MISSION STATEMENT

Peptide Ltd. is a leading biotechnology company and owns exclusive international rights to market a number of neurological drugs developed from unique peptides. It also owns a portfolio of patents and most significantly the "Peptide Technology' that has been patented, (US Patent #5,989,857) therefore permitting the development of hundreds of novel therapeutic proteins for which we have exclusive research, manufacturing, marketing and distribution rights.

OVERVIEW

Far too many people who have been diagnosed with disabling diseases find themselves without medical insurance to pay for the medication they so desperately require. In most instances the annual cost of treatments exceeds $100,000.00. The financial burden alone places tremendous stress upon the entire family.

GLOBAL OUTLOOK

There are many crippling and fatal diseases globally which are threatening to overwhelm the countries involved. Many Third World Countries have meagre resources to support efforts towards finding a solution to their healthcare crisis. Furthermore, medications and vaccines developed outside these domains are beyond their financial reach, and as such, further exacerbating the situation.

The only solution is to introduce cost-effective options. The development of agents which will help detect, monitor and treat some of the world's most common ailments is the driving force behind Esperanza's efforts. Improving the quality of life for millions of people is the ultimate goal.

ESPERANZA PROFILE

Esperanza has a broad base of research interests encompassing many forms of disease. Staffed by medical professionals from diverse disciplines, a solid foundation has been established upon which exciting research is being conducted. Such diverse talents create a single entity with a single focus - the research of novel approaches to the treatment of disease.

Esperanza's research technology has been in development for many years. The company now seeks to enter into clinical studies and is ready to submit to drug regulatory approval agencies.

Esperanza's current focus will be divided into two research projects; one on neurological disorders and the other on viral disorders. In neurology, research will concentrate on Multiple Sclerosis (MS). MS is a disease which affects as many as 3 million people globally. In virology, research will concentrate on inhibiting HIV infection. This research will lead to, in both indications, a novel, more tolerable and cost effective therapeutic solution.

ENABLING TECHNOLOGIES

Esperanza will be continuing basic and applied research into the use of unique peptide molecules.

Esperanza's "Peptide Technology" permits the development of hundreds of novel therapeutic proteins for which owns and maintains Intellectual Properties and Patents worldwide.

Essentially, Esperanza takes proteins, denatures them by chemical modification, and identifies novel applications for them. The company also has the ability to generate such peptides by genetic engineering and protein synthesis.

So far, six new antiviral compounds have been studied, three compounds for use in neurological /neuromuscular disorders and others which have demonstrated anti-tumor properties. Other modified proteins are being identified which will have application for the treatment of diabetes, incontinence and muscular dystrophy.

The first of these is a novel therapeutic peptide called alpha-Immunokine, a modified protein derived from a neuroactive anti-cholinergic molecule.

Another development is Micro Emulsion Technology (MET), a topical delivery system which is based on glycerine spheres. Glycerine is an FDA approved wound healing agent. MET alone displays excellent healing properties and is also able to encapsulate small molecules and large proteins providing very stable delivery. Esperanza has successfully field tested it's first drug in this delivery format. Antibodies have also been incorporated into this unique system.

Finally, the recent development of a proprietary oral delivery format for Immunokine and the Esperanza Homeopathic NeuroPeptide sublingual spray has eliminated the necessity of patients injecting themselves with protein molecules. Early studies show the format to have an efficiency of over 95 percent. Long term MS patients have been enthusiastic since it provides much greater convenience over the original injectable dosage forms. This sublingual route of administration, when combined with the drug's negligible side-effects and stability, will also assist in improved patient compliance when treating such conditions as early HIV infection and AIDS. For more detailed information, or for answers to specific questions, please feel free to contact us click here for further details.

CLINICAL TRIAL PROGRAM

Esperanza plans to continue trials in both humans and animals. In humans, the first application of Immunokine will be the treatment of Multiple Sclerosis. Acceptance of its safety data and trial design has been received from the Food and Drug Administration (FDA), the British Medicines and Healthcare Regulatory Agency (MHRA) and the Canadian Health Protection Branch (HPB).

The trial will treat all forms of MS, a first for the industry. With appropriate funding, Phase I/II trials are expected to be conducted in the U.S. the U.K. and Canada. Multinational phase III trials are expected to commence in the same areas of the world following the above noted Phase I/II trials. A one year trial in Adrenomyeloneuropathy was completed in Britain, staging an application for Orphan Drug Status under the FDA providing early entry onto the market for this rare disorder. The results of this Phase I Trial published in The Journal of The American Academy of Neurology click here to view.

It is believed that Immunokine peptide could supersede interferon-based treatments whose sales currently generate over $3 billion annually. With less than 6 percent of over 3 million MS patients globally receiving no medications specifically for their condition, Immunokine’s efficacy and cost will guarantee significant market penetration.

In the veterinary therapeutics arena, trials in dogs with a variety of cancers will also begin in the 1st quarter of 2007 and be complete in less than 6 months. This will take place under the jurisdiction of the USDA.

The market for an effective adjunct tumor therapy of companion animals is enormous. In the U.S., there are 110 million cats and dogs. Dogs are 3 times more likely to develop cancer than humans. There is a real need for such therapeutics in this arena. Furthermore, efficacy in this segment points to Immunokine’s potential use in human tumor therapy.

CLINICAL TRIAL FUNDING

To date Esperanza has expended it's funds on research and development in order to bring it's lead drug, Immunokine, into clinical trials. The company is in the process of raising $40 million in order to commence these trials.

Esperanza's focus is to proceed into human clinical trials in the U.S. and Canada under ICH guidelines. In order to initiate Phase I/II testing, funding of $15 million is required. This sum is expected to cover the initial cost of the clinical evaluation and chronic toxicity/ reproductive studies required for approval.

Phase III trials are planned to encompass several international sites in Canada, Europe and the U.S.A. The reasoning behind this approach is to take advantage of the International Conference on Harmonization and gain simultaneous approval in the 3 major markets for MS. Funding for these trials, is anticipated to be in the region of $25 million. These funds would also provide for initial marketing efforts.

The funding requirement for the veterinary trials described above is approximately $3 million. USDA trial requirements are not as laborious as those of the Center for Veterinary Medicine (CVM) under the FDA. Also, the USDA has global recognition for drugs licensed by them which CVM does not. The trial will be designed and conducted at an established center of excellence such as Auburn University (Alabama). Trials and licensing should be complete within 18 months of commencement. Esperanza seeks to identify financial sponsors with interest in these afflictions to maximize our critical efforts. For additional information, please click here.