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Ozarelix (SPI-153)

A fourth generation luteinizing hormone releasing hormone (LHRH) antagonist

Hormone-dependent prostate cancer
Benign prostatic hyperplasia (BPH)
Endometriosis

Intramuscular

Luteinizing hormone releasing hormone antagonist
Suppression of testosterone

(Exhibited in clinical trials to date)

Immediate and complete suppression of testosterone
No risk of testosterone surge or clinical flare
Improved solubility compared to other antagonists

There is currently a Phase 2b study of ozarelix for the treament of BPH. This study is a randomized, placebo-controlled trial involving approximately 75 men suffering from BPH. They were dosed with 15 mg. of ozarelix or placebo on day 1 and day 15 and will be followed for 9 months.

The study will evaluate safety and assess the clinical efficacy of ozarelix as a treatment for BPH. The primary endpoint of the study will be the improvement of BPH symptoms as measured by the IPSS.

The study will also measure urine flow, residual urine volume and quality of life. Data from this trial is expected to be available in the 1st half of 2008.

Ozarelix is currently being evaluated for initial indications of hormone-dependent prostate cancer and benign prostatic hypertrophy. We also plan to evaluate this compound for the treatment of endometriosis.

Ozarelix may prove to be an important addition in treating hormone-dependent prostate cancer patients because of its ability to induce prolonged testosterone suppression in healthy volunteers as shown in early trials.

For benign prostatic hypertrophy, ozarelix has the potential to reduce testosterone just enough to reduce both prostate size and symptoms.

Ozarelix is a Luteinizing Hormone Releasing Hormone agonist (a substance that blocks the effects of a natural hormone found in the body).

Mechanistically, LHRH antagonists exert rapid inhibition of luteinizing hormone and follicle stimulating hormone with an accompanying rapid decrease in sex hormones and would therefore be expected to be effective in a variety of hormonally dependent disease states including ovarian cancer, prostate cancer, BPH, infertility, uterine myoma and endometriosis.

BPH is a non-cancerous enlargement of the prostate that is caused by testosterone. Unlike LHRH agonists, ozarelix has the potential to reduce testosterone just enough to reduce both prostate size and symptoms without the severe side effects associated with a reduction in testosterone.

Current therapies for BPH either address its symptoms but not the underlying condition, or block growth of new prostate cells and reduce prostate size with only moderate relief of symptoms.

There are two classes of drugs to treat BPH. The first, alpha-adrenergic receptor blockers, are believed to work by relaxing the smooth muscle in the urethra and bladder without addressing the underlying condition of the enlarged prostate.

Drugs in the second category, 5-alpha reductase inhibitors, work by blocking production of the hormones that stimulate the growth of new prostate cells thereby stopping and eventually reversing enlargement of the prostate. This class of drugs has a slow onset of action, typically requiring daily treatment for many months before improving patient symptoms.

Drugs in both classes can have significant side effects, including decreased libido, impotence, abnormal ejaculation, rhinitis, and cardiovascular effects such as dizziness, fainting and lightheadedness.

Many patients ultimately fail existing medical therapy, leading to over 350 thousand surgical procedures annually in the United States, despite the risks of serious surgical complications including impotence and incontinence.

We believe that Ozarelix could provide rapid relief of the symptoms of BPH.

Ozarelix is available for outlicensing in India.

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