++++will now be limited to NSCLC and ovarian cancer
According to guidance I recieved from the company last year, the objective in this trial was to determine which tumor type responds favorably to ADH-1 after repeat dosing. I feel fairly confident in assuming tumor response was noted in these two indications thus the plan to move forward with the weekly dosing schedule in these tumor types.
++++ U.S. phase-2 combination trial with chemotherapy is expected to start soon. The NCI is planning to run additional U.S. trials
I anxiously await the NCI pre-clinical data supporting the above trial.
ADH IMHO, certainly qualifies as a Biotech Value! C'mon GSK step up to the plate!!! Going fishing today and tomorrow! ;-)
[These data are from a 20-patient monotherapy trial and they don’t exactly knock your socks off: one unconfirmed (i.e. less than one-month duration) partial response and two cases of stable disease. It’s unlikely that ADH-1 will be a bona fide cancer treatment as a monotherapy, and hence the interesting results will come when ADH-1 is used in combination with chemotherapy in newer trials. The main point of the trial reported here was to test tolerability and find a maximum tolerated dose (MTD); at 2,400mg/m2/week, an MTD wasn’t reached, which is a good sign. The phase-2 portion of this trial is already in progress (#msg-10948363). As a reminder, GSK has an option to license ADH-1, and they will probably make a go-no-go decision after seeing phase-2 data of ADH-1 in combination with chemo. I’m long ADH due to the tiny valuation and the vig from a GSK opt-in, which in all likelihood would make the stock a 5-bagger. But make no mistake: this is a high-risk proposition.]
>> Adherex Presents Phase Ib Data From European ADH-1 Trial at ASCO 2006 Annual Meeting: ADH-1 was well tolerated and showed additional evidence of anti-tumor activity
ATLANTA, GEORGIA--(MARKET WIRE)--Jun 3, 2006 -- Adherex Technologies Inc. (TSX:AHX.TO)(AMEX: ADH ), a biopharmaceutical company with a broad portfolio of oncology products under development, today announced data from the Phase Ib part of its Phase Ib/II European study of the molecularly targeted anti-cancer drug, ADH-1, which is being presented at the 2006 American Society of Clinical Oncology Annual Meeting, a major international cancer conference (Abstract No. 3042, poster display/discussion session 8 a.m.-1 p.m.).
The data includes 20 patients who received an aggregate of 123 doses (41 cycles) of ADH-1 given on a weekly schedule with doses ranging from 150 to 2400 mg/m(2). ADH-1 was well tolerated in all five doses tested, displayed predictable pharmacokinetics (which is important for proper drug dosing), and demonstrated evidence of anti-tumor activity in three patients with advanced, therapy-resistant cancer, including one patient with an unconfirmed partial response and two with prolonged stable disease. A maximum tolerated dose was not defined.
"ADH-1 continues to be well tolerated in our single-agent studies. We have encountered no limitations in the tolerance of the drug, and it has shown additional evidence of anti-tumor activity in three tumor types. Now that we have completed the Phase Ib part of this study, we are enrolling additional patients with ovarian and lung cancers using ADH-1 as a single agent at doses of 2400 mg/m(2)," said William P. Peters, M.D., Ph.D., Adherex's Chairman and CEO. "It is very encouraging that this drug continues to show both patient tolerability over a very broad dose range and evidence of anti-tumor activity. Both of these features are important for the ultimate success of cancer drugs. Our development program continues on track with ongoing Phase II studies in North America and Europe and near term plans for studies combining ADH-1 with other molecularly-targeted drugs and chemotherapies."
The three patients in which evidence of anti-tumor activity was noted included a 61-year-old woman with N-cadherin positive fallopian tube carcinoma and lymph node metastases. This patient, whose anti-tumor activity was previously reported, received four cycles of ADH-1 (one at 150 mg/m(2) and three at 300 mg/m(2), achieved a 30% aggregate reduction in her lymph node metastases at the end of cycle three, meeting the criteria for a partial response by RECIST criteria, and a 37% reduction at the end of cycle four. New bone lesions were however noted at the end of cycle four, making this patient's response an unconfirmed partial response. The second patient is a 32-year-old woman with N-cadherin positive ovarian cancer who has experienced stable disease for more than six months and continues on study. The third patient is a 40-year-old woman with N-cadherin positive colorectal cancer who has experienced stable disease for more than three months and continues on study. This brings the number of patients who have shown evidence of anti-tumor activity in our Phase I experience to a total of seven patients.
Adherex is also evaluating the anti-tumor activity and tolerability of repeated weekly doses of single agent ADH-1 in a Phase II trial with six sites in Canada and one site in the U.S., with additional U.S. sites to be added. That study is expected to enroll an aggregate of 100 patients with N-cadherin positive lung, esophageal, adrenocortical, kidney or liver cancers. Adherex expects this trial to complete in the second half of 2006. In addition, the Company plans to expand the ADH-1 development program by evaluating ADH-1 in combination with other cancer therapies, with Phase I/II trials expected to begin in mid 2006.
About Adherex Technologies
Adherex Technologies Inc. is a biopharmaceutical company dedicated to the discovery and development of novel cancer therapeutics. We aim to be a leader in developing innovative treatments that address important unmet medical needs in cancer. We currently have multiple products in the clinical stage of development, including ADH-1 (Exherin(TM)), eniluracil and sodium thiosulfate (STS). ADH-1, our lead biotechnology compound, selectively targets N-cadherin, a protein present on certain tumor cells and established blood vessels that feed solid tumors. Eniluracil, an oral dihydropyrimidine dehydrogenase (DPD) inhibitor, was previously under development by GlaxoSmithKline for oncology indications. STS, a drug from our specialty pharmaceuticals pipeline, protects against the disabling hearing loss that can often result from treatment with platinum-based chemotherapy drugs. With a diversified portfolio of unique preclinical and clinical-stage cancer compounds and a management team with expertise in identifying, developing and commercializing novel cancer therapeutics, Adherex is emerging as a pioneering oncology company. For more information, please visit our website at www.adherex.com. <<
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