|
|
 Product Technology Our Lead Product Candidates - NEMIFITIDE
Nemifitide, the company's flagship compound has been under development for many years. This unique pentapeptide is administered by subcutanious injection, although it may eventually be available as an intranasal treatment. It has shown phenomenal efficacy in treatment resistant (refractory) depression. Patients who have failed numerous other depression therapies will be the primary candidates for Nemifitide. The company believes that Nemifitide will be the new powerful therapeutic tool of choice for patients that suffer from this debilitating disease when conventional medications do not work. Nemifitide has been given to over 430 humans in 12 clinical trials. One of those trials was specifically designed for the treatment of refractory patients. Many patients who participated showed overwhelming positive changes in their depression rating scores.
In double-blinded placebo controlled trials, Nemifitide has demonstrated strong evidence 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 430 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 six to nine subcutaneous or needleless injections over a one to two 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 compliance.
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 inhalation.
Little or no potential for adverse reactions with other drugs. Based on studies conducted, 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.
|
|
