Amarillo Biosciences Inc (OBB : AMAR) closed on Friday .55..
Amarillo Biosciences is a development stage company. The Company develops and markets 19 patents and 8 pending applications relating to low dosage oral & non-oral natural interferon alpha used in the treatment of human and animal diseases.
Website:http://www.amarbio.com
OFFICERS:
Joseph Cummins, Chairman/President/CEO/CFO
Kathleen Keller, COO
Edward Morris, Secretary
Amarillo Biosciences Inc
800 West Ninth
Amarillo, TX
79101
United States
Phone:806-376-1741
Email:ABI@AmarBio.com
Preferred
Authorized - 10,000,000
Issued shares - none
Common
Authorized - 20,000,000
Issued shares - 7,912,405 in 2001
HUMAN HEALTH APPLICATIONS
Sjogren's Syndrome. Sjogren's syndrome is a chronic autoimmune disorder characterized by dryness of the eyes and mouth. It can exist as a primary disorder or in association with other autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus and scleroderma. Patients with primary Sjogren's syndrome may have clinical signs such as rash, arthritis, pneumonitis and nephritis. Typical symptoms include the sensation of burning in the eyes, dryness of the mouth, skin, nose and vagina, difficulty swallowing, painful throat and fatigue. Oral candidiasis (a fungus infection of the mouth) may also arise as a result of reduced saliva flow. Although Sjogren's syndrome is not life threatening, it can cause extreme discomfort and seriously impair quality of life.
Topical use of artificial tears is the prevailing treatment for the dry eye symptom of the disease. Artificial tears must be used on a regular basis. Intensive oral hygiene is prescribed to prevent progressive oral problems that may develop as a result of the disease. Topical and systemic means of increasing salivary flow may provide transient relief of symptoms.
The Company has completed two 24-week Phase III clinical trials of the use of interferon alpha lozenges in the treatment of primary Sjogren's syndrome. Results of both Phase III clinical trials demonstrate an improvement in saliva production in treated patients. The studies were double-blinded, placebo-controlled tests in which a total of 497 patients were treated three times daily for 24 weeks with a lozenge containing either 150 international units (IU) of interferon alpha or a placebo. Analysis of participants who completed the trials, designated as evaluable patients, found a significant (p=0.01) increase in unstimulated whole saliva (UWS) production among the interferon alpha treated patients, as compared to those who received placebo. Increases in UWS are important to the Sjogren's patient since UWS represents the basal salivary flow that is present over 90% of the day.
The Company discussed the results of these studies with the FDA in February 2001. The FDA felt the demonstrated improvement in UWS flow was encouraging, but not sufficient for marketing approval as UWS was a secondary, rather than a primary study endpoint. The FDA suggested that the Company sponsor an additional, large-scale Phase III study that would include UWS flow as the primary endpoint. Instead, the Company proposed a study designed to demonstrate, by biopsy, improvement at the site of disease activity, the salivary glands. The Company believes that if successful, the salivary gland study results, along with the beneficial UWS results generated in the twin Phase III studies would form a reasonable basis for the approval of oral interferon alpha in the treatment of Sjogren's syndrome. Even though the FDA stated their belief that the data package would still be insufficient, the Company plans to conduct a biopsy study, and if successful, to file for marketing approval.
Fibromyalgia Syndrome. The Company completed a second Phase II clinical trial in fibromyalgia in March 2000. Fibromyalgia syndrome has only recently been recognized as a separate clinical entity, much to the relief of patients suffering from chronic pain and stiffness. The market in the U.S. has been estimated at 5-10 million patients, which may well be underestimated.
In ABI's initial Phase II fibromyalgia study, 6 weeks of low-dose oral interferon alpha treatment resulted in a significant (p<0.05) reduction in stiffness upon waking ("morning stiffness") compared to placebo. Patients reported feeling better than they had in years. Based on these results, a second, longer study was conducted.
The most recently completed Phase II clinical study showed promising results. Patients participating in the study were divided into three groups, and each individual was given three lozenges per day for three months. The three lozenges given to members of the first group contained 50 IU of interferon alpha each, the second group was given one 50 IU interferon alpha lozenge and two placebos, while members of the final group received three placebos. All three groups reported a reduction in morning stiffness, but across the entire study the improvement was most pronounced in those taking one 50 IU lozenge of interferon alpha per day. However, the results did not reach statistical significance relative to the controls, nor did increasing the dose to three interferon alpha lozenges per day improve the results.
The Company believes that a modified Phase II study design would confirm the therapeutic benefit of low-dose oral interferon alpha in the treatment of morning stiffness in patients suffering from fibromyalgia. Upon successful completion of an additional Phase II study, ABI would then plan on working with a corporate partner to conduct the Phase III clinical trials necessary to secure marketing approval.
ABI's oromucosal interferon alpha is being tested as a treatment for IPF under an Advanced Technology Program Grant awarded by the State of Texas to the Texas Tech University Health Sciences Center in Lubbock. The $100,000 grant is being used by the Health Science Center to support a pilot study of 20 patients with IPF. ABI is collaborating on this research with Lorenz O. Lutherer, MD, PhD, professor, physiology, and Cynthia A. Jumper, MD, associate professor patient care, internal medicine, and is providing support in the form of study drug, data management and biostatistical analysis.
Asthma. There are 14-17 million asthma patients in the U.S. alone. ABI's mechanism of action data predict that natural human interferon alpha will benefit many patients with asthma. Low-dose oral interferon beta has been shown to inhibit the late, but not the early asthmatic response in ovalbumin-sensitized guinea pigs. Oral mucosal administration of interferon alpha to mice reduced allergen-specific IgE production and allergen-induced eosinophil recruitment. Anecdotal human data suggest that low-doses of interferon alpha given orally 3 times per day will significantly relieve some asthmatic symptoms. A pilot study to test oral interferon alpha in asthma patients at the Cleveland Clinic is planned for 2002.
This is a key note here and very important for any Bio-Tech company....
STRATEGIC ALLIANCE WITH HBL
In September 1997, HBL and ABI entered license agreements granting exclusive rights to ABI to develop interferon gamma for oral use in humans and for all routes of administration in animals and tumor necrosis factor alpha for oral and topical uses in humans and for all routes of administration in animals; the rights were granted worldwide, except Japan. In June 2000, HBL and ABI amended their license agreement on interferon gamma to include the inhalation route of administration.
OTHER AGREEMENTS
On September 7, 2001, the Company executed a License Agreement with Atrix Laboratories, Inc. of Fort Collins, Colorado, providing the rights to oral low-dose interferon alpha for the treatment of Behcet's disease and oral papillomavirus warts in HIV-positive patients. The U.S. Food and Drug Administration (FDA) has granted this product orphan drug status for both indications. Under the terms of the agreement, Atrix paid $485,000 for licensing, orphan drug designations, and clinical supplies. Atrix will fund the research and development of the product and will perform the work at their facilities in Fort Collins, Colorado. As part of the agreement, the Company receives payments for specific clinical and regulatory milestones and will receive a royalty based on sale of any product developed.
PATENTS AND PROPRIETARY RIGHTS
One patent was issued in 2000. This patent is "Treatment of Fibromyalgia With Low Dose Interferon" (U.S. Patent No. 6,036,949) issued March 14, 2000, valid until March 5, 2018. Notice of Allowance of Claims was received on a patent entitled "Solid Interferon Dosage Form and Method Therefor" and the issue was paid to the U.S. Patent and Trademark Office (PTO) on October 30, 2001. The PTO is expected to issue the patent in March 2002 and the patent will have a life of 17 years from date of issue.
Filings:
http://www.edgar-online.com/bin/edgardoc/finSys_main.asp?dcn=0000950134-02-002958
This is a smart play,but does carry a certain amount of risk.Bio-technology is the field and a very important aspect in our lives...As the baby boomers are getting older,a need for more concentration in preventive medicine and cures for the many disceases that plaque us today is imperative
Bio-technology is always a long-term play and clinical trials seems to take forever,but once an approval is granted,these stocks always take off.....
As always, apply sound DD and invest smartly..
Have a good day
ET
Amarillo Biosciences is a development stage company. The Company develops and markets 19 patents and 8 pending applications relating to low dosage oral & non-oral natural interferon alpha used in the treatment of human and animal diseases.
Website:http://www.amarbio.com
OFFICERS:
Joseph Cummins, Chairman/President/CEO/CFO
Kathleen Keller, COO
Edward Morris, Secretary
Amarillo Biosciences Inc
800 West Ninth
Amarillo, TX
79101
United States
Phone:806-376-1741
Email:ABI@AmarBio.com
Preferred
Authorized - 10,000,000
Issued shares - none
Common
Authorized - 20,000,000
Issued shares - 7,912,405 in 2001
HUMAN HEALTH APPLICATIONS
Sjogren's Syndrome. Sjogren's syndrome is a chronic autoimmune disorder characterized by dryness of the eyes and mouth. It can exist as a primary disorder or in association with other autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus and scleroderma. Patients with primary Sjogren's syndrome may have clinical signs such as rash, arthritis, pneumonitis and nephritis. Typical symptoms include the sensation of burning in the eyes, dryness of the mouth, skin, nose and vagina, difficulty swallowing, painful throat and fatigue. Oral candidiasis (a fungus infection of the mouth) may also arise as a result of reduced saliva flow. Although Sjogren's syndrome is not life threatening, it can cause extreme discomfort and seriously impair quality of life.
Topical use of artificial tears is the prevailing treatment for the dry eye symptom of the disease. Artificial tears must be used on a regular basis. Intensive oral hygiene is prescribed to prevent progressive oral problems that may develop as a result of the disease. Topical and systemic means of increasing salivary flow may provide transient relief of symptoms.
The Company has completed two 24-week Phase III clinical trials of the use of interferon alpha lozenges in the treatment of primary Sjogren's syndrome. Results of both Phase III clinical trials demonstrate an improvement in saliva production in treated patients. The studies were double-blinded, placebo-controlled tests in which a total of 497 patients were treated three times daily for 24 weeks with a lozenge containing either 150 international units (IU) of interferon alpha or a placebo. Analysis of participants who completed the trials, designated as evaluable patients, found a significant (p=0.01) increase in unstimulated whole saliva (UWS) production among the interferon alpha treated patients, as compared to those who received placebo. Increases in UWS are important to the Sjogren's patient since UWS represents the basal salivary flow that is present over 90% of the day.
The Company discussed the results of these studies with the FDA in February 2001. The FDA felt the demonstrated improvement in UWS flow was encouraging, but not sufficient for marketing approval as UWS was a secondary, rather than a primary study endpoint. The FDA suggested that the Company sponsor an additional, large-scale Phase III study that would include UWS flow as the primary endpoint. Instead, the Company proposed a study designed to demonstrate, by biopsy, improvement at the site of disease activity, the salivary glands. The Company believes that if successful, the salivary gland study results, along with the beneficial UWS results generated in the twin Phase III studies would form a reasonable basis for the approval of oral interferon alpha in the treatment of Sjogren's syndrome. Even though the FDA stated their belief that the data package would still be insufficient, the Company plans to conduct a biopsy study, and if successful, to file for marketing approval.
Fibromyalgia Syndrome. The Company completed a second Phase II clinical trial in fibromyalgia in March 2000. Fibromyalgia syndrome has only recently been recognized as a separate clinical entity, much to the relief of patients suffering from chronic pain and stiffness. The market in the U.S. has been estimated at 5-10 million patients, which may well be underestimated.
In ABI's initial Phase II fibromyalgia study, 6 weeks of low-dose oral interferon alpha treatment resulted in a significant (p<0.05) reduction in stiffness upon waking ("morning stiffness") compared to placebo. Patients reported feeling better than they had in years. Based on these results, a second, longer study was conducted.
The most recently completed Phase II clinical study showed promising results. Patients participating in the study were divided into three groups, and each individual was given three lozenges per day for three months. The three lozenges given to members of the first group contained 50 IU of interferon alpha each, the second group was given one 50 IU interferon alpha lozenge and two placebos, while members of the final group received three placebos. All three groups reported a reduction in morning stiffness, but across the entire study the improvement was most pronounced in those taking one 50 IU lozenge of interferon alpha per day. However, the results did not reach statistical significance relative to the controls, nor did increasing the dose to three interferon alpha lozenges per day improve the results.
The Company believes that a modified Phase II study design would confirm the therapeutic benefit of low-dose oral interferon alpha in the treatment of morning stiffness in patients suffering from fibromyalgia. Upon successful completion of an additional Phase II study, ABI would then plan on working with a corporate partner to conduct the Phase III clinical trials necessary to secure marketing approval.
ABI's oromucosal interferon alpha is being tested as a treatment for IPF under an Advanced Technology Program Grant awarded by the State of Texas to the Texas Tech University Health Sciences Center in Lubbock. The $100,000 grant is being used by the Health Science Center to support a pilot study of 20 patients with IPF. ABI is collaborating on this research with Lorenz O. Lutherer, MD, PhD, professor, physiology, and Cynthia A. Jumper, MD, associate professor patient care, internal medicine, and is providing support in the form of study drug, data management and biostatistical analysis.
Asthma. There are 14-17 million asthma patients in the U.S. alone. ABI's mechanism of action data predict that natural human interferon alpha will benefit many patients with asthma. Low-dose oral interferon beta has been shown to inhibit the late, but not the early asthmatic response in ovalbumin-sensitized guinea pigs. Oral mucosal administration of interferon alpha to mice reduced allergen-specific IgE production and allergen-induced eosinophil recruitment. Anecdotal human data suggest that low-doses of interferon alpha given orally 3 times per day will significantly relieve some asthmatic symptoms. A pilot study to test oral interferon alpha in asthma patients at the Cleveland Clinic is planned for 2002.
This is a key note here and very important for any Bio-Tech company....
STRATEGIC ALLIANCE WITH HBL
In September 1997, HBL and ABI entered license agreements granting exclusive rights to ABI to develop interferon gamma for oral use in humans and for all routes of administration in animals and tumor necrosis factor alpha for oral and topical uses in humans and for all routes of administration in animals; the rights were granted worldwide, except Japan. In June 2000, HBL and ABI amended their license agreement on interferon gamma to include the inhalation route of administration.
OTHER AGREEMENTS
On September 7, 2001, the Company executed a License Agreement with Atrix Laboratories, Inc. of Fort Collins, Colorado, providing the rights to oral low-dose interferon alpha for the treatment of Behcet's disease and oral papillomavirus warts in HIV-positive patients. The U.S. Food and Drug Administration (FDA) has granted this product orphan drug status for both indications. Under the terms of the agreement, Atrix paid $485,000 for licensing, orphan drug designations, and clinical supplies. Atrix will fund the research and development of the product and will perform the work at their facilities in Fort Collins, Colorado. As part of the agreement, the Company receives payments for specific clinical and regulatory milestones and will receive a royalty based on sale of any product developed.
PATENTS AND PROPRIETARY RIGHTS
One patent was issued in 2000. This patent is "Treatment of Fibromyalgia With Low Dose Interferon" (U.S. Patent No. 6,036,949) issued March 14, 2000, valid until March 5, 2018. Notice of Allowance of Claims was received on a patent entitled "Solid Interferon Dosage Form and Method Therefor" and the issue was paid to the U.S. Patent and Trademark Office (PTO) on October 30, 2001. The PTO is expected to issue the patent in March 2002 and the patent will have a life of 17 years from date of issue.
Filings:
http://www.edgar-online.com/bin/edgardoc/finSys_main.asp?dcn=0000950134-02-002958
This is a smart play,but does carry a certain amount of risk.Bio-technology is the field and a very important aspect in our lives...As the baby boomers are getting older,a need for more concentration in preventive medicine and cures for the many disceases that plaque us today is imperative
Bio-technology is always a long-term play and clinical trials seems to take forever,but once an approval is granted,these stocks always take off.....
As always, apply sound DD and invest smartly..
Have a good day
ET
