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Biotech / Medical : Indications -- Cancer -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (384)	5/29/2003 10:16:11 PM
From: Miljenko Zuanic	Respond to of 1840

Now, this will be true task for AC/FDA! Press Release Source: Allos Therapeutics, Inc. Allos Therapeutics to Submit a New Drug Application for RSR13 for the Treatment of Brain Metastases From Breast Cancer Thursday May 29, 6:00 am ET WESTMINSTER, Colo., May 29 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH - News) today announced that it will submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to market RSR13 (efaproxiral) as a treatment for brain metastases from breast cancer. The company's decision follows a recent pre-NDA meeting with the FDA in which the company reviewed preliminary safety and efficacy data from its recently completed pivotal Phase 3 clinical trial and, specifically, the results in patients with metastatic breast cancer. RSR13 has fast-track designation from the FDA, and the company will begin a rolling submission of the NDA early in the third quarter of 2003. The company expects to complete the application in the fourth quarter of this year. The results in patients with metastatic breast cancer represented a key observation from the Phase 3 trial. In a subset of 115 patients with metastatic breast cancer who received whole brain radiation therapy (WBRT) plus RSR13, patients achieved a median survival of 8.67 months versus 4.57 months for patients receiving WBRT alone (p=0.006). Overall, patients experienced a 51% reduction in risk of death in the RSR13 arm versus control. The increase in overall survival was further supported by an increased tumor response rate in the brain. Seventy-two percent (72%) of metastatic breast cancer patients receiving RSR13 achieved either a complete or partial response compared to 53% of patients in the control arm (p=0.04). In addition, Kaplan- Meier estimates for survival at 6, 12 and 18 months are 62%, 34% and 30%, respectively, in the RSR13 arm versus 42%, 17% and 0%, respectively, in the control arm. "The FDA has expressed a clear interest in approving drugs that provide significant clinical benefit to patients, that are safe and that fulfill an unmet medical need," said Michael E. Hart, President and CEO of Allos Therapeutics, Inc. "Our decision to move forward with an NDA submission is based on consistent and compelling data observed in patients with metastatic breast cancer in which median survival was doubled in the RSR13 treatment arm. We will continue to work closely with the FDA during this process." The company announced preliminary results of its pivotal Phase 3 trial in a press release on April 23, 2003 in which the reported survival benefit observed did not reach statistical significance in either of the pre-specified intent-to-treat groups using a primary unadjusted log-rank analysis of patients who received RSR13 plus WBRT versus patients who received WBRT alone. Further analysis of the intent-to-treat data using a Cox multiple regression analysis indicates that RSR13, when combined with WBRT, resulted in a statistically significant 22.5% reduction in risk of death (p=0.01). "When using a Cox analytical model to estimate the treatment effect of RSR13 with whole brain radiation therapy on survival among all patients, a survival benefit is demonstrated," explained Hart. "However, we have elected to focus our NDA submission on the data from the metastatic breast cancer patients because of the overall strength and consistency of the results."

To: Icebrg who wrote (384)	6/2/2003 4:39:11 AM
From: Icebrg	Read Replies (1) \| Respond to of 1840

Interim evaluation of Active Biotech's TTS CD2 for renal cancer shows encouraging results in clinical Phase IIa [We don't have so many cancertargeting companies, so I thought I should paste it here] 02/06-2003 Active Biotech is to present the results from clinical trials of its TTS (Tumour Targeted Superantigens) CD2 substance at the 39th ASCO (American Society for Clinical Oncology) Annual Meeting (May 31 - June 3, 2003), a major annual scientific conference. During the conference, preliminary results will be presented from an ongoing Phase IIa study on advanced renal cancer and results from Phase I studies on lung-cancer patients (see also press release dated April 23, 2003 at www.activebiotech.com). Initial analyses of tumour response in the ongoing open Phase IIa study on patients with advanced renal cancer at a progressive stage treated with TTS CD2 show encouraging results. The majority of the renal-cancer patients included in the study previously underwent treatment with Interleukin-2 or Interferon-alpha, but the disease progressed nonetheless. Following treatment with TTS CD2, 40 percent of the evaluated patients had stable disease, meaning that their tumours have stopped growing, 4 months after the commencement of treatment. One patient shows a "partial response," entailing a reduction in tumour size of more than 30 percent according to RECIST criteria. Following treatment, this patient's tumour has shrunk to less than 10 percent of its original size. Other patients had some reduction in tumour burden but did not achieve a "partial response". The side effects of the treatment are few and mild. Recruitment to this Phase II study is complete and the entire study is expected to be fully reported by the end of the year. "The treatment has been very well tolerated and shows encouraging activity even in patients who have failed standard therapies", says Professor Robert Hawkins at the Christie Hospital in Manchester, who is responsible for the Phase II study. Background: Today, almost 80,000 people are affected by renal cancer annually, and during 2003, the disease will cause an estimated 34,000 deaths in Europe and the US. Renal cancer is primarily treated surgically and with immunotherapies such as Interferon-alpha or Interleukin-2. These immunotherapies have proven effective but only help a limited number of patients. Furthermore, renal cancer responds poorly to chemotherapy. There is an extensive need for new treatments in this area. The level of details is even worse than the Abgenix/Amgen effort the other day. I will try to get hold of at least the abstracts to see if these patients were still in a state of steady stable disease after 4 months (which would be a good result) or if the tumor had started to progress again. It would also be helpful to learn how advanced the cancer was. The agent is a mAb fused to a bacterial toxin. This combination is supposed to generate a very aggressive immune response. How they manage to avoid that the agent is attacked while still en route, I have not really managed to figure out. And to make things even more complicated. A new improved version TTS-CD3 has already been introduced into the clinic. The company - Active Biotech - is a leftover from the time Pharmacia was a completely Swedish company. Erik