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Pharmaceutical company offers phase I trial update for DAVANAT.
2004 NOV 4 - (NewsRx.com & NewsRx.net) -- Pro-Pharmaceuticals, Inc., (Amex:PRW) announced that a number of patients in its phase I clinical trial are receiving additional cycles (3, 4, & 5) of DAVANAT-1. DAVANAT-1 is a combination of DAVANAT plus 5-Fluorouracil (5-FU).
The phase I trial was designed for refractory patients to be dosed in two cycles. In cycle 1, patients are dosed with DAVANAT alone for 4 consecutive days and then evaluated for the next 24 days. In cycle 2, patients are dosed with DAVANAT-1 for 4 consecutive days and then evaluated for the next 24 days. As a result of patients being dosed with additional cycles, the company believes it will complete the phase 1 trial early next year.
In June, the company reported interim phase I data for the first five cohorts that suggested both DAVANAT and DAVANAT-1 were well tolerated in patients. The phase I study is open label and designed to evaluate the safety and tolerability of escalating doses of DAVANAT (30 to 280 mg/m2) alone and in combination with a stable dose of 5-FU (500 mg/m2) .
The phase I study is in its sixth and final cohort and is expected to evaluate 32 patients, all with solid tumors. Patients dosed to date suffer from colorectal, liver, ...
- Pro-Pharmaceuticals Reports Phase I for DAVANAT-1 in Refractory Cancer Patients...
- Press release article from: Business Wire June 23, 2004 700+ words
...the First Five Dose Escalations Indicate DAVANAT(R) in Combination With 5-fluorourcil...interim Phase l results of its lead compound DAVANAT(R) alone and in combination with the proven chemotherapeutic drug 5-FU (DAVANAT(R)-1) in refractory solid tumor...
- Pro-Pharmaceuticals Announces Dosing of Patients with DAVANAT(R) in Phase II,...
- Press release article from: Business Wire November 27, 2006 700+ words
...open-label, multi-center trial of DAVANAT([R]) with Avastin([R]), 5...with an endpoint of tumor shrinkage. "DAVANAT([R]) is the first of a new class...enhancing affect and toxicity reduction of DAVANAT([R])when co-administered with...
- Pro-Pharmaceuticals' Phase I Data Show DAVANAT/5-FU Well-Tolerated in Cancer...
- Press release article from: Business Wire May 16, 2005 700+ words
...s (ASCO) Annual Meeting Proceedings, indicates DAVANAT(R) and DAVANAT(R) /5-FU are well-tolerated in cancer patients...Maximum Tolerated Dose (MTD) were not reached when DAVANAT(R) (280 mg/m2) was administered alone or in...
- Pro-Pharmaceuticals Receives ''Compassionate Use'' IND for Use of DAVANAT/5-FU...
- Press release article from: Business Wire May 12, 2005 700+ words
...Investigational New Drug (IND) for the use of DAVANAT(R)/5-FU with a patient who has cholangiocarcinoma with liver metastases. DAVANAT(R) DAVANAT(R) is a proprietary polysaccharide in a CARBOSOME...
- Pro-Pharmaceuticals Updates Progress of Clinical Trials & DAVANAT(R) 505 (b)(2)...
- Press release article from: Business Wire July 9, 2007 700+ words
...Plans to Submit Manufacturing Data for DAVANAT([R]) 505 (b)(2) Filings to the...indications may represent orphan drug status for DAVANAT([R]), the Company's target delivery...data requested by the FDA this year for DAVANAT([R]) 505 (b)(2) filings as a...
- Pro-Pharmaceuticals Provides Phase I Trial Update of DAVANAT in Refractory...
- Press release article from: Business Wire October 4, 2004 700+ words
...patients in its Phase I clinical trial are receiving additional cycles (3, 4, & 5) of DAVANAT-1. DAVANAT-1 is a combination of DAVANAT(R) plus 5-Fluorouracil (5-FU). The Phase I trial was designed for refractory patients...
- Pro-Pharmaceuticals Collaborates with Chemwerth to Scale-up Production of...
- Press release article from: Business Wire February 20, 2007 700+ words
Chemwerth Scales-up DAVANAT([R]) to 100 Kilos per Batch NEWTON, Mass...up production of its lead drug candidate, DAVANAT([R]) to 100 kilograms for initial marketing needs. DAVANAT[R] is a carbohydrate polymer composed of...
- Davanat with 5-FU well tolerated in study patients with advanced solid tumors.
- Newspaper article from: Cancer Weekly July 20, 2004 700+ words
...phase I results of its lead compound Davanat alone and in combination with the proven chemotherapeutic drug 5-FU (Davanat-1) in refractory solid tumor patients...development and manufacturing, said, "Both Davanat and Davanat-1 were well tolerated...
Source: HighBeam Research, Pharmaceutical company offers phase I trial update for DAVANAT.