DOR BioPharma, Inc.

Errata for May 9^th, 2007 Oncologic Drug Advisory Committee Meeting Briefing Document

Note: Corrections to the briefing document are highlighted in yellow with the changed information included as a strikethrough.

Update to Section 2.6.1.6., page 24, Section Header

2.6.1.6 FDA-required Post-hoc Analysis: Overall Survival Post-transplantation Post-randomization (Study ENT 00-02)

Update to Section 2.6.2.1, page 27, 3^rd paragraph, second sentence:

At study day 30 (the primary endpoint evaluation), significantly more subjects in the BDP group than in the placebo group succeeded in achieving ≥ 70% of their estimated daily caloric requirements without flares of aGVHD (71% [22/31] in the BDP group versus 41% [13/3112/29] in the placebo group; p = 0.02 by the chi-square test).

Update to Section 2.6.2.1, page 28, 1^st full paragraph on page, 2^nd and 5^th sentences.

As for Study ENT 00-02, the FDA requested a retrospective analysis of survival data from Study 875. Similar to the survival outcomes observed for Study ENT 00-02, an analysis of survival at Day 200 post-transplantation in Study 875 showed that the BDP group had a higher survival rate (90%) compared with the placebo group (79%) (odds

ratio = 0.34; 95% CI: 0.07-1.72; p = 0.1881 by the Cochran-Mantel-Haenszel test) (Figure 2-8). Similarly, the risk of mortality by 200 days post-transplantation 56% lower for the BDP group compared with the placebo group (hazard ratio = 0.44; p = 0.2415 by Wald chisquare test). After 1 year from the date of randomization in Study 875, 6 of the 31 subjects (19%) who were randomized to receive BDP had died versus 9 of the 29 (31%) subjects who were randomized to receive placebo. The risk of mortality during this 1-year period was 45% lower for subjects in the BDP group compared with the placebo group (hazard ratio = 0.55; 95% CI: 0.20-1.56; p = 0.2556 by the stratified logrank test) (Figure 2-10) (Figure 2-9).

Update to Section 4.2, page 58, Table 4-3.

Table 4-3. Primary Cancer Diagnosis (Study ENT 00-02, ITT Analysis Set)

	Placebo		BDP		Overall
Subjects randomized	67		62		129
Primary cancer diagnosis
Acute myelogenous leukemia	22	33%	19	31%	41	32%
Acute lymphocytic leukemia	7	10%	9	14%	16	12%
Chronic myelogenous leukemia	8	12%	8	13%	16	12%
Non-Hodgkin’s lymphoma	7	10%	6	10%	13	10%
Myelodysplastic syndrome	6	9%	2	3%	8	6%
Multiple myeloma	1	1%	6	10%	7	5%
Chronic lymphocytic leukemia	4	6%	2	3%	6	5%
Chronic myelomonocytic leukemia	3	5%	2	3%	5	4%
Aplastic anemia	2	3%	1	2%	3	2%
Hodgkin’s disease	2	3%	1	2%	3	2%
Myelofibrosis	2	3%	1	2%	3	2%
Acute promyelocytic leukemia	0	0%	2	3%	2	2%
Other^a	4 3	6% 5%	4 3	6% 5%	8 6	6% 5%
Acute myelogenous leukemia	22	33%	19	31%	41	32%
In first remission	15	22%	9	15%	24	19%
In second or later remission	5	7%	5	8%	10	8%
Persistent or relapsed disease	2	3%	5	8%	7	5%
Chronic myelogenous leukemia	8	12%	8	13%	16	12%
In chronic phase	4	6%	5	8%	9	7%
In accelerated phase or blast crisis	3	5%	3	5%	6	5%
Not reported	1	1%	0	0%	1	<1%
Risk of relapse post-transplant^b
Higher risk	29	43%	40	65%	69	53%
Lower risk	22 38	63 % 57%	22	35%	60	47%
^a Other primary diagnoses include (1 each): Biphenotypic acute leukemia, extramedullary leukemia tumor, renal cell carcinoma, myeloproliferative syndrome, plasmacytic leukemia, and polythyemia vera.
^b Subjects were considered to have a lower risk of relapse post-transplantation if the indication for transplantation was one of the following diagnoses: aplastic anemia, chronic lymphocytic leukemia, chronic myelogenous leukemia in chronic phase, chronic myelomonocytic leukemia, acute myelogenous leukemia in first remission, myelodysplastic syndrome, myelofibrosis, myeloproliferative syndrome, and polycythemia vera. Subjects with other diagnoses were considered to have a higher risk of relapse post-transplant.

Update to Section 4.2.1, page 60, Table 4-5.

Table 4-5. GVHD Treatment Failure Status through Study Day 50 (Study ENT 00-02, ITT Analysis Set)

	Placebo		BDP		Overall
Subjects randomized	67		62		129
Met criteria for GVHD treatment failure
Yes	30	45%	18	29%	48	37%
No	37	55%	44	71%	81	63%
Completed 50-day treatment period^a	30	45%	37	60%	67	52%
Withdrawn from study early	7	10%	7	11%	14	11%
Adverse event	3	4%	3	5%	6	5%
Protocol violation	1	1%	4	6%	5	4%
Non-compliance	3	4%	0	0%	3	2%
Action which resulted in GVHD treatment failure
Increased dose of corticosteroids	28	42%	18	29%	46	36%
Changed immunosuppressant medications	1	1%	0	0%	1	<1%
Received open-label BDP	1	1%	0	0%	1	<1%
Sites of recurrent GVHD which resulted in treatment failure
Gut	23	34%	15	24%	38	29%
Skin	4	6%	0	0%	4	3%
Gut & skin	0	0%	2	3%	2	2%
Liver	1	1%	1	2%	2	2%
Lung	1	1%	0	0%	1	<1%
Not reported	1	1%	0	0%	1	<1%
^a Completed the 50-day protocol treatment period without meeting the criteria for GVHD treatment failure.

Update to Section 4.2, page 93, Figure 4-12.

Figure 4-12. FDA Requested Post-Hoc Analysis: Overall Survival
Post-Randomization (Study 875: ITT Analysis Set)

Hazard ratio estimated from a Cox proportional hazards model stratified by the two-level factor for donor type (HLA-matched sibling vs. unrelated or HLA-mismatched donor). P-value calculated from the stratified log-rank test. Nominal significance level of 0.05 (two-sided). No adjustment for multiple testing.

Changes in above Figure:

	0-2	3-4	5-6	7-8	9-10	11-12
BDP	9/31	1/22	0/21	0/21	0/0 0/19	0/8
Placebo	11/29	2/18	1/16	3/15 1/15	0/0 2/14	0/7

Update to Section 4.4, page 98, Figure 4-15.

Figure 4-15. Overall Survival for Studies 875 and ENT 00-02 Combined
(Integrated ITT Analysis Sets)

P-value is based on the log-rank test (stratified by donor type and study). Nominal significance level of 0.05 (two-sided). No adjustment for multiple testing.

Changes in above Figure:

	0-2	3-4	5-6	7-8	9-10	11-12
BDP	33/93	4/52	0/23	0/21	0/0 0/19	0/8
Placebo	42/96	3/46	1/18	3/15 1/15	0/0 2/14	0/7

Update to Table 5-14, page 134, Title

Reference Limits for Normal Abnormal HPA Axis Function