More MS news articles for Dec 2001

Nastech Announces Positive Results from Phase II Clinical Trial of Nasally Administered Apomorphine for Erectile Dysfunction

http://news.excite.com/news/pr/011213/ny-nastech-results

Updated: Thu, Dec 13 7:00 AM EST

HAUPPAUGE, N.Y., Dec. 13 /PRNewswire/ -- Nastech Pharmaceutical Company Inc. (NASDAQ:NSTK) reported today the results of a Phase II clinical trial in 184 men with erectile dysfunction (ED) that concluded its nasally administered apomorphine formulation demonstrated excellent efficacy, was well tolerated with minimal side effects, and has an onset of action, about 15 minutes after dosing, that uniquely matches normal human sexual response physiology. The study supports the final stages of the clinical development of the product and Nastech expects the pivotal Phase III trials to begin early next year.

"These results support our belief that nasally administered apomorphine may be an attractive alternative to the PDE-5 inhibitor class of therapies in the treatment of erectile dysfunction, and thus represents a significant commercial opportunity to address the multi-billion dollar worldwide ED market," said Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech. "We are currently in negotiations to complete a worldwide development and marketing agreement for this product and we believe the results of this study strongly support these commercialization efforts."

SITE OF ACTION

Normal human sexual response begins with sensory input to the brain. The focus of this "central" input is the hypothalamus, a region of the brain that, among other functions, controls erectile function via nerves from the brain via the spinal cord to blood vessels in the penile tissue. Apomorphine is a potent dopamine agonist that promotes erectile function by stimulating receptors in the hypothalamus. The PDE-5 inhibitor class of ED therapies does not function in the brain but only on the final step in erectile function. In addition, unlike the class of PDE-5 inhibitors that produce hypotension, headaches, and other side effects due to non-specific interactions in the body, apomorphine acts specifically on the D1/D2 class of dopamine receptors that are responsible for the initiation of the erectile response in the brain. Nastech's nasally administered formulation is the subject of numerous patent applications in the U.S., European Union countries, Japan, and other major countries.

TIME OF ONSET

Prior pharmacokinetic trials indicated that nasally administered apomorphine has a maximum blood level about 15 minutes after dosing and also appears in the cerebral spinal fluid at high levels within 20 minutes after administration. Therefore, this trial was designed to obtain efficacy data 15 minutes after dosing. Research begun in the 1950s by Masters and Johnson and others demonstrate that this time of onset coincides with normal human sexual response physiology.

EFFICACY

The study involved men up to 75 years of age with ED of all etiologies (50% psychogenic, 26% mixed organic, and 24% diabetic) and severities (64% were moderate or severe at baseline as judged by the IIEF domain score). There were no patient restrictions as to prior use of ED medications nor was pre-qualification with use of a RigiScan(R) (indicative of mild erectile dysfunction) needed for inclusion in the study. The men were randomly placed in four dosage groups: placebo, 0.25 mg, 0.50 mg, and 1.0 mg apomorphine with treatment consisting of up to 18 doses and efficacy recorded after every administration and after every eight doses using validated ED efficacy questionnaires. The treatment group demographics were not different with respect to age (mean of 56 to 60 years), ethnicity, ED etiology, or ED severity.

The ability to achieve some erection was found in 81%, 89%, and 91% of the men treated with 0.25 mg, 0.50 mg, and 1.0 mg nasally administered apomorphine, respectively. With respect to erections sufficient for vaginal penetration, 69%, 73%, and 82% of men reported success in the three-apomorphine dosage groups compared to 35% for the placebo group (1.0 mg vs. placebo, p < 0.0001). Nasally administered apomorphine compared to placebo also demonstrated statistically significant improvements in erectile function (including erection sufficient to complete sexual intercourse with ejaculation), confidence in erection, orgasmic function, and intercourse satisfaction.

SAFETY

No significant adverse events were reported among the 184 patients enrolled in the study. Side effects were infrequent, mild to moderate in intensity, of short duration, and resolved without intervention. Side effects above 1% were unusual taste (5%) and dizziness (3%). There were no reported instances of hypotension, syncope or pre-syncopal events, including vomiting, sweating, flushing or vasodilatation, hot flashes, or pallor.

ERECTILE DYSFUNCTION

ED is defined as the inability to achieve and/or maintain an erection adequate for satisfactory sexual function. Approximately 30 million men in the U.S. and 150 million men worldwide suffer from ED (Deutsche Banc Alex. Brown, June 2001). The ED market is expected to have peak sales of over six billion dollars worldwide. The condition is correlated with increasing age, cardiovascular disease, hypertension, diabetes, hyperlipidemia and smoking. In addition, neurogenic risk factors such as radical prostatectomy, spinal cord injury and multiple sclerosis, certain prescription drugs, and psychogenic issues may contribute to ED. The U.S. market for nasally administered apomorphine for ED treatment, based on the product profile achieved in the At Home Phase II Study reported here, is forecast to achieve peak sales of over $850 million (Defined Health, December 2001). See Safe Harbor Statement below concerning these forward-looking statements.

FEMALE SEXUAL DYSFUNCTION

In addition to developing nasally administered apomorphine for treatment of ED, Nastech is currently conducting a randomized, double blind, placebo-controlled Phase II clinical trial in approximately 75 women suffering from female sexual dysfunction (FSD). The study is designed to assess the safety and efficacy of nasally administered apomorphine in increasing sexual satisfaction in women.

NASTECH CONFERENCE CALL AND WEBCAST - TODAY

Management will discuss Nastech's Phase II Apomorphine data during a conference call, which will be broadcast live over the Internet, at 11 a.m. EST today, December 13, 2001. To access the call, please dial: 1-800-592-3872. The reservation number is 20095307. In conjunction with Nastech's conference call, you are invited to listen to its conference call and view an on-line slide presentation that will be simultaneously broadcast live over the Internet at: http://www.videonewswire.com/event.asp?id=2434

ABOUT NASTECH

Nastech Pharmaceutical Company Inc., recognized worldwide as a leader in nasal drug delivery technology, is dedicated to improving patient care by using "Formulation Science," a systematic approach to drug development using biophysics, physical chemistry, and pharmacology to maximize therapeutic efficacy and safety, and provide new therapeutic options. Additional information on Nastech is available at http://www.Nastech.com

NASTECH SAFE HARBOR STATEMENT

Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that are subject to a variety of risks and uncertainties. Total market size projections reported herein were obtained from third parties and are forward-looking statements. Apomorphine market size projections reported herein were contained in a study commissioned and paid for by the Company and are forward-looking statements. Furthermore, the Company has performed no independent verification of these forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement made by the Company. These factors include, but are not limited to: (i) the Company's ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company's ability to obtain required governmental approvals, including product and patent approvals; (iii) the Company's ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Company's ability to develop and commercialize its products before its competitors. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the Company's research and development program. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in the Company's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in the Company's most recent Annual Report on Form 10-K.
 

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