BLUE HP finds another basket case. ALTH. News seems OK to my untrained eye. But the 144s, oy.
biz.yahoo.com
At their current burn rate, they'd run out of dough in about a year and a half. However, they're heading for PIII, so the burn will likely increase. So we can look forward to dilution unless they score some milestones that spike the cash flow. I haven't looked yet.
I thought I'd run it by the biofreaks with respect to science while I hunt down the partnership info. Lead product PII data presented at ASCO looked decent to me, but I'm no expert. First snip is the PR, the second is the abstract:
>>SAN FRANCISCO, May 13, 2001 /PRNewswire via COMTEX/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH today presented positive response rate and survival results from its Phase II trial of RSR13 combined with radiation therapy in patients with non-small cell lung cancer. The latest findings were presented at the annual meeting of the American Society of Clinical Oncology (ASCO).
The poster presentation entitled "Positive Phase II Results of RSR13 and Concurrent Radiation Therapy After Induction Chemotherapy with Paclitaxel and Carboplatin for Locally Advanced Inoperable Non-Small Cell Lung Cancer" was presented by Hak Choy, M.D., Clinical Director, Center for Radiation Oncology, Vanderbilt University Medical Center. Dr. Choy presented updated response and survival data from a 52-patient, open-label, multi-center, Phase II clinical trial of induction chemotherapy followed by chest radiation therapy in combination with RSR13 for stage IIIA/IIIB non-small lung cancer.
Analyzing the data from 44 evaluable patients receiving RSR13 plus radiation therapy demonstrated an overall response rate of 89% within the radiation therapy portal in the chest, with 80% partial responses and 9% complete responses. The estimated 1-year survival rate was 65% and projected 2-year survival rate was 51%. Median survival had not been reached. The 1-year progression-free rate was 55%, and the 2-year rate was 21%. These response rates and survival results are significantly higher than those reported in prior studies of induction chemotherapy and chest radiation therapy alone.
The efficacy endpoints of this study were complete and partial response rates in the chest (radiation portal), overall survival, progression-free interval in the chest and time to progression outside of the chest. Response rate was determined by a CT scan or MRI taken 2 months post-radiation therapy. The patients received two courses of induction paclitaxel and carboplatin chemotherapy followed by daily intravenous RSR13 combined with chest radiation therapy for 32 doses.
"The results are encouraging because they further suggest that RSR13 may enhance the efficacy of standard thoracic radiation therapy for locally advanced, unresectable, stage IIIA/IIIB non-small cell lung cancer. The findings support more advanced clinical studies of RSR13 with radiation therapy for this stage of non-small cell lung cancer," said Dr. Choy.
Approximately 172,000 cases of lung cancer are diagnosed in the US each year. Non-small cell lung cancer is the most common form of lung cancer accounting for approximately 80% of cases. The rationale for using induction chemotherapy in locally advanced non-small cell lung cancer is that chemotherapy may prevent the growth of systemic disease and, concurrently, reduce the local tumor involvement in the lungs and chest which may then be better treated with surgery, radiation therapy, or both, the primary modes of therapy to treat local disease. However, inadequate local tumor control of disease in the chest after radiation therapy remains a significant problem. RSR13, when used in combination with radiation therapy, is intended to enhance the efficacy of radiation therapy and improve local control resulting in prolonged survival. Based upon the positive results of this trial, the Company is evaluating its best path for continued development in this indication.
The Company also announced plans to increase the number of patients enrolled in its ongoing Phase III randomized study of RSR13 combined with standard whole brain radiation therapy versus standard whole brain radiation therapy alone for the treatment of patients with brain metastases. The purpose of increasing the number of patients in this pivotal study is to conduct an appropriately powered subgroup analysis of patients with brain metastases from only breast cancer and non-small cell lung cancer. As a result of this change, the Company expects to increase the study size from 408 patients to 501 patients. With this change, the trial is designed to demonstrate a 35% increase in median survival in the subgroup of patients as well as all patients enrolled in the study. The Company has concurrence from the FDA that the subgroup survival analysis, if positive, would support a NDA submission and labeling claim for this subset of patients. At projected enrollment rates, the Company anticipates completing enrollment of the trial during the second half of 2002. Patient enrollment will be facilitated through the current investigative sites in North America and at least an additional 30 investigative sites in Europe and other countries.
"We believe that the potential for receiving approval on this subgroup of patients is worth the investment of increased development time and provides for a greater probability of success," said Stephen J. Hoffman, M.D., Ph.D., Chief Executive Officer and President of Allos. "Once completed, we believe this clinical trial will be the largest and most robust ever conducted in this patient population."
About Allos Therapeutics
Allos Therapeutics, Inc. is a pharmaceutical company focused on developing and commercializing innovative small molecule drugs, initially for improving cancer treatments. The Company has initiated its first pivotal Phase 3 trial for the treatment of metastatic brain tumors with its lead clinical candidate, RSR13. RSR13 is a synthetic small molecule that increases the release of oxygen from hemoglobin, the oxygen carrying protein contained within red blood cells. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy and some chemotherapy agents in the treatment of cancer. By increasing tumor oxygenation, RSR13 has the potential to enhance the efficacy of standard radiation therapy and certain chemotherapeutic drugs. Unlike chemotherapeutics or other radiosensitizers, RSR13 does not have to cross the blood brain barrier and enter the tumor for efficacy. Enhancement of oxygen release from hemoglobin to oxygenate the tumor is the means of enhancing the effectiveness of radiation therapy and chemotherapy.<<
snip
>>1248
Positive Phase II Results of RSR13 and Concurrent Radiation Therapy After Induction Chemotherapy with Paclitaxel and Carboplatin for Locally Advanced Inoperable Non-Small Cell Lung Cancer.
Hak Choy, A Nabid, B Stea, W Roa, L Souhami, F Yunus, P Roberts, D Johnson, Vanderbilt-Ingram Cancer Center, Nashville, TN; Ctr Universitaire de Sante de L'Estrie, Sherbrooke, PQ, Canada; University of Arizona Health Science Ctr, Tuscon, AZ; Cross Cancer Ctr, Edmonton, AB, Canada; Montreal General Hosp, Montreal, PQ, Canada; Boston Cancer Ctr, Memphis, TN.
RSR13 is a synthetic allosteric modifier of hemoglobin which decreases hemoglobin's oxygen binding affinity. By increasing tumor oxygenation, RSR13 has the potential to enhance the efficacy of standard radiation therapy. We conducted a prospective, open-label, multi-center Phase II study to determine the response rate, toxicity, and survival of induction paclitaxel and carboplatin followed by concurrent daily infusion of RSR13 and thoracic radiation therapy (TRT). Fifty-two patients with unresectable stage IIIA and IIIB NSCLC from 13 institutions were entered into the study from August of 1998 until June 2000. Two patients were not eligible and 3 never received RSR13. RSR13 (75 mg/kg with possible adjustments to 100 or 50 mg/kg) was infused over 30 minutes prior to daily TRT (32 fractions at 2 Gy, total 64 Gy). TRT was delivered for 7 weeks after two cycles of induction paclitaxel (225 mg/m2) and carboplatin (AUC=6). Seventy-one percent of patients completed more than 90% of RSR13 doses. To date, 30 of 47 patients have response results by reaching the 2-month post RSR13-TRT time point. Overall response rate was 87% (26/30), with complete and partial response rates of 6.6 % and 80%, respectively. Estimated one-year overall survival rate for all 47 patients is 0.68 (95% CI, 0.54-0.85). Median survival time has not been reached. 29% of patients experienced one or more episodes of transient RSR13-induced hypoxemia during the treatment secondary to the acute pharmacodynamic effect of RSR13. Grade [greater than or equal to] 3 radiation pneumonitis was observed in 11.7% of patients. There were no other reports of Grade 3 or 4 treatment related toxicities including radiation esophagitis. Concurrent daily RSR13 and TRT is a relatively well-tolerated outpatient regimen. The preliminary response rate and one-year survival rate from this regimen are very encouraging. These findings warrant further clinical evaluation of RSR13-TRT in a Phase III trial for Stage III NSCLC.<<
Also wondering what the IP situation is in this area. Want to look for such clues, here's the 10-K:
10kwizard.com
The ugly visual:
siliconinvestor.com
With accompanying filings -- 5 pages worth, folks:
insidertrader.com
ipolockup.com
Now this looks mostly like VC doing their usual thing. But they sure are doing it with gusto here. And ASCO didn't slow them down much. Is this a bogus therapeutic approach powering a pump and dump (well, pretty much a dump so far), or a legitimate contender overly beaten up by folks in its own corner, but about to bounce back (dump & pump, I guess)?
Top of head comments before we start digging?
Cheers, Tuck |
