Quantcast

Bionovo Comments on Recent Hormone Therapy (HT) Risk Disclosures

October 25, 2010

EMERYVILLE, Calif., Oct. 25 /PRNewswire/ — Bionovo Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women’s health and cancer derived from botanicals, today commented on the Journal of the American Medical Association (JAMA) publication on an eleven year trial studying the risks associated with the use of Hormone Therapy (HT) for the treatment of menopausal symptoms such as hot flashes.

“These study results join a long list of known HT risks, which we have summarized in an attached exhibit. Currently, all HT and other estrogen products prescribed for the treatment of hot flashes come with seven ‘black box’ warnings on the label, of potentially life-threatening side effects. Related to this, it has been reported that there are pending more than 5,000 lawsuits for damages due to HT use,” said Tom Chesterman, SVP and CFO of Bionovo.

“There are no safe, effective treatments for the 40 million menopausal women suffering from hot flashes in the United States today. Bionovo’s drugs may provide new, safe and effective treatments for the alleviation of hot flashes and other menopausal symptoms. We have published recently on new paradigms for ethical drug development that have the potential to replace hormone therapy. Our drug candidate, Menerba, for the treatment of menopausal hot flashes, is about to enter advanced clinical trials,” continued Mr. Chesterman. “We hope that we will be able to demonstrate that Menerba is a safe and effective treatment for hot flashes, while not increasing the risk of breast cancer. In fact, if the animal model data are confirmed eventually in human trials, we may see that Menerba has the potential to prevent breast cancer.”

About Menerba

Menerba is an oral botanical drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause. Menerba is an estrogen receptor beta (ER-b) selective drug, developed as an alternative to the products currently on the market which have been shown to increase the risk for breast and uterine cancers. It has been shown that the increased risk of breast and uterine cancers is associated with activation of estrogen receptor alpha (ER-a) and that activation of estrogen receptor beta (ER-b) blocks the growth promoting effects on breast cancer cells. The active ingredients in Menerba are derived from botanicals with centuries of recorded safe, effective use in traditional Chinese medicine (TCM). Bionovo recognizes the opportunity to commercialize a product that would be as effective as hormone therapy, without the health risks. Menerba has completed a Phase 2 trial with positive results for efficacy and has been evaluated by an independent Data and Safety Monitoring Board and passed through a standard two-round examination for safety. Menerba also has been shown in animal studies to prevent the proliferation of breast cancer and to have a beneficial effect on osteoporosis, though this has not yet been studied in humans.

About Bionovo, Inc.

Bionovo, Inc. is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women’s health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources, which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes it has discovered new classes of drug candidates within its rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and its stock is traded on the NASDAQ Capital Market under the symbol “BNVI.” For more information about Bionovo and its programs, visit http://www.bionovo.com.

Forward Looking Statements

This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at http://www.sec.gov. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.

Risks Associated With Hormone Therapy


                              Relative
            Outcome              Risk             Publication
                                          Writing Group for the WHI
                                          Investigators. Risks and
                                          Benefits of Estrogen Plus
                                          Progestin in Healthy
                                          Postmenopausal Women:
                                          Principal Results from the
                                          WHI Randomized Controlled
                             1.29         Trials. JAMA. 2002; 288 (3):
    Coronary heart disease   (E+P)*       321-333.
    Coronary heart disease   1.18
     Death                   (E+P)       WHI Paper
    Nonfatal myocardial      1.32
     infarction              (E+P)       WHI Paper
                             1.41
    Stroke                   (E+P)       WHI Paper
    Venous thromboembolic    2.11
     disease                 (E+P)       WHI Paper
                             1.03
    Cancer                   (E+P)        WHI Paper
                             1.26
    Invasive breast cancer    (E+P)       WHI Paper
                                          Anderson GL; Judd HL; et al.
                                          Effects of Estrogen plus
                                          progestin on gynecologic
                                          cancers and associated
                                          diagnostic procedures: The
                                          WHI randomized Trial. JAMA.
                             1.58         2003 Oct 1; 290 (13):
    Ovarian cancer            (E+P)       1739-48.
                                          Grady; Gebretsadik T;
                                          Kerlikowski K; et al.
                                          Hormone replacement therapy
                             2.30 (E)     and endometrial cancer
                             9.50         risk:ameta- analysis.
                             (E) >10      Obstet Gynecol. 1995
    Endometrial cancer       yr           Feb;85(2):304-13
    Global index**           1 .15 (E+P) WHI Paper
                                          Shumaker, S; Legault C; Rapp
                                          S; et al. Estrogen plus
                                          progestin and the incidence
                                          of dementia and mild
                                          cognitive impairment in
                                          postmenopausal women: the
                                          WHI memory study: a
                                          randomized controlled trial.
                             2.05         JAMA. 2003; 289(20):
    Dementia                 (E+P)        2651-2662.
                                          Hendrix, S; Cochrane, B;
                                          Nygaard, I. Effects of
                                          Estrogen with and without
                                          Progestin on Urinary
    Urinary incontinence     1.87(E       Incontinence. JAMA. 2005;
     (stress)                alone)       293(8): 935-948.
                                          Chlebowski, R; Schwartz, AG,
                                          Wakelee, H, et al. Oestrogen
                                          plus progestin and lung
                                          cancer in postmenopausal
                                          women (WHI trial): a post-
                                          hoc analysis of a randomised
                                          controlled trial. Lancet.
                             1.23         2009 Oct 10; 374 (9697):
    Lung cancer incidence    (E+P)        1243-51.
                                          Chlebowski, R; Schwartz, AG,
                                          Wakelee, H, et al. Oestrogen
                                          plus progestin and lung
                                          cancer in postmenopausal
                                          women (WHI trial): a post-
                                          hoc analysis of a randomised
                                          controlled trial. Lancet.
    NSCLC (non-small lung    1.28         2009 Oct 10; 374 (9697):
     cancer)                 (E+P)        1243-51.
                                          Chlebowski, R; Anderson, G;
                                          Manson, JE.; et all. Lung
                                          Cancer Among Postmenopausal
                                          Women Treated with Estrogen
                                          Alone in the WHI Randomized
    SCLC (small lung                      Trial. J Natl Cancer Inst
     cancer)                1.58 (E)      2010; 102: 1413-1421
                                          Chlebowski, R; Schwartz, AG,
                                          Wakelee, H, et al. Oestrogen
                                          plus progestin and lung
                                          cancer in postmenopausal
                                          women (WHI trial): a post-
                                          hoc analysis of a randomised
                                          controlled trial. Lancet.
                             1.71         2009 Oct 10; 374 (9697):
    Death from lung cancer   (E+P)        1243-51.
                                          Chlebowski, R; Schwartz, AG,
                                          Wakelee, H, et al. Oestrogen
                                          plus progestin and lung
                                          cancer in postmenopausal
                                          women (WHI trial): a post-
                                          hoc analysis of a randomised
                                          controlled trial. Lancet.
                             1.87         2009 Oct 10; 374 (9697):
    Death from NSCLC         (E+P)        1243-51.
                                          Chlebowski, R; Anderson, G;
                                          Manson, JE.; et all. Lung
                                          Cancer Among Postmenopausal
                                          Women Treated with Estrogen
                                          Alone in the WHI Randomized
                                          Trial. J Natl Cancer Inst
    Death from SCLC         2.11(E)       2010; 102: 1413-1421
                                          Chlebowski, R; Anderson G;
                                          Gass, M, et al. Estrogen
                                          plus progestin and breast
                                          cancer incidence and
                                          mortality in postmenopausal
    Increase in invasive     1.25         women. JAMA. 2010; 304(15):
     breast cancer           (E+P)        1684-1692.
                                          Chlebowski, R; Anderson G;
                                          Gass, M, et al. Estrogen
                                          plus progestin and breast
                                          cancer incidence and
                                          mortality in postmenopausal
    Increase in invasive     1.25         women. JAMA. 2010; 304(15):
     breast cancer           (E+P)        1684-1692.
                                          Chlebowski, R; Anderson G;
                                          Gass, M, et al. Estrogen
                                          plus progestin and breast
                                          cancer incidence and
                                          mortality in postmenopausal
    Increase in deaths of    1.96         women. JAMA. 2010; 304(15):
     breast cancer           (E+P)        1684-1692.
                                          Grodstein F; Colditz GA;
                                          Stampfer MJ. Postmenopausal
                                          hormone use and
                                          cholecystectomy in a large
                                          prospective study. Obstet
    Cholecystitis            2.1          Gynecol. 1994 Jan:
     (gallbladder attack)    (HRT)        83(1):5-11.
                                          Maalouf N; Sato, A; Welch B;
                                          et al. Postmenopausal
                                          hormone use and the risk of
                                          Nephrolithiasis. Arch Intern
    Nephrolithiasis          1.21         Med. 2010; 170(18):
     (kidney stones)         (HRT)        1678-1685


    *E+P: Estrogen + Progesterone, E: Estrogen only, HRT: Hormone
     Replacement Therapy

    **Global index: the first event for each participant from among the
     following types: CHD, stroke, PE, breast cancer, endometrial cancer,
     colorectal cancer, hip fracture and death due to other causes.

SOURCE Bionovo, Inc.


Source: newswire



comments powered by Disqus