Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1999-05-27
2001-04-24
Celsa, Bennett (Department: 1627)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S002600, C435S042000, C435S170000, C435S252100, C435S252900, C435S253400
Reexamination Certificate
active
06221847
ABSTRACT:
FIELD OF THE INVENTION
The present invention is generally directed to a composition and method for treating bacterial infections. More particularly, the present invention is directed to the use of a protein produced by bacteria from dairy or classical propionibacteria that inhibits the growth of bacteria that cause acne. Additionally, the bacteriocin of the present invention has been shown to be effective at inhibiting or killing a number of different gram-positive and gram-negative bacterial isolates which cause clinical infection in human and animal patients.
BACKGROUND OF THE INVENTION
Acne (formally known as “acne vulgaris”) is a skin disease which afflicts, in some form, approximately 80 to 90 percent of all teenagers. Acne can also affect many adults and infants. The severity of acne can range from minor skin lesions called comedones to nodules and cysts which can potentially permanently scar skin tissue.
The areas of the body that are commonly affected by acne are the face, chest and upper back. These areas of the body have a high sebaceous gland concentration which causes the skin to be oily.
Acne is believed to start with increased release of hormones in the body such as androgens. Young adults going through puberty, for instance, tend to produce more hormones such as androgens. It is believed that androgens stimulate the sebaceous glands to produce more sebum, which is an oily substance released on the skin. Sebum is a lipid-laden product comprised of a mixture of fats, waxes and fatty materials.
As more and more is produced, sebum can agglomerate and form solid plugs known as comedones in the hair follicles. Formation of a comedone, in turn, causes layers of dead skin known as keratin to accumulate and be retained within the lining of the follicles. The buildup of keratin causes hyperkeratosis of the follicular opening, which can completely close off the follicular canal.
Within the follicular canal are bacteria indigenous to the follicular lining. Included in the bacteria are anaerobic, gram positive organisms classified for instance as
Propionibacterium acnes
or
Propionibacterium granulosum.
When comedones form in the follicular opening, these bacteria feed on the sebum. Specifically, the bacteria produce lipases that hydrolyze triglycerides and release free fatty acids. The fatty acids thus generated in combination with the bacteria activate the immune system of the body causing inflammation, swelling and redness around the follicle. Depending upon the degree of inflammation, pustules, cysts, nodules, and papules may form.
In the past, many different treatments have been proposed for curing acne. Such treatments include topical keratolytic agents, topical or systematic antibiotics, or hormonal treatments designed to limit sebum secretion. Unfortunately, some of these treatments can produce adverse side affects.
Topical keratolytic agents include, for instance, tretinoin and benzoyl peroxide. These anti-acne agents prevent the blockage of follicular canals and reopen clogged follicular openings by breaking down keratin. Some keratolytic agents, however, can irritate the skin causing excessive dryness, scaling, swelling, burning, peeling, redness and allergic reactions.
Antibiotics that have been used in the past to treat acne include tetracycline, erythromycin, clindamycin, meclocyclin, metronidazole, minocycline and doxycycline. While administration of these drugs is often effective in treating acne, antibiotics have several disadvantages. For example, when taken orally, antibiotics may cause many undesirable side effects including abdominal cramps, black tongue, fatigue, depression, nausea, and other various effects. When applied topically, the antibiotics can lose their effectiveness if used for a prolonged period of time due to resistance developed by the bacteria.
The hormones estrogen and antiandrogens have also been used to treat acne in severe cases. These hormones when taken orally, however, can feminize adolescent males and can increase the risk of blood clots and cancers. Thus, hormones are rarely administered orally.
In view of the disadvantages associated with current acne treatments, a need exists for an acne preventive agent that does not create any of the above adverse side effects. A need also exists for an anti-acne agent that destroys the bacteria that causes the inflammation associated with acne.
SUMMARY OF THE INVENTION
The present invention recognizes and addresses the foregoing disadvantages, and others of prior art constructions and methods.
In summary, the present invention is generally directed to an anti-bacterial protein referred to as a bacteriocin, that can be used to destroy and inhibit the growth of the bacteria that are responsible for the inflammatory symptoms associated with acne. In addition to its usefulness as a treatment for acne, the bacteriocin of the present invention is also useful as a broad spectrum antibiotic, and has been shown to effectively inhibit the growth of, or kill, a variety of clinically relevant bacteria, including both gram-positive and gram negative bacterial isolates.
As used herein, the term “clinically relevant” bacteria refers to bacterial isolates responsible for causing significant morbidity and mortality in human and animal patients. Among such isolates are a number of members of the Enterobacteriaceae family. For example,
Escherichia coli
is a gram negative organism which is a major cause of watery or bloody diarrhea. Additionally,
E. coli
infection is a common cause of bacteremia and meningitis in newborns. Other members of the Enterobacteriaceae family which are associated with significant morbidity include
Proteus vulgaris, Enterobacter aerogenes, Shigella flexneri
and
Serratia marcescens.
According to the present invention, the bacteriocin is produced by a bacteria from the genus Propionibacterium and particularly from the classical or dairy strains. For instance, in one embodiment, the bacteriocins can be produced from
Propionibacterium jensenii,
and more particularly by the B1264 strain of
Propionibacterium jensenii.
It has been discovered that these bacteriocins not only can be used to treat acne and other bacterial infections but are stable across a pH range and at relatively high temperatures. This stability coupled with the fact that the bacteriocin is produced by a food related organism, makes the bacteriocin of the present invention a highly effective and desirous agent for treating acne and other clinically relevant bacterial infections.
Bacteriocins produced by
Propionibacterium jensenii
are discussed in U.S. Pat. No. 5,639,659 which is incorporated herein by reference in its entirety. In the prior application, the bacteriocins were used primarily to inhibit the growth of bacteria cultures of
Lactobacillus bulgaricus
and
Streptococcus thermophilus
in order to control the pH of a food product, such as yogurt. It was not disclosed nor was it apparent in that application, however, that the bacteriocins may also be used to inhibit the bacteria associated with acne and other medical ailments.
Accordingly, it is an object of the present invention to provide a method and a composition for treating acne.
Another object of the present invention is to provide a method and composition for treating acne that involves the use of bacteriocins produced from one or more strains of bacteria classified in the genus Propionibacterium.
Another object of the present invention is to provide a composition containing bacteriocins produced by
Propionibacterium jensenii
that destroy and inhibit the growth of bacteria associated with acne.
It is another object of the present invention to provide a topical preparation for treating acne that contains bacteriocins produced by
Propionibacteriurn jensenii.
Still another object of the present invention is to provide a method for destroying and inhibiting the growth of
Propionibacterium acnes
and
Propionibacterium granulosum
using a bacteriocin produced by
Propionibacterium jensenii.
It is still another object of the present invention
Barefoot Susan F.
Ratnam Priya
Celsa Bennett
Clemson University
Dority & Manning P.A.
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