YMB YM Bio.'b'ser1

    YM BioSciences achieves primary objective with Norelin(TM) study

 

    MISSISSAUGA, ON, May 25 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer product development company, announced today that

Norelin(TM), its anti-cancer vaccine targeting the gonadotropin releasing

hormone (GnRH), has successfully completed a proof of concept study in men

with hormone dependent prostate cancer (HDPC). The majority of patients with

HDPC treated with Norelin(TM) developed antibodies to GnRH, demonstrating the

development of an immunological response, which was the primary objective of

the trial.

    The trial enrolled patients in two stages. In the first stage (results

reported in June of 2003), 12 patients were enrolled and treated with the

Company's proprietary formulation of Norelin(TM) and were followed for 90

days. In the second stage, four patients were enrolled starting in mid-2004

and followed for 180 days before determining whether or not they responded.

YM originally planned to enroll a total of 12 patients in the second stage,

but voluntarily terminated enrollment of the trial when delays in trial

implementation resulted in clinical supplies of the drug exceeding stability

time-limits. The drug substance demonstrated excellent stability for four

years, more than sufficient to consider it commercializable.

    Patients from the first stage whose testosterone dropped significantly

at 90 days were advanced onto a long-term booster program. Seven of the 12

enrolled patients developed anti-GnRH antibodies and two went on to achieve

castrate levels of testosterone by day 120. Those two patients received

booster doses for approximately two years and are in long-term follow-up. They

remain at castrate levels with normalized PSA and have not demonstrated any

sign of disease progression at more than 2.5 years.

    Three patients from the first stage and three patients from the second

stage received at least five doses of the vaccine and these patients were

followed for 120 days. All responded to the vaccine, developing antibodies and

achieving testosterone suppression. Three of these patients achieved complete

castration of testosterone and normalized PSA.

    David Allan, Chairman & CEO of YM BioSciences commented "The first cohort

demonstrated the proof of concept but also suggested that we needed to follow

patients longer than the initial target of 90 days to observe a good response.

While the second cohort only enrolled a total of four patients who were to be

followed for 180 days, the data are sufficiently compelling to take this drug

forward into larger trials."

    Adverse events reported included injection site pain in 8/16 (50%)

patients, hot flashes 3/16 (19%), nausea 2/16 (13%), decreased libido 1/16

(6%) and headache 1/16 (6%). There was no testosterone flare and no bone pain

or worsening of symptoms reported.

    Sean Thompson, Director of Corporate Development for YM BioSciences and

project leader for Norelin(TM) added, "We are pleased with the results of this

proof of concept study and now understand the appropriate dosing regimen and

the follow-up schedule for this product. We additionally have early evidence

that this approach may be better tolerated than currently available therapies.

We now need to manufacture more material, study a larger group of patients and

then go to the FDA with a registration plan."

 

    About YM BioSciences

    YM BioSciences Inc. is a cancer product development company. Its lead

drug, tesmilifene, is a small molecule chemopotentiator currently undergoing a

700-patient pivotal Phase III trial in metastatic and recurrent breast cancer.

Published results from tesmilifene's first Phase III trial in the same

indication demonstrated a substantial increase in survival for women treated

with the combination of tesmilifene and chemotherapy compared to chemotherapy

alone, demonstrating that tesmilifene significantly enhanced the therapeutic

effect of chemotherapy. In addition to tesmilifene, the Company is developing

Norelin(TM), described above, and TheraCIM hR3, an EGFr humanized monoclonal

antibody on which Phase II clinical data have recently been released in

pediatric glioma and nasopharyngeal cancer, and for which Phase III IND

applications have been filed. YM BioSciences recently acquired DELEX

Therapeutics Inc., a private clinical stage biotechnology company developing

AeroLEF(TM), a unique inhalation-delivered formulation of the established

drug, fentanyl, to treat acute pain including cancer pain. This product has

completed a Phase IIa trial with positive results and YM proposed to advance

AeroLEF(TM) through a Phase IIb pain trial in 2005.

 

    Except for historical information, this press release may contain

forward-looking statements, which reflect the Company's current expectation

regarding future events. These forward-looking statements involve risk and

uncertainties, which may cause but are not limited to, changing market

conditions, the successful and timely completion of clinical studies, the

establishment of corporate alliances, the impact of competitive products and

pricing, new product development, uncertainties related to the regulatory

approval process and other risks detailed from time to time in the Company's

ongoing quarterly and annual reporting.

 

  

    For further information: James Smith, the Equicom Group Inc.,

Tel. (416) 815-0700 x 229, Fax (416) 815-0080, Email:

jsmith(at)equicomgroup.com; YM BioSciences Inc., Tel. (905) 629-9761,

Fax (905) 629-4959, Email: ir(at)ymbiosciences.com

    (YM.  YMI  YMBA)

 

 

 



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