3SOF

VION may rock and roll this week. The following is the abstract of the main paper to be presented by VION at the ASCO meeting. Should have a bullish PR is the morning.


phase II trial of VNP40101M in patients with relapsed or refractory small cell lung cancer (SCLC) with or without brain metastases.

Sub-category:
   
Small Cell Lung Cancer

Category: Lung Cancer

Meeting: 2007 ASCO Annual Meeting
   
   
Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 7724
Author(s):
   
T. Mekhail, S. Gettinger, G. Blumenschein, R. Axelrod, M. Haigentz, M. J. Guarino, A. L. Cahill, D. Spigel, F. A. Greco
Abstract:
   
Background: Relapsed or refractory SCLC patients (pts) have a poor prognosis. Median survival at relapse is 2-3 months; brain metastases (mets) are common. Alkylating agents have demonstrated activity in SCLC. Cloretazine is a new alkylator that is active against selected alkylating agent resistant tumor cell lines. Xenograft models show distribution across the blood-brain barrier. This study investigates VNP40101M safety and activity in SCLC patients who have relapsed or are refractory to standard 1st line chemotherapy. Methods: Pts are entered in 2 groups based on response to prior chemotherapy: sensitive relapse (chemotherapy-free interval >3 months); or resistant/refractory (chemotherapy-free interval <3 months). Eligibility criteria include: measurable or evaluable disease; life expectancy of >2 months; and ECOG PS of 0-2. Pts with brain mets are eligible. 31 pts received VNP40101M IV at a starting dose of 125 mg/m2/wk × 3, every 6 weeks. Due to a high incidence of grade 3-4 thrombocytopenia (34%), an amended protocol reduced the dose of VNP40101M to 100 mg/m2 at the same schedule. 13 pts received the reduced dose. Pts are evaluated by RECIST criteria after each 6-week cycle. Results: 44 of 87 planned pts have been treated at 7 sites. Of 41 evaluable pts, 21 patients have sensitive relapse disease, and 20 have resistant/refractory disease. Median age is 64 years (44-86). Median number of cycles received is 1 (1-3). Grade 3-4 thrombocytopenia was seen in 11/31 pts at the 125 mg/m2 dose and 3/13 pts at the 100 mg/m2 dose. Gr 3-4 non-hematologic toxicity is rare, except for fatigue (10%) and GI effects (10%).

The response rate (PR) is 6/21 (29%) in the sensitive relapse group, and 1/20 (5%) in the resistant/refractory group. 2/6 PRs, in the sensitive relapse group, occurred at the reduced dose level. 16 pts had brain mets at study entry. Of these, there were 3 PRs (2 with measurable regression of brain mets) and 3 stable diseases.

Conclusions: The study is ongoing to confirm efficacy and safety. VNP40101M has activity against SCLC in the 2nd line setting including pts with brain metastases; further study is warranted.

KEYS: RESPONSE RATE OF 29% IN ONE GROUP/STUDY CONFIRMS EFFICACY AND SAFETY

http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=47&abstractID=33847

VION PRESENTS EXCITING RESULTS AT ASCO.......

VION'S CLOREZATINE PHASE II SMALL CELL LUNG CANCER TRIALS SHOW EXCELLENT RESULTS......A SECOND PAPER USING CLOREZATINE FOR PEDIATRIC BRAIN TUMORS WILL BE PRESENTED THIS AFTERNOON..

REGARDING PHASE II SMALL CELL LUNG CANCER TRIALS:

Dr. F. Anthony Greco, Director of the Sarah Cannon Research Institute in Nashville, Tennessee, commented, "Cloretazine® (VNP40101M) has impressive activity in small cell lung cancer in the second-line setting, including activity against brain metastases, and further evaluation is warranted."

Ann Cahill, Vion's Vice President, Clinical Development, said, "Our solid tumor clinical development plan for Cloretazine® (VNP40101M), which includes our Phase II trial in small cell lung cancer, and the recently completed trials in adult and pediatric brain tumors, is an important part of the overall clinical development program for this novel alkylating agent." Ms. Cahill added, "We are encouraged by this promising data in small cell lung cancer."

INTRO ON THIS AFTERNOON'S VION PRESENTATION:

Additional data from a Phase I trial conducted by the Pediatric Brain Tumor Consortium of Cloretazine® (VNP40101M) as a single agent in pediatric brain tumors will be presented at the ASCO Annual Meeting in poster U1 in S Hall A2 at the McCormick Place Convention Center on Monday, June 4, 2007 from 1 to 5 p.m.

http://biz.yahoo.com/prnews/070604/nym064.html?.v=74

Recent data, yet to be published,  shows remarkable Clorezatine activity in many types of cancer:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17256135&query_hl=5&itool=pubmed_docsum

http://www.ncbi.nlm.nih.gov/sites/entrez?itool=abstractplus&db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=17522334

VION has lots of potential. During last weeks CC they mentioned an NDA filing for a ph2 trial which they are working on and that they are looking for a partnership.
If any of these catalysts will be announced (and my guess is within a couple of weeks) then this stock will be over $1.