimmune diseases which appear to have the same proinflammatory Th-1 activity. Advanced Biotherapy is headquartered in Los Angeles with laboratories in Columbia, Maryland. The company has an extensive patent portfolio including a number of patents and many patents pending.
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. Some of these forward-looking statements may be identified by the use of words in the statements such as "hope," "appears," "may," "goal," "anticipate," "estimate," "expect," "project," "intend," "planning or plans," "believe," "could," or other words and terms of similar meaning. The risks and uncertainties which may affect the development, operations and results of our business include, but are not limited to the following: risks associated with clinical trials, the uncertainties of research and product development programs, the uncertainties of the regulatory approval process, the risks of competitive products, the risks of our current capital resources, the uncertainties as to the availability of future capital and our future capital requirements, and the risks associated with the extent and breadth of the Company's patent portfolio. There are no assurances that the Company's product candidates will receive regulatory approval. The foregoing discussion of the pending clinical investigations and the effect of the patents issued and pending involves risks and uncertainties, including but not limited to the risks that third parties may be successful in challenging such patents; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc.
Edmond Buccellato, CEO, 818-883-6716
Fax 818-883-3353
Email: ed@advancedbiotherapy.com
Website: www.advancedbiotherapy.com
Copyright Business Wire 2005
News-Noted Scientist in Autoimmune Diseases Joins Advanced Biotherapy's Scientific Board
WOODLAND HILLS, Calif., Mar 3, 2005 (BUSINESS WIRE) -- Advanced Biotherapy,
Inc. (OTCBB: ADVB), dedicated to pioneering the development and use of
therapeutic antibodies, announced today that Dr. Yehuda Shoenfeld, one of the
world's foremost immunologists and Director of the Center for Autoimmune
Diseases at the Sheba Medical Center, Israel's largest hospital, has joined the
Company's scientific advisory board.
Edmond Buccellato, CEO of Advanced Biotherapy, commented: "We are honored to
have Dr. Shoenfeld join our board and look forward to his contribution and depth
of knowledge regarding the emergence of our therapeutic strategy in treating
autoimmune diseases." As the Incumbent of the Laura Schwarz-Kipp Chair for
Research of Autoimmune Diseases in Tel-Aviv University, his clinical and
scientific works have focused on autoimmune/rheumatic diseases, and he has
published more than 1000 papers in peer-reviewed journals such as New England
Journal of Medicine and Lancet, among other notable scientific journals, and has
authored and edited 10 books, some of which are cornerstones in science and
clinical practice, such as "The Mosaic of Autoimmunity," "Infections and
Autoimmunity" and the textbook "Autoantibodies." He is on the editorial board of
32 journals in the field of rheumatology and autoimmunity, and is founding
editor of both the Israel Medical Association Journal, the representative
journal of science and medicine in the English language in Israel, and
Autoimmunity Reviews. Recently Dr. Shoenfeld received the distinguished Carol
Nachman Award for Rheumatology 2004 for outstanding innovative research work in
the field of clinical and experimental rheumatology. We look forward to our
collaboration with him.
About Advanced Biotherapy
The Company has demonstrated the effectiveness of its pioneering scientific
strategy in the use of therapeutic antibodies by conducting investigational
clinical trials treating patients suffering from AIDS, multiple sclerosis,
rheumatoid arthritis, corneal transplant rejection, uveitis and certain
autoimmune skin conditions, including psoriasis and alopecia, all Th-1 mediated
autoimmune diseases which appear to have the same proinflammatory Th-1 activity.
Advanced Biotherapy is headquartered in Los Angeles, with laboratories in
Columbia, Md. The company has an extensive patent portfolio, including 6 issued
patents and over 38 patents pending.
Statements made in this news release, other than statements of historical fact,
are forward-looking statements and are subject to a number of uncertainties that
could cause actual results to differ materially from the anticipated results or
other expectations expressed in our forward-looking statements. Some of these
forward-looking statements may be identified by the use of words in the
statements such as "hope," "appears," "may," "goal," "anticipate," "estimate,"
"expect," "project," "intend," "planning or plans," "believe," "could," or other
words and terms of similar meaning. The risks and uncertainties which may affect
the development, operations and results of our business include, but are not
limited to, the following: risks associated with clinical trials, the
uncertainties of research and product development programs, the uncertainties of
the regulatory approval process, the risks of competitive products, the risks of
our current capital resources, the uncertainties as to the availability of
future capital and our future capital requirements, and the risks associated
with the extent and breadth of the Company's patent portfolio. There are no
assurances that the Company's product candidates will receive regulatory
approval. The foregoing discussion of the pending clinical investigations and
the effect of the patents issued and pending involves risks and uncertainties,
including, but not limited to, the risks that third parties may be successful in
challenging such patents, or that granted claims may be held invalid or
interpreted differently by a court of law, or that new technologies will be
developed that are superior in treating the diseases targeted by Advanced
Biotherapy, Inc. Readers are cautioned not to place reliance on these
forward-looking statements, which speak only as of the date the statements were
made. See the Company's public filings with the Securities and Exchange
Commission for further information about risks and uncertainties that may affect
the Company and the results or expectations expressed in our forward-looking
statements, including the section captioned "Factors That May Affect The
Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal
year ended December 31, 2003.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc.
Edmond Buccellato, 818-883-6716
Fax: 818-883-3353
Email: ed@advancedbiotherapy.com
Website: www.advancedbiotherapy.com
Copyright (C) 2005 Business Wire. All rights reserved.
News - Advanced Biotherapy Responds to Emergence of HIV Drug Resistance Emphasizing Its Clinical Research of an Immune Based Approach to Treating HIV
WOODLAND HILLS, Calif., Feb 16, 2005 (BUSINESS WIRE) -- Advanced Biotherapy,
Inc. (OTCBB: ADVB), dedicated to pioneering the development and use of
therapeutic antibodies, responds to breaking news regarding a recently
discovered new resistant strain of the HIV virus that was detected in New York
City, as reported by CBS affiliate WCBS-TV New York on February 11, 2005 --
"Health officials warn that a rare strain of the HIV virus has reached New York
City - New Strain Does Not Respond To Common Treatments." According to the
city's health commissioner, Dr. Thomas Frieden, the patient who contracted this
virus was determined to be resistant to 19 of the 20 FDA approved
anti-retroviral drugs.
Edmond Buccellato, CEO of Advanced Biotherapy, states, "HIV's usual course of
progression to the development of AIDS is known to normally take several years,
often upwards of 10 years. In the case of this newly discovered strain, 3 months
after HIV diagnosis, the individual had progressed to AIDS. Experts caution that
the spread of this deadly strain may have been expedited by the rapid disease
progression and greater infectivity of this particular strain. With the
increasing incidence of multi-class drug resistance, it is our opinion that our
approach to controlling HIV infection by augmenting the immune system responses
will be successful."
Dr. Bellanti, the principal investigator of the Georgetown FDA-approved phase I
clinical trial, states, "The greatest challenge faced by HIV-treating clinicians
has been the management of virologic failure and metabolic complications of
anti-HIV treatment. The recent emergence of this highly drug-resistant HIV
strain not only highlights this challenge but also stresses the need to seek new
alternative treatment measures. Our study is directed to determine the clinical
effectiveness of inhibiting Tumor Necrosis Factor-alpha (TNF-alpha) in
HIV-infected subjects who have received prior antiretroviral treatment with
standard therapy and who have failed to respond. We have begun the study and
hope to report encouraging results in the near future."
While normal production of the key TNF-alpha cytokine helps the immune system
fight disease, its overproduction has the contrary effect of promoting not only
greater viral replication in AIDS patients, but also a number of mental and
physical disorders associated with immune system breakdown. A complex cellular
relationship referred to as the cytokine "network" or "cascade" is responsible
for helping the immune system communicate and direct responses against viruses,
bacteria, fungi and tumors. HIV appears to disrupt the normal balance of this
network. Restoring the functioning of this network may improve the ability of a
patient's immune system to fight the AIDS virus.
About Advanced Biotherapy
The Company has demonstrated the effectiveness of its pioneering scientific
strategy in the use of therapeutic antibodies by conducting investigational
clinical trials treating patients suffering from AIDS, multiple sclerosis,
rheumatoid arthritis, corneal transplant rejection, uveitis and certain
autoimmune skin conditions, including psoriasis, and alopecia, all Th1 mediated
autoimmune diseases which appear to have the same proinflammatory Th-1 activity.
Advanced Biotherapy is headquartered in Los Angeles with laboratories in
Columbia, Maryland. The company has an extensive patent portfolio including 6
issued patents and over 38 patents pending.
Statements made in this news release, other than statements of historical fact,
are forward-looking statements and are subject to a number of uncertainties that
could cause actual results to differ materially from the anticipated results or
other expectations expressed in our forward-looking statements. Some of these
forward-looking statements may be identified by the use of words in the
statements such as "hope," "appears," "may," "goal," "anticipate," "estimate,"
"expect," "project," "intend," "planning or plans," "believe," "could," or other
words and terms of similar meaning. The risks and uncertainties which may affect
the development, operations and results of our business include, but are not
limited to the following: risks associated with clinical trials, the
uncertainties of research and product development programs, the uncertainties of
the regulatory approval process, the risks of competitive products, the risks of
our current capital resources, the uncertainties as to the availability of
future capital and our future capital requirements, and the risks associated
with the extent and breadth of the Company's patent portfolio. There are no
assurances that the Company's product candidates will receive regulatory
approval. The foregoing discussion of the pending clinical investigations and
the effect of the patents issued and pending involves risks and uncertainties,
including but not limited to the risks that third parties may be successful in
challenging such patents; or that granted claims may be held invalid or
interpreted differently by a court of law; or that new technologies will be
developed that are superior in treating the diseases targeted by Advanced
Biotherapy, Inc. Readers are cautioned not to place reliance on these
forward-looking statements, which speak only as of the date the statements were
made. See the Company's public filings with the Securities and Exchange
Commission for further information about risks and uncertainties that may affect
the Company and the results or expectations expressed in our forward-looking
statements, including the section captioned "Factors That May Affect The
Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal
year ended December 31, 2003.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc., Woodland Hills, Calif.
Edmond Buccellato, 818-883-671
Fax: 818-883-3353
ed@advancedbiotherapy.com
www.advancedbiotherapy.com
Copyright (C) 2005 Business Wire. All rights reserved.
News - ADVB -- Advanced Biotherapy, Inc.
Advanced Biotherapy Completes Investigational Pilot Clinical Trial in Genital Herpes
WOODLAND HILLS, Calif., Jan 19, 2005 (BUSINESS WIRE) -- Advanced Biotherapy, Inc. (OTCBB:ADVB), dedicated to pioneering the development and use of therapeutic antibodies, announced that the Company completed a pilot investigational study using antibodies to interferon-gamma in the treatment of patients suffering from Genital Herpes at the Department of Skin and Venereal Diseases, Russian State Medical University, Moscow, Russia.
Mr. Edmond Buccellato, President and CEO, stated, "Patients with recurrent herpes simplex virus type 2 (HSV-2) genital lesions were treated topically for several days with our investigational antibodies to interferon-gamma. Our principal investigators reported that itching and pain were relieved within hours of the application of the antibody, and the eroded area of the skin epithelialized within 3-4 days. Observation continues. Research indicates that the HSV-2 causing recurrent genital lesions may belong to a special category of viruses, such as HIV and certain other viruses, in which interferons promote rather than stop viral replication. The idea of such a category of viruses was proposed several years ago by Dr. S. Skurkovich, our head of research and development."
Genital herpes, for which there is no specific cure, is almost always sexually transmitted. It can be a very painful disease manifested as a rash, bumps, blisters, cuts, or sores in or around the genital area accompanied by itching, burning, tingling, or swelling.
Mr. Buccellato concluded, "We continue to significantly expand our intellectual property estate regarding 'field of use' not only related to antibodies and other inhibitors to interferon-gamma, but also for use of inhibitors to other cytokines, such as TNF-a and IL-1, for therapeutic purposes."
According to the U.S. Centers for Disease Control and Prevention, 45 million people in the United States ages 12 and older, or 1 out of 5 of the total adolescent and adult population, are infected with HSV-2. Because the infection is so widespread, the Company puts great significance on this work.
About Advanced Biotherapy
The Company, a pioneer in anticytokine therapy, has demonstrated the effectiveness of its pioneering scientific strategy by conducting investigational clinical trials treating patients suffering from AIDS, multiple sclerosis, rheumatoid arthritis, corneal transplant rejection and certain autoimmune skin conditions, including psoriasis, and alopecia, all Th1 mediated autoimmune diseases which appear to have the same proinflammatory Th-1 activity. Advanced Biotherapy is headquartered in Los Angeles with laboratories in Columbia, Maryland. The company has an extensive patent portfolio including 7 issued patents and over 38 patents pending.
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. Some of these forward-looking statements may be identified by the use of words in the statements such as "appears," "may," "goal," "anticipate," "estimate," "expect," "project," "intend," "plan or plans," "believe," "could," or other words and terms of similar meaning. The risks and uncertainties which may affect the development, operations and results of our business include, but are not limited to the following: risks associated with clinical trials, the uncertainties of research and product development programs, the uncertainties of the regulatory approval process, the risks of competitive products, the risks of our current capital resources, the uncertainties as to the availability of future capital and our future capital requirements, and the risks associated with the extent and breadth of the Company's patent portfolio. There are no assurances that the Company's product candidates will receive regulatory approval. The foregoing discussion of the pending clinical investigations and the effect of the patents issued and pending involves risks and uncertainties, including but not limited to the risks that third parties may be successful in challenging such patents; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc.
Edmond Buccellato or Amy Buccellato, 818-883-6716
Fax: 818-883-3353
ed@advancedbiotherapy.com
amy@advancedbiotherapy.com
www.advancedbiotherapy.com
Copyright (C) 2005 Business Wire. All rights reserved.
News - ADVB -- Advanced Biotherapy, Inc.
Advanced Biotherapy Inc. Makes Presentation at the Adult AIDS Clinical Trials Group Winter Meeting
Dr. Joseph Bellanti Presents Protocol of Company's Immune-Based Therapy to Treat AIDS
LOS ANGELES, Dec 8, 2004 (BUSINESS WIRE) -- Advanced Biotherapy, Inc. (OTCBB:ADVB), dedicated to pioneering the development and use of therapeutic antibodies, announced that Dr. Joseph Bellanti, Professor of Pediatrics and Microbiology-Immunology at the International Center for Interdisciplinary Studies of Immunology at Georgetown University School of Medicine, presented the Company's-sponsored Phase I FDA-approved clinical trials in AIDS patients at the Adult AIDS Clinical Trial Group (AACTG) winter meeting held at the Baltimore Marriott this past Sunday.
Mr. Edmond Buccellato, the Company's Chief Executive Officer stated, "We are delighted that Dr. Bellanti, one of the Country's foremost scientists, lecturers and authors in the field of immunology presented our Company-sponsored clinical trial protocol to this esteemed group of leading HIV/AIDS scientists and community advocates. The AACTG, the largest HIV clinical trials organization in the world, plays a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV/AIDS in the United States and the developed world. This organization has been pivotal in providing the data necessary for the approval of therapeutic agents, including treatment and prevention strategies. The AACTG is composed of, and directed by, leading clinical scientists in HIV/AIDS therapeutic research. Being recognized by this prestigious and influential group, with a focus in developing novel and effective therapeutic agents to treat this devastating worldwide disease, was truly an honor."
The AACTG is the largest clinical trial research program and network of the National Institute of Health and is internationally recognized, having conducted over 3900 clinical trials for the investigation of treatments for HIV. Currently involved at more then 60 highly regarded academic institutions, the AACTG, and the research they conduct, is wholly sponsored by federal funding from the National Institutes of Health. All currently approved antiretroviral drugs have been evaluated by the AACTG prior to their approval.
Mr. Buccellato further commented, "A complex cellular relationship referred to as the cytokine 'network' or 'cascade' is responsible for helping the immune system communicate and direct responses against viruses, bacteria, fungi and tumors. HIV appears to disrupt the normal balance of this network. Restoring the functioning of this network may improve the ability of a patient's immune system to fight the AIDS virus. The Georgetown study provides an opportunity to confirm our view that AIDS has a significant autoimmune component and we may have a significant effect in controlling this disease by blocking the pathological elements at the source of the immune system breakdown. The results may pave the way for new and exciting therapies for treating AIDS, particularly in those patients who are now unresponsive to antiretroviral drugs. We also hope to receive support from the AACTG as they are federally funded. The AACTG is presently funding the investigation of agents for immune modulation and restoration in HIV patients."
About Advanced Biotherapy
The Company has demonstrated the effectiveness of its pioneering scientific strategy in the use of therapeutic antibodies by conducting investigational clinical trials treating patients suffering from AIDS, multiple sclerosis, rheumatoid arthritis, corneal transplant rejection, uveitis and certain autoimmune skin conditions, including psoriasis, and alopecia, all Th1 mediated autoimmune diseases which appear to have the same proinflammatory Th-1 activity. Advanced Biotherapy is headquartered in Los Angeles with laboratories in Columbia, Maryland. The company has an extensive patent portfolio including 6 issued patents and over 38 patents pending.
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. Some of these forward-looking statements may be identified by the use of words in the statements such as "hope," "appears," "may," "goal," "anticipate," "estimate," "expect," "project," "intend," "planning or plans," "believe," "could," or other words and terms of similar meaning. The risks and uncertainties which may affect the development, operations and results of our business include, but are not limited to the following: risks associated with clinical trials, the uncertainties of research and product development programs, the uncertainties of the regulatory approval process, the risks of competitive products, the risks of our current capital resources, the uncertainties as to the availability of future capital and our future capital requirements, and the risks associated with the extent and breadth of the Company's patent portfolio. There are no assurances that the Company's product candidates will receive regulatory approval. The foregoing discussion of the pending clinical investigations and the effect of the patents issued and pending involves risks and uncertainties, including but not limited to the risks that third parties may be successful in challenging such patents; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc., Woodland Hills, Calif.
Edmond Buccellato, 818-883-6716
Fax: 818-883-3353
ed@advancedbiotherapy.com
www.advancedbiotherapy.com
Copyright (C) 2004 Business Wire. All rights reserved.
Good News - ADVB -- Advanced Biotherapy, Inc.
Advanced Biotherapy Inc. Receives ``Notice of Allowance'' from Patent Office for Use of Antibodies to Treat Uveitis
LOS ANGELES, Dec 1, 2004 (BUSINESS WIRE) --
Company Expands Antibody Patent Portfolio for Treatment of Eye Disease
and Plans to Develop Franchise for Treatment of Ocular Diseases
Advanced Biotherapy, Inc. (OTCBB:ADVB), dedicated to pioneering the development and use of therapeutic antibodies, announced that the Company has received a "Notice of Allowance" from the United States Patent and Trademark Office for the use of inhibitors, including antibodies, to interferon-gamma to treat Uveitis, an autoimmune condition causing inflammation inside the eye. The patent is expected to be issued within 120 days and will extend through 2020.
Mr. Buccellato, the Company's Chief Executive Officer, stated, "The Company performed an investigational study at the Research Institute of Pediatric Hematology of Moscow, Russia, where six children, ages 2.5 to 15, suffering from juvenile rheumatoid arthritis (JRA)-associated uveitis, were given a short-course of treatment with antibody to interferon-gamma in the form of eyedrops. For comparison, 15 patients with JRA-associated Uveitis were treated with standard therapy (non-steroidal anti-inflammatory drugs). The administration of our antibodies as an adjuvant to standard therapy was more effective than standard therapy alone. Most patients who also received the antibody treatment were observed to experience a reduction in the duration of the acute period by one half, reduced severity of symptoms during the acute period, and a significant increase in the length of remission after this short-course of therapy. A study is also being considered by the Company to treat Uveitis in animals (also covered by our patent) which are significant markets."
Mr. Buccellato concluded, "In addition to investigational studies using our antibodies in the form of eyedrops in Corneal Transplant Rejection and now Uveitis, we are also in the preliminary planning stages of a study in another acute ocular disease using antibodies to interferon-gamma. Our objective is to create a major franchise in this space."
Uveitis is an inflammation inside the eye, specifically affecting one or more of the three parts of the eye that make up the uvea: the iris (the colored part of the eye), the ciliary body (behind the iris, responsible for manufacturing the fluid inside the eye) and the choroid (the vascular lining tissue underneath the retina). The structures of the uvea are collectively known as the uveal tract. Uveitis is a serious ocular condition. It is the third leading cause of blindness worldwide, accounting in the United States for 10-15% of all blindness. Untreated, under-treated Uveitis or repeated episodes of inflammation within the eye can lead to scarring and blindness.
About Advanced Biotherapy
The Company has demonstrated the effectiveness of its pioneering scientific strategy in the use of therapeutic antibodies by conducting investigational clinical trials treating patients suffering from AIDS, Multiple Sclerosis, Rheumatoid Arthritis, Corneal Transplant Rejection, Uveitis and certain autoimmune skin conditions, including Psoriasis, and Alopecia, all Th1 mediated autoimmune diseases which appear to have the same proinflammatory Th-1 activity. Advanced Biotherapy is headquartered in Los Angeles with laboratories in Columbia, Maryland. The company has an extensive patent portfolio including 6 issued patents and over 38 patents pending.
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. Some of these forward-looking statements may be identified by the use of words in the statements such as "appears," "may," "goal," "anticipate," "estimate," "expect," "project," "intend," "planning or plans," "believe," "could," or other words and terms of similar meaning. The risks and uncertainties which may affect the development, operations and results of our business include, but are not limited to the following: risks associated with clinical trials, the uncertainties of research and product development programs, the uncertainties of the regulatory approval process, the risks of competitive products, the risks of our current capital resources, the uncertainties as to the availability of future capital and our future capital requirements, and the risks associated with the extent and breadth of the Company's patent portfolio. There are no assurances that the Company's product candidates will receive regulatory approval. The foregoing discussion of the pending clinical investigations and the effect of the patents issued and pending involves risks and uncertainties, including but not limited to the risks that third parties may be successful in challenging such patents; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc.
Edmond Buccellato, 818-883-6716
Fax: 818-883-3353
ed@advancedbiotherapy.com
www.advancedbiotherapy.com
Copyright (C) 2004 Business Wire. All rights reserved.
ADVB Annual Meeting on Thursday, December 16, 2 P.M., Mariott Hotel in Woodland Hills, CA. Should be interesting.
Even a cursory review of the company's press releases lets one know that there is something very significant going on. The company is on the cusp of beneficial joint ventures with other manufacturers, FDA testing, and subsequent product marketing. They have strong patent protection. The company has demonstrated proof of concept for use of their treatment for a number of autoimmune diseases. Phase I testing for high viral load HIV patients is slated to begin. I would advise that interested investors pay close attention, read the press releases, view the SEC filings, and visit the company website (http://www.advancedbiotherapy.com).
Steve
News-ADVB -- Advanced Biotherapy, Inc.
Advanced Biotherapy's Senior Scientist Invited to Speak at Berlex Workshop
Dr. Skurkovich Invited as One of 40 Internationally Renowned Experts Throughout the World
WOODLAND HILLS, Calif., Oct 19, 2004 (BUSINESS WIRE) -- Advanced Biotherapy, Inc. (OTCBB:ADVB), dedicated to pioneering the development and use of therapeutic antibodies, announced that Simon Skurkovich, MD, Ph.D, D.Sc., Senior Scientist of Advanced Biotherapy, Inc., has been invited as one of 40 internationally renowned experts to present an authoritative paper regarding the Company's approach to treating autoimmune skin diseases using anticytokine therapy. The workshop entitled "Cytokines as Potential Therapeutic Targets for Inflammatory Skin Diseases" is sponsored by Berlex and organized by the Ernst Schering Research Foundation. It will be held November 17-19, 2004 in Napa, California.
Mr. Edmond Buccellato, President and CEO, stated, "We are honored that Dr. Skurkovich, who pioneered anticytokine therapy, is being recognized in the United States as a leading thinker and innovator in the treatment of autoimmune disease, including autoimmune skin diseases. Through his efforts, the company has sponsored a number of proof-of-concept investigational clinical studies in humans suffering from a variety of skin diseases including Psoriasis, Alopecia Areata, Vitiligo, and certain `orphan' skin diseases including Epidermolysis Bullosa."
Images of patients who have received the Company's investigational therapeutic antibodies can be viewed at the Company's website at www.advancedbiotherapy.com.
The Ernst Schering Research Foundation organizes scientific workshops on select topics in basic research in the fields of biology, medicine and chemistry with internationally renowned experts. Berlex is the US affiliate of Schering AG, one of the world largest pharmaceutical companies.
About Advanced Biotherapy
The Company has demonstrated the effectiveness of its pioneering scientific strategy by conducting investigational clinical trials treating patients suffering from AIDS, multiple sclerosis, rheumatoid arthritis, corneal transplant rejection and certain autoimmune skin conditions, including psoriasis, and alopecia, all Th1 mediated autoimmune diseases which appear to have the same proinflammatory Th-1 activity. Advanced Biotherapy is headquartered in Los Angeles with laboratories in Columbia, Maryland. The company has an extensive patent portfolio including five issued patents and 39 patents pending.
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. Some of these forward-looking statements may be identified by the use of words in the statements such as "appears," "may," "goal," "anticipate," "estimate," "expect," "project," "intend," "plan or plans," "believe," "could," or other words and terms of similar meaning. The risks and uncertainties which may affect the development, operations and results of our business include, but are not limited to the following: risks associated with clinical trials, the uncertainties of research and product development programs, the uncertainties of the regulatory approval process, the risks of competitive products, the risks of our current capital resources, the uncertainties as to the availability of future capital and our future capital requirements, and the risks associated with the extent and breadth of the Company's patent portfolio. There are no assurances that the Company's product candidates will receive regulatory approval. The foregoing discussion of the pending clinical investigations and the effect of the patents issued and pending involves risks and uncertainties, including but not limited to the risks that third parties may be successful in challenging such patents; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003.
Edmond Buccellato, CEO
Advanced Biotherapy, Inc.
6355 Topanga Canyon Blvd., Suite 510
Woodland Hills, CA 91367
Tel. 818-883-6716
Fax 818-883-3353
Email: ed@advancedbiotherapy.com
Website: www.advancedbiotherapy.com
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc.
Amy Buccellato, 818-883-6716
amy@advancedbiotherapy.com
Copyright (C) 2004 Business Wire. All rights reserved.
NEWS-ADVB -- Advanced Biotherapy, Inc.
Com ($0.001)
COMPANY NEWS AND PRESS RELEASES FROM OTHER SOURCES:
Advanced Biotherapy Completes Investigational Pilot Clinical Trial in Herpes; CEO Comments on Company's Business Development Plan
WOODLAND HILLS, Calif., Oct 11, 2004 (BUSINESS WIRE) -- Advanced Biotherapy, Inc. (OTCBB:ADVB), dedicated to pioneering the development and use of therapeutic antibodies, announced that the Company completed a pilot investigational study using antibodies to interferon-gamma in the treatment of patients suffering from Herpes Simplex Virus Type 1 at the Department of Skin and Venereal Diseases, Russian State Medical University, Moscow, Russia.
Mr. Edmond Buccellato, President and CEO, stated, "Patients with severe, chronic recurring herpes simplex type 1 (a herpes virus that causes cold sores and fever blisters mostly around the mouth) unresponsive to standard treatment were treated topically with antibodies to interferon-gamma. The patients noted rapid reduction of the burning and pain around the lesions. After 2 days, scabs formed which quickly faded by the 5th day. We are very encouraged with the results which warrant further study. The reason we investigated this disease is because it appears that interferon-gamma may be implicated, and because the scientific literature indicates that Th-1 mediated cells, cells that cause inflammation, have been found in the lesions. This may indicate that herpes could have a Th-1 autoimmune component. Our goal is to develop a therapeutic antibody approach to treat Th-1 mediated autoimmune diseases."
Herpes simplex type 1 is a viral infection of the skin that may occur repeatedly. When the virus is cleared from the skin by the immune system it hides in the nerves and is never completely removed from the body. It is estimated that nine out of ten people worldwide have been exposed to herpes. Herpes simplex begins as a group of small red bumps that blister, preceded by itching and burning of the area. The blisters begin to dry after a few days and form a yellow crust. The crust then falls off and the redness slowly goes away. The process takes approximately 10-14 days. Herpes simplex type 1 is commonly transmitted by kissing or close contact. Herpes can spread from person to person even when an infected individual has no outbreak or symptoms.
Business Plan
Mr. Buccellato further commented, "For several years, the Company has implemented its business plan to secure a broad patent portfolio for the use of antibodies, principally to interferon-gamma, for therapeutic treatment of three specific disease areas: 1. Autoimmune skin diseases including psoriasis and alopecia; 2. Patients suffering from corneal transplant and solid organ transplant rejection and, 3. Specific infectious diseases which are -- AIDS patients in virologic failure and now possibly herpes, all very significant markets."
He concluded, "The Company's business development plan will now principally focus on the following five specific elements: 1. Research and development as well as licensing agreements with selected pharmaceutical companies seeking opportunities related to our patented scientific approaches, 2. Commencement and completion of our FDA approved Phase I clinical trial at Georgetown University Medical Center, 3. Initiation of US clinical trials in a selected autoimmune skin disease and corneal transplant rejection, 4. Evaluation of possible merger, acquisition or sale candidates and, 5. Evaluation of appropriate financing opportunities."
About Advanced Biotherapy
The Company has demonstrated the effectiveness of its pioneering scientific strategy by conducting investigational clinical trials treating patients suffering from AIDS, multiple sclerosis, rheumatoid arthritis, corneal transplant rejection and certain autoimmune skin conditions, including psoriasis, and alopecia, all Th1 mediated autoimmune diseases which appear to have the same proinflammatory Th-1 activity. Advanced Biotherapy is headquartered in Los Angeles with laboratories in Columbia, Maryland. The company has an extensive patent portfolio including five issued patents and over 38 patents pending.
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. Some of these forward-looking statements may be identified by the use of words in the statements such as "appears," "may," "goal," "anticipate," "estimate," "expect," "project," "intend," "plan or plans," "believe," "could," or other words and terms of similar meaning. The risks and uncertainties which may affect the development, operations and results of our business include, but are not limited to the following: risks associated with clinical trials, the uncertainties of research and product development programs, the uncertainties of the regulatory approval process, the risks of competitive products, the risks of our current capital resources, the uncertainties as to the availability of future capital and our future capital requirements, and the risks associated with the extent and breadth of the Company's patent portfolio. There are no assurances that the Company's product candidates will receive regulatory approval. The foregoing discussion of the pending clinical investigations and the effect of the patents issued and pending involves risks and uncertainties, including but not limited to the risks that third parties may be successful in challenging such patents; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003.
Edmond Buccellato, CEO
Advanced Biotherapy, Inc.
6355 Topanga Canyon Blvd., Suite 510
Woodland Hills, CA 91367
Tel. 818-883-6716
Fax 818-883-3353
Email: ed@advancedbiotherapy.com
Website: www.advancedbiotherapy.com
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc.
Amy Buccellato, 818-883-6716
amy@advancedbiotherapy.com
Copyright (C) 2004 Business Wire. All rights reserved.
News-ADVB -- Advanced Biotherapy, Inc.
Com ($0.001)
COMPANY NEWS AND PRESS RELEASES FROM OTHER SOURCES:
Advanced Biotherapy Invited By William Blair & Company to Make Presentation At 7th Annual Private Equity Conference
WOODLAND HILLS, Calif., Oct 4, 2004 (BUSINESS WIRE) -- Advanced Biotherapy, Inc. (OTCBB:ADVB), dedicated to pioneering the development of immune-based therapies, announced that Edmond Buccellato, President and CEO of Advanced Biotherapy, Inc. has been invited to make a presentation at the William Blair & Company 7th Annual Private Equity Conference, which will take place on October 12th and 13th at the Four Seasons Hotel in Chicago. The audience will be comprised of institutional private equity and venture investors. More than 400 investors from 300 private equity firms were represented at last year's conference. William Blair & Company is a Chicago-based investment firm offering investment banking, asset management, equity research, institutional and private brokerage, and private capital to individual, institutional, and corporate clients. The Firm's offices are located in Chicago, Hartford, London, San Francisco, Tokyo, Vaduz, and Zurich.
Mr. Buccellato will present an overview of the Company and highlight its key scientific and intellectual property developments regarding its treatments of autoimmune diseases, and collaborations which include sponsorship of an FDA-approved Phase I clinical trial for AIDS patients in virologic failure at Georgetown University Medical Center. Mr. Buccellato will also present the Company's growth strategy, market and market size, competitive advantage, management team and financial overview.
About Advanced Biotherapy:
Advanced Biotherapy, Inc. is dedicated to pioneering the development of immune-based therapies for treating autoimmune diseases. The Company seeks to treat these diseases by regulating the immune system through the use of novel therapies, which inhibit certain (interferon-gamma and tumor necrosis factor-alpha) immune system cells that cause inflammation in the body. The Company has demonstrated the effectiveness of its pioneering scientific strategy by conducting investigational clinical trials treating patients suffering from HIV/AIDS, multiple sclerosis, rheumatoid arthritis, corneal transplant rejection and certain autoimmune skin conditions, including psoriasis, and alopecia. Advanced Biotherapy is headquartered in Los Angeles with laboratories in Columbia, Maryland. The company has an extensive patent portfolio including five issued patents and over 38 patents pending.
This press release does not constitute an offer, or an invitation to make an offer, to buy or sell any securities of the Company. This press release contains forward-looking statements regarding our business operations. These statements are based upon the Company's beliefs and expectations. They are not guarantees of future performance and involve certain risks, uncertainties, and assumptions that are difficult to predict. The Company operates in a rapidly changing environment that involves a number of risks, some of which are beyond the Company's control. We caution you that our performance and results could differ materially from what is expressed, implied, or forecast by our forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings for more detailed information on the risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect the Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003. Furthermore, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult our periodic reports on Form 10-QSB and Form 8-K for further disclosures we make on related subjects.
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in forward-looking statements made by Advanced Biotherapy, Inc. or Innogenetics NV in this news release. Some of these forward-looking statements may be identified by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," "could" or other words and terms of similar meaning. The risks and uncertainties which may affect the development, operations and results of Advanced Biotherapy's business include, but are not limited to the following: risks associated with clinical trials, the uncertainties of research and product development programs, the uncertainties of the regulatory approval process, the risks of competitive products, the risks of our current capital resources, the uncertainties as to the availability of future capital and our future capital requirements, and the risks associated with the extent and breadth of Advanced Biotherapy's patent portfolio. Similar risks and uncertainties as well as others may affect Innogenetics. There are no assurances that Advanced Biotherapy's product candidates will receive regulatory approval; no assurances can be given about Innogenetics' product candidates. The foregoing discussion of the pending clinical investigations and the effect of the patents issued and pending involves risks and uncertainties, including but not limited to the risks that third parties may be successful in challenging such patents; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. No assurances can be given regarding Innogenetics' product candidates or patents. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See Advanced Biotherapy's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in its forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in Advanced Biotherapy's Annual Report on Form10-KSB for the fiscal year ended December 31, 2003.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: Advanced Biotherapy, Inc.
Amy Buccellato, 818-883-6716
amy@advancedbiotherapy.com
www.advancedbiotherapy.com
or
Innogenetics
Jean-Christophe Donck, +32 (0)9 329 1701
jeandon@innogenetics.com
www.innogenetics.com
Copyright (C) 2004 Business Wire. All rights reserved.
NEWS...
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K/A
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest reported) July 14, 2004
Advanced Biotherapy, Inc.
(Exact name of registrant as specified in its chapter)
Delaware 0-26323 51-0402415
----------------------------- ------------ -------------------
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
6355 Topanga Canyon Boulevard, Suite 510 91367
---------------------------------------- -----
Woodland Hills, California (Zip Code)
-------------------------- ----------
(Address of principal executive offices)
Registrant's telephone number, including area code (818) 883-6716
----------------
This Form 8-K/A amends Form 8-K filed on August 4, 2004. The purpose of this Amendment to Form 8-K is to correct the description and listing of Exhibit 10.13 to reflect that the Exhibit contains a redacted portion which is covered by an application for confidential treatment previously filed with the Securities & Exchange Commission.
Item 5. OTHER EVENTS.
The registrant published a press release on July 30, 2003 which reported that Advanced Biotherapy, Inc. has entered into an agreement to conduct joint clinical investigations with the Russian Federation Ministry of Health/State Institute of Transplantation and Artificial Organs.
Item 7. FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits.
Designation Description of Exhibit
10.13 Agreement for Joint Clinical Investigations between
the State Institute of Transplantation and Artificial Organs
of the Ministry of Health of the Russian Federation and
Advanced Biotherapy, Inc.; Subject to Redaction and
Application for Confidential Treatment Pursuant to
Rule 24b-2.
99.1 Press Release, dated July 30, 2003
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ADVANCED BIOTHERAPY, INC.
(Registrant)
Date: July 14, 2004 By: /s/ Edmond Buccellato
------------------------------------
Edmond Buccellato, President and CEO
INDEX TO EXHIBITS
Exhibit Description
10.13 Agreement for Joint Clinical Investigations between
the State Institute of Transplantation and Artificial Organs
of the Ministry of Health of the Russian Federation and
Advanced Biotherapy, Inc.; Subject to Redaction and
Application for Confidential Treatment Pursuant to
Rule 24b-2.
99.1 Text of Press Release, dated July 30, 2003
--------------------------------------------------------------------------------
Exhibit 10.13
SUBJECT TO REDACTION
AND
APPLICATION FOR CONFIDENTIAL TREATMENT
PURSUANT TO RULE 24B-2
AGREEMENT FOR JOINT CLINICAL INVESTIGATIONS
Both sides note that the first treatment of autoimmune diseases by removal of interferons (cytokines) was proposed in 1974 by Professor S.V. Skurkovich (Nature, 1974;247:551-2). He also proposed to remove TNF-(alpha) in various autoimmune conditions, including AIDS (J IFN & Cytokine Res 1989;9:S2 and other publications and patents). The use of anticytokines in autoimmune conditions has received wide experimental and clinical confirmation in various laboratories of the world. As is known, organ transplant rejection is also connected with autoimmune mechanisms. In joint investigations positive results were obtained with the use of antibodies to interferon-(gamma) in corneal transplants (Treatment of corneal transplant rejection in humans with anti-interferon-(gamma) antibodies. Am J Opthalmol 2002;133:829-30).
Based on this, the State Institute of Transplantation and Artificial Organs of the Ministry of Health of the Russian Federation ("Institute" herein) in the person of the Academician Russian Medical and Professor Valery Ivanovich Shumakov and Advanced Biotherapy, Inc. (ABI- USA) in the person of Professor S.V. Skurkovich, vice-president of ABI, agree to conduct joint clinical investigations on the reduction or prevention of organ transplant rejection by anticytokine therapy. In our joint investigation mainly anti-interferon-(gamma) antibodies will be used after transplantation of the heart, lung, liver, or pancreatic beta-islet cells.
Treatment of other conditions besides transplantation is possible.
ABI will supply the Institute with antibodies to interferon g and antibodies to TNIF-(alpha) and laboratory reagents (immunological) monitoring in accordance with a protocol for anticyotkine therapy.
[REDACTED - Confidential Portion Omitted and Filed Separately with the Securities and Exchange Commission]
Publications of the results of the clinical trials will be done jointly. ABI has the right to use the results of the trials as it wishes. The first publications of the treatment of each condition will be in English and the first author will be a representation of ABI. Later, if any Russian language reports are published, the first authors will be members of the Institute.
If the Institute wishes to send a representative to a conference outside of Russia to present the results of the clinical testing, ABI will pay expenses (registration, travel and hotel) for one attendee per conference.
This agreement is made and signed in English and Russian languages and has the same validity.
/s/Simon Skurkovich /s/Valery Ivanovich Shumakov
---------------------------- -------------------------------------------
on behalf of on behalf of
Advanced Biotherapy, Inc. the State Institute of Transplantation and
Artificial Organs of the Ministry of Health
of the Russian Federation
--------------------------------------------------------------------------------
EXHIBIT 99.1
PRESS RELEASE Source: Advanced Biotherapy, Inc.
ADVANCED BIOTHERAPY INC. LAUNCHES PROGRAM TO STUDY ANTIBODY THERAPY IN TREATING
ORGAN TRANSPLANT REJECTION Wednesday July 30, 8:43 pm ET
ANNOUNCES JOINT CLINICAL INVESTIGATION AGREEMENT WITH RUSSIA'S LEADING TRANSPLANT CENTER
LOS ANGELES--(BUSINESS WIRE)--July 30, 2003-- Advanced Biotherapy Inc. (OTCBB:ADVB - News) -- a developer of new antibody therapies for treating severe and widespread autoimmune diseases -- today announced that it has entered into an agreement to conduct joint clinical investigations with the Russian Federation Ministry of Health/State Institute of Transplantation and Artificial Organs. Under the agreement, the Institute will conduct human studies on select organ transplant patients using Advanced Biotherapy's investigational antibody therapies. The objective of the joint investigation is to evaluate the Company's antibody therapies in preventing or halting organ transplant rejection.
Advanced Biotherapy's antibody therapies are based on a pioneering theory first published nearly three decades ago in the journal Nature by Simon Skurkovich, M.D., Ph.D., D.Sc. -- the Company's director of research and development. Since it was first proposed, the concept of neutralizing the body's overproduction of certain immunomodulator substances to treat autoimmune diseases has achieved wide support in the international scientific community and has achieved commercial viability.
Autoimmune diseases are the result of an inappropriate immune response in which the body's immune system attacks healthy cells and organs. Certain chemicals called cytokines are hyperproduced, which brings about the autoimmune condition. One of Advanced Biotherapy's antibody therapies is designed to remove or neutralize these excessive cytokines known as gamma interferon and tumor necrosis factor-alpha, induced by gamma interferon.
Removal of these agents is associated with therapeutic effects, and could possibly be a universal treatment for certain types of autoimmune diseases. Advanced Biotherapy has already achieved encouraging results in clinical trials in rheumatoid arthritis, multiple sclerosis, various autoimmune skin diseases (psoriasis, alopecia areata, vitiligo, pemphigus, epidermolysis bullosa), and others.
"As a result of our strong patent position and the very promising investigational clinical study results we have already achieved in a number of autoimmune conditions at various well-respected research institutes in Moscow, Russia, as more specifically reported by the Company in its recent Securities and Exchange reports, we have accepted an invitation from Russia's leading transplant institute to conduct human studies," says Ed Buccellato, Advanced Biotherapy's CEO. "The State Institute of Transplantation and Artificial Organs is Russia's largest transplant center. It conducts more than 100 kidney transplants alone each year, in addition to heart, liver and lung transplants. It is now known that the body reacts to organ and cell transplantation in much the same way it reacts to an autoimmune disease. The Company maintains that treatment for organ transplant rejection can be similar to treatment for autoimmune diseases."
In a previous joint clinical investigation conducted at the Research Institute of Eye Diseases of the Russian Academy of Medical Sciences, positive results were obtained with the use of Advanced Biotherapy's investigational antibodies in patients suffering from corneal transplant rejection ("Treatment of Corneal Transplant Rejection in Humans with Anti-Interferon-Gamma Antibodies," Am. J. Ophthalmology 2002; 133:829-30). As reported, antibodies to interferon-gamma halted corneal transplant rejection in all patients that were treated.
The Company also recently performed investigational clinical testing at the Research Institute of Pediatric Hematology of Russia of its anti-interferon gamma antibody on several children with type I diabetes, an autoimmune disease. Results of this study, allowing all patients to lower their daily insulin dose, are scheduled to be presented in Berlin at the "8th International Workshop on Autoantibodies and Autoimmunity" in September.
--------------------------------------------------------------------------------
Mr. Buccellato further commented, "In the Institute's clinical investigations, the Company's first project will be to administer our investigational antibodies to gamma interferon and to tumor necrosis factor-alpha after transplant of insulin-producing pancreatic beta cells in type I diabetic patients."
Mr. Buccellato added, "We also find it quite encouraging that a number of noted U.S.-based biotechnology companies have, and continue, to conduct investigational clinical trials in Russia."
About Advanced Biotherapy
Advanced Biotherapy, Inc. is pioneering the development of new antibody therapies for treating severe and widespread autoimmune diseases. Its investigational therapies attack autoimmune diseases at their source, neutralizing biologic imbalances that impair immune system function. Core technology is protected under U.S. patents and patents pending for the exclusive use of a class of antibodies to the protein known as gamma interferon and to tumor necrosis factor-alpha for treating a range of diseases. The company is headquartered in Woodland Hills, California. www.advancedbiotherapy.com
Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. The risks and uncertainties which may affect the development, operations and results of our business include, but are not limited to the following: risks associated with clinical trials, the uncertainties of research and product development programs, the uncertainties of the regulatory approval process, the risks of competitive products, the risks of our current capital resources, the uncertainties as to the availability of future capital and our future capital requirements, and the risks associated with the extent and breadth of the Company's patent portfolio. The foregoing discussion of the pending clinical investigations and the effect of the patents issued and pending involves risks and uncertainties, including but not limited to the risks that third parties may be successful in challenging such patents; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2002.
--------------------------------------------------------------------------------
Contact:
Advanced Biotherapy, Inc.
Amy Buccellato, 818-883-6716
www.advancedbiotherapy.com
--------------------------------------------------------------------------------
End of Filing
© 2004 / EDGAR Online, Inc.
News: Advanced Biotherapy Developing Treatment for Acne; Company Continues to Build Patent Estate for Treatment of Inflammatory Diseases
WOODLAND HILLS, Calif., Jun 30, 2004 (BUSINESS WIRE) -- Advanced Biotherapy, Inc. (OTCBB: ADVB), dedicated to pioneering the development of immune-based therapies, today announced the submission of a patent application to the U.S.
Patent and Trademark Office for the treatment of acne vulgaris (pimples). This new approach is based on the encouraging results of preliminary studies conducted at the Russian State Medical University, which used the Company's investigational anti-inflammatory therapy to treat this skin disease.
"Our patent pending for acne ensures that we can focus on developing and testing new acne treatments for the 25 million Americans suffering with this severe skin condition," said Edmond Buccellato, Chief Executive Officer of Advanced
Biotherapy, Inc. "The U.S. demand for acne drugs exceeded $1.1 billion in 2003, and continues to be the most rapidly growing therapeutic category in the dermatology sector, which confirms the need for new acne treatments."
Imbalances in the immune system are suspected in many skin diseases including acne. Acne is considered by many leading experts to be a short-term disorder occurring mostly in adolescents. Acne occurs as a result of hormone dysfunction
and special acne bacteria, both of which disturb the production of cytokines, important factors in immunity.
Advanced Biotherapy is currently investigating an approach to control cytokine production to inhibit severe acne outbreaks.
Acne often involves physical pain and can lead to scarring on prominent areas of the body, such as the face. More importantly, acne can lead to embarrassment and
psychosocial suffering in afflicted individuals, especially in susceptible adolescents, even if acne is mild.
About Advanced Biotherapy
Advanced Biotherapy, Inc. is dedicated to pioneering the development of immune-based therapies for treating autoimmune diseases such as, multiple sclerosis, rheumatoid arthritis, and skin diseases such as psoriasis. The company seeks to treat these diseases by regulating the immune system through
the use of novel therapies, which inhibit certain (interferon-gamma and tumor necrosis factor-alpha) immune system cells that cause inflammation in the body. The company has demonstrated the effectiveness of its pioneering scientific
strategy by conducting investigational clinical trials treating patients suffering from multiple sclerosis, rheumatoid arthritis, corneal transplant rejection and certain autoimmune skin conditions, including psoriasis, alopecia
and HIV/AIDS. Advanced Biotherapy is headquartered in Los Angeles with laboratories in Columbia, Maryland.
This press release contains forward-looking statements regarding our patent application and business operations. These statements are based upon the Company's beliefs and expectations. They are not guarantees of future performance and involve certain risks, uncertainties, and assumptions that are difficult to predict. The Company operates in a rapidly changing environment that involves a number of risks, some of which are beyond the Company's control. We caution you that our performance and results could differ materially from
what is expressed, implied, or forecast by our forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and
uncertainties. Factors that could cause or contribute to such differences include, but are not limited to, risks that third parties may be successful in challenging such patent; or that the Company's patent application will not receive approval; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. Readers are cautioned not to place reliance on these forward-looking statements,
which speak only as of the date the statements were made. See the Company's public filings for more detailed information on the risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May
Affect the Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003. Furthermore, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult our periodic reports on Form 10-QSB and Form 8-K for further disclosures we make on related subjects.
SOURCE: Advanced Biotherapy, Inc.
CONTACT: KNB Communications, LLC
Patricia Sugrue, 212-505-2441
psugrue@knbpr.com
or
Advanced Biotherapy, Inc.
Amy Buccellato, 818-883-6716
amy@advancedbiotherapy.com
Copyright (C) 2004 Business Wire. All rights reserved.
Of no less importance than the other serious diseases for which the company has treatments, the company's recent patent application for treating acne (pimples) stands out (pun intended). The patent application is based on promising results in demonstrated trials in Russia. In view of the widespread (pun intended) incidents of the disease, particularly in adolescents, it would appear that the economic potential for the company has explosive potential. Not to make a mountain out of a molehill.
Steve
Advanced Biotherapy (ADVB) is an undiscovered, research and development company. It has developed treatments for a wide range of autoimmune disorders, including Multiple Sclerosis, Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis. Recently it obtained a Patent Office Notice of Allowance for treatment of asthma and allergies. It has applied for patent protection for an immune system based treatment for acne. The company recently announced that it would commence Phase I testing for HIV patients who have become resistant to conventional treatment.
Once the company's treatments complete the research phase, and pass into the market, I would expect the company to gain substantial recognition and probable share price appreciation.
Steve
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