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YMB YM Bio.'b'ser1

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Share Name Share Symbol Market Type Share ISIN Share Description
YM Bio.'b'ser1 LSE:YMB London Ordinary Share CA9842382041 CLASS B PFD SHS SER 1 NPV
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 0.00 -
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

Research Update

02/06/2008 4:18pm

UK Regulatory


    YM BIOSCIENCES REPORTS NIMOTUZUMAB NSCLC CLINICAL DATA AT ASCO ANNUAL MEETING

    MISSISSAUGA, June 2 /CNW/ - YM BioSciences Inc. (AMEX: YMI, TSX: YM,
AIM: YMBA), an oncology company that identifies, develops and commercializes
differentiated products for patients worldwide, today announced that updated
preliminary trial results, including survival, response rate and overall
safety data, from its escalating dose trial of nimotuzumab were presented in a
poster presentation on June 1st, 2008 at the Annual Meeting of the American
Society of Clinical Oncology (ASCO). The phase I trial is evaluating
nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth
factor receptor, in combination with external radiotherapy in palliative
treatment of patients diagnosed with stage IIb, III or IV non-small cell lung
cancer (NSCLC) ineligible for chemotherapy-containing regimens.
    "The median survival of 60 weeks in the palliative setting reported in
this trial compares favorably with other recent trials in the same scenario,
and suggests that the combination of nimotuzumab with radiation has the
potential to provide a survival advantage to patients over radiation alone in
the curative setting, the only alternative available to patients who are
ineligible for, or unable to tolerate, chemotherapy-containing regimens," said
David Allan, Chairman and CEO of YM BioSciences. "There is a significant
subset of patients whose overall condition does not permit administration of
chemotherapy in a combined-modality treatment to enhance their curative
prospects."
    Substantial radiological responses and meaningful clinical responses were
seen in patients treated with the combination of nimotuzumab and radiation in
each dosing cohort. This included an 89% Disease Control Rate of which 50%
were Partial Responses. Eleven of the 18 patients were Stage IV, five were
stage IIIb and two were Stage IIIa. No Stage II patients were enrolled.
Patients were treated for eight weeks and then every two weeks until
progression. Continued treatment for prolonged periods was very well tolerated
and there was no evidence of rash at any of the three dose levels (100mg,
200mg and 400mg). Although the drug specifically targets the EGF receptor, the
minimal side-effects, and particularly the absence of severe cases of rash,
cutaneous manifestations and hypomagnesemia continue the prospect of
nimotuzumab being therapeutically attractive in this setting.
    Investigation of nimotuzumab's survival benefit in a curative patient
population ineligible for combined-modality treatment is the subject of a
planned late stage trial. In a recent palliative trial in Stage III/IV
patients (J Clin. Oncol. 2004 Mar 1;22(5):801-10), the median survival in that
patient population was reported to be from 6.8 months to 8.2 months
(approximately 28-35 weeks). Furthermore, in an RTOG/ECOG trial in Stage III
patients who were candidates for curative treatment (J Natl Cancer Inst 1995
Feb 1;87(3):198-205), standard and hyperfractionated radiation in "good risk"
patients resulted in a median overall survival of 11.4 and 12.3 months
respectively or approximately 47 to 53 weeks. These results are provided for
reference only and readers are cautioned that differences in patient
populations with respect to YM's phase I or its proposed phase III with
historical RT-alone prevent direct comparisons.
    "The data from this trial further supported by as-yet unpublished data
from a parallel trial in Korea, continue to confirm that as has been
established from clinical trials and commercial sales of nimotuzumab in more
than 2,500 patients worldwide, nimotuzumab has a visibly and clinically
preferential side-effect profile to the other EGFR targeting molecules
currently being marketed," added Mr. Allan.

    The poster presented at ASCO was entitled: "Preliminary results of an
escalating dose phase I clinical trial of the anti-EGFR monoclonal antibody
nimotuzumab in combination with external radiotherapy in patients diagnosed
with stage IIb, III or IV non-small cell lung cancer (NSCLC) unsuitable for
radical therapy" (Abstract number 3037):

    About YM BioSciences

    YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. The Company has
two late-stage products: nimotuzumab, a humanized monoclonal antibody that
targets the epidermal growth factor receptor (EGFR) and is approved in several
countries for treatment of various types of head and neck cancer; and
AeroLEF(TM), a proprietary, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain.

    This press release may contain forward-looking statements, which reflect
the Company's current expectation regarding future events. These
forward-looking statements involve risks and uncertainties that may cause
actual results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, 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. Certain of the assumptions
made in preparing forward-looking statements include but are not limited to
the following: that nimotuzumab will continue to demonstrate a competitive
safety profile in ongoing and future clinical trials; that AeroLEF(TM) will
continue to generate positive efficacy and safety data in future clinical
trials; and that YM and its various partners will complete their respective
clinical trials within the timelines communicated in this release. We
undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.

For further information: Enquiries: Thomas Fechtner, the Trout Group LLC,
Tel. (646) 378-2931, Email: tfechtner@troutgroup.com; James Smith, the
Equicom Group Inc., Tel. (416) 815-0700 x 229, Email:
jsmith@equicomgroup.com; Nominated Adviser, Canaccord Adams Limited, Ryan
Gaffney, Tel. +44 (0)20 7050 6500
(YMBA)


 



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