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 Product Technology Our Lead Product Candidates - Nemifitide (INN 00835)
- Tetracycline-Based Compounds
(MMP Inhibitors)
Although we have a number of products in different stages of development, and have patented a very large number of peptides. Nemifitide, a pentapeptide compound administered by subcutaneous or needleless injection, has emerged as our lead product candidate after extensive research and development. Nemifitide is one of a new class of synthetic small peptide antidepressants which we believe will provide a powerful new therapeutic tool in the treatment of depression and transform the way this debilitating illness is treated.
In double-blinded placebo controlled trials, nemifitide has demonstrated strong eveidence of efficacy in depressed patients. The clinical profile included a more robust and rapid onset of action with long duration and minimal adverse side effects. Extensive testing over the last ten years has demonstrated that nemifitide has distinct advantages over other drugs currently marketed to treat depression.
Rapid onset of action and symptomatic relief.The initial effects of nemifitide are observable in the first three to five days of treatment. Peak effects occur within one to two weeks, versus four to eight weeks for currently available antidepressants. Nemifitide may be used for severely depressed patients who require rapid symptomatic relief, as effectiveness can be clinically measured within 3-5 days of initiating treatment.
Little or no side effects. Nemifitide, to date, has been administered to over 400 patients and volunteers with only one patient discontinuing treatment due to side effects. This is in marked contrast to all other currently available antidepressants, which often cause short and long-term side effects frequently resulting in the premature discontinuation of treatment.
Many patients experience complete symptomatic relief. Many patients who respond to nemifitide enter into complete remission from their depression, as opposed to simply experiencing some improvement in their condition.
Potential to treat severely refractory patients. Preliminary results from an open-label pilot study (a clinical trial without the use of a placebo) in severely refractory patients(patients who have not responded to several classes of antidepressant therapy over long periods of time) have shown a response rate of over 40%. This generated a considerable amount of interest in the scientific community and, we believe, this could give nemifitide a novel role in treating this debilitating illness. It is estimated that approximately 5% to 10% of patients suffering from major depression have the refractory form of the illness.
Freedom from regular daily treatment. Because nemifitide is administered via ten to fifteen subcutaneous or needleless injections over a two to three week period, and has a long duration of effective action, it allows for intermittent clinical treatment (every four to six months) versus the chronic daily dosing required with most existing antidepressant medications. This may result in dramatically improved patient complience.
Potential to treat other CNS disorders. In addition to treating major depression, nemifitide and other patented peptides we intend to develop may be effective in the treatment of mild depression, anxiety disorders, as well as other central nervous system disorders such as anorexia, bulimia, panic disorder and post-traumatic stress disorder.
Potential for alternative forms of administration. Preliminary evidence indicates that nemifitide may be administered through needleless injections. We also intend to explore other forms of delivery, including a transdermal patch (through the skin by way of a patch) as well as nasal inhilation.
Little or no potential for adverse reactions with other drugs. Based on studies conducted to date, nemifitide is not expected to show significant drug-drug interaction in human beings. This is especially beneficial in the treatment in the geriatric population and cardiac patients with depression.
We believe nemifitide has the potential to revolutionize the antidepressant market. Antidepressant sales constitute the largest segment of the CNS market, approximately 24%. In 2004, global sales of antidepressant agents exceeded $15 billion. Based on the sales of other antidepressants, we believe that nemifitide, properly marketed, has the potential to become the treatment of choice for depression and to capture a substantial portion of the worldwide market after commercialization.
In addition, Tetragenex Pharmaceuticals Inc. continues to synthesize and test compounds in its platform of small peptides. To date, we have evaluated more than 200 of these compounds, and our efforts are ongoing. This work has already identified several drug candidates that are believed to show even greater activity in pre-clinical testing than nemifitide, and these compounds have been designated as potential second-generation drugs.
- Tetracycline-Based Compounds (MMP Inhibitors)
In addition to our nemifitide development program we have synthesized and are currently developing and patenting a platform of new and unique chemically-modified tetracycline molecules to be used in the treatment of certain types of cancer (prostate, breast, melanoma and multiple myeloma) and antibiotic-resistant bacterial infections. Tetracyclines are a family of naturally occurring antibiotics that have been demonstrated to be potent inhibitors of matrix metallo-proteinases, or MMPs, enzymes which are key in the promotion of many human disorders.
Our tetracycline-based product candidates are currently in the pre-clinical development stage. To date, we have synthesized and developed approximately one hundred tetracycline-based chemical compounds, and are patenting these compounds as they are synthesized and developed. Through in vitro studies, we have discovered two new general classes of tetracyclines that we believe demonstrate great promise for use in the treatment of prostate cancer and melanoma.
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