In this open-label study using Omega-5^e (Cetyl Myristoleate) was administered orally to Seventy-one patients suffering from various pain symptoms from a variety of issues. Ninety-two percent of the patients showed marked reduction of pain and inflammation when treated with Omega-5^e. All patients had a history of pain treatment with conventional pharmaceutical agents, herbal agents, physical therapy, or a combination of these treatment choices. Patients were not asked to discontinue the use of their existing medications but rather were asked to report any improvements in their conditions and any reductions in their medications as they used Omega-5^e.

Thirty-five of the patients in this study presented themselves to the pain clinic, "Neuronet Institute, Klaus Brill, M.D., director." located in St. Wendel, Germany and the balance of the patients presented themselves to David Eckes, M.D., Hastings, MN. Criteria for admission stipulated that the patient have at least a one-year history of continuous inflammatory pain problems that were out of control. Patients filled out WOMAC questionnaires, logged their use of other analgesics for their stated problem, and completed a side effect profile. The pain scale of 0 through 7 was used to grade pain. Zero (0) represented no pain and seven (7) represented the pain one would experience with passing a kidney stone, having a labor pain, or major toothache. These patients were followed through a minimum of twelve weeks of treatment on enteric-coated Omega-5^e then data was collected and analyzed.

Seventy-one patients were logged in; they were followed regularly with questionnaires and physician reviews. Five patients left the study; two because of headaches believed to have been caused from soy allergies and three because of ineffective relief.

Classification of responding patients:
Osteoarthritis or Rheumatoid Arthritis: 55 patients
Fibromyalgia: 8 patients
Repetitive stress injuries: (i.e. tendonitis, fasciitis, muscle pain/spasm) 5 patients
Psoriasis: 2 patients
Migraine headaches: 1 patient

Osteoarthritis/Rheumatoid Arthritis:

55 patients had an average starting pain level of 5.2. Following enteric-coated Omega-5^e treatment their average "study completed pain level" was 1.4 representing a drop of 3.8 from the 5.2 levels. That is an average 73% reduction in pain level.

Fibromyalgia: 8 patients had an average starting pain level of 5.8. Following enteric-coated omega-5^e treatment their average "study completed pain level" was 0.8 representing a drop of 5.0 from the 5.8 levels. That is an average 86% reduction in pain level.

Repetitive stress injuries: 5 patients had an average starting pain level of 5.6. Following enteric-coated Omega-5^e treatment their average "study completed pain level" was 0.8. That is an average 85% reduction in pain level.

Psoriasis/dermatitis: 2 patients entered the study. One patient was a non-responder and left the study. One patient entered the study without pain, but a cosmetic level of 7 was issued on admission for his psoriasis condition. Following combined use of enteric-coated Omega-5^e capsules and lotion the patient reported significant improvement in the flaking, itching, and overall appearance of psoriatic plaques on the skin's surface. The final rating in the cosmetic features was graded at 1.

Migraine headache: 1 patient reported that the frequency of migraines headaches and the intensity of the headache pain were at a 7 level before taking a therapeutic dose of enteric-coated Omega-5^e. Frequency and intensity of headache pain levels dropped to a level of 1 following the treatment program.

Analysis of the study's results shows the following: Of the 71 patients initially entered into the study, 4 were non-responders, and one was eliminated because of a presumed side effect. That is, 5/71 or 7% did not finish the study. The remaining 66 patients responded favorably to a 12-week program of Omega-5^e treatment, a positive response rate of 92%.

If we group together all 66 responding patients with pain complaints, (i.e. the patients with OA/RA, fibromyalgia, repetitive stress injury, and migraine) the average entry level of pain was 5.4. The average exit level of pain was 1.3. The drop of 4.1 in pain level represents an average reduction of 76% in pain levels. The average dose of Omega-5 AlphaFlex^® was 3.2 capsules daily.

Of the original 71 patients analyzed in this study, 22 exited with no pain; i.e. 34% were pain free while on the enteric-coated Omega-5^e program.

Enteric-coated Omega-5^e effectively reduces moderate inflammatory pain levels in a variety of joint and muscles diseases. Analysis of our research data also suggests that Omega-5^e can reduce disability related to migraine headaches and psoriasis. Seven percent of admitted patients were classified as non-responders and did not complete the study. "CHIPCO5" verifies that enteric-coated Omega-5^e has broad-spectrum anti-inflammatory and analgesic applications.

Cetyl Myristoleate (Omega-5^e) is the putative effective ingredient in the formulation being tested in this study and is delivered using a patented process that protects it from upper gastro-intentional deactivation and a proprietary formulation both of which work together to increase bio-availability. It is formed commercially through the esterfication of myristoleic acid (a 14 carbon cis-monoenoic acid of the omega-5 series) and cetyl alcohol. Omega-5^e appears to have broad spectrum, anti-inflammatory properties (University of Nevada Animal research, 2001, K. Hunter, Ph.D., et. al) as a treatment for diverse rheumatic symptoms.¹

We are aware of one animal² and three human³ studies investigating the efficacy of CM for OA symptoms. Two of these were open-label and reported in the form of press releases⁴. The third study is a recently completed double blind, placebo-controlled trial of the effects of a CM-containing nutritional supplement (Celadrin^TM) among 100 patients with osteoarthritis. This study reportedly demonstrated significant benefits favoring the treatment of OA with CM.

Cetyl alcohol is a 16 carbon saturated fatty alcohol. It is commonly used as a spreading agent for topical dermatological preparations and often in pulmonary inhaler formulations. Because of its highly lipophilic nature, it readily penetrates skin and tissues like a bioactive substance. Prior to 1986, several sources reported contact allergies resulting from exposure to cetyl alcohol. But a more recent study suggests that these allergies were the result of trace impurities within the cetyl alcohol preparations, as patch testing with a variety of (99.9% pure) analytical reagent grade fatty alcohols (including cetyl alcohol) resulted in no allergic reactivity. Furthermore, cetyl alcohol has been indicated as a treatment for psoriasis scales, and has been reported to reduce Rhus allergic contact dermatitis when mixed with paraffin wax in a topical formulation.

Soybean oil, lecithin, manganese sulfate, pantothenic acid, zinc, and grape seed extract are also present in the Omega-5^e formulation.

Osteoarthritis:
Osteoarthritis (OA), is another common age-related disorder, which causes a substantial burden of disability and economic cost in the elderly⁶. Despite its frequency in the population, therapeutic options for osteoarthritis are limited⁷. For example, non-steroidal anti-inflammatory drugs, the most frequent medications prescribed for osteoarthritis, are associated with a 10% risk of gastric or duodenal ulcer⁸ and pose risks of kidney disease and central nervous system symptoms; most recently COX-2 NSAIDs also pose an increased risk of significant cardiovascular disease. According to the New England Journal of Medicine, June 1999, PMID 10577093, 15,000 arthritis patients die each year in the U.S. as a direct result of NSAID's toxic side effects; as a result, there has been a phenomenal upsurge in public interest in safe nutritional and nutraceutical remedies for osteoarthritis, as exemplified by the enormous demand for Glucosamine and Chondroitin products, even if only modestly efficacious, such products could have considerable utility in the treatment of this common disorder because of their safety. While the FDA does not regulate nutritional products as drugs, there is increasing recognition by all parties of the need to test the claims made for these compounds in rigorous scientific studies.

There are many factors that can cause OA; although age is a risk factor, research has shown that OA is not an inevitable part of aging. It is also common in athletes who sustain multiple joint injuries over time. OA occurs equally in men and women before age 55, but more often in women after that age. The primary cause is mechanical (for example, joint damage caused by running or excess weight-bearing) but, more rarely, it may be metabolic, genetic, or chemical in nature. Genetics has a role in the development of OA, particularly in arthritis of the hands. Some people may be born with defective cartilage or with slight defects in the way that joints fit together. As a person ages, these defects may cause early cartilage breakdown in the joint. In the process of cartilage breakdown, there may be some inflammation, with enzymes released and more cartilage damage.

Osteoarthritis (OA) is a chronic disease causing deterioration of the joint cartilage and the formation of new bone (bone spurs) at the edges of the joints. The cartilage of the affected joint wears down until there is none left and the opposing bones rub together. The joints most commonly affected are those of the hands and fingers, hips, knees, big toe, and spine.

Osteoarthritis is a common age-related disorder, with radiographic changes present in the knees of over 10% of the population aged over 45 years, which causes a substantial burden of disability and economic cost in the elderly⁹. Its prevalence in the U.S., is believed to exceed 60 million people, and the incidence of symptomatic¹⁰ knee and hip OA has been estimated at 200/100,000 person years¹¹. It is responsible for some 68 million days lost from work per year¹², and for 70% of all hip replacements at a cost of $3 billion, in the US annually¹³.

Despite its frequency in the population, therapeutic options in osteoarthritis are limited.¹⁴ Current treatment recommendations highlight analgesics especially acetaminophen and Non-steroidal anti-inflammatory drugs. NSAIDs widely used to treat osteoarthritis have not been found to be superior to acetaminophen for relieving pain or disability. While acetaminophen and non-steroidal drugs have been shown to be more efficacious than placebo for remediation of symptoms in osteoarthritis, their efficacy is limited. Long term NSAID use is associated with a risk of gastric or duodenal ulcer¹⁵ and also poses high risks of kidney disease and central nervous system symptoms. Acetaminophen is thought to be safer than NSAIDS because they reduce the risk of GI ulcers, but Acetaminophen may cause long term adverse hepatic side effects in patients using the drug regularly at high doses. Side effects from the long-term use of NSAIDS and Acetaminophen do include death.

Other treatment modalities for OA include exercise and muscle strengthening, but data supporting the efficacy of these modalities are incomplete and compliance with exercise regimens over the long term is inadequate.¹⁶ Joint replacement surgery is effective in alleviating joint pain, but is performed only after years of pain and disability and may not return patients to their pre-morbid state of function.¹⁷ In short, new treatments for OA are badly needed, especially ones that have favorable toxicity profiles and/or might have the potential for affecting the long-term course of disease.

Inflammation, tissue swelling usually accompanied by pain and heat, is the body's generic response to a host of insults: invasion by bacteria or viruses, injury, or reactions to one's own tissues. Within limits, inflammation is a valuable ally in the body's fight against invaders; but left unchecked, inflammation exposes a decidedly dangerous side. Chronic inflammation is characteristic of such disorders as asthma, chronic hepatitis, lupus and rheumatoid arthritis.

A major precursor of PGE2 is the omega-6 polyunsaturated fatty acid arachidonic¹⁸ acid. This substance is (too) abundantly present in the diet of industrialised countries. Omega-3-fatty acid is excellently suited to replace their omega-6 counterparts and, therefore, have an anti-inflammatory effect. The hybrid Omega-5^e, cetyl myristoleate, may also work here." Probably also other fatty acids (such as myristoleic acid) are able to replace arachidonic acid and thus might also be able to counteract inflammation.

Mechanism of joint inflammation: The picture above is a simplified representation of the immune process in juvenile idiopathic arthritis synovium. The cells present are in the rheumatoid synovium interacting with each other. An auto-antigen is presented by an antigen-presenting cell (activated macrophage) to a T cell. The T cell then becomes activated and secretes potent inflammatory mediators. These inflammatory mediators induce adhesion molecules, angiogenesis, activate fibroblasts and inflammatory cells, such as macrophages, into the joint. The inflammatory mediators begin degradation of cartilage.

In a recent study, reported an improvement in knee range of motion and overall function in patients suffering from OA of the knee when employing cetylated fatty acids.¹⁹ However, no biochemical parameters were analyzed.

Recently, it was shown that a cetylated monounsaturated fatty acid (e.g., myristoleic acid) conferred protection against adjuvant-induced arthritis in rats. However, the mechanism of action was not established.²⁰

Another recent report suggested that myristoleic acid may act by inhibition of 5-lipoxygenase, that is responsible for the synthesis of leukotrienes, which are potent mediators of inflammation. (Pancreatology 2003;3;209-269 Dr. X. Z. Ding, et al, Northwestern University, School of Medicine).

The incidence of osteoarthritis (OA) is rising among the elderly. Non-steroidal anti-inflammatory drugs (NSAIDS), including COX-2 inhibitors, are commonly used treatments; however, long term use of these agents may lead to significant adverse events. Recently, reports from Merck Pharmaceuticals have demonstrated the adverse side effects of VIOXX (a COX-2 inhibitor) wherein the incidence of cardiac events was increased 10 fold over non COX-2 users. There is a need for alternative products that benefit patients with OA without harmful side effects. Recently, several products containing cetyl myristoleate oil have become available. However, well-controlled studies that investigate CM's effects on pro-inflammatory parameters are just now beginning.

The primary objective of the study is to demonstrate the efficacy of Omega-5^e as an agent that can positively affect and reduce general pain and inflammatory conditions."

Patient's term of participation in this study was a minimum of 12 weeks up to a maximum of 156 weeks of continuous use. This extended participation has shown, without exception, continued improvement in the original disease or injury issue and reduction or elimination their dependence upon pharmaceutical drugs. The study looks at improvement in mobility, reduction in pain levels, increased quality of life and reduction of non-essential pharmaceutical drug use.

"To demonstrate the efficacy of Omega-5^e in reducing pain in and/or inflammation in a variety of disease or injury states."

Determine if Omega-5^e is a broad-spectrum anti-inflammatory analgesic agent based on the subjective WOMAC protocol (see page 12 below).

Patients must document all existing complaints including whether other complaints such as eczema, migraines, sun burn, injury burns, herpes virus, shingles pain, acne, injury pain, disease pain, changed during the course of the trial.

Patients must report all negative side effects experienced during the course of treatment.

Patients must report any decrease in the use of any pharmaceutical agents as a result of using Omega-5^e.

TEST DRUG: Cetyl Myristoleate (Omega-5^e)
Patients in the Omega-5^e group will receive capsules containing:

Patient will be his or her own control. Patient will be required to have a minimum one year history of treatment for chronic pain. Injury patients will be the only exception to this one-year restriction.

Patient will provide a one-year history of all physicians' sought for treatment and a list of prescribed medications together with a personal evaluation of their effectiveness.

Study Design: Patients will be asked to consume 3 to 6 capsules per day with makeup days allowed for missed dosages. Patients, at heir discretion, will be allowed to increase or reduce their dosage to determine what dose they require to treat their symptoms.

After initial clinical assessment, patients will keep a record of their daily dietary and medication routine. Subjects receiving medication for other ailments will be asked to maintain their current dosing regimen. In addition, patients currently taking medication for pain or inflammation will be asked to continue their medication on an as needed basis.

Patient will be allowed to use a "rescue medication" for any flare-ups; but it should be the same medication each time. All rescue medications shall be recorded together with their results.

The WOMAC (English and German translation) questionnaire for the patients will be employed.

Clinical Assessment: Patients will be assessed bi weekly and then monthly for those patients with the longest histories of use. The clinical investigator will interview and evaluate each patient by physical examination. Observations for pain, stiffness, and discomfort will be recorded.

All Patients will be asked to complete the appropriate questionnaires found in the WOMAC.

The same staff member will meet with the patient during each visit.

The questions are taken from the WOMAC, which has been used extensively in European and American OA studies since 1980.

The Western Ontario and McMaster Universities (WOMAC) osteoarthritis index is a tri-dimensional disease-specific self-administered health status questionnaire (see Table 3).^21,22 It probes clinically important, patient relevant symptoms in the areas of pain, stiffness, and physical function in patients with OA of the hip or knee.²³ The index as used herein consists of 14 questions (5 pain, 2 stiffness, 7 physical function) which can be completed by the patient in a few minutes. WOMAC has high test retest reliability for all scales, and validation studies have showed high correlations with other indices probing the same dimensions including MHIQ, Doyle, the Lequesne index and others.²⁴ Responsiveness has been tested in non-steroidal trials and each aggregated subscale score (e.g. pain) has been found to detect the effect of NSAID's,²⁵ and to detect a clinically important statistically significant difference in efficacy between two NSAIDs.²⁶ In terms of sensitivity to change, WOMAC has been compared to other measures of patient status in OA including HAQ, AIMS, the Doyle index the Lequesne index and measures of walk time, range of motion, and has generally been found to be more sensitive to change (relative efficiency compared to other instruments 1).²⁷ It can be utilized in a site-specific fashion and has been shown to discriminate between outcomes in opposite joints in the same patients.²⁸ The WOMAC has been recommended as a measure for assessing 'slow-acting' drugs in OA, and has been employed in recently completed clinical trials of glucosamine and chondroitin for knee OA.²⁹

Dosage: Self-Determined.
Patients were asked to start on 3 capsules per day and to increase or decrease their dosage to determine to minimum level of product they could take and still see a clinical benefit to using the product.

1. Patients Demographic and Baseline Characteristics
2. Reasons for Study Termination for All Randomized Patients
3. Patients' Shift from Categories of Moderate, Severe or Extreme
4. Frequency of Adverse Events
5. Pharmaceutical Medications History
6. Racial Distribution of Internet Users

Table 1: Patients' Demographic and Baseline Characteristics

Table 2: Reasons for Study Termination for All Randomized Patients

Table 3: Patients' Shift from Categories of Moderate, Severe, or Extreme (Scores 0 through 7)

Table 4: Frequency of Adverse Events

Table 5: Pharmaceutical Medications History

Table 6: Racial Distribution of Internet Users

NOTE: Sierra Life Sciences, Inc., Tradename for their Muscle and Joint Formula containing Omega-5^e enteric capsules and topical lotion is AlphaFlex®. Omega-5^e appears throughout this business plan with and without the TM symbol but always refers to SLSI's Tradename Omega-5^e. "CM" used herein, refers to cetyl myristoleate, the ester of myristoleic acid of which Omega-5^e is. Sierra Life Sciences, Inc., and "SLSI" refer to the same closely held, Nevada corporation.